Dietary Supplement GMP Warning Letters
This article was originally published in The Tan Sheet
Executive Summary
NYSW Beverage Brands responds to FDA that some ingredients are provided with specification sheets from suppliers. The agency advises the firm is “still responsible for establishing specifications” and that “reliance on the specification sheets provided by your supplier is insufficient to meet” GMP requirements.
You may also be interested in...
Dietary Ingredient Identity Testing Exemptions Remain A Puzzle
The trade groups ask FDA to keep open the door for supplement firms to petition for 100% identity testing exemptions under an IFR published in 2007. AHPA and NPA say supplement manufacturers have insufficient guidance on information the agency expects in petitions for identity testing waivers.
Supplier Qualification Guideline Touts Flexibility, Defers Best Practices
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.
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.