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CRN President Issues MPL Update to Members


In an open letter to members, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), updated the CRN community on the status of the association’s effort to create a dietary supplement registry at the U.S. Food and Drug Administration (FDA).

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In the letter, Mister reassured members that CRN would continue to advocate for the advancement of the bill and also wanted to address the disinformation that CRN believes is circulating that “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.”

“Contrary to what you may have heard, the negotiations for dietary supplement product listing continue with progress made each day toward getting a final bill that CRN can support,” Mister said. “The press reports you may have read about a ‘stripped-down, user fee only bill’ are still a possibility, and in fact, if CRN is not able to reach agreement on the ‘must have’ changes to the Senate Committee passed bill, CRN would even support that bare bones reauthorization of the user fees without any mention of dietary supplements. But we are not at that juncture yet, and for now, we continue our discussions with the Hill.

“Recent articles have quoted sources who say that the provisions related to dietary supplements should not be included in the FDA Safety & Landmark Advancements (FDASLA) Act,” Mister continued.” “They have insisted that legislation should be limited to only pharmaceutical and device issues. That opinion is both naïve and ill-informed. Drug user fees have been reauthorized five times since the Prescription Drug User Fee Act (PDUFA) was first enacted in 1992. Since then, this must-pass piece of legislation every five years has been both tacked on to other larger bills (in 2002, it was part of a much larger bioterrorism bill) and been a vehicle for a variety of other FDA-related proposals including devices and food (in 2017, it even included prohibited acts related to food). So the notion that FDASLA must remain “pure” to drugs and devices only is an effort to deflect attention from the real issues.”

Mister added that given the divided, partisan environment in Congress today, very little legislation is able to advance to the President’s desk.

As to why CRN supports the creation of the mandatory product listing (MPL), Mister noted that “CRN’s Board of Directors first expressed support for this initiative in 2018, shortly after CRN created the Supplement OWL (online wellness library), the industry’s voluntary version of label transparency. 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, and our reasons for supporting it, in trade press, consumer press and regulatory journals,” Mister stated.

To read the full letter, visit www.crnusa.org/membership-member-center/my-crn/office-of-the-president/MPL-Update-080822.