The Council for Responsible Nutrition (CRN) has submitted a Citizen Petition to the FDA requesting that the agency to reconsider its interpretation of the Drug Preclusion Clause. According to the Washington, DC-based trade association, the Clause has been, and will likely continue to be, misapplied to dietary supplement ingredients that FDA has previously acknowledged as lawfully marketed, which threatens future innovation in the supplement marketplace.
The Drug Preclusion Clause—a provision in the 1994 Dietary Supplement Health and Education Act (DSHEA)—excludes certain dietary supplement ingredients from the supplement definition where that ingredient is the same as an active drug ingredient and the drug use was “first-to-the-market.”
The petition raises the concern that “FDA’s tentative positions with regard to various aspects of the so-called ‘drug preclusion’ provision found in section 201(ff)(3)(B) (codified at 21 U.S.C. § 321(ff)(3)(B)), as have been discussed in various FDA documents and guidance, such as those related to NAC, NMN, and new dietary ingredients, have the effect of diminishing the purpose of that provision, and the careful balance Congress intended between drug and dietary supplement interests, as well as the plain reading of the words.”
Furthermore, the petition continues, “These positions have the potential to inject significant uncertainty and inequities into the supplement marketplace and to upend the intended balance in the law between pharmaceutical and dietary supplement interests. The totality of FDA’s various viewpoints on the application of the statute–with respect to pyridoxamine, vinpocetine, NAC, other ingredients, and now NMN–unfairly promotes pharmaceutical research at the expense of dietary supplements, consumer access, and public health.”
“We are deeply distressed by FDA’s decision to revoke the status of these ingredients as dietary supplements, which threatens future innovation, because by doing so, they’ve flipped the script on how drug preclusion is supposed to work, leaving all parties—manufacturers, retailers and consumers—in a sort of regulatory limbo going forward,” said Steve Mister, CRN president and CEO. “Without a reexamination of FDA’s position, and guidance that lends clarity and predictability to the process, manufacturers are discouraged from continued innovation of new ingredients, and retailers are not sure whether they should, or are able to, continue to make these products available to the public for fear of selling ‘illegal’ supplements.”
As a result, the petition concludes that “Reversing the agency’s position as we have requested here and providing guidance for the discretionary use of rulemaking under drug preclusion [can] help ensure DSHEA is read consistently and fairly to the benefit of public health.”
For more information, visit www.crnusa.org.
