FDA Concludes That a New Regulatory Pathway for CBD Is Needed

On January 26, the U.S. Food and Drug Administration (FDA or the Agency) announced that it is prepared to work with Congress to develop a new regulatory pathway for cannabidiol (CBD).¹ In doing so, the Agency made clear that the existing regulatory frameworks for dietary supplements, food or food additives, and animal food are not appropriate. More specifically, the FDA emphasized that it was not apparent that CBD products could meet applicable safety standards to allow the use of CBD in dietary supplements, conventional foods, food additives, or even animal food. Simultaneous to this announcement, the FDA denied three citizen petitions asking the Agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.²

These developments are consistent with the position that the FDA has taken in recent years regarding the use of CBD in dietary supplements and food products. The Agency has repeatedly warned the public about illegally marketed CBD-containing products, citing concerns about the potential for harm to the liver, the male reproductive system, and even children and pregnant persons.³ Numerous Warning Letters have also been issued to companies emphasizing that the use of CBD (which is not generally recognized as safe and effective) in dietary supplements and foods causes them to be misbranded and/or adulterated under the federal Food, Drug and Cosmetic Act (FFDCA).⁴

Despite these warnings, the CBD market has continued to grow. Recognizing the public’s desire for access to CBD products, the FDA convened a "high-level internal working" group to explore potential regulatory pathways for CBD products. The working group reviewed studies related to Epidiolex, published scientific literature, information submitted to a public docket, and studies conducted and commissioned by the Agency. Based on this review, the FDA concluded that CBD products could not meet safety standards for dietary supplements or food additives, as there was not “adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.” Similarly, the Agency found insufficient evidence to determine how CBD products could meet the safety standard for substances in animal food. Accordingly, the FDA has determined that it will not pursue rulemaking to allow the use of CBD in dietary supplements, conventional foods, or animal food.

Instead, the FDA is proposing to create an altogether new regulatory pathway that would provide access and appropriate oversight for CBD-containing products for humans and animals. What this regulatory pathway will look like and when it will be implemented remains to be seen. FDA’s announcement states only that a new regulatory pathway would provide safeguards (e.g., clear labels, prevention of contaminants, CBD content limits, minimum purchase age) and oversight to manage and minimize risks related to CBD products and that the Agency is “prepared to work with Congress on this matter.”

Until a new regulatory framework is created, the FDA will continue to monitor the marketplace and exercise its enforcement discretion to take action against CBD and other cannabis-derived products to protect public health.

If your company needs help determining how this new FDA development may impact your ability to sell CBD products, Buchanan’s experienced regulatory team is here to help.