[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-kingdom-harvest-625058-05042022":3,"fda-latest-sync-dates":28},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":11,"response_letter_date":8,"closeout_date":8,"case_status":12,"letter_url":13,"reference_number":8,"marcs_cms_no":14,"product_type":15,"delivery_method":16,"recipient_name":17,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},2696,"kingdom-harvest-625058-05042022","Warning Letter","Kingdom Harvest",null,"Center for Drug Evaluation and Research | CDER","Unapproved New Drugs\u002FMisbranded\u002FCannabidiol (CBD) Products","2022-05-04","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fkingdom-harvest-625058-05042022","625058","Animal & VeterinaryDrugsFood & Beverages","Via Email","Shelle Rogers","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Email\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Animal & Veterinary\u003Cbr>Drugs\u003Cbr>Food & Beverages                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Shelle Rogers\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">CEO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Kingdom Harvest\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">212 South Church Street\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Hendersonville\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">NC\u003C\u002Fspan> \u003Cspan class=\"postal-code\">28792\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:info@kingdomharvest.com\"> info@kingdomharvest.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research | CDER\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp align=\"center\" style=\"text-align:center\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:center 3.25in right 6.0in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">WARNING LETTER\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:center 3.25in right 6.0in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">May 4, 2022\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp align=\"center\" style=\"text-align:center\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:center 3.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cb>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">RE: # 625058\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Dear Ms. Rogers:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-family: "Times New Roman", serif; font-size: 11pt;\">\u003Cspan style=\"font-family:"Arial",sans-serif\">This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.kingdomharvest.com from October 2021 through April 2022 and\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-family: "Times New Roman", serif; font-size: 11pt;\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> has determined that you take orders there for various human and animal products, which you represent as containing cannabidiol (CBD) or Delta-8 tetrahydrocannabinol (THC). We have also reviewed your social media websites at \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: Arial, sans-serif; font-size: 11pt;\">https:\u002F\u002Fwww.facebook.com\u002Foriginalkingdomharvest\u002F and \u003C\u002Fspan>\u003Cspan style=\"font-family: "Times New Roman", serif; font-size: 11pt;\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fwww.instagram.com\u002Fkingdomharvest\u002F?hl=en\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan class=\"MsoHyperlink\" style=\"font-family: "Times New Roman", serif; font-size: 12pt; color: blue;\">\u003Cspan style=\"text-decoration:underline\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">; \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-family: "Times New Roman", serif; font-size: 11pt;\">\u003Cspan style=\"font-family:"Arial",sans-serif\">which direct consumers to your website \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">www.kingdomharvest.com\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-family: "Times New Roman", serif; font-size: 11pt;\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> to purchase your products. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-family: "Times New Roman", serif; font-size: 11pt;\">\u003Cspan style=\"font-family:"Arial",sans-serif\">The claims on your website and social media accounts establish that your products, some of which are available in multiple varieties, “D8 sublingual oil,” “Delta 8 Disposable Vape Cartridge,” “Whole-Spectrum Hemp Extract,” “CBD Vape,” “Blood Sugar Support,”\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-family: "Times New Roman", serif; font-size: 11pt;\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“CBD Gummies,” “Stella’s Baby Care Diaper Cream,” “Pain Relieving CBD Cream\u003Cspan style=\"layout-grid-mode:line\">,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,” \u003C\u002Fspan>“Immune Boost Water Soluble Mix,” “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Delta 8 Chewing Gum,” “Delta 8 Gummies,” “Delta 8 Peanut Brittle,” and “Delta 8 Syrup,” (hereinafter referred to as “your CBD and Delta-8 THC products for humans”), are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your CBD and Delta-8 THC products for humans are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">FDA has also determined that your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Delta 8 Chewing Gum,” “Delta 8 Gummies” (all varieties), “Delta 8 Peanut Brittle,” “Delta 8 Syrup,” “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets” products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll). \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">In addition, the claims on your website and social media websites establish that \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">your products, “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” “Pet Essentials Joint Support Tablets,” “CBD Infused Pet Shampoo,” and “CBD Infused Pet Paw Balm,” which you promote as products containing CBD for use in animals, are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and are adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find specific information about how FDA regulates cannabis-derived products at \u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fnews-events\u002Fpublic-health-focus\u002Ffda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd\" style=\"color:blue; text-decoration:underline\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fwww.fda.gov\u002Fnews-events\u002Fpublic-health-focus\u002Ffda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">The Agency is particularly concerned that you market CBD products for food-producing animals. Specifically, your website promotes your “Ranch & Livestock Natural Whole-Spectrum Hemp Extract” product for use in cows and other large variety ranch and livestock animals. In addition to raising potential concerns regarding safety for the animals themselves, CBD products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals. There is currently a lack of data on the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and on safe levels of any potential residues for the human consumer. We request that you take immediate action to cease the sale of any unapproved CBD products for food-producing animals.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Over the past several years, FDA has warned the public on various illegally marketed CBD containing products, including those marketed for infants, such as your “Stella’s Baby Care Diaper Cream.”\u003Ca href=\"#_ftn1\" name=\"_ftnref1\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[1]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa> FDA has also observed a proliferation of products containing another cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. See \u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fconsumer-updates\u002F5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc\" style=\"color:blue; text-decoration:underline\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fconsumer-updates\u002F5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">. This letter is to inform you that your firm markets Delta-8 THC-containing products, and Delta-8 THC may pose a serious health risk to consumers.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">We also observed that your website makes claims that your products may be intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.\u003Ca href=\"#_ftn2\" name=\"_ftnref2\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[2]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Dietary Supplement Labeling\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Information on your website at www.kingdomharvest.com indicates that you intend to market some of your CBD products, including, but not limited to, “Immune Boost Water Soluble Mix,” and all varieties of “Blood Sugar Support” and “CBD Gummies” as dietary supplements. For example, the product website describes “Immune Boost Water Soluble Mix” with reference to the goal of creating a “high-quality supplement” and the product websites expressly describe each “Blood Sugar Support” and “CBD Gummies” product as a “dietary supplement.” Your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.