The Food and Drug Administration (FDA) has asked Congress to help develop a “cross-agency strategy” for creating a “new regulatory pathway” for CBD.
In short, FDA states a “new regulatory pathway” is needed for CBD before FDA will change its current enforcement strategy. While it looks to many in the industry that the FDA is simply punting on its obligation to regulate CBD, it may simply be that Congress threw a hot CBD potato to the FDA. A careful reading of the FDA’s position on this makes it somewhat clear that Congress may have overlooked the scientific and medical considerations and expected the FDA to do by regulating what FDA believes Congress needs to do by legislation.
On Jan. 26, 2023, FDA refused to do what the CBD industry has been urging and issued a press release entitled “FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward“ stating:
“Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter.”
At the same time, FDA denied three industry Citizen Petitions filed by the Consumer Healthcare Products Association, Council for Responsible Nutrition, and the Natural Products Association. These petitions sought, among other things, a regulatory pathway to market dietary supplements containing CBD, to find CBD is a lawful dietary ingredient, and for FDA to exercise “enforcement discretion” where a safety review is submitted.
In denying the Citizen Petitions, the FDA recounts the history of the Dietary Supplement Health Education Act of 1994 (DSHEA) and the challenge distinguishing between the regulation of drugs and items considered food. DSHEA introduced a new concept of “new dietary ingredient” (NDI) which requires proof of safety. The NDI regulatory pathway figured significantly in the industry Citizen Petitions and FDA’s response.
The FDA noted that Congress removed “hemp” from the definition of “marijuana” under the Controlled Substances Act (CSA) in the 2018 Farm Bill but “did nothing to change how ‘hemp’ is regulated under the FD&C Act.” As a result, CBD can be grown and sold but is not a food or dietary supplement (or cosmetic). The FDA explains that it excluded CBD from the definition of “dietary supplement” on a number of grounds, most notably because CBD had not been historically “marketed as” a dietary supplement or a conventional food and because FDA had approved the prescription drug Epidiolex, with the active ingredient CBD in 2018. For the FDA, it is one thing if a food generally recognized as safe is later approved as a drug (i.e., fish oil and Vacepta) it is entirely different when, as here, an approved drug is sought to be treated as food.
In December 2019, the FDA posted a “high-level” summary of a literature review it had commissioned concerning CBD entitled the Safety of CBD in Humans – A Literature Review stating, in part, “[t]here are many unanswered questions about the science, safety, and quality of products containing cannabidiol (CBD)(FDA Docket).” In its January 26, 2023 pronouncements, FDA echoes these concerns stating that the “use of CBD raises various safety concerns, especially with long-term use” and that scientific study has demonstrated potential for liver damage, harm to the male reproductive system and interactions with medications.”
In the meantime, for the FDA it is status quo as Congress considers whether to heed the FDA’s call, and the FDA will “continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate.”
In the event Congress accepts the FDA’s invitation to create a new regulatory game plan for CBD, participation by industry, health professionals and consumer groups will play an important role in driving good policy.
Clark Hill is ready to assist with any questions about the impact of this action by the FDA and in formulating any game plan as this issue works its way through the legislative process.
Please contact the author, Michael A. Walsh. at email@example.com
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