FDA Increases Scrutiny of CBD Product Marketing LanguageDecember 2, 2019 – Alerts
A recent spate of FDA warning letters to companies selling CBD-containing products underscores the risk these manufacturers and distributors face if the language used in their marketing strategies implies that they can be used to treat or prevent disease.
FDA Oversight of CBD Products
Although the 2018 Farm Bill removed hemp from the definition of "marijuana" in the Controlled Substances Act, the FDA has clearly expressed that it will continue to hold the characterization of oral CBD-containing products as non-dietary supplements per the definition of a “dietary supplement” under section 201(ff)(3)(B) of the Food, Drug and Cosmetic Act (FD&C Act). The FDA also signaled that it will explore pathways for lawful marketing of CBD products and is open to engage with state and local regulatory partners to further clarify requirements under the FD&C Act.
Current FDA thinking shows that if an article, including CBD, is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, or has been authorized for investigation as a new drug with completed and publicly available clinical evaluations, then products containing that substance are outside the definition of a "dietary supplement." There are no exceptions that can apply based on the FDA’s current view of the available scientific evidence.
The common theme among the FDA’s warning letters was that manufacturers of CBD-containing products have engaged in marketing strategies that violate the FD&C Act by suggesting that their products can be used to prevent or treat a disease.
Problematic marketing phrases highlighted in the issued warning letters included:
- “CBD relieves pain and inflammation”
- “Studies show that CBD prevents human experimental psychosis and is effective in open case reports and clinical trials in patients with schizophrenia, with a remarkable safety profile.”
- “Our formulations have been proven to be effective at reducing inflammation, and minimizing the way cancer cells manipulate neighbor cell.”
- “Not only does the research show that CBD benefits including being effective in fighting breast cancer cells, data also suggest that it can be used to inhibit the invasion of lung and colon cancer, plus it possesses anti-tumor properties in gliomas and has been used to treat leukemia.”
- “CBD lowers incidence of diabetes”
- “Several pre-clinical reports showing anti-tumor effects of CBD …have found reduced [cancer] [sic] cell viability, increased cancer cell death, decreased tumor growth, and inhibition of metastasis.”
- “CBD for opioid addiction”
- “A potential new treatment for opioid addiction has been found in a new review of previous research of cannabidiol (CBD).”
- “10 little known uses for CBD” include “PTSD.” “Fibromyalgia.” “Schizophrenia.” “Diabetes,” etc.
- “[CBD] inhibits cancer cell growth”
- “There is extensive scientific and clinical research, including research by the US government, which exposes CBD’s potential as a treatment for a wide range of conditions, including… ADD and ADHD, Alcoholism, Antibiotic-resistant Infections, Autism…”
- “CBD Oil infused balm is a powerful topical cream designed for sore muscles, or areas where pain is felt.”
- “CBD Pain Relief Roll-on GEL”
- “CBD can help with many skin conditions. CBD has anti-inflammatory properties that can help with acne, psoriasis, and eczema.”
- “General equine anxiety”
- "Medicated/Anxiety/Calming/Inflammation/Veterinarian Approved"
Unless approved by the FDA, use of such phrases in any medium or packaging to market CBD products as a therapeutic for humans and/or animals or as a treatment of diseases will likely trigger the issuance of a warning letter.
For any questions about this alert or the FDA regulation of CBD products, please contact Shahnam Sharareh, PharmD, RAC at 609.844.3030, or [email protected] or any member of Fox Rothschild’s Cannabis Law Practice Group.