\u003Ca href=\"#_ftn3\" name=\"_ftnref3\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[3]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa> There is an exception if the substance was “marketed as” a dietary supplement or as a conventional human food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Unapproved New Human Drugs\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Based on a review of your websites, your \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">CBD and Delta-8 THC products for humans \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">are\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Examples of claims observed on your product labeling, including your website and social media websites, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">From your Facebook and Instagram social media websites www.facebook.com\u002Foriginalkingdomharvest\u002F and www.instagram.com\u002Fkingdomharvest\u002F:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">May 11, 2020 postings: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\n\n\t\u003Cul style=\"list-style-type:circle\">\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Cannabidiol (CBD) changes neurotransmission systems . . . Alters behavior response to Opioids . . . Pain management during Opioid withdrawal . . . Reduces Heroin cravings and relapse”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Fighting Opioid Addiction with Whole-Spectrum Hemp Extract . . . CBD Oil (otherwise known as cannabidiol) is scientifically proven to block the rewards of opioids”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“CBD Reduces Need for Opioid Use in Pain Treatment” \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“64-81% of acute trauma patients reduced opioid usage with cannabis while still managing pain”\u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003C\u002Ful>\n\t\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">April 27, 2020 postings:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\n\t\u003Cul style=\"list-style-type:circle\">\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Israeli researchers have launched three clinical trials that utilize CBD’s anti-inflammatory properties as potential COVID-19 treatment . . . Last week, InnoCan Pharma announced a collaboration with Tel Aviv University to instill CBD medicine through exosomes . . . The unconventional method will utilize the exosomes as “homing missiles,” as they can uniquely target cell organs damaged by COVID-19. Researchers then believe CBD’s anti-inflammatory properties will repair the damaged cells through a synergistic effect.” \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“The Battle Against COVID-19 Has A New Natural Weapon . . . University Launches CBD Treatment . . . kingdomharvest.com”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003C\u002Ful>\n\t\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">April 7, 2020 postings – “Whole-Spectrum Hemp Extract & CBD & The Fight Against COVID-19.” \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">From your website \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fkingdomharvest.com\u002F\u003Cfont color=\"#0000ff\">:\u003C\u002Ffont>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your website homepage:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Studies Show Our Whole-Spectrum Extract Utilizing CBDa Can Prevent Infection From COVID-19”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your blog post titled, “Cannabinoids Block Cellular Entry of COVID-19 and the Emerging Variants”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Importantly, cannabigerolic acid and cannabidiolic acid were equally effective against the SARS-CoV-2 alpha variant B.1.1.7 and the beta variant B.1.351.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“. . . [C]annabinoids . . . have the potential to prevent as well as treat infection by SARS-CoV-2.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your blog post titled, “Let’s [\u003C\u002Fspan>\u003C\u002Fspan>\u003Ci>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">sic\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fi>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">] Us Introduce You to Delta-8 THC”: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“If we try to list the properties or the effects of Delta-8 THC, it causes . . . pain relief, full-body relaxation and sleep.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Delta-8 THC flower is an ideal option for medical users of cannabis who want to enjoy the benefits of THC without the sedative effects.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your blog post titled, “How Does CBD Work for Relieving Pain & The Best CBD Pain Relief Product?”: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“CBD is among the most misinterpreted things on the planet . . . It is a magical medicine that has provided relief for countless people with chronic pain, from cancer pain to arthritis pain, migraine pain, body pain, and much more.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your blog post titled, “Discover the Benefits of CBD for Your Health and Wellness”: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">Hemp CBD can improve your overall health and wellbeing by providing relief for several medical ailments, including chronic pain, depression, anxiety, epilepsy” \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">Other benefits of hemp CBD include managing post-traumatic stress disorder (PTSD), sleep disorders and cancer treatments.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">“CBD has been shown to have \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">positive effects on adults and children who experience PTSD.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“One study\u003Cspan style=\"color:black\"> found hemp CBD helps slow tumor growth, reduces tumor invasion and induces tumor cell death. \u003C\u002Fspan>\u003Cspan style=\"color:#303030\">Another study\u003C\u002Fspan>\u003Cspan style=\"color:black\"> suggested CBD could provoke cell death and improve the effect of radiation on glioblastoma cells while causing no damage to healthy cells.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">Initial studies have suggested CBD can help make life easier for an individual with Parkinson's by easing muscle movements to prevent tremors. There is also research that suggests CBD can reduce the severity of psychosis symptoms, including hallucinations, delirium and delusions without causing any adverse effects.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for “D8” sublingual oil\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">:  \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Delta-8 consumers report many of the same effects as THC . . . and relief from some symptoms such as pain . . . Delta-8 can also help with insomnia.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for “Stella’s Baby Care Diaper Cream”: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Our Organic Diaper Cream contains our natural organic Whole-Spectrum Hemp Extract and just 7 other natural ingredients. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">In contrast, the leading diaper rash cream is 57% petroleum!”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your webpage explaining the “\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Effects of delta-8”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Delta-8 consumers report many of the same effects as THC, such as . . . relief from some symptoms such as pain . . .. Delta-8 can also help with insomnia.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for “\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Delta-8 THC Syrup”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Delta-8 THC Syrup from Kingdom Harvest is ideal for anybody experiencing a sleeping disorder or other ailments looking to be relieved.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Blood Sugar Support”: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Kingdom Harvest Blood Sugar support pills contain three active ingredients that work at the same time and may help you to maintain a healthy blood glucose level and prevent further complications.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Cinnamon powder contains many antioxidants that may help to reduce oxidative stress due to high blood glucose, improve insulin sensitivity, lower blood sugar levels, and prevent complications.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Meanwhile, alpha-lipoic acid . . . may help with glucose uptake in muscles and enhance insulin sensitivity.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Finally, cannabidiol (CBD) . . . prevents neurodegeneration, and decreases retinal complications.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for “Pain Relieving CBD Cream”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">         \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“600MG ▪ CBD \u002F CAPSAICIN MUSCLE PAIN CREAM . . . This topical muscle and joint relief cream act [\u003Ci>sic\u003C\u002Fi>] through its two active ingredients: capsaicin and cannabidiol (CBD) . . . Capsaicin is an active component of chili peppers known to help reduce pain intensity. Meanwhile, CBD interacts with endocannabinoid receptors in joints and muscles to promote a healthy inflammatory response and relieve occasional stiffness and soreness. Capsaicin is also known to be a neuroprotectant, as it may protect nerves from being damaged or degenerated.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for “Pain Relieving Cream”: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“200 MG CBD \u002F LIDOCAINE PAIN CREAM . . . The CBD with Lidocaine Cream contains the same main ingredient as the Capsaicin cream – CBD, which helps promote support and relief. However, the differing active ingredient is lidocaine, a local anesthetic.” \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for “CBD & Menthol Pain Freeze Roll-On”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“800MG CBD \u002F MENTHOL PAIN FREEZE . . . Our Pain Freeze Roll-On is a rich combination of our Organic Hemp Extract, Aloe, and Menthol. Available in a mess-free, roll-on applicator, this topical cream provides a rapid cooling effect, perfect for joint and muscle support.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"text-autospace:none\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Based on the above labeling claims, your \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">CBD and Delta-8 THC products for humans\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">are drugs. