CRN Outlines Stance on Mandatory Product Listing for Dietary Supplements

Steve Mister outlined progress being made toward passage of federal legislation to enact a product registry for dietary supplements.

dietary supplements

Washington, D.C.—The Council for Responsible Nutrition (CRN) released a statement from Steve Mister, President & CEO of the association, regarding progress being made toward passage of federal legislation to enact a product registry for dietary supplements. “I want to reassure you that we continue to advocate for advancing this legislation and honor the guiding principles for this initiative directed by CRN’s Board of Directors,” Mister said in the open letter posted to CRN’s website. “On the other hand, I am distressed to see so much disinformation being promoted that reflects lack of understanding of the complicated Congressional process, intentional misdirection and false information about what is in the bill, and intentional efforts to deceive the industry about the consequences of this legislation. So I would like to set the record straight.”

Mister clarified CRN’s stance on the legislation

He explained why CRN has strongly supported legislation to establish a product registry for dietary supplements. “CRN’s Board of Directors first expressed support for this initiative in 2018, shortly after CRN created the Supplement OWL, the industry’s voluntary version of label transparency,” Mister explained. “Since then, the Supplement OWL has grown to over 13,000 labels, but it’s clear that without a mandatory component, neither our efforts, nor even the NIH’s ODS label database, will fully capture the marketplace. FDA cannot properly regulate the industry if it doesn’t have visibility to know what products are on the market.

“Since 2019, we have written extensively about the need for a mandatory product listing [MLP], and our reasons for supporting it, in trade press, consumer press and regulatory journals.” Mister has outlined his stance in WholeFoods Magazine: Mandatory Product Listing: Beneficial, or Burdensome?

Given that, Mister said, “I was surprised to hear some industry stakeholders assert that the concept was being rushed through Congress and that it came as a surprise to the industry. You could say we have been exceedingly transparent on our position on the issue of transparency!”

CRN Points to “The Truth About DSHEA 2.0”

“Finally, some stakeholders continue to say that mandatory listing should wait and be included in a much broader package of reforms to DSHEA,” Mister said. “While CRN certainly has a wish list of other items we would like to change in the current law, that has to be balanced with pragmatism and a dose of what realistically can be accomplished in this Congress—or even in the next one. Changes to the law would likely have to be enacted with the cooperation, or at least not the opposition, of FDA. Many of the ideas being proposed, like private third-parties deputized to conduct facility inspections, do not have FDA buy-in yet and will require extensive negotiations to get FDA on board. Then the industry has to convince a deeply divided Congress to enact these reforms. These things take years—mandatory listing is achievable in this Congress.

“Still others are introducing the notion that complete pre-emption of all state laws related to dietary supplements should be a trade-off for a federal product registry. That is unrealistic and unattainable in this political climate. Just like the earlier argument that FDASLA should be limited to drug issues, this is a red herring to make the bill unpassable and to deflect attention from the real issues.”

Read CRN’s open letter, titled “MPL Update: CRN Still at the Table” in its entirety here.

Related: FDA Issues Final Guidance on “Enforcement Discretion” of NAC
CRN: 6 Issues with FDA’s NDI Draft Guidance for Dietary Supplements…
Vitamins a “Waste of Money” for Most Americans? Industry Responds