[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-biomd-plus-llc-618460-05042022":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},2694,"biomd-plus-llc-618460-05042022","Warning Letter","BioMD Plus LLC",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\u002Fbiomd-plus-llc-618460-05042022","618460","Animal & VeterinaryDrugsFood & Beverages","Via Email","Jonathan M. Levitt","\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\">Jonathan M. Levitt\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                    \n            \u003Cdd>BioMD Plus LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1371 Sheffield Pkwy\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Marietta\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">GA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">30062\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:support@biomdplus.com\"> support@biomdplus.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\" class=\"MsoHeader\" 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 class=\"MsoHeader\">\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 class=\"text-align-center\">\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\">RE: #618460\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\">Dear Jonathan Levitt:\u003Cb> \u003C\u002Fb>\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 to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.biomdplus.com in February 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). \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">We have also reviewed your social media websites at https:\u002F\u002Ftwitter.com\u002FbioMDplus\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">, https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\u002F and\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\u002F, which\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> direct consumers to your website \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">www.biomdplus.com to\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">purchase your products. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">The claims on your website and social media accounts establish that your products, \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">some of which are available in multiple varieties, “CBD Oil,” “CBD Capsules,” “Vegan CBD Gummies,” “CBD Pain Relief Cream,” “Delta 8 THC Gummies,” and “Delta 8 THC Vape Cartridge” (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 (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).  \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, your “Natural Pet CBD Oil” is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and is 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\">FDA has also determined that certain food products that you market are 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), because they bear or contain an unsafe food additive. \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\">Over the past several years, FDA has warned the public on various illegally marketed CBD-containing products. 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\">\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=\"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.biomdplus.com\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">indicates that you appear to market your CBD-containing “CBD Capsules” and “Vegan CBD Gummies” as dietary supplements. For example, the product webpages display a product label image with “hemp supplement” on them. However, 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=\"#_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> There is an exception if the substance was “marketed as” a dietary supplement or as a conventional 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\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\">Unapproved New 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 lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Based on a review of your website and social media accounts, \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">your 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 from your website www.biomdplus.com and social media accounts, \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Ftwitter.com\u002FbioMDplus\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">, https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\u002F and https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\u002F, 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 website www.biomdplus.com:\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\">On your blog post titled, \"Best CBD Oil for Stress & Depression: Can CBD Oil Help?\":\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\">“Many are turning to consume CBD oil for anxiety, depression, and bipolar disorder.”\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\">“The pre-clinical data support the possible use of CBD with Panic Disorder (PD), Obsessive-Compulsive Disorder (OCD), and Post Traumatic Stress Disorder (PTSD), and Bipolar Disorder.”\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, “CBD for Psychosis vs CBD Oil for Schizophrenia: Breaking News…”: \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\">“People are now taking CBD for anxiety, stress relief, proper pain medication, and to help fight addiction.” \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\">“High-level CBD can help manage symptoms of psychosis that come from schizophrenia.”\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, “CBD Oil Benefits”: \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\">“Relief for Chronic Pain . . . [t]hose who suffer from chronic pain from diseases such as fibromyalgia find relief in CBD. Taking CBD can relieve pain and even prevent the degeneration of the nervous system.”\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\">“IBD . . . [s]everal studies have suggested that one of the most important effects of CBD is that it may help patients with inflammatory bowel disease such as ulcerative colitis and Crohn’s disease.”