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">We are not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that any of these products are\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended or suggested in their labeling. Thus, your CBD and Delta-8 THC products for humans are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here,\u003Ca href=\"#_ftn4\" name=\"_ftnref4\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Csup>\u003Csup>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[4]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003C\u002Fsup>\u003C\u002Fa> new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a), 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your CBD and Delta-8 THC products for humans. There is no basis under the FD&C Act under which these products would be legally marketed without an approved application. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Misbranded Human Drugs\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Your \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">CBD and Delta-8 THC products for humans are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.) \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">These products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, because no FDA-approved applications are in effect \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">for your products.\u003Ca href=\"#_ftn5\" name=\"_ftnref5\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Csup>\u003Csup>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[5]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003C\u002Fsup>\u003C\u002Fa>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">CBD-containing Drugs\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Even if your \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Pain Relieving CBD Cream\u003Cspan style=\"layout-grid-mode:line\">,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,” and “\u003C\u002Fspan>Stella’s Baby Care Diaper Cream” products were considered nonprescription drugs, we note that a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. Nonprescription drug products that include CBD as an active ingredient are not GRASE and are new drugs which require an approved application to be legally marketed. CBD is not an active ingredient in any OTC monograph under section 505G of the FD&C Act. Even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements under section 505G of the FD&C Act under which certain nonprescription drug products may be marketed without an approved new drug application. In particular, such a product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e).\u003Ca href=\"#_ftn6\" name=\"_ftnref6\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Csup>\u003Csup>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[6]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003C\u002Fsup>\u003C\u002Fa>\u003Csup>, \u003Ca href=\"#_ftn7\" name=\"_ftnref7\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Csup>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[7]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003C\u002Fa>\u003C\u002Fsup>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">301(ll) and Adulterated Human Foods\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">We note that your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” and “CBD Infused Organic Tea” products appear to be conventional foods. It is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, as described above. There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), prohibits the introduction into interstate commerce of any food to which CBD has been added, but you may present FDA with any evidence bearing on this issue.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term \"food additive\" refers to any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.\u003Ca href=\"#_ftn8\" name=\"_ftnref8\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[8]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act (21 U.S.C. 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">There is no food additive regulation that authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from CBD. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. Therefore, based on our review, the use of CBD in conventional food products does not satisfy the criteria for GRAS status under 21 CFR 170.30.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food. Therefore, CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act, 21 USC 321(s), and is subject to the provisions of section 409 of the FD&C Act, 21 USC 348. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 USC 342(a)(2)(C)(i). Therefore, your “Broad-Spectrum THC Free Organic Honey,” “Fair-Trade Coffee,” and “CBD Infused Organic Tea” conventional food products contain an unsafe food additive within the meaning of section 409; therefore they are adulterated products within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp class=\"paragraph\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Further, there is no food additive regulation that authorizes the use of Delta-8 THC. We are not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that Delta-8 THC is GRAS for use in conventional foods.  \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp class=\"paragraph\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">We know of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. Our review of published scientific literature identified potential for adverse effects on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on our review, the use of Delta-8 THC in conventional food does not satisfy the criteria for GRAS status under 21 CFR 170.30. \u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">In addition, according to your product labeling, your “Delta 8 Chewing Gum,” “Delta 8 Peanut Brittle,” and “Delta 8 Syrup” products are foods to which Delta-8 THC has been added.  Specifically, your website promotes your “Delta 8 Syrup” for mixture with “any drink” and recommends “something carbonated.” Your “Delta 8 Chewing Gum” and “Delta 8 Peanut Brittle” are types of products typically considered to be conventional foods. Your “Delta 8 Gummies” (all varieties) also appear to be conventional foods to which Delta-8 THC has been added.  \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp class=\"paragraph\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"vertical-align:baseline\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">FDA is not aware of any other exception to the food additive definition that would apply to Delta-8 THC for use as an ingredient in a conventional food. Therefore, Delta-8 THC added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Delta-8 THC is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Unapproved New Animal Drugs\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">During our review of your website and your social media websites\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">, FDA determined that your firm is marketing the unapproved new animal drugs “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” “Pet Essentials Joint Support Tablets,” “CBD Infused Pet Shampoo,” and “CBD Infused Pet Paw Balm.” Based on our review of your website and social media websites, these products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and\u002For intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Examples of claims observed on your website and your social media websites that establish the intended use of your products as drugs include, but are not limited to, the following:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your Frequently Asked Questions (FAQ) webpage at https:\u002F\u002Fkingdomharvest.com\u002Fpages\u002Ffaq\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">, you provide the following information about CBD, which is an ingredient in \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” “Pet Essentials Joint Support Tablets,” “CBD Infused Pet Shampoo,” and “CBD Infused Pet Paw Balm”: \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Many CBD users have reported improvements in:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">                        • Stress\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">                        • Anxiety\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">                        • Sleep\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">                        • Pain levels\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">                        • Skin conditions including acne and eczema\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">                        • Epilepsy”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for “Ranch & Livestock Natural Whole-Spectrum Hemp Extract”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Like humans, our larger Ranch & Livestock pets have Endocannabinoid Systems that help bring balance to their bodies.  Introducing a whole-spectrum hemp extract into your horses, cows, alpacas, and any other large variety Ranch & Livestock animals on a daily routine can help promote an overall balance and improved quality of life.  Senior Ranch & Livestock Animals & Pets, those that live with certain conditions, and those in already good health can greatly benefit from a helping hand of natural cannabinoids found in Kingdom Harvest Ranch & Livestock formula.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your Facebook and Instagram social media websites at https:\u002F\u002Fwww.facebook.com\u002Foriginalkingdomharvest\u002F and https:\u002F\u002Fwww.instagram.com\u002Fkingdomharvest\u002F?hl=en, respectively, for your “Ranch & Livestock Natural Whole-Spectrum Hemp Extract\": \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">May 7, 2020 Facebook posting and May 6, 2020 Instagram posting with photographs of your \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Ranch & Livestock Natural Whole-Spectrum Hemp Extract” next to photographs of a horse, a cow, and an alpaca:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\n\n\t\u003Cul style=\"list-style-type:circle\">\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Like humans, our larger Ranch & Livestock pets have Endocannabinoid Systems that help bring balance to their bodies. Introducing a whole-spectrum hemp extract to your horses, cows, alpacas, and any other large variety Ranch & Livestock animals on a daily routine can help promote an overall balance and improved quality of life.  