FDA delays response to CRN petition on the drug preclusion clause

03-Nov-2023 - Last updated on 03-Nov-2023 at 20:39 GMT

For the second time in two months, the US Food and Drug Administration has declined to respond to a Citizen Petition, citing “competing agency priorities”.

The Council for Responsible Nutrition (CRN) received the response from the Agency regarding its Citizen Petition (submitted May 9), which requested the agency officially clarify its interpretation of the drug preclusion clause.

FDA has a statutory obligation to respond to Citizen’s Petition within the 180 days.

In an Interim Response letter dated November 2, Cara Welch, PhD, Director of the FDA’s Office of Dietary Supplement Programs, stated that the Agency has not reached a decision due to “competing agency priorities.

“However, be advised that our staff is evaluating your petition,” added Dr Welch.

CRN said it “remains optimistic that FDA is carefully evaluating the matter and receptive to restoring the balance between drug and dietary supplement innovation”.

Drug preclusion clause

CRN’s petition asks the FDA to address its position on how it interprets a number of provisions in the Dietary Supplement Health and Education Act (DSHEA), specifically those related to Investigational New Drug (IND).

In its simplest terms, the drug preclusion clause excludes an ingredient from use in dietary supplements if that ingredient was in a drug that was “first-to-the-market” or if the ingredient was previously studied for drug uses despite it otherwise qualifying as a lawful dietary ingredient.

FDA has invoked this provision to exclude several ingredients in recent years, including NAC, NMN, and CBD. In the case of NAC, he ingredient had been in the supplement market for years without FDA objection and it’s use in supplements preceded the passage of DSHEA.

In its petition, CRN contended the drug preclusion clause has been, and would likely continue to be, misapplied to dietary supplement ingredients, thus threatening future innovation. Among one of the most concerning issues raised in the CRN petition is FDA’s interpretation that confidential IND application information can serve as the basis for preclusion.

This lack of transparency, says CRN, can result in the supplement company spending millions of dollars to research the effectiveness and safety of a product that is ultimately destined to be removed from the market by the FDA. FDA’s interpretation is legally invalid and contradictory to Congress’ intent.

“We remain committed to helping the FDA understand how vital this issue is to our industry and public health, and how important it is to level the playing field between pharmaceutical companies and supplement manufacturers when it comes to creating incentives for innovating first-to-market products,” said Steve Mister, CRN’s President and CEO.

“If the FDA is truly in favor of innovation, a thorough, if not timely, analysis and response to our petition, would be a great place to start. And if FDA continues to believe the current statute is unclear or lacking a balanced approach, we call on the agency to work with us and Congress to address these issues in legislation.”

“Competing agency priorities”

This is the second time in as many months that FDA has issued Interim Responses to a Citizen Petition, having cited the same “competing agency priorities” to a Citizen Petition about NMN filed by the Natural Products Association (NPA) and the Alliance for Natural Health (ANH).