As has been reported here and all over, the passage of the 2018 Farm Bill has led to a massive boom in the sale and marketing of products containing Cannabidiol (CBD). Indeed, everywhere from your local grocery store to hip, big-city smoothie shop now carry an array of products infused with CBD.
Although the 2018 Farm Bill did remove the federal prohibition on the manufacture and sale of hemp–and by extension, hemp-derived CBD–the U.S. Food and Drug Administration (FDA) quickly stepped in to make clear that the Agency had jurisdiction to regulate certain CBD-containing products under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA has not yet issued formal Regulations explaining what types of products may run afoul of the FD&C Act. However, over the past year, the FDA has made clear through its statements and enforcement actions that it has two priorities in this arena: (1) companies claiming that its CBD products can prevent, diagnose, treat, or cure serious diseases such as cancer; and (2) companies using CBD as an additive to food or drink.
In further clarifying its position against CBD marketed products as a dietary supplement or as a food additive, the FDA announced on November 25 that it has issued warning letters to 15 companies alleging illegal sale of products containing CBD in violation of the FD&C Act. (Click here for the FDA’s formal announcement of the warning letters). Despite some prior indications that FDA continues to explore pathways for lawful marketing of the CBD containing products, and that the Agency is open to engage with the State and local regulatory partners to further clarify the requirements under the FD&C Act, the message coming from the FDA was loud and clear.
Based on the current scientific information supporting the safety of CBD in food, the FDA cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food. The common theme among the issued warning letters was that the manufacture of such products employed an overall marketing strategies that inferred that the product can be used to prevent or treat a disease, as drugs, in violation of FD&C Act.
Among commonly problematic phrases in the issued warning letters are the following:
- “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.”
- “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.”
Unless approved by the FDA, use of any such phrases in any medium; website, social media, packaging, to market the CBD products for treatment of diseases or for other therapeutic uses for humans and/or animals will be viewed as a violation of section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1). Therefore, companies selling CBD-containing products must review their marketing and advertising materials in conjunction with warning letters issued by the FDA, and continue to monitor further enforcement efforts by the Agency.
For more information about the FDA’s regulation of Cannabis and CBD-Containing Products, I encourage you to review this helpful page on the FDA’s website.
This post was co-authored by Shahnam Sharareh, PharmD, RAC, a Princeton, NJ-based Partner in Fox Rothschild’s Intellectual Property and Pharma & Biotech practices. Shahnam can be contacted at 609-844-3030 or firstname.lastname@example.org
Joseph McNelis works in Fox Rothschild’s Blue Bell, PA office. He focuses his practice on labor and employment matters, and also tracks legal developments in the cannabis industry in Pennsylvania and nationwide. Joe can be contacted at 610-397-2332 or email@example.com.