Washington, D.C.—The Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN) has published its review the oral toxicity of cannabidiol (CBD). The authors of the review stated: "The toxicological profile of CBD raises safety concerns, especially for long term consumption by the general population."

The Natural Products Association (NPA) weighed in on the review. Daniel Fabricant, Ph.D., NPA President and CEO, said: “Using drug standards to conduct a ‘supplement study’ is at the very least disingenuous and at the worst very harmful for the foundering and rudderless regulatory process on CBD. Instead of using actual dietary supplement data and research like the data we supplied to the agency in our citizen’s petition, the FDA instead chose to use drug data to draw conclusions that are three times the dose of the CBD drug Epidiolex. This is extremely troubling, confusing, and sets us back even further on one of our top priorities for the past several years, which is meaningful progress on a regulatory path for something that’s ubiquitous in the market.”

The petition, which was submitted alongside a NDIN from the company cbdMD, requested that FDA either:

  • Determine that CBD is not excluded from the definition of a dietary supplement, allowing the Commissioner to exercise enforcement discretion in cases where an ingredient has undergone the premarket safety review of a new dietary ingredient notification (NDIN), or
  • Recommend that the Secretary of Health and Human Services issue a regulation after notice comment, finding that CBD would be lawful.

Advocating for CBD, supplement access & more

CBD will be a focus at NPA's annual federal government advocacy fly-in day, which is scheduled for June 7, 2023 (interested parties can reserve a spot and make hotel reservations here). Dr. Fabricant said, "This year’s fly-in day will present attendees with the opportunity to talk about the industry's most pressing issues, including the drug exclusion clause, reshoring, NMN, and CBD. If you’re passionate about ensuring consumers have access to products that will improve their health and ensuring the industry has clear and fair rules to deliver these products, this event is for you.” 

NPA is also urging the industry to take part in grassroots efforts to protect access to supplements.

A current priority: New York lawmakers have reintroduced a bill to restrict access to supplements on the premise that eating disorders and dietary supplements are connected. An earlier bill had been vetoed. NPA cautioned: "If we don't act, safe and popular supplements such as creatine will face restricted access and require a photo ID for purchase...We can all agree eating disorders are serious illnesses. However, legislative proposals like S5823/A5610 demonstrate policy-making that lacks science-based evidence. Please write to your members of the New York legislature urging their opposition to S5823/A5610."

Industry members can join the grassroots effort by accessing NPA's action center.

Related: FDA: Existing Regulatory Frameworks for Foods & Supplements Not Appropriate for CBD

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