The FDA has become increasingly concerned about products containing cannabidiol (CBD) and/or delta-8 tetrahydrocannabinol (delta-8), stating that such products are potentially unsafe, make claims in violation of the Federal Food, Drug and Cosmetic Act (FFDCA) and “are packaged and labeled in ways that may appeal to children.” These concerns along with recent reports related to delta-8 and CBD products led to the issuance of five additional warning letters.
In these warning letters, the FDA stated that certain products containing CBD and/or delta-8 were unapproved new drugs sold in violation of FFDCA § 505(a), § 301(d) [21 U.S.C. 355(a), 331(d)] and were misbranded under FDCA § 502(f)(1) [ 21 U.S.C. 352(f)(1)] as they are marketed by companies as unapproved treatments for various medical conditions or for other therapeutic uses. In referencing the addition of CBD and delta-8 in foods, such as gummies, chocolate and caramels, the FDA determined certain food products were adulterated under FFDCA § 402(a)(2)(C)(i) [ 21 U.S.C. 342(a)(2)(C)(i)], because delta-8 is deemed an unsafe food additive. Additionally, for those companies that also sold animal products containing delta-8, the FDA stated such products were unapproved and unsafe new animal drugs under FFDCA § 512(a) [21 U.S.C. § 360b(a)], and are adulterated under FFDCA § 501(a)(5) [21 U.S.C. 351(a)(5)].
In other words, these warning letters honed in on marketed products containing CBD or delta-8 claiming to treat medical conditions in humans and animals, promoting such products as dietary supplements, and/or adding CBD or delta-8 to human and animal foods as an unapproved food additive. Specific claims made by the manufacturers that received said warning letters include:
- Blog Post: “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/AIDS, and multiple sclerosis.”
- Blog Post: “Fighting Cancer...Δ8 may also have cancer-fighting properties… [t]he researchers treated mice with cancer for 20 consecutive days with a combination of the isomer and cannabinol. The result? Tumors reduced in size.”
- Twitter Post: “CBD Oil Benefits... Pain Relief and Inflammation... Helps Fight Cancer... Relieves Nausea…Treats Seizures…Lowers Risk of Diabetes…Anxiety…Depression…Panic Disorders…OCD…PTSD…Neurological Disorders...”
- Facebook Page: “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!”
- Facebook and Instagram Posts: “Israeli researchers have launched three clinical trials that utilize CBD’s anti-inflammatory properties as potential COVID-19 treatment…Last week, InnoCan Pharma announced a collaboration with Tel Aviv University to instill CBD medicine through exosomes…The unconventional method will utilize the exosomes as “homing missiles,” as they can uniquely target cell organs damaged by COVID-19. Researchers then believe CBD’s anti-inflammatory properties will repair the damaged cells through a synergistic effect.”
Considering the FDA’s recent focus on cannabis products, and the alleged increase in adverse event report relating to CBD and delta-8 products, the FDA will likely continue reviewing product pages and social media sites related to cannabis products and issue warning letters accordingly. As such, it will be important for your company to review all marketing and promotional materials, including that which is on social media, to ensure you are not unintentionally making unsubstantiated claims regarding your product. It will also be important for your company to understand and be prepared for any safety initiatives or regulations the FDA may put in place regarding such products.