\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, “CBD Oil for Sundowning, Dementia, Alzheimer’s Disease & Disorientation”:\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\">“The dementia-related conditions that can be helped by CBD Oil include Alzheimer’s disease, Vascular Dementia, Dementia with Lewy bodies (DLB), Parkinson’s disease, Frontotemporal dementia and Huntington’s disease.”\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\">“CBD could help remove dementia from brain cells.”\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, “Delta-8 THC: Discover This New Cannabinoid from Cannabis”: \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\">“[D]elta-8-THC was administered to eight children being treated for hematologic cancers. The children were 3 to 13 years old . . . [t]hey all experienced vomiting because of the chemo . . . they received delta-8-THC with their chemotherapy treatments, every single child stopped vomiting during and after their chemo sessions!”\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\">“[D]elta-8-THC has also been used to relieve pain, ease anxiety”\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 Long Does It Take For Results Using CBD Oil To Take Affect With OCD?”: \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 oil is an effective natural treatment for OCD.”\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 To Take CBD Oil For Crohn’s Disease? Finding The Right Dosage”:\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\">“The study suggests that cbd oil or a derivative of it could be a useful treatment for Crohn’s.” \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, “Is CBD Oil Good For Idiopathic Pulmonary Fibrosis? The Ultimate Therapeutic Guide”:\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\">“[T]here are numerous studies that suggest CBD oil has the potential to treat a wide variety of health issues and could be effective in treating IPF [idiopathic pulmonary fibrosis].”\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 Delta 8 Gummies product webpage: \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\">“Another benefit that many people don’t know is that Cannabidiol can help with the growth and healing of damaged tissue, and it can also help reduce chronic pain and the likelihood of developing certain cancers, such as breast and prostate.”\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\">“The benefits of Delta 8 are the following . . . Reduce depression . . . Reduce anxiety and panic attacks . . .”\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 CBD Pain Relief Cream webpage: \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\">“bioMDplus Pain Cream in 500mg strength is a new formulated pain relief topical cream that made for use on sore muscle areas and areas where there is pain. bioMDplus Pain Cream infused with the Quality Full Spectrum CBD. bioMDplus CBD Cream provides effective, fast and long-lasting pain relief.”\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\">“Begin by rubbing small amounts of CBD cream to the affected area and wait for about an hour. You can increase the quantity depending on how fast it works. If the effects of the cream are slow to kick in, then its [\u003Ci>sic\u003C\u002Fi>] recommended to re-apply CBD cream after every 3-4 hours. . . . Using CBD cream is like using a moisturizing lotion, but making sure to apply the optimal dosage of CBD cream isn’t easy. Users have to determine the milligrams of CBD in the cream and decide whether it’s good enough for pain relief. CBD creams with low amounts of CBD will probably be less useful than those with higher concentrations. Begin by using small amounts of CBD cream before slowly increasing it until you find relief. Moreover, applying CBD cream on the body isn’t known to produce any significant side effects.”\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\">“CBD creams work when directly applied to the skin, which makes them an excellent alternative to traditional creams when it comes to pain relief. . . . For the most part, the effects of CBD cream can be felt 15-20 minutes and can keep working for as long as 6 hours or more.”\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\">“Applying CBD-infused creams is generally a straightforward process. Look for the areas of your body most affected by pain and discomfort, and apply small amounts of CBD cream around those areas for local treatment. . . . Elbows, knees, and joint . . . Bottoms of the feet and impact points . . . Face, particularly around the temples and the nose . . . Neck and shoulders” \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 social media websites:\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\">On your Facebook Social Media page https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\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\">July 28, 2020 post – “Recent research has linked CBD with several benefits for the heart and circulatory system, including the ability to lower high blood pressure. High blood pressure is linked to higher risks of a number of health conditions, including stroke, heart attack, and metabolic syndrome.”\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\">April 14, 2020 post – “500mg: CBD & Menthol Pain Cream . . . bioMDplus 500mg CBD Pain Cream is a newly formulated pain relief topical cream made to soothe sore muscles and alleviate chronic joint pain. Derived from our signature potent hemp oil infused with peppermint oil, eucalyptus oil, menthol and our signature terpene blend, this cream allows for a unique and STRONG combination of natural ingredients and CBD to aid in POWERFUL relief. You can use our new topical pain cream to FIGHT back against sore muscles and achy joints!”\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\">April 7, 2020 post – “Just what does CBD do for the body and why are people so interested in this substance? . . . Pain relief from arthritis or inflammatory diseases . . . Treatment of insomnia . . . Lowering anxiety levels . . . May lower diabetes risk . . . Could lower levels of obesity”\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 Twitter Social Media Page \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Ftwitter.com\u002FbioMDplus\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\">August 4, 2021 post – “62% of CBD users used it to treat health conditions. The most common uses were for pain, anxiety and depression.”