The FDA held a stakeholder call on May 25, 2023 to provide additional information related to its January 26 announcement that it believes a new regulatory framework for cannabidiol (CBD) products is necessary. For example, the FDA determined that CBD cannot be safely used as a food additive or dietary supplement and that a new regulatory framework is also needed to ensure that inhalable hemp products are subject to FDA regulation. The agency is collaborating with Congress to create a new approach to providing proper safeguards and oversight to manage and reduce these risks.
The FDA shared some important details during the stakeholder call regarding the possibilities of the framework. For instance, it could include standard oversight measures, precautions to minimize the risk of contaminants, and safeguards to address specific risks, such as purity restrictions for CBD content and clear labeling guidelines. The panelists emphasized the “harm reduction” concept of the program rather than “harm removal.” If certain guardrails could be provided for certain product categories without the need for a product-by-product approval process, this approach could have the potential to pare back regulatory oversight of many hemp-derived products. Although CBD was the focus of the discussion, this new framework could apply to hempseeds as well, which are already subject to regulation. FDA also does not intend to include marijuana in this new framework.
The FDA intends to continue enforcing the products that it judges to be most dangerous until a new pipeline is developed.
A high-level internal working group that FDA convened to explore potential regulatory pathways for cannabidiol (CBD) products announced by way of a January 26, 2023 statement that existing regulatory pathways are not appropriate for CBD. As reported on this blog, the FDA working group examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies conducted and commissioned by FDA, and concluded it is “not apparent how CBD products could meet the safety standards for dietary supplements or food additives.”
FDA’s January statement also announced that the Agency is prepared to work with Congress on legislation to create a new CBD-specific regulatory pathway that is necessary to move forward.On May 25, 2023, in the last of three webinars intended to address lingering questions following its January statement, FDA reiterated that it is up to Congress to create a legal status for CBD and other hemp-derived cannabinoids.
FDA’s Stakeholder Webinar: “A New Way Forward for Cannabidiol (CBD) and Other Hemp Products” outline the factors that lead FDA to conclude statutory barriers prevent the regulation of these products as a food or dietary supplement. Specifically, FDA cited CBD’s inherent risk profile (e.g., liver injury, interactions with certain medications, and possible harm to the male reproductive system) and the limited risk management options for the food ingredient and dietary supplement pathways (i.e., the inability for FDA to weigh any potential benefits against the safety risks).
FDA’s webinars advocate for the creation of a “harm reduction” approach for regulating CBD and other hemp-derived cannabinoids that would permit the Agency to set rules addressing known issues with current products, e.g., variable CBD content, incomplete ingredient labeling, contamination, and the risk of ingestion by children. While recognizing the growing popularity of CBD and other hemp products, FDA insists it can take the harm reduction approach only if Congress enacts legislation for a specific new regulatory framework.
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