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
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
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
"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