[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-delta-8-hemp-618368-05042022":3,"fda-latest-sync-dates":27},{"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":8,"recipient_title":8,"body_html":17,"body_text":18,"body_fetched_at":19,"medical_device_id":8,"raw":20,"created_at":25,"updated_at":26},2692,"delta-8-hemp-618368-05042022","Warning Letter","Delta 8 Hemp",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\u002Fdelta-8-hemp-618368-05042022","618368","DrugsFood & Beverages","Via Email","\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\">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>\u003C\u002Fdd>\n                    \n            \u003Cdd>Delta 8 Hemp\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">1116 S Main Street\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Los Angeles\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">90015\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:info@delta8cart.net\"> info@delta8cart.net\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 align=\"center\" style=\"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: # 618368\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fb>\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 style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Dear Delta 8 Hemp:\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 the Internet address https:\u002F\u002Fdelta8thc.market\u002F in April 2022 and has determined that you take orders there for various human products, which you represent as containing Delta-8 tetrahydrocannabinol (THC). \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">The \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">claims on your website 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, “Delta 8 THC Distillate Oil,\" “Delta 8 THC Vape Cartridge,” “Delta 8 THC Disposable Vape Pen,”  “Delta 8 THC Tincture,” “Delta 8 Infused Gummies,” and “Delta 8 Infused Sour Gummies” (hereinafter referred to as “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\">\u003Cspan style=\"color:black\">FDA has also determined that \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">your “Delta 8 Infused Gummies” and “Delta 8 Infused Sour Gummies” products are adulterated under 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\">\u003Cspan style=\"color:black\"> 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\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 that 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\">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 websites, \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">your 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 https:\u002F\u002Fdelta8thc.market\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\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">On your blog post titled, “3 Ways to Boost Your Immune System with Delta-8 THC”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">“Delta-8 THC can be used to suppress the immune response in your body. If a patient is suffering from autoimmune diseases, Delta-8 THC will offer some relief and support. Some of these diseases include lupus, HIV\u002FAIDS, and multiple sclerosis.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">“Delta-8 THC prevents rapid cell growth while promoting cellular death . . . people who have a hyperactive immune system will gain significantly since such properties assist in the healing process.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">“If you have cancer, rheumatoid arthritis, and migraines, Delta-8 THC can help alleviate the pain because it has immunosuppressant properties.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">“[R]esearchers have currently noted that Delta-8 THC reduces inflammation, prevents autoimmune diseases, and offers pain relief.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">On your blog post titled, “Does Delta-8 THC help to Reduce Anxiety?”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">“Where there are many benefits of Delta-8 THC, such as ways to boost your immune system with Delta-8 THC, some reason [\u003Ci>sic\u003C\u002Fi>] to try Delta-8 THC are as follows:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\n\n\t\u003Cul style=\"list-style-type:circle\">\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">Substance Abuse Treatment”\u003C\u002Fspan>\u003C\u002Fspan>\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\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">“Yes, Delta-8 THC does help to reduce anxiety.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">On your webpage titled, “What is Delta 8 THC?”:\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cul>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">“In non-medical terms, researchers linked Delta 8-THC to anti-nausea (antiemetic), anti-anxiety (anxiolytic), and pain relief (analgesic) benefits, among other effects . . . It could also protect brain cells thanks to its neuroprotective effects.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">“The most notable benefits linked to Delta 8-THC include:\u003C\u002Fspan>\u003C\u002Fspan>\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\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">Help with pain and inflammation\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\t\t\u003Cli style=\"margin-left:8px\">\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">Eliminate nausea in cancer patients”\u003C\u002Fspan>\u003C\u002Fspan>\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\">\u003Cspan style=\"text-decoration:none\">\u003Cspan style=\"text-underline:none\">Posted on this page is your YouTube video titled “What is this Delta 8 Stuff?” which includes the text “Delta-8 is known to be successful in many cancer treatments.”\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"text-autospace:none\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">Your Delta-8 THC\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> products for humans are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).  With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 355(a).  FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-mentioned products. \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 Delta-8 THC\u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\"> products for humans are 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.) Your Delta-8 THC products for humans are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use because no FDA-approved applications are in effect for your products. \u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">The introduction or delivery for introduction into interstate commerce of misbranded drugs violates 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\">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 Infused Gummies” and “Delta 8 Infused Sour Gummies” \u003C\u002Fspan>\u003C\u002Fspan>\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">products are foods 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 also be aware that, as defined in section 201(s) of the FD&C Act, 21 U.S.C. 321(s), the term \"food additive\" refers to any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.