Elder Ranch & Livestock Animals & Pets, those that live with certain conditions, and those in already good health can greatly benefit from the helping hand of natural cannabinoids found in Kingdom Harvest Ranch & Livestock formula.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003C\u002Ful>\n\t\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your Instagram social media website at (https:\u002F\u002Fwww.instagram.com\u002Fkingdomharvest\u002F?hl=en) for your “Canine Whole-Spectrum Hemp Extract”\u003Cspan class=\"MsoHyperlink\" style=\"color:blue\">\u003Cspan style=\"text-decoration:underline\">:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">November 27, 2019 posting with a photograph of your \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Canine Whole-Spectrum Hemp Extract” with a dog in the background:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\n\n\t\u003Cul style=\"list-style-type:circle\">\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Reported benefits include reduction of stress and anxiety, improving mood, pain relief, controlling seizures, and reduction of inflammation.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003C\u002Ful>\n\t\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your Facebook and Instagram social media websites at https:\u002F\u002Fwww.facebook.com\u002Foriginalkingdomharvest\u002F and https:\u002F\u002Fwww.instagram.com\u002Fkingdomharvest\u002F?hl=en, respectively, for your “Feline Chicken Flavor Zero THC Hemp Extract”\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">May 8, 2020 posting with a photograph of your \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Feline Chicken Flavor Zero THC Hemp Extract” next to a photograph of a cat and photograph of a partially filled medicine dropper held in front of a cat’s face:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\n\n\t\u003Cul style=\"list-style-type:circle\">\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Reported benefits include reduction of stress and anxiety, improving mood, pain relief, controlling seizures, and reduction of inflammation and many more.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003C\u002Ful>\n\t\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Pet Essentials Joint Support Tablets”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Pet Essentials CBD Joint Support helps support your pet’s joint health through six active ingredients: . . . \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\n\n\t\u003Cul style=\"list-style-type:circle\">\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">CBD may help minimize discomfort . . . \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Chondroitin . . . may help . . . to reduce discomfort . . .\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Turmeric powder has natural properties, which make it a strong anti-inflammatory agent.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003C\u002Ful>\n\t\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“CBD Infused Pet Shampoo”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“When used directly on your fur baby’s area that you are looking to treat and clean, our CBD Whole-Spectrum PET Shampoo doesn’t just clean, soothe, and alleviate irritations. It fights inflammation at the source.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your product webpage for \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“CBD Infused Pet Paw Balm”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Because CBD PET Paw Balm does not need to be metabolized, a topical dosage is strong, reliable, and starts working quickly. When used directly on the tattooed area that you are looking to treat and protect, our CBD Whole-Spectrum PET Paw Balm doesn’t just alleviate irritations. It fights inflammation at the source.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">These products are \"new animal drugs\" under section 201(v) of the FD&C Act, 21 U.S.C. § 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. §§ 360b, 360ccc, and 360ccc-1. These products are not approved or index listed by the FDA, and therefore these products are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated under section 501(a)(5) of the FD&C Act 21 U.S.C. § 351(a)(5). The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the FD&C Act 21 U.S.C. § 331(a).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">301(ll) and Adulterated Animal Foods\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">You should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term “food additive” refers to any substance the intended use of which results in its becoming a component of any animal food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.\u003Ca href=\"#_ftn9\" name=\"_ftnref9\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[9]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in animal food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the animal food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i).  Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).   \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">There is no food additive regulation that authorizes the use of CBD in animal food. We are not aware of any information to indicate that CBD is the subject of a prior sanction, as described above. Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods. FDA’s regulations in Title 21, Code of Federal Regulations 570.30(a)-(c), 21 CFR 570.30(a)-(c), describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30). \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in animal food. Therefore, CBD added to animal food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act, 21 U.S.C. 348. Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">To the extent that you market any of your products containing CBD as animal food, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any animal food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, as described above. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:.25in\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">According to your product labeling, “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets,” are animal foods to which CBD has been added. Specifically, your website and social media websites refer to these products being mixed into meals (“Ranch & Livestock Natural Whole-Spectrum Hemp Extract” and “Canine Whole-Spectrum Hemp Extract”) or intended for consumption based on flavor labeling (“Feline Chicken Flavor Zero THC Hemp Extract” and bacon-flavored “Pet Essentials Joint Support Tablets”). Therefore, the introduction or delivery for introduction into interstate commerce of these products is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp align=\"center\" style=\"text-align:center\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">*           *           *\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Your response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">FDAADVISORY@fda.hhs.gov. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp> \u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Sincerely,\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u002FS\u002F\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:4.75in 346.5pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Donald D. Ashley\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:4.75in 346.5pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Director\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Office of Compliance\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Center for Drug Evaluation and Research\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Food and Drug Administration\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u002FS\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Neal Bataller\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Director\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Division of Drug Compliance\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Office of Surveillance & Compliance\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Center for Veterinary Medicine\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Food and Drug Administration\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u002FS\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Ann M. Oxenham\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Director\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Office of Compliance\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Center for Food Safety and Applied Nutrition\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Food and Drug Administration \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cdiv> \n\u003Chr align=\"left\" size=\"1\" width=\"33%\">\n\u003Cdiv id=\"ftn1\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size:10pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Ca href=\"#_ftnref1\" name=\"_ftn1\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">[1]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa> \u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">As stated in previous FDA warning letters, the use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations. For example, infants may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of infants to absorb, metabolize, distribute, or excrete such drug products or their metabolites.