FDA concludes that existing Regulatory Framework is not applicable for CBD

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

After a careful review, the FDA has concluded that a new regulatory pathway for cannabidiol (CBD) is needed that balances the desire for access to CBD products with the regulatory oversight needed to manage risks.

Background

There is currently a growing CBD market, e.g. CBD products sold as dietary supplements. However, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive. The agency already issued various Warning Letters to manufacturers of CBD products for human and animal consumption for illegally selling these products as food or dietary supplements.

The FDA's existing foods and dietary supplement regulations provide only limited tools for managing many of the risks associated with CBD products. Therefore, the U.S. FDA convened a high-level internal working group to explore potential regulatory pathways for CBD products.

According to the FDA, "the use of CBD raises several safety concerns, especially with long-term use. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant". Thus, a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include, for example, clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children.

Given the available evidence, it is not clear how CBD products could meet safety standards for dietary supplements or food additives. For example, the agency has not found adequate evidence to determine how much CBD can be consumed, and for how long. In addition, it is not apparent how CBD products could meet the safety standard for substances in animal food. Therefore, a new regulatory pathway could provide access and oversight for certain CBD-containing products.

For more information please see the 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.