On the heels of the U.S. Federal Trade Commission's (FTC's) recent law enforcement crackdown against deceptive marketing of cannabidiol (CBD) products, the U.S. Food and Drug Administration (FDA or the Agency) has also taken action against companies for unlawful marketing of CBD products. Specifically, FDA on December 22 issued five warning letters to companies for illegally marketing unapproved CBD products claiming to treat medical conditions, in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA).
Although this is not the first time that FDA has taken issue with companies for selling CBD products claiming to prevent, diagnose, mitigate, treat or cure diseases, it is the first action taken against such companies since FDA announced earlier in the year that it would be taking a more relaxed approach to CBD enforcement. As we previously reported, FDA had stated in a March 2020 report to Congress, as well as in a public statement by the Commissioner the same month, that the Agency would be prioritizing enforcement decisions on a risk-based approach. FDA's position regarding CBD products marketed as dietary supplements and foods containing CBD is clear: both are prohibited under the FFDCA and the Agency will take enforcement action against companies selling such products at any time. However, with respect to other FDA-regulated consumer products, under its newly articulated risk-based approach, the Agency said that it would prioritize enforcement against those that pose the greatest risk to consumers, including (1) products containing contaminants (e.g., heavy metals, high levels of THC or other potentially harmful substances); (2) products marketed with false claims or statements (e.g., omitted ingredients); (3) products marketed for use by vulnerable populations (e.g., children or infants); and (4) products that otherwise put the public health at risk.
The warning letters issued by FDA last week appear in line with these stated priorities. All five letters address the illegal marketing of unapproved CBD products falsely claiming to treat medical conditions. Under the FFDCA, claims that a product can prevent, diagnose, mitigate, treat or cure diseases causes that product to be viewed as a new drug requiring FDA approval in order to be marketed. The CBD products in question, which have not undergone the Agency's rigorous review process to establish safety and efficacy in preventing, diagnosing, mitigating, treating or curing disease, cannot legally make such claims.
Notably, several of the letters cited CBD products that were of especially concerning to FDA from a public health perspective due to the unique routes of administration (outside of the more typical food or dietary supplement routes). For example, two companies sold CBD eye drop products for use in humans and in pets, while another sold a metered-dose inhaler containing CBD. Yet another company marketed a product intended to be administered intranasally.
This latest round of warning letters suggest that, even with a more relaxed enforcement approach FDA is nevertheless still monitoring the activities of the CBD industry and keeping an eye on consumer products containing CBD. Companies selling products in this space should continue to be very careful about the claims that they make about their products and continue to monitor FDA's actions for further updates.
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