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ABSTRACT: Some vitamin and dietary supplements are sporting a new certification seal from the U.S. Food and Drug Administration (FDA) designated representative in hopes of assuring consumers that the product lives up to its ingredient labeling claims.
COMMENTARY: The United States Pharmacopeia (USP), an independent agency that serves as the government's official compendium for dietary supplement standards, has begun to issue the certification on hundreds of products that it has independently tested as part of its Dietary Supplement Verification Program (DSVP).
This new program is voluntary and open to all manufacturers of dietary supplements operating in the U.S., a $17-billion-a-year market that includes vitamins, minerals, herbs, botanicals, and sports supplements sold over the counter and consumed by two of every three Americans.
To receive the certification, manufacturers must submit products they select to a "vigorous" seven-step testing and evaluation process that the USP says it ensures meets all labeling claims — first in independent laboratories and then on store shelves. This process includes testing and auditing of declared ingredients, their amounts or dosages, and meeting requirements of limits on contaminants.
So far, hundreds of supplements by two leading manufacturers have been tested and issued the certification. Products that will receive the certification label include those by Nature Made, which just began to hit shelves at some 30,000 stores nationwide, and those under the Kirkland brand, which will be displayed at Costo stores beginning next week.
Together, Nature Made and Kirkland produce about 30% of all vitamins and minerals consumed nationally, and about 20% of the total supplement market, said Richard Wailes, USP's head of sales and marketing. Four other manufacturers have signed up for the certification program and their products will carry the "Dietary Supplement Verified" certification in 2003.
Under the program, manufacturers can submit any products they choose and pay for all testing by USP, which has been establishing drug and other product standards since 1820 and has worked hand-in-hand with the FDA since the federal agency was created in 1938.
Because the FDA regulates dietary supplements as foods and not "conventional" medicines, manufacturers typically do not have to get FDA approval before producing or selling dietary supplements. The FDA can take action only if a product is deemed unsafe and is already on the market.