FSMA Supplier Verification Rule Affects Finished Supplement Importers
This article was originally published in The Tan Sheet
Proposed FSMA rules would subject imported food products, including supplements, to the same safety standards as domestically produced food. The proposals are reminders that although supplement manufacturing is exempt from FSMA provisions redundant to GMP requirements, the act adds regulatory burdens for some firms.
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“We don't have to look much further than our consumer complaint and adverse event systems to see that these upgrades are needed. Each year we receive nearly 10,000 consumer complaints and adverse event reports regarding FDA regulated foods and dietary supplements,” says Susan Mayne.
Guidance states regulatory violation of refusing to permit entry of FDA investigator to inspect or not permitting an inspection includes “statements, actions, and passive behaviors that prevent or delay us from scheduling or fully conducting an inspection.”
FDA Center for Food Safety and Applied Nutrition Director Michael Landa says rules for preventive controls for human food and the foreign supplier verification program are “in the final stages of review.” However, the rule for accreditation of third-party inspectors is stalled.