The Food and Drug Administration (FDA) has communicated a commitment to ensuring that firms marketing dietary supplements are not misleading particularly vulnerable consumers (e.g., elderly, cancer patients, or children) with baseless disease treatment or prevention product claims. Prior FDA leadership was vocal about the need to closely monitor the dietary supplement industry because of the significant footprint the industry has established. Couple the bustling supplement industry with the awakening cannabis and cannabis derived industry, and there is colossal business opportunity. The opportunity, however, must be married with measured restraint, particularly in advertising and marketing claims.
Trailing the 2018 Farm Bill, FDA is pushing forward with its information-gathering efforts to determine if it will embark on a rule making process to allow the marketing of cannabidial (CBD) as a dietary supplement. Currently, dietary supplement products containing CBD cannot be legally marketed in the United States. As previously explained, under current federal law, marketing is prohibited because CBD is an active ingredient in an FDA approved drug that was the subject of substantial clinical investigations.
On July 22, Curaleaf Inc., a Massachusetts firm, received a warning letter from the FDA, citing the company for marketing products containing CBD (i.e., CBD lotion, pain-relief patch, tincture and vape pen) in violation of the Food Drug and Cosmetic Act (FD&C Act). Curaleaf operates online and has dispensaries in 12 states. The company markets medical marijuana and sells dietary supplement products containing CBD derived from hemp, under its Curaleaf Hemp brand and Bido brand for pets. This is the fourth letter this year that the agency has issued to a firm that markets products containing CBD. The Agency’s letter identified a number of statements from Curaleaf’s website that FDA says establishes that the “products 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/or intended to affect the structure or any function of the body.” The FDA specifically called out product claims and social media promotion that touted these products as treating Alzheimer’s disease, anxiety, depression, cancer, opioid withdrawal and Parkinson’s disease. Curaleaf was also cited for marketing CBD products for use in pets that suffer from arthritis and pain associated with aging.
In response to the FDA’s warning letter, Curaleaf removed all of the FDA-identified violative statements from its website and third-party sites, removed its Curaleaf Hemp blog and scrubbed social media posts that were noncompliant. CVS, a major retail outlet that carried some of the topical Curaleaf Hemp brand products, is removing the products from its stores following the FDA’s warning letter.
The cannabis industry has to tread lightly during this time of uncertainty as the FDA works towards its end of summer/early fall timeline to report on its status in considering a new regulatory framework for products containing cannabis or cannabis derived compounds. Stakeholders have provided the agency with thought leadership on a number of relevant areas, including quality systems considerations, research restrictions and requirements, and manufacturing concerns.
It remains to be seen how high the bar will be to legally market dietary supplement products that contain CBD. Any new regulations or policy guidance will maintain the FDA’s longstanding and important role in policing curative and therapeutic claims to protect consumers. For now, the FDA enforcement bullseye appears to narrowly encompass dietary supplements that contain CBD and are marketed with claims to treat serious diseases.