Two Steps Forward, One Step…? FDA Addresses Cannabidiol in the Existing Regulatory Frameworks for Foods and SupplementsFebruary 22, 2023
Last October, President Joe Biden directed the Secretary of Health and Human Services (“HHS”) and the Attorney General to begin the administrative process of reviewing current marijuana scheduling under federal law. Then, Congress passed and the President signed the Medical Marijuana and Cannabidiol Research Expansion Act into law in December. Last month, the Food and Drug Administration (“FDA”) announced in a release that it would not conduct rulemaking that would allow cannabidiol (“CBD”) to be marketed in dietary supplements or conventional foods because “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.” FDA Statement, FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward.
FDA Principal Deputy Commissioner Janet Woodcock, M.D. issued the release on January 26th stating that she had chaired an FDA “high-level internal working group to explore potential regulatory pathways for CBD products.” Dr. Woodcock announced that a new regulatory pathway is needed, noting that FDA is prepared to work with Congress on the matter. She also announced denial of three citizen petitions asking FDA to conduct rulemaking to allow CBD products marketed as dietary supplements.
The release explained that studies have suggested that CBD can potentially harm the liver and male reproductive system and can interact with certain medications. Exposure to vulnerable populations including children and pregnant women is also a safety concern.
A new regulatory pathway, the statement opines, would provide safeguards and oversight, managing and minimizing risks related to CBD products. But what would an adequate regulatory pathway require? What safeguards would it employ? The statement explains that risk management tools could include clear labeling, prevention of contaminants, CBD content limits, and age restrictions to mitigate the risk of ingestion by children. A new pathway could also provide access and oversight for animal CBD-containing products.
FDA’s current food and dietary supplement authorities provide limited tools for managing the risks associated with CBD products. Under current law, the statement warns, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.
The working group reviewed studies related to CBD-based Epidiolex, published scientific literature, information submitted to a public docket, and studies conducted and commissioned by FDA. The working group determined it is not apparent how CBD in dietary supplements and foods could meet safety standards because FDA has “not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.”
The release further noted that CBD also poses risks to animals and humans who could unknowingly be exposed to CBD by consuming meat, milk, and eggs from animals that ingest CBD. For that reason, FDA also does not intend to pursue rulemaking that would allow CBD in animal food because it is not apparent how CBD products could meet the safety standards for animal food. As with CBD in dietary supplements and human food, a new regulatory pathway could provide access and oversight for CBD-containing animal products.
The release warned that FDA would continue to take enforcement action, in coordination with state regulators, to protect the public against CBD and other cannabis-derived products. FDA promised to remain diligent in monitoring the marketplace, identifying products that pose risks and acting within its authorities. The statement observed that FDA looks forward to working with Congress to develop a cross-agency strategy to regulate CBD-containing products to protect public health and safety.
Meanwhile, dietary supplements and foods containing CBD continue to be marketed and consumed. Key among questions raised by the release are:
- What will the new regulatory pathway look like?
- How will FDA work with Congress on CBD in dietary supplements and foods?
- Will Congressional Democrats and Republicans work together on these issues or will such efforts be hindered by partisan deadlock?
- How long will it take to agree upon and establish an acceptable regulatory pathway?
Inquiring minds are waiting.