Is CBD a Drug or a Supplement? FDA Confuses Again.
(Thursday, August 19, 2021)
FDA recently rejected a petition to classify CBD as a dietary ingredient saying that since it has already approved a drug containing CBD, all CBD products are drugs and cannot be classified as dietary supplements. There are many reasons this argument from FDA is hollow and baffling. While on the record FDA has consistently argued that CBD is a drug, it has at the same time not regulated any of the widely available CBD supplements, oils, tinctures, and other products, creating confusion for the consumers and the industry alike. CBD products are widely available and popular. Information on CBD products at FDA’s website is confusing even for the experts as it describes the various risks of CBD products but stops short of calling them illegal. FDA has been consistently inconsistent in its stance regarding the CBD products. While it has stated time and again that CBD products need to be approved as a drug due to safety concerns, it has allowed food and dietary supplement products containing CBD to proliferate so long as they don’t make medical claims. The manufacturers do not need to register or in any way interact with the FDA, just stay away from making overtly medical claims. This wink-wink nudge-nudge approach has confused even medical professionals who get patients asking for opinion regarding the CBD products. To an average consumer there is no difference in a drug containing CBD and the myriad of products they can buy online or the next-door grocery store. To be fair the New Dietary Ingredient (NDI) request filed by Charlotte’s Web for CBD was deficient in many ways as pointed out by FDA in its rejection letter. The key evidence for safety of the ingredient was a publication which did not contain complete details of the raw data based on which the conclusions were made. The NDI application apparently lacked several critical elements FDA expects in such applications per its guidance on the topic. The applicant’s response to FDA’s critique shows their lack of understanding of basic regulatory norms for such documents. For example, FDA only accepts toxicity data presented in GLP-compliant reports, and sales of a product without active safety data collection cannot be used as real-world safety data. That said, FDA needs to clarify its policies and enforce the rules. If CBD products are indeed drug products, non-enforcement of these rules seems like a dereliction of responsibility by FDA. If on the other hand, if FDA believes CBD products are safe enough to be sold as supplements, oils, and tinctures, it needs to classify CBD as a dietary ingredient and apply manufacturing quality rules. The current regulatory regimen is a confusing, subjective, and non-transparent, and it does not serve the FDA or the consumers it is apparently trying to protect from CBD products.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC