FDA stated that it “is actively working to evaluate potential lawful pathways for the marketing of CBD.”
Consumers want answers from FDA on how it plans to regulate the multibillion dollar market for CBD-related products—and they’re not alone. Under the Further Consolidated Appropriations Act, 2020 (P.L. 116-94), Congress directed FDA to provide a report concerning the agency’s progress in receiving and evaluating data to help inform a policy of enforcement discretion and a process by which FDA will evaluate cannabidiol (meeting the definition of hemp) in FDA-regulated products.
On March 5, 2020, FDA submitted the requested report, painting a more detailed view of its CBD-related activities than the public has seen to date. From a high level, FDA noted that it remains concerned about the potential safety risks posed by mislabeled or contaminated CBD-infused products. At the same time, FDA stated that it “is actively working to evaluate potential lawful pathways for the marketing of CBD.”
A common refrain throughout the report highlights the minimal amount of relevant scientific data collected and analyzed to date. In echoing its past calls for research into CBD, FDA identified a number of questions to which it seeks answers, including:
- What happens if you use CBD daily for sustained periods of time?
- What level of intake triggers the known risks associated with CBD?
- How do different methods of exposure affect intake (e.g., oral consumption, topical, smoking or vaping)?
- What is the effect of CBD on the developing brain (such as children who take CBD)?
The report discusses FDA’s current views on a range of product categories commonly associated with CBD, including those discussed below.
FDA notes the existence of “a clear regulatory pathway for CBD drug development and approval,” pointing to the 2018 approval of prescription drug Epidiolex. However, FDA acknowledges that there are currently no approved nonprescription drugs containing CBD, nor do any over-the-counter drug monographs include CBD as an active ingredient.
As with CBD in human drugs, FDA encourages continuing research into potential therapeutic benefits of CBD-containing products for the treatment of animal diseases.
As FDA has made clear in its warning letters over the past few years, FDA repeats that CBD products cannot lawfully be sold as dietary supplements. However, FDA acknowledges that it “has the authority to remove this exclusion through rulemaking” and states that it is “actively evaluating potential rulemaking to allow CBD in dietary supplements.”
Though it takes the position that CBD cannot lawfully be added to food (for humans or animals), FDA encourages industry participants to develop and share relevant information relating to potential conditions under which CBD might be safely added to food.
While it recognizes that cosmetic ingredients don’t typically require premarket approval, FDA cautions that CBD may not be added to cosmetics if it causes the cosmetic to be adulterated or misbranded (i.e., if it causes the cosmetic to be deleterious or otherwise injurious to users).
FDA’s Plan: Stay the Course
Moving forward, FDA states that it will, among other things, continue to engage with other federal, state, local, territorial, tribal and international regulatory partners and counterparts in developing a CBD regulatory framework. FDA will also work to generate research data to help inform CBD-related decision making. In terms of actions involving the current CBD market, FDA says it is developing a plan to comply with Congress’ requested product sampling of the CBD marketplace to ascertain levels of product mislabeling or adulteration. Further, FDA says that it is evaluating issuance of a risk-based enforcement policy, noting that it “intends to continue taking action to address violations” it identifies “that put the public at risk.”
Taken as a whole, the CBD report provided by FDA does not describe a major pivot in policy. Still, it is clear that FDA appears to be pursuing workable solutions for an industry sorely in need of direction from the federal government.
For Further Information
If you have any questions about this Alert, please contact Frederick R. Ball, Justin M. L. Stern, Seth A. Goldberg, any of the attorneys in our Life Sciences and Medical Technologies Industry Group, any of the attorneys in our Cannabis Industry Group, or the attorney in the firm with whom you are regularly in contact.
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