\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\">July 25, 2021 post – “CBD Oil for Depression, Anxiety, and Bipolar disorder.”\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 Instagram Social Media Page https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\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\">July 4, 2020 post – “75% of PTSD patients saw a reduction in PTSD symptoms, when they were using CBD products compared to when they were not.”\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\">November 5, 2019 post – “A recent study showed that CBD administration can prevent the death of the neurons and reduce brain damage in the event of a stroke. CBD also reduced stroke-related seizures.”\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 CBD and Delta-8 THC products for human use 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 human use are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p). \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">With certain exceptions not applicable here,\u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"#_ftn2\" name=\"_ftnref2\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Csup>\u003Csup>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">[2]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003C\u002Fsup>\u003C\u002Fa>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> new drugs\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 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.) 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. 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\">your products\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-family:"Arial",sans-serif\">.\u003Ca href=\"#_ftn3\" name=\"_ftnref3\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Csup>\u003Csup>\u003Cspan lang=\"EN\" style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[3]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003C\u002Fsup>\u003C\u002Fa> \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 introduction or delivery for introduction into interstate commerce of misbranded drugs 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 “CBD Pain Relief Cream” was considered a nonprescription drug, 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).\u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"#_ftn4\" name=\"_ftnref4\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Csup>\u003Csup>\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">[4]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003C\u002Fsup>\u003C\u002Fa>\u003Csup>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">, \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fsup>\u003Ca href=\"#_ftn5\" name=\"_ftnref5\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan style=\"font-size:12.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">[5]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\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\">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\">According to your product labeling, your “Delta 8 THC Gummies” product is a food to which Delta-8 THC has been added.  \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 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 it 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.\u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"#_ftn6\" name=\"_ftnref6\" style=\"color:blue; text-decoration:underline\" title=\"\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[6]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\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 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. 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 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 your 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 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. \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Therefore, your “Delta 8 THC Gummies” are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because they bear or contain an unsafe food additive. Introduction of these 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\">\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\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\">Based on our review of your website and social media websites, your \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“Natural Pet CBD Oil” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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, this product is an unapproved new animal drug and marketing it violates the FD&C Act.\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 from your website\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fbiomdplus.com, and \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">your social media websites \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\u002F, https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">, and https:\u002F\u002Ftwitter.com\u002Fbiomdplus, that provide evidence of the intended use of your “Natural Pet CBD Oil” as a drug include, but are not 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\">On your product page for “\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Natural Pet CBD Oil”:\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\">“Whether you’re using CBD oil for pain relief or anxiety, the right full spectrum CBD oil for dogs dosage depends on a number of factors. . . .”\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\">“[L]inalool [an ingredient in your Natural Pet CBD Oil] may relieve . . . depression.”\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\">“Humulene [an ingredient in your Natural Pet CBD Oil] . . . may help to reduce inflammation.”\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 blog titled, “How Effective Is CBD For Pets?”: \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 tinctures are reported to help pets with seizures.”