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Any reorganization structure for human foods proposed by U.S. Food and Drug Administration (FDA) must include dietary supplements and the new deputy commissioner must be accountable for supplement regulation, the Council for Responsible Nutrition (CRN) President & CEO Steve Mister and SVP Scientific & Regulatory Affairs Andrea Wong, PhD, stated in a letter to FDA Commissioner Robert Califf, MD on March 28.
CRN’s letter followed a meeting with agency officials in January to discuss the Reagan-Udall Foundation report, “Operational Evaluation of the FDA Human Foods Program.”
“Facilitating a stronger collaboration between the section of FDA charged with developing policy—the Office of Dietary Supplement Programs (ODSP)—and the section that has the most routine interaction with the industry—the Office of Regulatory Affairs (ORA)—should be a priority for the deputy commissioner,” Mister and Wong noted.
CRN’s letter called out the agency’s delays on several issues including:
• New Dietary Ingredients (NDIs) final guidance
• Rulemaking regarding drug preclusion exemption for n-acetyl-l-cysteine (NAC)
• Inspections/testing and enforcement actions
“CRN is concerned that delayed action and the lack of strong enforcement actions to remove blatantly illegal products from the market pose a risk to consumer safety,” Mister and Wong wrote.
FDA’s former deputy commissioner for food policy testified that the agency’s structure and culture exacerbated delays, as reported by the Washington.
CRN’s letter also called for collaboration with industry stakeholders, noting issues with the “Supplement Your Knowledge” educational materials released in June 2022, developed with no input from industry prior to their release.
CRN pointed to its Supplement OWL database of product labels, ingredient listings, label claims, and other information as a template for mandatory product listing of dietary supplements, which FDA has called for a mandatory product listing of dietary supplements.
“Given the acknowledgment that FDA is understaffed and under-resourced with respect to many aspects of its food program, and especially with respect to the burgeoning dietary supplement marketplace, FDA would be well-served to seek collaboration from established industry stakeholders like CRN,” Mister and Wong advised.
Optimizing FDA reorganization is one of CRN’s top policy priorities for 2023, the organization stated.
For more information, visit www.crnusa.org.
