Yesterday, the Food and Drug Administration (FDA) submitted a report to Congress providing an update on the agency’s evaluation of potential regulatory pathways for CBD products, as well as a description of how FDA expects to proceed moving forward.
In its report, FDA summarized the landscape surrounding CBD drugs, dietary supplements, foods, cosmetics, and vape products. FDA then identified next steps, including potentially adopting a risk-based enforcement policy, reopening the public hearing docket to facilitate information sharing, evaluating differences between “full spectrum” or “broad spectrum” hemp extracts and CBD isolate products, and sampling products on the market. Below is a summary of FDA’s report and analysis of the most impactful takeaways.
Assessing the CBD Landscape
FDA first addressed its ongoing evaluation of CBD safety. As it has in the past, FDA emphasized that it is aware of several risks associated with CBD, including liver injury, drug-drug interactions, drowsiness, and the possibility of male reproductive toxicity. FDA also highlighted several areas in which it is still seeking more safety information, including the effects of sustained daily CBD use, safe levels of intake, the impact of different methods of exposure, the effect on unborn children and newborns, interactions with herbs and botanicals, the potential for male reproductive toxicity, and the impact on animals.
FDA then discussed how CBD products fit into each of FDA’s different regulatory pathways. The agency explained that the drug approval process is a viable pathway for CBD products, as evidenced by the approval of Epidiolex. Moving forward, FDA would like to encourage the development of new CBD drug products, and the agency suggested that industry take advantage of resources like the agency’s Botanical Review Team (BRT), which can provide assistance to those seeking to develop such products. Additionally, FDA wants to ensure that adequate incentives exist to promote clinical research, as the agency fears that the widespread availability of consumer CBD products could discourage clinical research and stunt the development of CBD in the medical context. While FDA also supports research into potential CBD animal drugs, the agency acknowledged that no such products have been approved at this time.
Next, FDA discussed the dietary supplement pathway. The agency explained that currently, CBD products cannot be sold as dietary supplements, but the agency is considering rulemaking that would allow CBD in this product category. FDA expressed concerns, however, about potential limitations on its ability to exercise oversight for CBD-containing dietary supplements. In particular, the agency noted that it lacks authority to require dietary supplement marketers to tell FDA what products they are selling, and that expanding its dietary supplement program could greatly increase agency workload. FDA also expressed its view that it currently has limited authority to address dangerous dietary supplement products, which is something the agency thinks consumers should understand. Moving forward, FDA plans to begin collecting product-specific information of the type usually submitted in new dietary ingredient notifications. The agency recognizes concerns about the submission of proprietary information, so it is working to establish a clear process by which such information can be submitted while maintaining appropriate protections against disclosure of trade secrets or confidential commercial information.
Regarding food products, FDA explained that it is not currently lawful to add CBD to human or animal food. The agency is encouraging continued research into whether CBD could safely be added to food.
FDA advised CBD cosmetic producers to ensure the safety of their products, even though cosmetics do not require premarket approval and CBD is not prohibited for use in this product category. FDA also explained that more evidence regarding dermal penetration and sensitization of topically applied CBD products is needed.
Finally, FDA briefly addressed vape products. The agency expressed its concern that CBD vapes pose toxicity concerns and might attract children and adolescents, and warned that CBD vape products meeting the definition of tobacco products will be regulated as such.
FDA’s Next Steps
FDA identified a number of next steps for the agency to take regarding the CBD landscape. Most notably, FDA is evaluating the issuance of a risk-based enforcement policy that would provide transparency and clarity regarding factors that FDA intends to take into account in prioritizing enforcement decisions. Such a policy would balance the goals of protecting the public and providing clarity to industry and to consumers. Elsewhere, the agency emphasized its concerns about products that are being marketed with claims of therapeutic benefit, that are contaminated with heavy metals or other harmful substances, that are marketed with false claims, or that target vulnerable populations. These are likely the products that FDA would enforce against most vigorously.
The agency announced several other plans as well. FDA will reopen the public hearing docket indefinitely in order to facilitate the public exchange of information. FDA also plans to collaborate with regulatory counterparts throughout different levels of government to encourage the further exchange of ideas. Additionally, the agency will seek information regarding the content of “full spectrum” and “broad spectrum” hemp extracts. Finally, in an effort to collect more data, FDA has initiated new CBD studies, and the agency is developing an action plan to sample products in the CBD marketplace to determine the extent to which products are mislabeled or adulterated.
FDA’s assessment of the landscape and proposed next steps indicate that more certainty might be on the horizon, though the agency offers no concrete timeline. In particular, a risk-based enforcement policy would allow stakeholders to proceed with a better awareness of the types of activities that would trigger FDA scrutiny. Moreover, if FDA does indeed pursue a rulemaking that allows CBD in dietary supplements, stakeholders would gain access to a new pathway to market for at least certain products addressed by FDA’s potential rule. Lastly, FDA’s interest in researching “full spectrum” and “broad spectrum” hemp extracts is an important step toward the agency developing a better understanding of these products and creating an appropriate regulatory framework.
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