\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\">“Thanks to the natural anti-in\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">f\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">lammatory properties in CBD, it also makes for a great candidate in helping with anxiety, in\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fl\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">ammation, and arthritis.”\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\">Under the heading “Top Uses CBD for Pets”:\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\">“Anxiety[:] One of the major bene\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fi\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">ts reported with CBD is that it can help . . . alleviate their anxiety. Most pets will suffer from varying degrees of anxiety, especially dogs and cats.”\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\">“Pain . . . CBD can greatly help with [pain]. So any in\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fl\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">ammatory pain that your pet may be suffering from may be greatly reduced with CBD. Since CBD has natural anti-in\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fl\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">ammatory properties, it works especially well for in\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fl\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">ammation-induced pain.”\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\">“Arthritis[:] Although there are yet to be more tests on the effectiveness of CBD against arthritis, there is a substantial reason and some tests that prove its ef\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fi\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">cacy. Of course, the inherent anti-in\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fl\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">ammatory properties of CBD do make it very valuable in providing substantial relief to arthritis. Moreover, research also supports these claims, ensuring that CBD can be a good substitute for regular arthritis medicine.”\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\">“Seizures[:] Seizures among pets can be a very serious concern, but research suggests that CBD can help in reducing certain types of seizures in dogs. . . . In dogs, research conducted on idiopathic epilepsy showed that CBD assisted in reducing the intensity of seizures. So if your dog suffers from the condition, CBD can prove to be useful in bringing relief.”\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=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your webpage blog titled, “Full Spectrum CBD Oil for Dogs”:\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\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Here are a few problems full-spectrum CBD oil can help treat:” \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\">\u003Cb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Pain Including Joint Pain[:] It’s believed that CBD oil can reduce pain, especially neuropathic pain in dogs. It’s also said to be effective in reducing joint pain and arthritis, which is why it’s often recommended for older dogs.”\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\">“Inflammation[:] CBD oil is anti-in\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fl\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">ammatory and can help reduce chronic in\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fl\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">ammation in dogs due to genetics, parasites, metabolic diseases, food allergies, bacterial \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">overgrowth, and environmental stress.”\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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Anxiety[:] If your dog gets stressed or anxious then you may consider using CBD oil as it has been linked to less anxiety and stress.”\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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Digestion Problems . . . Regular use of full-spectrum CBD oil for dogs can treat this problem as it’s said to eliminate digestive issues”\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\">“Pain Symptoms[:] There are reasons to believe that the best full-spectrum CBD oil for dogs can help alleviate symptoms of pains in dogs. . . . The use of CBD oil may not cure the disease but it can help reduce the pain and suffering.”\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\">“Seizures[:] Some experts are of the belief that regular use of full-spectrum CBD oil can reduce the risk of seizures in dogs. The AKC Canine Health Foundation is working with the Colorado State University to evaluate the use of full-spectrum CBD oil in treatment-resistant epileptic dogs. biomdplus offers the best full-spectrum CBD oil for dogs. Our product is meant to provide all the above-mentioned bene\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">fi\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">ts to dogs of all ages.”\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=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On both your Facebook and Instagram social media websites at https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\u002F and\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\u002F respectively:\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\">Facebook and Instagram July 23, 2020 postings with a photograph of a cat looking at your “Natural Pet CBD Oil” product:\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\">“Use bioMD+ CBD products made for cats to help with . . . 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\">Facebook and Instagram October 5, 2019 postings with a photograph of a dog licking a woman’s face:\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\">“For pets who . . . have swollen joints, or separation anxiety CBD has helped many!”