NORTHRIDGE, Calif--March 7, 2003--As reported hours ago in the Associated Press, the Food and Drug Administration (FDA) today released the proposed rule on Good Manufacturing Practices (GMPs) for dietary supplements. Pharmavite LLC, manufacturers of Nature Made(R) vitamins, minerals and other dietary supplements and Nature's Resource(R) herbal products, applauds the FDA action. The proposed GMPs, which will set manufacturing standards for vitamins, minerals and other dietary supplements, are scheduled for publication in the March 13, 2003 Federal Register.
"We congratulate Commissioner Mark McClellan and urge FDA to finalize the rule soon," said Brent Bailey, Pharmavite president.
Bailey said Pharmavite may provide specific technical comments on the proposed rule as requested by FDA, but notes the company supports an expeditious finalization to increase FDA enforcement powers. "Once finalized, FDA will have the power to enforce rigorous GMP manufacturing standards. This will help rid the industry of sub par manufacturers and ultimately build consumer confidence in our industry."
Without FDA GMPs, many quality vitamin and supplement manufacturers have adhered to manufacturing standards recommended by the United States Pharmacopeia (USP), a not-for-profit organization that has set pharmaceutical and dietary supplement quality standards since 1820. The FDA has long looked at USP as an official compendium of standards for drugs and dietary supplements.
FDA first gave Advance Notice of Proposed Rulemaking for GMPs in 1997. FDA was given authority to set manufacturing guidelines with passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994.
About Pharmavite LLC
Founded in 1971, Northridge, California-based Pharmavite LLC manufactures and distributes Nature Made(R) vitamins and minerals, SAM-e, Nature's Resource(R) herbal products and other science-based supplements designed to promote health. Pharmavite's manufacturing facilities have been inspected and found to be in compliance with United States Pharmacopeia's Good Manufacturing Practices, the industry's most stringent standards.
Pharmavite is also the first participant in the United States Pharmacopeia's Dietary Supplement Verification Program (DSVP). DSVP is designed to build consumer confidence in dietary supplements and helps assure a product's quality, purity and composition through a rigorous inspection process.
Nature Made is America's number one, broadline brand of vitamins and minerals in the food, drug and mass channels. The Nature Made Wellness Advisor (NatureMade.com), an online educational initiative, utilizes sophisticated analytical tools to provide consumers with personalized health tips and wellness solutions. Nature's Resource (NaturesResource.com) offers one of the nation's strongest herbal supplement education programs for consumers and medical professionals.
The dietary supplement industry is regulated by the U.S. Food and Drug Administration and the Federal Trade Commission, as well as by government agencies in each of the 50 states.