In the comments, NPA expressed its concern that FDA is falling behind on the Food Safety Modernization Act (FSMA) inspectional cycle, according to a press release. NPA has asked FDA to issue an import alert for supplements or ingredients that fail to comply with NDI regulations. In fiscal year 2019, there were fewer than 50 notifications submitted to FDA to establish the safety of new dietary ingredients.
Related: NPA Asks 2020 Candidates to Take Positions on Health Issues Associations Submit Proposed Framework for NDI Master File Industry Associations Commend FDA for Taking Swift ActionNPA has proposed the following two-step approach to protect consumers while FDA is unable to conduct facility inspections during the COVID-19 pandemic:
- Issue an import alert for adulterated ingredients. An import alert places the responsibility back on the importer to ensure that the products being imported into the U.S. are in compliance with FDA regulations. The import alert requires no additional resources, the release explains, but would provide important information to the Agency to facilitate their enforcement of current dietary supplement regulations. This authority was last used in 2014 in response to safety concerns related to the import of kratom.
- Expand participation in SSCI. The Supplement Safety and Compliance Initiative is an industry-driven program led by leading retailers to provide a harmonized benchmark to recognize various safety standards throughout the entire dietary supplement supply chain. Dietary supplements must meet or exceed the SSCI benchmark to be accepted in major retailers. NPA’s second recommendation is therefore to expand the number of companies who agree to meet these industry-specific quality assurance standards.