\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=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">On your Twitter social media website at \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">https:\u002F\u002Ftwitter.com\u002FbioMDplus\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\">October 13, 2020 posting of a graphic titled “CBD FOR PETS . . . What can CBD do for your pet?” (checklist at the bottom next to clipboard titled “CONDITIONS TREATED”):\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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cb>\u003Cspan style=\"font-size:14.0pt\">\u003Cspan style=\"font-family:"Segoe UI Symbol",sans-serif\">?\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> Allergies”\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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cb>\u003Cspan style=\"font-size:14.0pt\">\u003Cspan style=\"font-family:"Segoe UI Symbol",sans-serif\">? \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Anxiety”\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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cb>\u003Cspan style=\"font-size:14.0pt\">\u003Cspan style=\"font-family:"Segoe UI Symbol",sans-serif\">? \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Cancer Management”\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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cb>\u003Cspan style=\"font-size:14.0pt\">\u003Cspan style=\"font-family:"Segoe UI Symbol",sans-serif\">? \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Inflamation \u003Ci>[sic]\u003C\u002Fi>”\u003Ci> \u003C\u002Fi>\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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cb>\u003Cspan style=\"font-size:14.0pt\">\u003Cspan style=\"font-family:"Segoe UI Symbol",sans-serif\">? \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Glaucoma” \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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cb>\u003Cspan style=\"font-size:14.0pt\">\u003Cspan style=\"font-family:"Segoe UI Symbol",sans-serif\">? \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Skin Irritation” \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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cb>\u003Cspan style=\"font-size:14.0pt\">\u003Cspan style=\"font-family:"Segoe UI Symbol",sans-serif\">? \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Seizures and Epilepsy”\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\">“\u003C\u002Fspan>\u003C\u002Fspan>\u003Cb>\u003Cspan style=\"font-size:14.0pt\">\u003Cspan style=\"font-family:"Segoe UI Symbol",sans-serif\">? \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Arthritis”\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=\"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\">“Natural Pet CBD Oil” product is a “new animal drug” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is 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\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\">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. This product is not approved or index listed by the FDA, and therefore this product is considered 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). Introduction of this adulterated 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 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>\u003Ca href=\"mailto:FDAADVISORY@fda.hhs.gov\" style=\"color:blue; text-decoration:underline\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">FDAADVISORY@fda.hhs.gov\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\u003Cspan lang=\"EN\" 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> \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\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 style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Donald D. Ashley\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\">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 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 lang=\"EN\" style=\"\">\u003Cspan style=\"font-family: Arial, sans-serif; font-size: 11pt;\">\u002FS\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan lang=\"EN\" style=\"\">\u003Cspan style=\"font-family: Arial, sans-serif; font-size: 11pt;\">Neal Bataller\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:351.0pt 355.5pt 5.0in 364.5pt 369.0pt 5.25in 5.5in 441.0pt\">\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=\"tab-stops:2.5in 351.0pt 355.5pt 5.0in 364.5pt 369.0pt 5.25in 5.5in 441.0pt\">\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>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:351.0pt 355.5pt 5.0in 364.5pt 369.0pt 5.25in 5.5in 441.0pt\">\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>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:351.0pt 355.5pt 5.0in 364.5pt 369.0pt 5.25in 5.5in 441.0pt\">\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>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:351.0pt 355.5pt 5.0in 364.5pt 369.0pt 5.25in 5.5in 441.0pt\">\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\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-family: Arial, sans-serif; font-size: 11pt;\">\u002FS\u002F\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-family: Arial, sans-serif; font-size: 11pt;\">Ann Oxenham\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:351.0pt 355.5pt 5.0in 364.5pt 369.0pt 5.25in 5.5in 441.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan 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=\"tab-stops:351.0pt 355.5pt 5.0in 364.5pt 369.0pt 5.25in 5.5in 441.0pt\">\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>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:351.0pt 355.5pt 5.0in 364.5pt 369.0pt 5.25in 5.5in 441.0pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan 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>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"tab-stops:351.0pt 355.5pt 5.0in 364.5pt 369.0pt 5.25in 5.5in 441.0pt\">\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\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 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\">[1]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa> \u003Cspan lang=\"EN\" style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">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 \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2\u002F3 Clinical Trial of Epidiolex 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.