On May 27, the Council for Responsible Nutrition (CRN) issued a statement by Steve Mister, president and CEO, regarding the FDA Safety and Landmark Advancements Act (FDASLA) introduced by the Senate HELP Committee.
“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.”
For more information, visit www.crnusa.org.