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn2\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size:10pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Ca href=\"#_ftnref2\" name=\"_ftn2\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">[2]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa> \u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at \u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Ftrumpwhitehouse.archives.gov\u002Fpresidentialactions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F\" style=\"color:blue; text-decoration:underline\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Ftrumpwhitehouse.archives.gov\u002Fpresidentialactions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn3\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size:10pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Ca href=\"#_ftnref3\" name=\"_ftn3\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">[3]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa> \u003Cspan lang=\"EN\" style=\"font-size:9.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">CBD is the active ingredient in the approved drug product \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:9.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">Epidiolex\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:9.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:9.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">Epidiolex\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:9.0pt\">\u003Cspan style=\"background:white\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"color:black\">.  (See \u003C\u002Fspan>GW Pharmaceuticals Receives Investigational New Drug (IND) From FDA for Phase 2\u002F3 Clinical Trial of Epidiolex(R) in the Treatment of Dravet Syndrome\u003Cspan style=\"color:black\">). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect.  Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan> \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn4\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size:10pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Ca href=\"#_ftnref4\" name=\"_ftn4\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">[4]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa> \u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">For example, under section 505G of the FD&C Act, 21 U.S.C. 355h, certain nonprescription drug products may be lawfully marketed without an approved application if applicable conditions are met, including conformity with an applicable OTC monograph. However, your products could not be lawfully marketed under section 505G, because based on your claims regarding these products, including on your website labeling, your products are marketed for uses not considered nonprescription indications. Further, even if certain of your products, such as your “Pain Relieving CBD Cream,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,” and “Stella’s Baby Care Diaper Cream,” were marketed only for nonprescription indications, they would not meet the conditions under section 505G for lawful marketing without an approved application. For example, CBD—considered an active ingredient under 21 CFR 201.66(b)(2) due to its prominent featuring on your product labeling—is not an active ingredient in any OTC monograph under section 505G of the FD&C Act. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn5\">\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Ca href=\"#_ftnref5\" name=\"_ftn5\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[5]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> Further, even if your products were marketed only for nonprescription indications, these products would be misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they would be nonprescription drugs subject to section 505G of the FD&C Act that do not comply with the requirements for marketing under that section (see footnote 1) and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn6\">\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"text-autospace:none\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Ca href=\"#_ftnref6\" name=\"_ftn6\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[6]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> 21 CFR 330.1(e) requires in relevant part that \"the product contains only suitable inactive ingredients which are safe in the amounts administered.\" A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance). CBD has no known functional role as an inactive ingredient in a finished drug product.  \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn7\">\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"text-autospace:none\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Ca href=\"#_ftnref7\" name=\"_ftn7\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[7]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> Additionally, an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage. CBD has known pharmacological activity with demonstrated risks. For example, the labeling for Epidiolex (cannabidiol) prescription oral solution includes risks for the drug such as liver injury, interactions with other drugs or supplements, potential for male reproductive toxicity, somnolence, insomnia, diarrhea, decreased appetite, abdominal pain, upset stomach, changes in mood, irritability, and agitation. See \u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"https:\u002F\u002Fwww.accessdata.fda.gov\u002Fdrugsatfda_docs\u002Flabel\u002F2020\u002F210365s005s006s007lbl.pdf\" style=\"color:blue; text-decoration:underline\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fwww.accessdata.fda.gov\u002Fdrugsatfda_docs\u002Flabel\u002F2020\u002F210365s005s006s007lbl.pdf\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">. It is unknown whether the levels of CBD used in your CBD products have pharmacological activity or pose any concern for safety events.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn8\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size:10pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Ca href=\"#_ftnref8\" name=\"_ftn8\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[8]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> Under section 201(s) of the FD&C Act [21 U.S.C. 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food, (2) pesticide chemicals, (3) color additives, (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act), (5) new animal drugs, and (6) dietary ingredients in or intended for use in a dietary supplement.\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\n\u003Cdiv id=\"ftn9\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size:10pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Ca href=\"#_ftnref9\" name=\"_ftn9\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[9]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> Under section 201(s)(5) of the FD&C Act, 21 U.S.C. § 321(s)(5), new animal drugs are excluded from the food additive definition. If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\u003C\u002Fdiv>\n\u003C\u002Fdiv>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email\n\nProduct:\n\nAnimal & Veterinary\nDrugs\nFood & Beverages\n\nRecipient:\n\nRecipient Name\n\nShelle Rogers\n\nRecipient Title\n\nCEO\n\nKingdom Harvest\n\n212 South Church Street\n\nHendersonville, NC 28792\n\nUnited States\n\ninfo@kingdomharvest.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nMay 4, 2022\n\nRE: # 625058\n\nDear Ms. Rogers:\n\nThis letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.kingdomharvest.com from October 2021 through April 2022 and has determined that you take orders there for various human and animal products, which you represent as containing cannabidiol (CBD) or Delta-8 tetrahydrocannabinol (THC). We have also reviewed your social media websites at https:\u002F\u002Fwww.facebook.com\u002Foriginalkingdomharvest\u002F and https:\u002F\u002Fwww.instagram.com\u002Fkingdomharvest\u002F?hl=en; which direct consumers to your website www.kingdomharvest.com to purchase your products. The claims on your website and social media accounts establish that your products, some of which are available in multiple varieties, “D8 sublingual oil,” “Delta 8 Disposable Vape Cartridge,” “Whole-Spectrum Hemp Extract,” “CBD Vape,” “Blood Sugar Support,” “CBD Gummies,” “Stella’s Baby Care Diaper Cream,” “Pain Relieving CBD Cream,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,” “Immune Boost Water Soluble Mix,” “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Delta 8 Chewing Gum,” “Delta 8 Gummies,” “Delta 8 Peanut Brittle,” and “Delta 8 Syrup,” (hereinafter referred to as “your CBD and Delta-8 THC products for humans”), are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your CBD and Delta-8 THC products for humans are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).\n\nFDA has also determined that your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Delta 8 Chewing Gum,” “Delta 8 Gummies” (all varieties), “Delta 8 Peanut Brittle,” “Delta 8 Syrup,” “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets” products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. Furthermore, it is a prohibited act to introduce your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” “CBD Infused Organic Tea,” “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets” products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).\n\nIn addition, the claims on your website and social media websites establish that your products, “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” “Pet Essentials Joint Support Tablets,” “CBD Infused Pet Shampoo,” and “CBD Infused Pet Paw Balm,” which you promote as products containing CBD for use in animals, are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and are adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).\n\nAs explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find specific information about how FDA regulates cannabis-derived products at https:\u002F\u002Fwww.fda.gov\u002Fnews-events\u002Fpublic-health-focus\u002Ffda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.