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Supplement legislation criticized by trade groups

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WASHINGTON— The Consumer Healthcare Products Association (CHPA) and the Council for Responsible Nutrition (CRN) have issued statements condemning a Senate bill that they say would put an “unnecessary and costly burden” on the dietary supplement industry. The legislation, known as S. 4348, the FDA Safety and Landmark Advancement Act of 2022 (FDASLA), was passed on Tuesday by the Senate HELP Committee.

“While CHPA remains highly supportive of an appropriate listing system for dietary supplements that will enhance consumer safety, we are strongly concerned that the dietary supplement provisions of this legislation are overly broad and will place unnecessary and costly burdens on the entire industry,” CHPA president and CEO Scott Melville said in a statement. Moreover, the legislation falls short of the comprehensive reforms needed to appropriately and effectively modernize the regulatory framework for dietary supplements.

CRN-CHPA Logos“CHPA remains committed to working with congressional leaders in both parties on an appropriate listing system that paves the way for increased visibility into the dietary supplement marketplace, while also providing consumers with the assurances they deserve regarding dietary supplements sold in the United States.”

CRN was also critical of the legislation, saying that a mandatory product listing program for dietary supplements would provide needed transparency for consumers and the Food and Drug Administration, but it must be done in a way that does not stifle innovation or harm businesses.

“The outcome of today’s Senate HELP Committee vote on the FDA Safety and Landmark Advancement Act of 2022 (FDASLA)—which fails to include protections necessary for responsible industry to thrive—is highly disappointing,” CRN president and CEO Steve Mister said. “As the industry’s leading proponent for a federal mandatory product listing program operated by FDA, CRN remains steadfast in our belief that such a program can provide consumers and the agency the transparency they want and need from the marketplace.

“However, that transparency does not require confidential business information to go unprotected and should not necessitate trading away assurances that the authority to create the listing will not be misused. Responsible industry invests millions of dollars each year to researching, developing, and testing—ingredient innovation that powers the $54 billion dietary supplement market. Leaving out these essential business protections will needlessly stifle that innovation.

“Any legislation we support must safeguard consumers and responsible industry with these essential protections:

  • Unwavering language that FDA may neither reject a submission nor create qualifications on submissions that would permit the agency to reject a listing
  • Protections for confidential or proprietary business information from public release
  • Limits on the information provided to FDA to those items that appear on the label
  • No creation of broad, new prohibited acts, which could have unintended consequences for the industry

“We remain committed to engaging congressional leaders and their staffs on this issue and thank, in particular, Sens. Dick Durbin (D-IL), Mike Braun (R-IN), and Mitt Romney (R-Utah), for their leadership on this issue. CRN cannot support FDASLA as advanced by the Senate HELP Committee. We will continue to pursue a mandatory listing program that simultaneously increases transparency for consumers and FDA without sacrificing essential protections for industry.”

 

 


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