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New FDA CBD Study is Disingenuous at Best, Harmful at Worst, Says NPA

| May 1, 2023

On April 24, the Natural Products Association (NPA) responded to a study conducted by the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN), reviewing the oral toxicity of cannabidiol (CBD).

“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,” said Daniel Fabricant, PhD, president and CEO of NPA. “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.”

In February of 2022, in a citizen’s petition to the FDA, the NPA requested to determine cannabidiol (CBD) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B), allowing the Commissioner the ability to exercise enforcement discretion in a specific and selective manner consistent with the premarket safety review of a new dietary ingredient notification or recommend the Secretary of Health and Human Services (HHS) issue a regulation after notice comment, finding CBD would be lawful. The NPA’s full citizen petition was submitted alongside a new dietary ingredient notification by the company cbdMD for regulatory determination on one of its products.

For more information, visit www.npanational.org.

On April 24, the Natural Products Association (NPA) responded to a study conducted by the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN), reviewing the oral toxicity of cannabidiol (CBD).

“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,” said Daniel Fabricant, PhD, president and CEO of NPA. “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.”

In February of 2022, in a citizen’s petition to the FDA, the NPA requested to determine cannabidiol (CBD) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B), allowing the Commissioner the ability to exercise enforcement discretion in a specific and selective manner consistent with the premarket safety review of a new dietary ingredient notification or recommend the Secretary of Health and Human Services (HHS) issue a regulation after notice comment, finding CBD would be lawful. The NPA’s full citizen petition was submitted alongside a new dietary ingredient notification by the company cbdMD for regulatory determination on one of its products.

For more information, visit www.npanational.org.

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