On March 22, 2021, the U.S. Food and Drug Administration (FDA) issued warning letters to two companies, Honest Globe Inc. and Biolyte Laboratories LLC, for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters specifically addressed the illegal marketing of unapproved drugs containing CBD intended for the treatment of pain relief. To date, the FDA has not approved any over-the-counter (OTC) drugs containing CBD and the FDA contends that none of the products cited in the warning letters meet the requirements to be legally marketed without an approved New Drug Application. The FDA's news release and warning letters can be found here.

The 2018 Farm Bill legalized the production of hemp at the federal level; however, hemp products intended for human or animal consumption are still subject to the FD&C Act and regulations promulgated by the FDA. Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat, or prevent a disease or affect the structure or function of the body of humans is a drug. OTC drugs must receive prior approval by the FDA via a New Drug Application (NDA) approval or meet the requirements of an OTC Monograph (which would not require prior approval by the FDA), including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient. Only one CBD-containing prescription drug has been approved by the agency so far.

Though the companies marketed CBD as an inactive ingredient in the drugs, the FDA alleged that this was a misnomer. While CBD was listed as an inactive ingredient, the product labeling clearly represented CBD as an active ingredient. The letters explain that CBD has a known pharmacological effect on humans, with demonstrated risks, and therefore cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Based on this statement, it would appear that the FDA would take action against manufacturers of OTC drug products containing CBD, even if CBD is labeled as an inactive ingredient and no claims are made for the CBD ingredient. Indeed, the FDA's approval of the one CBD-containing prescription drug underscores that the agency is not barring all approvals of CBD-containing prescriptions, only those prescriptions that do not go through the proper channels for approvals.

The latest series of warning letters were sent to companies whose products have not gone through the FDA drug approval process and are considered unapproved new drugs. No FDA evaluation of whether these unapproved drug products are effective for the uses advertised, proper dosage, or how CBD-containing OTC drugs could interact with other drugs to create side effects or other safety concerns has taken place to date. The letters also cite substandard manufacturing practices at each company, including the failure to comply with current good manufacturing practices.

The FDA has requested written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information as to why they believe these products are not in violation of the law.

Though the FDA contends that it continues to be focused on exploring potential pathways for CBD products to be lawfully marketed, but is also committed to educating and protecting consumers about the potential risks related to the safety of CBD products, this latest round of warning letters suggests that hopes for non-enforcement of federal hemp policy under the Biden administration are likely misguided. The agency does not intend to stop policing the industry generally and CBD companies in particular. It's clear the agency is pursuing a multi-faceted approach to regulating CBD claims. The FDA will continue alerting the public to potential safety and efficacy concerns with unapproved CBD products (to facilitate this, the FDA publishes a comprehensive list of consumer information and communications that can be accessed here). At the same time, companies that commercialize violative CBD products will be confronted with significant agency enforcement actions.

For More Information

For more information please contact David Hoffmeister, Jamie Ravitz, Georgia Ravitz, Paul Gadiock, Eva Yin, or any other member of Wilson Sonsini's FDA Regulatory, Healthcare, and Consumer Products practice.