\n\nThe Agency is particularly concerned that you market CBD products for food-producing animals. Specifically, your website promotes your “Ranch & Livestock Natural Whole-Spectrum Hemp Extract” product for use in cows and other large variety ranch and livestock animals. In addition to raising potential concerns regarding safety for the animals themselves, CBD products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals. There is currently a lack of data on the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and on safe levels of any potential residues for the human consumer. We request that you take immediate action to cease the sale of any unapproved CBD products for food-producing animals.\n\nOver the past several years, FDA has warned the public on various illegally marketed CBD containing products, including those marketed for infants, such as your “Stella’s Baby Care Diaper Cream.”[1] FDA has also observed a proliferation of products containing another cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. See https:\u002F\u002Fwww.fda.gov\u002Fconsumers\u002Fconsumer-updates\u002F5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc. This letter is to inform you that your firm markets Delta-8 THC-containing products, and Delta-8 THC may pose a serious health risk to consumers.\n\nWe also observed that your website makes claims that your products may be intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.[2]\n\nDietary Supplement Labeling\n\nInformation on your website at www.kingdomharvest.com indicates that you intend to market some of your CBD products, including, but not limited to, “Immune Boost Water Soluble Mix,” and all varieties of “Blood Sugar Support” and “CBD Gummies” as dietary supplements. For example, the product website describes “Immune Boost Water Soluble Mix” with reference to the goal of creating a “high-quality supplement” and the product websites expressly describe each “Blood Sugar Support” and “CBD Gummies” product as a “dietary supplement.” Your products cannot be dietary supplements because they do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act, 21 U.S.C. 321(ff). FDA has concluded, based on available evidence, that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.[3] There is an exception if the substance was “marketed as” a dietary supplement or as a conventional human food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.\n\nUnapproved New Human Drugs\n\nBased on a review of your websites, your CBD and Delta-8 THC products for humans are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and\u002For intended to affect the structure or any function of the body.\n\nExamples of claims observed on your product labeling, including your website and social media websites, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:\n\nFrom your Facebook and Instagram social media websites www.facebook.com\u002Foriginalkingdomharvest\u002F and www.instagram.com\u002Fkingdomharvest\u002F:\n\nMay 11, 2020 postings:\n\n“Cannabidiol (CBD) changes neurotransmission systems . . . Alters behavior response to Opioids . . . Pain management during Opioid withdrawal . . . Reduces Heroin cravings and relapse”\n\n“Fighting Opioid Addiction with Whole-Spectrum Hemp Extract . . . CBD Oil (otherwise known as cannabidiol) is scientifically proven to block the rewards of opioids”\n\n“CBD Reduces Need for Opioid Use in Pain Treatment”\n\n“64-81% of acute trauma patients reduced opioid usage with cannabis while still managing pain”\n\nApril 27, 2020 postings:\n\n“Israeli researchers have launched three clinical trials that utilize CBD’s anti-inflammatory properties as potential COVID-19 treatment . . . Last week, InnoCan Pharma announced a collaboration with Tel Aviv University to instill CBD medicine through exosomes . . . The unconventional method will utilize the exosomes as “homing missiles,” as they can uniquely target cell organs damaged by COVID-19. Researchers then believe CBD’s anti-inflammatory properties will repair the damaged cells through a synergistic effect.”\n\n“The Battle Against COVID-19 Has A New Natural Weapon . . . University Launches CBD Treatment . . . kingdomharvest.com”\n\nApril 7, 2020 postings – “Whole-Spectrum Hemp Extract & CBD & The Fight Against COVID-19.”\n\nFrom your website https:\u002F\u002Fkingdomharvest.com\u002F:\n\nOn your website homepage:\n\n“Studies Show Our Whole-Spectrum Extract Utilizing CBDa Can Prevent Infection From COVID-19”\n\nOn your blog post titled, “Cannabinoids Block Cellular Entry of COVID-19 and the Emerging Variants”:\n\n“Importantly, cannabigerolic acid and cannabidiolic acid were equally effective against the SARS-CoV-2 alpha variant B.1.1.7 and the beta variant B.1.351.”\n\n“. . . [C]annabinoids . . . have the potential to prevent as well as treat infection by SARS-CoV-2.”\n\nOn your blog post titled, “Let’s [sic] Us Introduce You to Delta-8 THC”:\n\n“If we try to list the properties or the effects of Delta-8 THC, it causes . . . pain relief, full-body relaxation and sleep.”\n\n“Delta-8 THC flower is an ideal option for medical users of cannabis who want to enjoy the benefits of THC without the sedative effects.”\n\nOn your blog post titled, “How Does CBD Work for Relieving Pain & The Best CBD Pain Relief Product?”:\n\n“CBD is among the most misinterpreted things on the planet . . . It is a magical medicine that has provided relief for countless people with chronic pain, from cancer pain to arthritis pain, migraine pain, body pain, and much more.”\n\nOn your blog post titled, “Discover the Benefits of CBD for Your Health and Wellness”:\n\n“Hemp CBD can improve your overall health and wellbeing by providing relief for several medical ailments, including chronic pain, depression, anxiety, epilepsy”\n\n“Other benefits of hemp CBD include managing post-traumatic stress disorder (PTSD), sleep disorders and cancer treatments.”\n\n“CBD has been shown to have positive effects on adults and children who experience PTSD.”\n\n“One study found hemp CBD helps slow tumor growth, reduces tumor invasion and induces tumor cell death. Another study suggested CBD could provoke cell death and improve the effect of radiation on glioblastoma cells while causing no damage to healthy cells.”\n\n“Initial studies have suggested CBD can help make life easier for an individual with Parkinson's by easing muscle movements to prevent tremors. There is also research that suggests CBD can reduce the severity of psychosis symptoms, including hallucinations, delirium and delusions without causing any adverse effects.”\n\nOn your product webpage for “D8” sublingual oil:\n\n“Delta-8 consumers report many of the same effects as THC . . . and relief from some symptoms such as pain . . . Delta-8 can also help with insomnia.”\n\nOn your product webpage for “Stella’s Baby Care Diaper Cream”:\n\n“Our Organic Diaper Cream contains our natural organic Whole-Spectrum Hemp Extract and just 7 other natural ingredients. In contrast, the leading diaper rash cream is 57% petroleum!”\n\nOn your webpage explaining the “Effects of delta-8”:\n\n“Delta-8 consumers report many of the same effects as THC, such as . . . relief from some symptoms such as pain . . .. Delta-8 can also help with insomnia.”\n\nOn your product webpage for “Delta-8 THC Syrup”:\n\n“Delta-8 THC Syrup from Kingdom Harvest is ideal for anybody experiencing a sleeping disorder or other ailments looking to be relieved.”\n\nOn your product webpage for “Blood Sugar Support”:\n\n“Kingdom Harvest Blood Sugar support pills contain three active ingredients that work at the same time and may help you to maintain a healthy blood glucose level and prevent further complications.”\n\n“Cinnamon powder contains many antioxidants that may help to reduce oxidative stress due to high blood glucose, improve insulin sensitivity, lower blood sugar levels, and prevent complications.”\n\n“Meanwhile, alpha-lipoic acid . . . may help with glucose uptake in muscles and enhance insulin sensitivity.”\n\n“Finally, cannabidiol (CBD) . . . prevents neurodegeneration, and decreases retinal complications.”\n\nOn your product webpage for “Pain Relieving CBD Cream”:\n\n“600MG ▪ CBD \u002F CAPSAICIN MUSCLE PAIN CREAM . . . This topical muscle and joint relief cream act [sic] through its two active ingredients: capsaicin and cannabidiol (CBD) . . . Capsaicin is an active component of chili peppers known to help reduce pain intensity. Meanwhile, CBD interacts with endocannabinoid receptors in joints and muscles to promote a healthy inflammatory response and relieve occasional stiffness and soreness. Capsaicin is also known to be a neuroprotectant, as it may protect nerves from being damaged or degenerated.”\n\nOn your product webpage for “Pain Relieving Cream”:\n\n“200 MG CBD \u002F LIDOCAINE PAIN CREAM . . . The CBD with Lidocaine Cream contains the same main ingredient as the Capsaicin cream – CBD, which helps promote support and relief. However, the differing active ingredient is lidocaine, a local anesthetic.”\n\nOn your product webpage for “CBD & Menthol Pain Freeze Roll-On”:\n\n“800MG CBD \u002F MENTHOL PAIN FREEZE . . . Our Pain Freeze Roll-On is a rich combination of our Organic Hemp Extract, Aloe, and Menthol. Available in a mess-free, roll-on applicator, this topical cream provides a rapid cooling effect, perfect for joint and muscle support.”\n\nBased on the above labeling claims, your CBD and Delta-8 THC products for humans are drugs. We are not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that any of these products are generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended or suggested in their labeling. Thus, your CBD and Delta-8 THC products for humans are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here,[4] new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a), 331(d). No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your CBD and Delta-8 THC products for humans. There is no basis under the FD&C Act under which these products would be legally marketed without an approved application. