NORTHRIDGE, Calif.--Aug. 11, 2003--Pharmavite LLC, manufacturer of Nature Made(R) vitamins, minerals and Nature's Resource(R) herbal products, submitted comments to the Food and Drug Administration (FDA) today urging development and enforcement of reasonable Good Manufacturing Practices (GMPs) for dietary supplements.
The proposed GMPs, which will set manufacturing standards for vitamins, minerals and other dietary supplements, were published in the March 13, 2003 Federal Register. Today marks the closing date of the comment period. The FDA will now review all comments and publish a final ruling, expected in 2004.
"Responsible manufacturers have been waiting for final GMPs since 1994, when the Dietary Supplement Health and Education Act was first passed," said Brent Bailey, Pharmavite president. "Today, we're an important step closer to the final rule that will give the FDA the power to enforce rigorous manufacturing standards. This will help rid the industry of sub par manufacturers and ultimately build consumer confidence in our industry."
Bailey said Pharmavite's comments reflected the company's overall support for GMPs, but cautioned against certain requirements that exceed current GMPs for drugs. In commenting on manufacturing, the company suggested a greater reliance on process control steps and written manufacturing procedures, rather than excessive post-production testing requirements. Further, Pharmavite strongly supported the need for written procedures related to the control of manufacturing equipment, materials and processes.
While awaiting the FDA to set 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. In an effort to further help quality supplement manufacturers self regulate and build consumer confidence, the USP created the Dietary Supplement Verification Program (DSVP) in 2002. DSVP is a rigorous supplement testing program that goes beyond the FDA's just proposed GMPs and serves to verify a product's quality, purity and potency. Pharmavite was the first participant in the DSVP and carries the DSVP certification mark on the majority of its Nature Made products. The FDA has long looked to USP as an official compendium of standards for drugs and dietary supplements.
Pharmavite has been a strong supporter and active participant in the initiative led by the Council for Responsible Nutrition, the industry's leading trade association, to develop the industry draft GMPs that were submitted to the FDA in November 1995 and later published by the FDA as the Advanced Notice of Proposed Rulemaking in 1997. The 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.