NPA files citizen’s petition to FDA for CBD dietary supplement assessment

23 Feb 2022 --- The Natural Products Association (NPA) is demanding the Food and Drug Administration (FDA) assesses if cannabidiol (CBD) qualifies as a dietary supplement.

In a citizen’s petition, NPA requests that the FDA concludes that CBD is a legal dietary element that is not barred from the Dietary Supplement Health and Education Act (DSHEA)’s relevant definitions of a dietary supplement.

“For more than four years, the dietary supplement industry has done all but beg the FDA to make safety determinations for CBD. In that time, 36 US states have established regulatory standards and the EU has decided on an interim level for CBD consumption,” says Daniel Fabricant, president and CEO of NPA.

“While we wait for a broader regulatory path for CBD, today’s action by NPA paves the way for the agency to review individual products and render an opinion on a case-by-case basis.”

NPA’s citizen’s petition was submitted alongside the company cbdMD’s new dietary component notification for a regulatory determination on one of its products.

The petition states that if FDA determines that CBD is not legal and is not included in the DSHEA criteria of a dietary supplement, the agency should clarify that it will scientifically analyze all safety data linked to CBD, including any safety data submitted as part of any premarket regulatory submission.

CBD legality and NAC issue
CBD would be found to be legal if the FDA granted the commissioner enforcement discretion in a manner consistent with the premarket safety review of a new dietary ingredient notification. Additionally, this can be done by recommending that the Secretary of Health and Human Services (HHS) issue a regulation after notice comment.The citizen’s petition may result in CBD’s regulatory uncertainty being resolved.

This latest petition closely follows a lawsuit against the FDA concerning the use of N-acetyl-L-cysteine (NAC) in supplements.

“Both issues surrounding NAC and CBD are glaring examples of the FDA fundamentally failing consumers and industry. Today’s citizen’s petition positions NPA to have all options available and will ensure CBD’s regulatory uncertainty is rectified,” Fabricant adds.

These topics have also received more fuel with the voting in of Dr. Robert Califf as the commissioner of the FDA. In light of this, industry has been calling for guidance for specific ingredients, such as CBD.

Regulations concerning CBD
The NPA also supported new proposed legislation introduced in the US Senate that directs the FDA to set a safe daily CBD consumption level.

To restore declining customer trust and scientifically confirm CBD products, Open Book Extracts and Radicle Science previously formed a CBD validation collaboration.

Lastly, after the rejection of two new dietary ingredient notifications for full-spectrum hemp extract containing CBD by the FDA, there were calls for better regulation of hemp-derived goods.

By Nicole Kerr