Pharmavite LLC Welcomes FDA Release of Final Good Manufacturing Practice Regulation
Number one mass market dietary supplement manufacturer ready to meet
NORTHRIDGE, Calif., June 22 /PRNewswire/ -- Pharmavite LLC, manufacturer and marketer of Nature Made(R) vitamins, minerals, herbs and other supplements, announced plans to swiftly adopt the Good Manufacturing Practice (GMP) final rulings for dietary supplements published today by the Food and Drug Administration (FDA). Pharmavite applauds the FDA for finalizing this important regulation that will set manufacturing standards for the dietary supplement industry. "Responsible manufacturers have been waiting for final GMPs since 1994, when the Dietary Supplement Health and Education Act (DSHEA) was first passed," said Connie Barry, Pharmavite's President and CEO. "We commend FDA for passing this final rule. FDA now has the power to enforce rigorous manufacturing standards that will rid the industry of noncompliant manufacturers. Ultimately, it will build consumer confidence in our industry." David Smith, Chief Science Officer for Pharmavite, said, "We are pleased that the rule includes thorough manufacturing safeguards and extensive quality, equipment and record-keeping requirements. Pharmavite is already in substantial compliance with these new regulations and will quickly implement the balance of the requirements." Smith also added that the GMPs are very rigorous and borrow heavily from drug industry GMPs, which will help put an end to the notion that supplements are unregulated. Large dietary supplement manufacturers must comply with the new GMP regulations by June 2008. Mid-size manufacturers (i.e., less than 500 but more than 20 employees) must meet the GMPs by June 2009. Small manufacturers (i.e. less than 20 employees) must meet the GMPs by June 2010. 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. Supplements manufactured to USP standards often carry the USP quality seal on their products. In 2002, in an effort to further help quality supplement manufacturers self-regulate and build consumer confidence, USP created a comprehensive dietary supplement verification program. The USP program verifies a product's integrity, purity and potency. Pharmavite was the first participant in the program, and now carries the distinctive USP verification mark on more than 90 of its products. The FDA has long looked to USP as an official compendium of standards for drugs and dietary supplements. "USP verification compliments FDA efforts and ensures consumer trust and confidence in our products," said Smith. 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 an 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. GMPs were first proposed in the March 13, 2003 Federal Register. About Pharmavite LLC For more than 30 years, Pharmavite has earned and maintained the trust of pharmacists, consumers, and retailers by manufacturing high-quality vitamins, minerals, herbs and other dietary supplements that are safe, effective and science-based. An industry leader, Pharmavite adheres 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 addition, Pharmavite participates in USP's Verification Program for dietary supplements. 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.
SOURCE Pharmavite LLC
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