CRN Objects to Missing Protections in FDA Safety and Landmark Advancements Act

MAY 27, 2022

WASHINGTON—The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today issued the following statement regarding the FDA Safety and Landmark Advancements Act (FDASLA) introduced by the Senate HELP Committee.

Statement by Steve Mister, President & CEO:

“The Council for Responsible Nutrition is disappointed with the FDA Safety and Landmark Advancements Act introduced today. 

“CRN has led the dietary supplement industry in advocating for a federal mandatory product listing program housed at the U.S. Food and Drug Administration (FDA). A strong mandatory listing program administered by FDA would provide consumers and regulators with a more complete understanding of the marketplace and the range of products and ingredients that are currently marketed as dietary supplements.  

“However, mandatory product listing should not be used as a barrier for a compliant dietary supplement to enter the market. Unfortunately, the current draft of this bill does not include this essential protection, nor does it safeguard confidential business information. In addition, this bill includes new language that would grant FDA broad authority to potentially prevent legitimate dietary supplements from entering the market at the whim of the agency.

“CRN is optimistic there are still opportunities to address concerns with the bill as introduced, and we look forward to working with Senate HELP Committee members and their staffs to achieve a proposal that safeguards consumers. Both responsible companies and consumers are better served when the agency has a comprehensive view of the products in the market. We remain committed to developing a program that increases transparency for this $54 billion marketplace by requiring supplement manufacturers to provide FDA with a copy of their labels and basic product information.

“However, this new legislation must:

  • Provide explicit assurance that FDA may neither reject a submission nor create qualifications on submissions that would permit the agency to reject a listing;
  • Include assurances that confidential or proprietary business information is protected from release to the public; and
  • Avoid creating new prohibited acts which could have unintended consequences for the industry.

“CRN is dismayed that none of the changes we offered to the discussion draft were incorporated in the bill as introduced. There is still time for the Senate to recognize and incorporate changes to address our objections; however, if our significant concerns are not addressed, CRN is prepared to oppose the inclusion of any provisions relevant to dietary supplements in the FDASLA.”

MEDIA:

 

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing more than 200 dietary supplement and functional food manufacturers, ingredient suppliers, and companies providing services to those manufacturers and suppliers. In addition to complying with a host of federal and state regulations governing dietary supplements and food in the areas of manufacturing, marketing, quality control and safety, our manufacturer and supplier members also agree to adhere to additional voluntary guidelines as well as to CRN’s Code of Ethics. For more information, visit www.crnusa.org. Follow us on Twitter @CRN_Supplements and LinkedIn