There is currently a growing interest in the development of therapies derived from cannabis and its components, including cannabidiol (CBD). These products containing cannabis or cannabis derivatives are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things. Therefore the FDA wants to give guidance on how the agency´s “authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products“.
Interest in these products increased last December when the US Congress passed the Agriculture Improvement Act of 2018 (the 2018 Farm Bill). Among other things, this law established a new category of cannabis classified as “hemp” – defined as cannabis and cannabis derivatives with extremely low (no more than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). The 2018 Farm Bill removed hemp from the Controlled Substances Act, which means that it is no longer a controlled substance under federal law.
FDA Working Group
The FDA will form a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed. According to FDA, the working group will consider “whether there are legislative options that might lead to more efficient and appropriate pathways than might be available under current law”. However, “this is a complicated topic and we expect that it could take some time to resolve fully. Nevertheless, we’re deeply focused on this issue and committed to continuing to engage relevant stakeholders as we consider potential paths forward” the agency says. The FDA working group plans to begin sharing information and/or findings with the public as early as Summer 2019.
In addition, the FDA is announcing a number of important new steps and actions to advance consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under FDA´s existing authorities, including:
- A public hearing on May 31, 2019, as well as a broader opportunity for written public comment, for stakeholders to share their experiences and challenges with these products, including information and views related to product safety.
- The formation of a high-level internal agency working group to explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.
- Updates to FDA´s webpage with answers to frequently asked questions on this topic to help members of the public understand how the FDA’s requirements apply to these products.
- The issuance of multiple warning letters to companies marketing CBD products with egregious and unfounded claims that are aimed at vulnerable populations.