\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 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\">[2]\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\"> 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 “CBD Pain Relief 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=\"ftn3\">\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\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 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\">[3]\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,\u003C\u002Fspan>\u003C\u002Fspan> \u003Cspan style=\"font-size:9.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">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=\"ftn4\">\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"text-autospace:none\">\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 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\">[4]\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=\"ftn5\">\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"text-autospace:none\">\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\"> 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=\"ftn6\">\n\u003Cp class=\"MsoFootnoteText\">\u003Cspan style=\"font-size:10pt\">\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\"> 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\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\nJonathan M. Levitt\n\nBioMD Plus LLC\n\n1371 Sheffield Pkwy\n\nMarietta, GA 30062\n\nUnited States\n\nsupport@biomdplus.com\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nMay 4, 2022\n\nRE: #618460\n\nDear Jonathan Levitt:\n\nThis letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at www.biomdplus.com in February 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\u002Ftwitter.com\u002FbioMDplus, https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\u002F and https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\u002F, which direct consumers to your website www.biomdplus.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, “CBD Oil,” “CBD Capsules,” “Vegan CBD Gummies,” “CBD Pain Relief Cream,” “Delta 8 THC Gummies,” and “Delta 8 THC Vape Cartridge” (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 (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).\n\nIn addition, your “Natural Pet CBD Oil” is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and is adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).\n\nFDA has also determined that certain food products that you market are 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), because they bear or contain an unsafe food additive.\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\nOver the past several years, FDA has warned the public on various illegally marketed CBD-containing products. 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\nDietary Supplement Labeling\n\nInformation on your website at www.biomdplus.com indicates that you appear to market your CBD-containing “CBD Capsules” and “Vegan CBD Gummies” as dietary supplements. For example, the product webpages display a product label image with “hemp supplement” on them. However, 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.[1] There is an exception if the substance was “marketed as” a dietary supplement or as a conventional 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 website and social media accounts, 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 from your website www.biomdplus.com and social media accounts, https:\u002F\u002Ftwitter.com\u002FbioMDplus, https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\u002F and https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\u002F, that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:\n\nFrom your website www.biomdplus.com:\n\nOn your blog post titled, \"Best CBD Oil for Stress & Depression: Can CBD Oil Help?\":\n\n“Many are turning to consume CBD oil for anxiety, depression, and bipolar disorder.”\n\n“The pre-clinical data support the possible use of CBD with Panic Disorder (PD), Obsessive-Compulsive Disorder (OCD), and Post Traumatic Stress Disorder (PTSD), and Bipolar Disorder.”\n\nOn your blog post titled, “CBD for Psychosis vs CBD Oil for Schizophrenia: Breaking News…”:\n\n“People are now taking CBD for anxiety, stress relief, proper pain medication, and to help fight addiction.”\n\n“High-level CBD can help manage symptoms of psychosis that come from schizophrenia.”\n\nOn your blog post titled, “CBD Oil Benefits”:\n\n“Relief for Chronic Pain . . . [t]hose who suffer from chronic pain from diseases such as fibromyalgia find relief in CBD. Taking CBD can relieve pain and even prevent the degeneration of the nervous system.”\n\n“IBD . . . [s]everal studies have suggested that one of the most important effects of CBD is that it may help patients with inflammatory bowel disease such as ulcerative colitis and Crohn’s disease.”\n\nOn your blog post titled, “CBD Oil for Sundowning, Dementia, Alzheimer’s Disease & Disorientation”:\n\n“The dementia-related conditions that can be helped by CBD Oil include Alzheimer’s disease, Vascular Dementia, Dementia with Lewy bodies (DLB), Parkinson’s disease, Frontotemporal dementia and Huntington’s disease.”\n\n“CBD could help remove dementia from brain cells.”\n\nOn your blog post titled, “Delta-8 THC: Discover This New Cannabinoid from Cannabis”:\n\n“[D]elta-8-THC was administered to eight children being treated for hematologic cancers. The children were 3 to 13 years old . . . [t]hey all experienced vomiting because of the chemo . . . they received delta-8-THC with their chemotherapy treatments, every single child stopped vomiting during and after their chemo sessions!”\n\n“[D]elta-8-THC has also been used to relieve pain, ease anxiety”\n\nOn your blog post titled, “How Long Does It Take For Results Using CBD Oil To Take Affect With OCD?”:\n\n“CBD oil is an effective natural treatment for OCD.”\n\nOn your blog post titled, “How To Take CBD Oil For Crohn’s Disease? Finding The Right Dosage”:\n\n“The study suggests that cbd oil or a derivative of it could be a useful treatment for Crohn’s.”