Companies selling cannabidiol (CBD) or Delta-8 tetrahydrocannabinol products (THC) were issued warning letters this week by the US FDA. This action was the first time the FDA has issued warning letters for products containing delta-8 THC, which has psychoactive and intoxicating effects.

The companies that were cited in this week's letters were also selling topically-applied CBD products in cream, lotion and balm format.

Shelle Rogers, CEO, Kingdom Harvest, Hendersonville, NC, has been issued a warning letter by the US Food and Drug Administration (FDA) following a review of its website (October 2021 through April 2022) as well as the company's social media sites. FDA said based on claims made, the company is selling unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Additionally, FDA said the CBD and Delta-8 THC products for humans are misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). Products cited by the agency include topical products such as Stella’s Baby Care Diaper Cream, Pain Relieving CBD Cream, Pain Relieving Cream, and CBD & Menthol Pain Freeze Roll-On.

In addition, FDA said the claims establish that its CBD Infused Pet Shampoo and CBD Infused Pet Paw Balm unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and are adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).

FDA noted in its May 4 letter that even if the company’s Pain Relieving CBD Cream, Pain Relieving Cream, CBD & Menthol Pain Freeze Roll-On and Stella’s Baby Care Diaper Cream products were “considered nonprescription drugs, we note that a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. Nonprescription drug products that include CBD as an active ingredient are not GRASE and are new drugs which require an approved application to be legally marketed. CBD is not an active ingredient in any OTC monograph under section 505G of the FD&C Act. Even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements under section 505G of the FD&C Act under which certain nonprescription drug products may be marketed without an approved new drug application. In particular, such a product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1(e).”

Chase Slappey, CEO of ATLRx, Inc., Alpharetta, GA, was issued a warning letter by the FDA following a review of its website (February 2022) as well as it social media channels. FDA says the company's CBD Salve, CBD Topical Full Spectrum Lotion and CBD Lavender Scented Hand Sanitizer” 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, FDA said the CBD and Delta-8 THC products for humans are misbranded.

The agency used langauge similar to that in the letter sent to Kingdom Harvest;  FDA noted that even if ATLRx's CBD Salve, CBD Topical Full Spectrum Lotion, and CBD Lavender Scented Hand Sanitizer “were considered nonprescription drugs, we note that a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. Nonprescription drug products that include CBD as an active ingredient are not GRASE and are new drugs which require an approved application to be legally marketed. CBD is not an active ingredient in any OTC monograph under section 505G of the FD&C Act. Even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements under section 505G of the FD&C Act under which certain nonprescription drug products may be marketed without an approved new drug application. In particular, such a product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR 330.1 (e).”

Another warning letter dated May 4, 2022 was sent to Terry Maxwell, CEO of M Six Labs, Inc., Saukville, WI, following a review of its website (February 2022). Prouducts cited by FDA include Chaz Ortiz CBD 500mg Essential Balm and Magnolia Botanicals CBD 500mg Balm Stick. FDA says based on claims, these are unapproved new drugs introduced or delivered for introduction into interstate commerce 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). In addition, these products are misbranded, noted FDA.

THC Products

Delta-8 THC is one of the more than 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects. Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages, according to FDA.

The warning letters sent by the agency address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum, and peanut brittle.

The FDA said it requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction, said FDA.