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).\n\nMisbranded Human Drugs\n\nYour CBD and Delta-8 THC products for humans are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. (See 21 CFR 201.5.)\n\nThese products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, because no FDA-approved applications are in effect for your products.[5] The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\n\nCBD-containing Drugs\n\nEven if your “Pain Relieving CBD Cream,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,” and “Stella’s Baby Care Diaper Cream” products were considered nonprescription drugs, we note that a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. Nonprescription drug products that include CBD as an active ingredient are not GRASE and are new drugs which require an approved application to be legally marketed. CBD is not an active ingredient in any OTC monograph under section 505G of the FD&C Act. Even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements under section 505G of the FD&C Act under which certain nonprescription drug products may be marketed without an approved new drug application. In particular, such a product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e).[6], [7]\n\n301(ll) and Adulterated Human Foods\n\nWe note that your “Broad-Spectrum THC Free Organic Honey,” “CBD Fair-Trade Coffee,” and “CBD Infused Organic Tea” products appear to be conventional foods. It is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, as described above. There is an exception if the substance was marketed in food before the drug was approved or before the substantial clinical investigations involving the drug had been instituted. However, based on available evidence, FDA has concluded that this is not the case for CBD. FDA is not aware of any evidence that would call into question its current conclusion that section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), prohibits the introduction into interstate commerce of any food to which CBD has been added, but you may present FDA with any evidence bearing on this issue.\n\nYou should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term \"food additive\" refers to any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.[8]\n\nFood additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in food is deemed to be unsafe under section 409(a) of the FD&C Act (21 U.S.C. 348(a), and causes the food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\n\nThere is no food additive regulation that authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in conventional foods. FDA's regulations in 21 CFR 170.30(a)-(c) describe the criteria for eligibility for classification of a food ingredient as GRAS. The use of a food substance may be GRAS based on either scientific procedures or, for a substance used in food before 1958, through experience based on common use in food (see 21 CFR 170.30).\n\nWe know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from CBD. Many unanswered questions and data gaps about CBD toxicity exist, and some of the available data raise serious concerns about potential harm from CBD. Our review of publicly available data associated with the one FDA-approved CBD drug, as well as our review of published scientific literature, identified potential for liver injury from CBD and potentially harmful interactions with certain drugs. In addition, studies in animals have shown that CBD can interfere with the development and function of testes and sperm, decrease testosterone levels, and impair sexual behavior in males. Therefore, based on our review, the use of CBD in conventional food products does not satisfy the criteria for GRAS status under 21 CFR 170.30.\n\nFDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in a conventional food. Therefore, CBD added to a conventional food is a food additive under section 201(s) of the FD&C Act, 21 USC 321(s), and is subject to the provisions of section 409 of the FD&C Act, 21 USC 348. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 USC 342(a)(2)(C)(i). Therefore, your “Broad-Spectrum THC Free Organic Honey,” “Fair-Trade Coffee,” and “CBD Infused Organic Tea” conventional food products contain an unsafe food additive within the meaning of section 409; therefore they are adulterated products within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of these adulterated foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\n\nFurther, there is no food additive regulation that authorizes the use of Delta-8 THC. We are not aware of any information to indicate that Delta-8 THC is the subject of a prior sanction (see 21 CFR Part 181). Furthermore, we are not aware of any basis to conclude that Delta-8 THC is GRAS for use in conventional foods.\n\nWe know of no basis for general recognition of safety for Delta-8 THC based either on scientific procedures or common use in food prior to January 1, 1958. Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of Delta-8 THC in food meets the criteria for GRAS status. Some of the available data raise serious concerns about potential harm from Delta-8 THC. Our review of published scientific literature identified potential for adverse effects on the central nervous and cardiopulmonary systems. In addition, studies in animals have suggested that gestational exposure to Delta-8 THC can interfere with neurodevelopment. Therefore, based on our review, the use of Delta-8 THC in conventional food does not satisfy the criteria for GRAS status under 21 CFR 170.30.\n\nIn addition, according to your product labeling, your “Delta 8 Chewing Gum,” “Delta 8 Peanut Brittle,” and “Delta 8 Syrup” products are foods to which Delta-8 THC has been added. Specifically, your website promotes your “Delta 8 Syrup” for mixture with “any drink” and recommends “something carbonated.” Your “Delta 8 Chewing Gum” and “Delta 8 Peanut Brittle” are types of products typically considered to be conventional foods. Your “Delta 8 Gummies” (all varieties) also appear to be conventional foods to which Delta-8 THC has been added.\n\nFDA is not aware of any other exception to the food additive definition that would apply to Delta-8 THC for use as an ingredient in a conventional food. Therefore, Delta-8 THC added to a conventional food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act. Under section 409, a food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. Delta-8 THC is not approved for use in any conventional food. Food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of an adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\n\nUnapproved New Animal Drugs\n\nDuring our review of your website and your social media websites, FDA determined that your firm is marketing the unapproved new animal drugs “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” “Pet Essentials Joint Support Tablets,” “CBD Infused Pet Shampoo,” and “CBD Infused Pet Paw Balm.” Based on our review of your website and social media websites, these products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and\u002For intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.\n\nExamples of claims observed on your website and your social media websites that establish the intended use of your products as drugs include, but are not limited to, the following:\n\nOn your Frequently Asked Questions (FAQ) webpage at https:\u002F\u002Fkingdomharvest.com\u002Fpages\u002Ffaq, you provide the following information about CBD, which is an ingredient in “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” “Pet Essentials Joint Support Tablets,” “CBD Infused Pet Shampoo,” and “CBD Infused Pet Paw Balm”:\n\n“Many CBD users have reported improvements in:\n\n• Stress\n\n• Anxiety\n\n• Sleep\n\n• Pain levels\n\n• Skin conditions including acne and eczema\n\n• Epilepsy”\n\nOn your product webpage for “Ranch & Livestock Natural Whole-Spectrum Hemp Extract”:\n\n“Like humans, our larger Ranch & Livestock pets have Endocannabinoid Systems that help bring balance to their bodies. Introducing a whole-spectrum hemp extract into your horses, cows, alpacas, and any other large variety Ranch & Livestock animals on a daily routine can help promote an overall balance and improved quality of life. Senior Ranch & Livestock Animals & Pets, those that live with certain conditions, and those in already good health can greatly benefit from a helping hand of natural cannabinoids found in Kingdom Harvest Ranch & Livestock formula.”\n\nOn your Facebook and Instagram social media websites at https:\u002F\u002Fwww.facebook.com\u002Foriginalkingdomharvest\u002F and https:\u002F\u002Fwww.instagram.com\u002Fkingdomharvest\u002F?hl=en, respectively, for your “Ranch & Livestock Natural Whole-Spectrum Hemp Extract\":\n\nMay 7, 2020 Facebook posting and May 6, 2020 Instagram posting with photographs of your “Ranch & Livestock Natural Whole-Spectrum Hemp Extract” next to photographs of a horse, a cow, and an alpaca:\n\n“Like humans, our larger Ranch & Livestock pets have Endocannabinoid Systems that help bring balance to their bodies. Introducing a whole-spectrum hemp extract to your horses, cows, alpacas, and any other large variety Ranch & Livestock animals on a daily routine can help promote an overall balance and improved quality of life. Elder Ranch & Livestock Animals & Pets, those that live with certain conditions, and those in already good health can greatly benefit from the helping hand of natural cannabinoids found in Kingdom Harvest Ranch & Livestock formula.”\n\nOn your Instagram social media website at (https:\u002F\u002Fwww.instagram.com\u002Fkingdomharvest\u002F?hl=en) for your “Canine Whole-Spectrum Hemp Extract”:\n\nNovember 27, 2019 posting with a photograph of your “Canine Whole-Spectrum Hemp Extract” with a dog in the background:\n\n“Reported benefits include reduction of stress and anxiety, improving mood, pain relief, controlling seizures, and reduction of inflammation.”