Introduction:
Principal Deputy Commissioner Janet Woodcock made a statement on January 26, 2023, about the FDA’s current regulation of cannabidiol (CBD) and the increasing demand for a “new regulatory pathway.”
This decision was made after the agency issued a previous statement rejecting three citizen petitions submitted by the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association asking the FDA to include cannabidiol in dietary supplement regulations (NPA).
In this article, we’ll summarize the FDA statement entitled “FDA Concludes that Existing Regulatory Framework for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward.”
FDA Safety Review:
A working group was established by the FDA to perform a thorough assessment of cannabidiol’s safety. Epidiolex, a medication with CBD as its active ingredient, was examined as part of this safety review, along with written scientific literature, data submitted to a public docket, and studies carried out and/or commissioned by the FDA.
The agency concluded by listing four major risks associated with CBD:
- Potential liver harm, as evidenced by “increased liver enzyme levels” in the drug trials snapshot for Epidiolex, a drug containing CBD as its active ingredient, as well as 11 studies referenced on page 6 of the FDA’s literature review.
- Interactions with a variety of medications, as evidenced by 17 studies cited on pages 21-22 of the FDA’s literature review. For more information, consult the Department of Pharmacology at Penn State’s drug interactions list.
- Potential harm to the male reproductive system, as evidenced by 22 studies cited on pages 24-26 of the FDA’s literature review.
- Risk to vulnerable populations, such as children, pregnant women, and the elderly.
What did FDA decide?
The FDA concluded that CBD could not meet the regulatory safety standards for foods or dietary supplements, based on the evidence gathered within the safety, citing the above risks, lack of evidence surrounding dosing, as well as a lack of safety evidence of the cumulative effects of CBD in the long term.
A New Regulatory Pathway
Considering this conclusion, the FDA is recommending a new regulatory pathway to “safeguard” consumers and provide “oversight to manage and minimize risks related to CBD products”. These risk management tools could include.
- Clear labeling
- Prevention of contamination
- CBD content limits
How is the industry responding to the news?
The FDA stated that it will continue to take action to protect the public’s health and safety and that it “looks forward” to working with Congress to “develop a cross-agency strategy” for CBD regulation.
This conclusion was met with “frustration” by the CRN, “anti-innovation” by the NPA, and “indecision” by the CHPA. It has however been met with support on the Canadian side of the border, notably by Dr. Gabriella Gobbi of McGill, who believes “the safety of patients should go first,” and Dr. James MacKillop of McMaster, who says that while the use of CBD at low doses is low risk, it is “not risk-free”.
What will this mean for CBD in the future?
FDA has had a stance for the last 4 years on CBD that it couldn’t be authorized as a dietary supplement under the drug preclusion clause. Since this motion has yet to be introduced in Congress, the New Dietary Ingredients (NDI) Notification as a route to market, CBD has not been completely closed. However, we are not confident that the FDA will reverse its position, making the NDIN pathway for CBD unlikely. We recommend that anyone interested in bringing CBD to the market keep an eye on our FDA updates regarding this new, yet-to-be-determined regulatory pathway.
Importing NHPs with CBD Ingredients:
The import of NHPs with CBD will most likely follow the current framework, although generally speaking, Canada resists the importation of cannabis products to safeguard the domestic market.
Filling more of the clinical and laboratory data gap in addition to proper educational resources for the willing and potential consumers will provide a suitable environment for the new regulatory framework to be established.