\u003C\u002Fspan>\u003C\u002Fspan>\u003Ca href=\"#_ftn1\" name=\"_ftnref1\" 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\">[1]\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 Infused Gummies” and “Delta 8 Infused Sour 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 foods into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fp>\n\n\u003Cp 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>\u003C\u002Fp>\n\n\u003Cp>\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan lang=\"EN\" style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u002FS\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan 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 style=\"font-size:12pt\">\u003Cspan style=\"font-family:"Times New Roman",serif\">\u003Cspan style=\"font-size:11.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">\u002FS\u002F\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003Cbr>\n\u003Cspan style=\"font-size:12pt\">\u003Cspan style=\"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\">Ann M. Oxenham\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\">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-family:"Arial",sans-serif\">\u003Cspan class=\"MsoFootnoteReference\" style=\"vertical-align:super\">\u003Cspan style=\"font-size:10.0pt\">\u003Cspan style=\"font-family:"Arial",sans-serif\">[1]\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fspan>\u003C\u002Fa>\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\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\nDrugs\nFood & Beverages\n\nRecipient:\n\nDelta 8 Hemp\n\n1116 S Main Street\n\nLos Angeles, CA 90015\n\nUnited States\n\ninfo@delta8cart.net\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWARNING LETTER\n\nMay 4, 2022\n\nRE: # 618368\n\nDear Delta 8 Hemp:\n\nThis letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https:\u002F\u002Fdelta8thc.market\u002F in April 2022 and has determined that you take orders there for various human products, which you represent as containing Delta-8 tetrahydrocannabinol (THC). The claims on your website establish that your products, some of which are available in multiple varieties, “Delta 8 THC Distillate Oil,\" “Delta 8 THC Vape Cartridge,” “Delta 8 THC Disposable Vape Pen,” “Delta 8 THC Tincture,” “Delta 8 Infused Gummies,” and “Delta 8 Infused Sour Gummies” (hereinafter referred to as “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\nFDA has also determined that your “Delta 8 Infused Gummies” and “Delta 8 Infused Sour Gummies” products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive.\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 that may pose a serious health risk to consumers.\n\nUnapproved New Human Drugs\n\nBased on a review of your websites, your 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 https:\u002F\u002Fdelta8thc.market\u002F that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:\n\nOn your blog post titled, “3 Ways to Boost Your Immune System with Delta-8 THC”:\n\n“Delta-8 THC can be used to suppress the immune response in your body. If a patient is suffering from autoimmune diseases, Delta-8 THC will offer some relief and support. Some of these diseases include lupus, HIV\u002FAIDS, and multiple sclerosis.”\n\n“Delta-8 THC prevents rapid cell growth while promoting cellular death . . . people who have a hyperactive immune system will gain significantly since such properties assist in the healing process.”\n\n“If you have cancer, rheumatoid arthritis, and migraines, Delta-8 THC can help alleviate the pain because it has immunosuppressant properties.”\n\n“[R]esearchers have currently noted that Delta-8 THC reduces inflammation, prevents autoimmune diseases, and offers pain relief.”\n\nOn your blog post titled, “Does Delta-8 THC help to Reduce Anxiety?”:\n\n“Where there are many benefits of Delta-8 THC, such as ways to boost your immune system with Delta-8 THC, some reason [sic] to try Delta-8 THC are as follows:\n\nSubstance Abuse Treatment”\n\n“Yes, Delta-8 THC does help to reduce anxiety.”\n\nOn your webpage titled, “What is Delta 8 THC?”:\n\n“In non-medical terms, researchers linked Delta 8-THC to anti-nausea (antiemetic), anti-anxiety (anxiolytic), and pain relief (analgesic) benefits, among other effects . . . It could also protect brain cells thanks to its neuroprotective effects.”\n\n“The most notable benefits linked to Delta 8-THC include:\n\nHelp with pain and inflammation\n\nEliminate nausea in cancer patients”\n\nPosted on this page is your YouTube video titled “What is this Delta 8 Stuff?” which includes the text “Delta-8 is known to be successful in many cancer treatments.”\n\nYour Delta-8 THC products for humans are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for any of the above-mentioned products.\n\nMisbranded Human Drugs\n\nYour Delta-8 THC products for humans are 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.) Your Delta-8 THC products for humans are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Under 21 CFR 201.100(c)(2) and 201.115, FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use because no FDA-approved applications are in effect for your products.\n\nThe introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).\n\nAdulterated Human Foods\n\nAccording to your product labeling, your “Delta 8 Infused Gummies” and “Delta 8 Infused Sour Gummies” products are foods to which Delta-8 THC has been added.\n\nYou should also be aware that, as defined in section 201(s) of the FD&C Act, 21 U.S.C. 321(s), the term \"food additive\" refers to any substance the intended use of which results in its becoming a component of any food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.[1]\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 Infused Gummies” and “Delta 8 Infused Sour 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 foods 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\nAnn M. Oxenham\n\nDirector\n\nOffice of Compliance\n\nCenter for Food Safety and Applied Nutrition\n\nFood and Drug Administration\n\n[1] 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.","2026-08-20T01:56:29.69+00:00",[21,22,23,9,10,24,24,24],"\u003Ctime datetime=\"2022-05-04T12:43:00Z\">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\u002Fdelta-8-hemp-618368-05042022\">Delta 8 Hemp\u003C\u002Fa>","","2026-08-18T06:42:29.262718+00:00","2026-08-20T02:24:56.48659+00:00",{"510k":28,"classification":29,"enforcement":30,"event":31,"pma":32,"warning_letter":33},"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"]