Supplier Qualification Guideline Touts Flexibility, Defers Best Practices
This article was originally published in The Tan Sheet
The Standardized Information on Dietary Ingredients Work Group publishes a guide to help supplement firms qualify ingredient suppliers under FDA good manufacturing practices. But with only three out of five major industry associations involved, not everyone is on board with the SIDI efforts.
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Failing to qualify suppliers “one of the more common citations” FDA inspectors find at supplement facilities, says ORA deputy director Michael Dutcher. “If you're not sort of reconfirming once in a while it could lead to a problem with your products that you weren't even expecting.”
The agency dispenses with notice and comment before imposing an IFR because the authority for expanded access to food product firms’ records was effective when FSMA became law in January 2011. FDA also publishes a draft guidance on FSMA-imposed records regulations.
The dietary supplement industry lost one of its most active and vocal scientific leaders in Washington when Andrew Shao departed the Council for Responsible Nutrition for an executive post with Herbalife.