CBD is a Drug: Says Another FDA Warning Letter to CBD Seller
(Thursday, May 12, 2022)
FDA has maintained enforcement discretion for CBD products by only warning companies that make overt medical claims about their CBD products but not doing much to stop the overall sale of these products. This week in a Warning Letter to another company selling CBD gummies, FDA explicitly stated that CBD products are drugs and not supplements but stopped short of any actions other than asking the company to respond within 15 days. The company simply stopped selling the CBD gummies and went about its business as usual. CBD products are popular and available easily at practically all supplement and drug stores, and online. Products containing various amounts and formulations of CBD are labeled as dietary supplements and openly advertised for various benefits. There has been few controlled clinical trials or scientifically acceptable data to support the claims, but the anecdotes prevail. And these products clearly do not meet the criteria to be called a dietary supplement. Over the last few years, CBD marketers have become very savvy at crafting their message; making claims that subtly hint at the medical benefits without making overt drug-like claims. Only companies that push the envelope just a tad further, like the company receiving the FDA Warning Letter this week, get warnings, but even these companies do not face any impactful consequences. The receivers of such FDA letters merely stop the sales of the brand being warned, rename, and go back to selling the same products with the new names. There have not been any punitive actions from the FDA, while in rare cases, the FTC imposed monetary penalties of small non-impactful amounts. At the same time, CBD products have blown into a multi-billion dollar market which has grown exponentially over the last 5 years, and is projected to reach 10 times its current market size over the next 5-8 years. The current FDA process for pseudo-regulating CBD products is non-productive, confusing to the consumers and physicians, and overall ineffective. It is about time FDA takes a clear stand about CBD products. With the broad legalization of marijuana in the country, there are fewer widely accepted safety concerns about CBD, which is one of the components of marijuana. It does not seem that even FDA is too worried about the safety of the CBD products. The Warning Letters merely cited medical claims made by the manufactures for products labeled as dietary supplements. From a practical point of view, there are few incentives for any manufacturer to explore the expensive formal approval for its CBD products as a drug when they can generate significant revenues in the current regulatory regime. There has been only one CBD containing drug product approved by the FDA several years ago. Unless FDA’s Warning Letters to the CBD products are followed by strong regulatory and financial penalties, the industry will keep ignoring such letters and keep selling the products as is. And the consumers will continue to be exposed to products with questionable benefits.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC