We’ve written previously about FDA’s denial of three petitions requesting that the agency issue a regulation that would allow cannabidiol (CBD) products to be marketed as dietary supplements. FDA also issued a call for a legislative fix to allow broader access to CBD products, stating that it did not consider existing dietary supplement and conventional food pathways appropriate for CBD and that the agency is interested in working with Congress to develop a new pathway that balances consumers’ desire to access CBD products with the regulatory oversight necessary to better manage the risks these products present.
In a move somewhat at odds with FDA’s position, Representatives Morgan Griffith (R-VA) and Angie Craig (D-MN) have recently re-introduced two bills: the CBD Product Safety and Standardization Act, which would require FDA to regulate CBD like other food ingredients, and the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act, which would legalize hemp and hemp-derived products (including CBD) for use as a dietary supplement.
The CBD Product Safety and Standardization Act would direct FDA to allow CBD derived from hemp in foods by treating it as an approved food additive or generally recognized as safe (GRAS). The bill would require FDA to issue a rule, with public notice and comment, to specify a maximum amount of cannabidiol derived from hemp per serving, as well as labeling and packaging requirements, and conditions of intended use.
This bill is curious for a number of reasons. First, the determination of safety of a food ingredient is usually a decision left to the agency, based upon scientific data, and determined not by legislators. Second, this bill seems to presume that there is a safe level, despite the Agency’s position that “FDA has seen only limited data about CBD safety and these data points to real risks that need to be considered before taking CBD for any reason.” It is unclear how, if the bill were enacted into law, FDA would carry out these requirements where the Agency believes it has insufficient data to make these public health decisions.
Similarly, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act provides that hemp, CBD derived from hemp, and any other ingredient from hemp “shall be lawful for use . . . as a dietary ingredient in a dietary supplement,” but conditions the legality on compliance with requirements for a dietary supplement under the Food, Drug, and Cosmetic Act. This requires similar public health decisions around the safety of dietary ingredients that FDA has expressed it has insufficient data to make.
The re-introduction of these two bills sends a message to FDA that some members of Congress want FDA to solve these problems under the current framework of the Food, Drug, and Cosmetic Act. Whether that message will be fully delivered by enacting these two bills into law, and what FDA will do once that message is received, remains to be seen.