\n\nOn your blog post titled, “Is CBD Oil Good For Idiopathic Pulmonary Fibrosis? The Ultimate Therapeutic Guide”:\n\n“[T]here are numerous studies that suggest CBD oil has the potential to treat a wide variety of health issues and could be effective in treating IPF [idiopathic pulmonary fibrosis].”\n\nOn your Delta 8 Gummies product webpage:\n\n“Another benefit that many people don’t know is that Cannabidiol can help with the growth and healing of damaged tissue, and it can also help reduce chronic pain and the likelihood of developing certain cancers, such as breast and prostate.”\n\n“The benefits of Delta 8 are the following . . . Reduce depression . . . Reduce anxiety and panic attacks . . .”\n\nOn your CBD Pain Relief Cream webpage:\n\n“bioMDplus Pain Cream in 500mg strength is a new formulated pain relief topical cream that made for use on sore muscle areas and areas where there is pain. bioMDplus Pain Cream infused with the Quality Full Spectrum CBD. bioMDplus CBD Cream provides effective, fast and long-lasting pain relief.”\n\n“Begin by rubbing small amounts of CBD cream to the affected area and wait for about an hour. You can increase the quantity depending on how fast it works. If the effects of the cream are slow to kick in, then its [sic] recommended to re-apply CBD cream after every 3-4 hours. . . . Using CBD cream is like using a moisturizing lotion, but making sure to apply the optimal dosage of CBD cream isn’t easy. Users have to determine the milligrams of CBD in the cream and decide whether it’s good enough for pain relief. CBD creams with low amounts of CBD will probably be less useful than those with higher concentrations. Begin by using small amounts of CBD cream before slowly increasing it until you find relief. Moreover, applying CBD cream on the body isn’t known to produce any significant side effects.”\n\n“CBD creams work when directly applied to the skin, which makes them an excellent alternative to traditional creams when it comes to pain relief. . . . For the most part, the effects of CBD cream can be felt 15-20 minutes and can keep working for as long as 6 hours or more.”\n\n“Applying CBD-infused creams is generally a straightforward process. Look for the areas of your body most affected by pain and discomfort, and apply small amounts of CBD cream around those areas for local treatment. . . . Elbows, knees, and joint . . . Bottoms of the feet and impact points . . . Face, particularly around the temples and the nose . . . Neck and shoulders”\n\nFrom your social media websites:\n\nOn your Facebook Social Media page https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\u002F:\n\nJuly 28, 2020 post – “Recent research has linked CBD with several benefits for the heart and circulatory system, including the ability to lower high blood pressure. High blood pressure is linked to higher risks of a number of health conditions, including stroke, heart attack, and metabolic syndrome.”\n\nApril 14, 2020 post – “500mg: CBD & Menthol Pain Cream . . . bioMDplus 500mg CBD Pain Cream is a newly formulated pain relief topical cream made to soothe sore muscles and alleviate chronic joint pain. Derived from our signature potent hemp oil infused with peppermint oil, eucalyptus oil, menthol and our signature terpene blend, this cream allows for a unique and STRONG combination of natural ingredients and CBD to aid in POWERFUL relief. You can use our new topical pain cream to FIGHT back against sore muscles and achy joints!”\n\nApril 7, 2020 post – “Just what does CBD do for the body and why are people so interested in this substance? . . . Pain relief from arthritis or inflammatory diseases . . . Treatment of insomnia . . . Lowering anxiety levels . . . May lower diabetes risk . . . Could lower levels of obesity”\n\nOn your Twitter Social Media Page https:\u002F\u002Ftwitter.com\u002FbioMDplus:\n\nAugust 4, 2021 post – “62% of CBD users used it to treat health conditions. The most common uses were for pain, anxiety and depression.”\n\nJuly 25, 2021 post – “CBD Oil for Depression, Anxiety, and Bipolar disorder.”\n\nOn your Instagram Social Media Page https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\u002F:\n\nJuly 4, 2020 post – “75% of PTSD patients saw a reduction in PTSD symptoms, when they were using CBD products compared to when they were not.”\n\nNovember 5, 2019 post – “A recent study showed that CBD administration can prevent the death of the neurons and reduce brain damage in the event of a stroke. CBD also reduced stroke-related seizures.”\n\nBased on the above labeling claims, your CBD and Delta-8 THC products for human use 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 human use 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,[2] new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 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.) 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. 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 your products.[3]\n\nThe introduction or delivery for introduction into interstate commerce of misbranded drugs 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 “CBD Pain Relief Cream” was considered a nonprescription drug, 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).[4], [5]\n\nAdulterated Human Foods\n\nAccording to your product labeling, your “Delta 8 THC Gummies” product is a food to which Delta-8 THC has been added.\n\nYou should 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 it 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.[6]\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 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. 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 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 your 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 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. Therefore, your “Delta 8 THC Gummies” are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act because they bear or contain an unsafe food additive. Introduction of these 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\nBased on our review of your website and social media websites, your “Natural Pet CBD Oil” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is 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, this product is an unapproved new animal drug and marketing it violates the FD&C Act.