Trade association proposes application of dietary supplement GMPs to raw material suppliers.
- FDA’s current Good Manufacturing Practice (GMP) regulations in 21 CFR Part 111 apply to finished dietary supplements, but not directly to the raw materials or dietary ingredients used in their production.
- In yet another development related to the New York Attorney General’s (AG) investigation into the marketing of herbal supplements, the Organic & Natural Health Association met with the AG’s office and proposed that the dietary supplement GMP regulations be expanded to encompass the production of raw materials (e.g., dietary ingredients) as well.
- Organic & Natural plans to file a citizen petition to request that FDA expand the scope of the dietary supplement GMPs. The CEO of Organic & Natural reportedly has not formally communicated with other dietary supplement trade associations regarding the scope of 21 CFR Part 111. Organic & Natural’s proposal is unlikely to be without its detractors, but the full extent of industry support or opposition remains to be seen.