\n\nOn your Facebook and Instagram social media websites at https:\u002F\u002Fwww.facebook.com\u002Foriginalkingdomharvest\u002F and https:\u002F\u002Fwww.instagram.com\u002Fkingdomharvest\u002F?hl=en, respectively, for your “Feline Chicken Flavor Zero THC Hemp Extract”:\n\nMay 8, 2020 posting with a photograph of your “Feline Chicken Flavor Zero THC Hemp Extract” next to a photograph of a cat and photograph of a partially filled medicine dropper held in front of a cat’s face:\n\n“Reported benefits include reduction of stress and anxiety, improving mood, pain relief, controlling seizures, and reduction of inflammation and many more.”\n\nOn your product webpage for “Pet Essentials Joint Support Tablets”:\n\n“Pet Essentials CBD Joint Support helps support your pet’s joint health through six active ingredients: . . .\n\nCBD may help minimize discomfort . . .\n\nChondroitin . . . may help . . . to reduce discomfort . . .\n\nTurmeric powder has natural properties, which make it a strong anti-inflammatory agent.”\n\nOn your product webpage for “CBD Infused Pet Shampoo”:\n\n“When used directly on your fur baby’s area that you are looking to treat and clean, our CBD Whole-Spectrum PET Shampoo doesn’t just clean, soothe, and alleviate irritations. It fights inflammation at the source.”\n\nOn your product webpage for “CBD Infused Pet Paw Balm”:\n\n“Because CBD PET Paw Balm does not need to be metabolized, a topical dosage is strong, reliable, and starts working quickly. When used directly on the tattooed area that you are looking to treat and protect, our CBD Whole-Spectrum PET Paw Balm doesn’t just alleviate irritations. It fights inflammation at the source.”\n\nThese products are \"new animal drugs\" under section 201(v) of the FD&C Act, 21 U.S.C. § 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.\n\nTo be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. §§ 360b, 360ccc, and 360ccc-1. These products are not approved or index listed by the FDA, and therefore these products are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated under section 501(a)(5) of the FD&C Act 21 U.S.C. § 351(a)(5). The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the FD&C Act 21 U.S.C. § 331(a).\n\n301(ll) and Adulterated Animal Foods\n\nYou should also be aware that, as defined in section 201(s) of the FD&C Act (21 U.S.C. 321(s)), the term “food additive” refers to any substance the intended use of which results in its becoming a component of any animal food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.[9]\n\nFood additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in animal food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the animal food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\n\nThere is no food additive regulation that authorizes the use of CBD in animal food. We are not aware of any information to indicate that CBD is the subject of a prior sanction, as described above. Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods. FDA’s regulations in Title 21, Code of Federal Regulations 570.30(a)-(c), 21 CFR 570.30(a)-(c), describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30).\n\nWe know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.\n\nFDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in animal food. Therefore, CBD added to animal food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act, 21 U.S.C. 348. Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\n\nTo the extent that you market any of your products containing CBD as animal food, you should be aware that it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any animal food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD, as described above.\n\nAccording to your product labeling, “Ranch & Livestock Natural Whole-Spectrum Hemp Extract,” “Canine Whole-Spectrum Hemp Extract,” “Feline Chicken Flavor Zero THC Hemp Extract,” and “Pet Essentials Joint Support Tablets,” are animal foods to which CBD has been added. Specifically, your website and social media websites refer to these products being mixed into meals (“Ranch & Livestock Natural Whole-Spectrum Hemp Extract” and “Canine Whole-Spectrum Hemp Extract”) or intended for consumption based on flavor labeling (“Feline Chicken Flavor Zero THC Hemp Extract” and bacon-flavored “Pet Essentials Joint Support Tablets”). Therefore, the introduction or delivery for introduction into interstate commerce of these products is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).\n\n* * *\n\nThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\n\nThis letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.\n\nPlease notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct these violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.\n\nYour response should be sent to U.S. Food and Drug Administration, CDER\u002FOC\u002FOffice of Unapproved Drugs and Labeling Compliance by email to FDAADVISORY@fda.hhs.gov.\n\nSincerely,\n\n\u002FS\u002F\n\nDonald D. Ashley\n\nDirector\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\nFood and Drug Administration\n\n\u002FS\u002F\n\nNeal Bataller\n\nDirector\n\nDivision of Drug Compliance\n\nOffice of Surveillance & Compliance\n\nCenter for Veterinary Medicine\n\nFood and Drug Administration\n\n\u002FS\u002F\n\nAnn M. Oxenham\n\nDirector\n\nOffice of Compliance\n\nCenter for Food Safety and Applied Nutrition\n\nFood and Drug Administration\n\n[1] As stated in previous FDA warning letters, the use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations. For example, infants may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of infants to absorb, metabolize, distribute, or excrete such drug products or their metabolites.\n\n[2] There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at https:\u002F\u002Fwww.phe.gov\u002Femergency\u002Fnews\u002Fhealthactions\u002Fphe\u002FPages\u002Fdefault.aspx. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020), available at https:\u002F\u002Ftrumpwhitehouse.archives.gov\u002Fpresidentialactions\u002Fproclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak\u002F.\n\n[3] CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See GW Pharmaceuticals Receives Investigational New Drug (IND) From FDA for Phase 2\u002F3 Clinical Trial of Epidiolex(R) in the Treatment of Dravet Syndrome). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.\n\n[4] For example, under section 505G of the FD&C Act, 21 U.S.C. 355h, certain nonprescription drug products may be lawfully marketed without an approved application if applicable conditions are met, including conformity with an applicable OTC monograph. However, your products could not be lawfully marketed under section 505G, because based on your claims regarding these products, including on your website labeling, your products are marketed for uses not considered nonprescription indications. Further, even if certain of your products, such as your “Pain Relieving CBD Cream,” “Pain Relieving Cream,” “CBD & Menthol Pain Freeze Roll-On,” and “Stella’s Baby Care Diaper Cream,” were marketed only for nonprescription indications, they would not meet the conditions under section 505G for lawful marketing without an approved application. For example, CBD—considered an active ingredient under 21 CFR 201.66(b)(2) due to its prominent featuring on your product labeling—is not an active ingredient in any OTC monograph under section 505G of the FD&C Act.\n\n[5] Further, even if your products were marketed only for nonprescription indications, these products would be misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because they would be nonprescription drugs subject to section 505G of the FD&C Act that do not comply with the requirements for marketing under that section (see footnote 1) and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.\n\n[6] 21 CFR 330.1(e) requires in relevant part that \"the product contains only suitable inactive ingredients which are safe in the amounts administered.\" A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance). CBD has no known functional role as an inactive ingredient in a finished drug product.\n\n[7] Additionally, an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage. CBD has known pharmacological activity with demonstrated risks. For example, the labeling for Epidiolex (cannabidiol) prescription oral solution includes risks for the drug such as liver injury, interactions with other drugs or supplements, potential for male reproductive toxicity, somnolence, insomnia, diarrhea, decreased appetite, abdominal pain, upset stomach, changes in mood, irritability, and agitation. See https:\u002F\u002Fwww.accessdata.fda.gov\u002Fdrugsatfda_docs\u002Flabel\u002F2020\u002F210365s005s006s007lbl.pdf. It is unknown whether the levels of CBD used in your CBD products have pharmacological activity or pose any concern for safety events.\n\n[8] Under section 201(s) of the FD&C Act [21 U.S.C. 321(s)], the following types of substances are excluded from the food additive definition: (1) pesticide chemical residues in or on a raw agricultural commodity or processed food, (2) pesticide chemicals, (3) color additives, (4) substances used in accordance with a “prior sanction” (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act), (5) new animal drugs, and (6) dietary ingredients in or intended for use in a dietary supplement.\n\n[9] Under section 201(s)(5) of the FD&C Act, 21 U.S.C. § 321(s)(5), new animal drugs are excluded from the food additive definition. If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).","2026-08-20T01:56:34.085+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2022-05-04T12:40:00Z\">05\u002F04\u002F2022\u003C\u002Ftime>\n","\u003Ctime datetime=\"2022-05-04T04:00:00Z\">05\u002F04\u002F2022\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fkingdom-harvest-625058-05042022\">Kingdom Harvest\u003C\u002Fa>","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"pma":33,"warning_letter":34},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]