\n\nExamples of claims from your website https:\u002F\u002Fbiomdplus.com, and your social media websites https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\u002F, https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\u002F, and https:\u002F\u002Ftwitter.com\u002Fbiomdplus, that provide evidence of the intended use of your “Natural Pet CBD Oil” as a drug include, but are not limited to, the following:\n\nOn your product page for “Natural Pet CBD Oil”:\n\n“Whether you’re using CBD oil for pain relief or anxiety, the right full spectrum CBD oil for dogs dosage depends on a number of factors. . . .”\n\n“[L]inalool [an ingredient in your Natural Pet CBD Oil] may relieve . . . depression.”\n\n“Humulene [an ingredient in your Natural Pet CBD Oil] . . . may help to reduce inflammation.”\n\nOn your webpage blog titled, “How Effective Is CBD For Pets?”:\n\n“CBD tinctures are reported to help pets with seizures.”\n\n“Thanks to the natural anti-inflammatory properties in CBD, it also makes for a great candidate in helping with anxiety, inflammation, and arthritis.”\n\nUnder the heading “Top Uses CBD for Pets”:\n\n“Anxiety[:] One of the major benefits reported with CBD is that it can help . . . alleviate their anxiety. Most pets will suffer from varying degrees of anxiety, especially dogs and cats.”\n\n“Pain . . . CBD can greatly help with [pain]. So any inflammatory pain that your pet may be suffering from may be greatly reduced with CBD. Since CBD has natural anti-inflammatory properties, it works especially well for inflammation-induced pain.”\n\n“Arthritis[:] Although there are yet to be more tests on the effectiveness of CBD against arthritis, there is a substantial reason and some tests that prove its efficacy. Of course, the inherent anti-inflammatory properties of CBD do make it very valuable in providing substantial relief to arthritis. Moreover, research also supports these claims, ensuring that CBD can be a good substitute for regular arthritis medicine.”\n\n“Seizures[:] Seizures among pets can be a very serious concern, but research suggests that CBD can help in reducing certain types of seizures in dogs. . . . In dogs, research conducted on idiopathic epilepsy showed that CBD assisted in reducing the intensity of seizures. So if your dog suffers from the condition, CBD can prove to be useful in bringing relief.”\n\nOn your webpage blog titled, “Full Spectrum CBD Oil for Dogs”:\n\n“Here are a few problems full-spectrum CBD oil can help treat:”\n\n“Pain Including Joint Pain[:] It’s believed that CBD oil can reduce pain, especially neuropathic pain in dogs. It’s also said to be effective in reducing joint pain and arthritis, which is why it’s often recommended for older dogs.”\n\n“Inflammation[:] CBD oil is anti-inflammatory and can help reduce chronic inflammation in dogs due to genetics, parasites, metabolic diseases, food allergies, bacterial overgrowth, and environmental stress.”\n\n“Anxiety[:] If your dog gets stressed or anxious then you may consider using CBD oil as it has been linked to less anxiety and stress.”\n\n“Digestion Problems . . . Regular use of full-spectrum CBD oil for dogs can treat this problem as it’s said to eliminate digestive issues”\n\n“Pain Symptoms[:] There are reasons to believe that the best full-spectrum CBD oil for dogs can help alleviate symptoms of pains in dogs. . . . The use of CBD oil may not cure the disease but it can help reduce the pain and suffering.”\n\n“Seizures[:] Some experts are of the belief that regular use of full-spectrum CBD oil can reduce the risk of seizures in dogs. The AKC Canine Health Foundation is working with the Colorado State University to evaluate the use of full-spectrum CBD oil in treatment-resistant epileptic dogs. biomdplus offers the best full-spectrum CBD oil for dogs. Our product is meant to provide all the above-mentioned benefits to dogs of all ages.”\n\nOn both your Facebook and Instagram social media websites at https:\u002F\u002Fwww.facebook.com\u002FbioMDplus\u002F and https:\u002F\u002Fwww.instagram.com\u002Fbiomdplus\u002F respectively:\n\nFacebook and Instagram July 23, 2020 postings with a photograph of a cat looking at your “Natural Pet CBD Oil” product:\n\n“Use bioMD+ CBD products made for cats to help with . . . pain”\n\nFacebook and Instagram October 5, 2019 postings with a photograph of a dog licking a woman’s face:\n\n“For pets who . . . have swollen joints, or separation anxiety CBD has helped many!”\n\nOn your Twitter social media website at https:\u002F\u002Ftwitter.com\u002FbioMDplus:\n\nOctober 13, 2020 posting of a graphic titled “CBD FOR PETS . . . What can CBD do for your pet?” (checklist at the bottom next to clipboard titled “CONDITIONS TREATED”):\n\n“? Allergies”\n\n“? Anxiety”\n\n“? Cancer Management”\n\n“? Inflamation [sic]”\n\n“? Glaucoma”\n\n“? Skin Irritation”\n\n“? Seizures and Epilepsy”\n\n“? Arthritis”\n\nYour “Natural Pet CBD Oil” product is a “new animal drug” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is 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. This product is not approved or index listed by the FDA, and therefore this product is considered 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). Introduction of this adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\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 Oxenham\n\nDirector\n\nOffice of Compliance\n\nCenter for Food Safety and Applied Nutrition\n\nFood and Drug Administration\n\n[1] 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 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[2] 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 “CBD Pain Relief 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[3] 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[4] 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[5] 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[6] 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.","2026-08-20T01:56:23.698+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\u002Fbiomd-plus-llc-618460-05042022\">BioMD Plus LLC\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"]