2014

Pharmavite LLC Welcomes FDA Release of Final Good Manufacturing Practice Regulation Number one mass market dietary supplement manufacturer ready to meet

FDA-mandated GMPs



    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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