On January 26, 2023, Principal Deputy Commissioner Janet Woodcock released a statement regarding the current state of cannabidiol (CBD) regulation by the FDA and a growing need for a “new regulatory pathway”.

This conclusion immediately followed a previous statement made by the agency, denying three citizen petitions that the FDA include cannabidiol in dietary supplement regulations, made by the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the Natural Products Association (NPA).

FDA Safety Review
The FDA convened a working group to conduct a comprehensive safety review of cannabidiol. This safety review included an examination of Epidiolex, a drug containing CBD as its active ingredient, published scientific literature, information submitted to a public docket, as well as studies conducted and/or commissioned by the FDA.

The agency listed 4 main risks areas associated with CBD which precipitated their conclusion:

1. Potential harm to the liver, as evidenced by “increased liver enzyme levels” within the drug trials snapshot for Epidiolex, a drug containing CBD as its active ingredient, as well as in 11 studies referenced on page 6 of the FDA’s literature review
2. Interactions with several different medications, as evidenced by 17 studies referenced on pages 21-22 of the FDA’s literature review. For more information, you can also reference this drug interactions list released by the Department of Pharmacology at Penn State
3. Potential harm to the male reproductive system, as evidenced by 22 studies referenced on pages 24-26 of the FDA’s literature review
4. Risk to vulnerable populations, such as children and those who are pregnant

The FDA’s Conclusion
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
In light of 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

Industry Response
The FDA promised to continue to take action to safeguard the health and safety of the public and “looks forward” to working with Congress to “develop a cross-agency strategy” for the regulation of CBD.
This conclusion has been met with “frustration” by the CRN, and was referred to as “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 the future of CBD?
To be determined. The stance of the FDA over the past 4 years was that CBD could not be authorized as a dietary supplement due to the drug preclusion clause, because it was first approved for use in the drug Epidiolex. Because this motion has yet to reach Congress, the door has not yet been completely shut on the New Dietary Ingredients (NDI) Notification as a pathway to market for CBD. However, we aren’t confident that the FDA would backpedal on its position, which makes the viability of the NDIN pathway for CBD unlikely. We recommend anyone who is looking to bring CBD to market keep an eye on FDA updates from us regarding this new yet-to-be-determined regulatory pathway.

This article provides a supplemental review of the FDA statement titled “FDA Concludes that Existing Regulatory Framework for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward”, and is not a substitute for reading the complete statement.

For more information about this article, or any other regulatory affairs matters, please contact us.