FDA Boxes CBD Out of Food and Diet Regs, Advocates Unhappy
In a statement released yesterday (Thurs Jan 26th), FDA Principal Deputy Commissioner Janet Woodcock announced that the agency has determined to create an entirely new regulatory pathway for CBD.
Per the statement, the FDA has “concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for CBD products with the regulatory oversight needed to manage risks.”
As expected, hemp and CBD advocates like the U.S. Hemp Roundtable are vocally unhappy with the decision—here’s a more detailed breakdown of the FDA’s decision and the (very swift) response from within the CBD industry.
Starting from Scratch: The FDA and CBD
In the same statement announcing their decision to rehash CBD regulation from the ground up, the FDA denied three citizen petitions—the U.S. Hemp Roundtable response tells us they were from the Consumer Health Products Association (CHPA), the Council For Responsible Nutrition (CRN), and the Natural Products Association (NPA)—that were pushing for a pathway to allow CBD products into dietary supplements.
This move indicates the extent to which the FDA is stepping back on CBD regulation—that is, essentially to square one—which the agency justifies by citing the following concerns:
- Safety concerns, especially related to long-term use: “Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the reproductive system,” Woodcock’s statement reads.
- Insufficient risk management capabilities in food and dietary regulatory structure: The statement cites an issue of “limited tools for managing many of the risks associated with CBD products,” referring to the existing food and dietary supplement regulations.
- Lack of information to satisfy safety standards: The statement uses the example of a lack of adequate evidence to “determine how much CBD can be consumed, and for how long, before causing harm.”
- Risks to animals: The main concern expressed in the FDA’s statement refers to the direct risks CBD poses to animals as well as the unknowing exposure of humans to CBD through the meat, milk, and other products of CBD-fed animals.
Finally, the announcement wraps up by promising continued action on the part of the FDA “against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate.”
The U.S. Hemp Roundtable’s Response
The impassioned, same-day rebuttal issued by the U.S. Hemp Roundtable is aptly summarized by their General Counsel, Jonathan Miller, as follows “We were extremely disappointed today with the FDA’s announcement concerning the regulation of CBD.”
The roundtable’s response went on to say in no less pointed words that the FDA “gets it wrong” when it comes to CBD safety.
Citing more than a decade of widespread retail sales of CBD, extensive safety data, and another vein of research delineating safe and unsafe CBD consumption levels, Miller and company are calling the FDA’s decision to exclude CBD from existing regulatory pathways unprecedented and burdensome.
The roundtable also has strong contentions with the FDA’s interpretation of “limited tools” for risk management, citing that the pathways already available under the Federal Food, Drug, & Cosmetic Act would require CBD products and producers to comply with current Good Manufacturing Practices (cGMPS), mandatory facility registration and compliance with the Food Safety and Modernization Act, appropriate labeling claims overseen by the FTC, and several other key requirements already in place.
However, as the roundtable acknowledges (and we agree), it is at least reassuring to see that the FDA is serious about a legislative pathway that clearly allows hemp-derived cannabinoids into dietary and supplement foods.
We expect to see the FDA working with congress and various regulatory agencies to start establishing the broader, foundational pieces of CBD legislation in the near future.