Washington, D.C.—The Council for Responsible Nutrition (CRN) has submitted a Citizen Petition to the U.S. Food and Drug Administration (FDA) calling for the agency to reconsider its interpretation of the Drug Preclusion Clause. The trade association contends that this clause has been, and will likely continue to be, misapplied to dietary supplement ingredients that the agency has previously acknowledged as lawfully marketed. And this, CRN says, threatens future innovation in the supplement marketplace. 

CRN explained: "In its simplest terms, the Drug Preclusion Clause—a provision in the 1994 Dietary Supplement Health and Education Act (DSHEA), which itself amended the Federal Food, Drug & Cosmetic Act—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.'"

A key concern raised by CRN

Under FDA’s current interpretation, a supplement company has no way of knowing if a drug company has started the process of preclusion because the date that triggers preclusion is confidential. CRN explained that, when dietary supplement companies attempt to see if the ingredient is being investigated as a drug, they can’t. "In fact, a drug company may have already put a stake in the ground and set the wheels in motion for that dietary supplement ingredient to be precluded from the market. Meanwhile, the dietary supplement manufacturer could spend millions of dollars researching the effectiveness, confirming the safety, and marketing an ill-fated product to consumers, which is destined to be removed." CRN stressed that this outcome "is certainly not what Congress intended when it wrote the law."

“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.” 

Drug preclusion law used unfairly 

For years, CRN said, there have been numerous instances of the preclusion law being used unfairly in this way. Recent examples include the ingredients NAC and NMN, which effectively removed products containing those ingredients from marketplaces like Amazon.

CRN's concern: FDA has removed these and other ingredients from the market without offering legally sound reasoning, consistent with DSHEA and prior FDA interpretations of drug preclusion, to support its decision making. 

“It’s akin to conducting a title search on a house, determining there are no liens, only to be told after you’ve bought the house that there were actually secret liens on the property, and you’ll have to forfeit your investment,” added Mister. “Yet that is exactly what is happening to supplement companies, which are acting in good faith and in accordance with publicly available information, in what could be perceived as an effort by the agency to unfairly protect the financial interests of pharmaceutical companies over those of supplement manufacturers. We continue to engage the agency on this critical issue.” 

Related:  NPA, ANH File Citizen’s Petition with FDA on NMN

β-NMN Is Not a Dietary Supplement? CRN Responds