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12/19/2002

Dietary Supplement Bottles May Bear New Certification Mark

Kate Traynor

The United States Pharmacopeia (USP) announced Tuesday that dietary supplement containers bearing the standard-setting organization's new certification mark are starting to appear in stores.

Richard Wailes, USP vice president of marketing and sales, described the certification mark as "a tool to help consumers understand that what's on the label is in the bottle."

Certification of dietary supplement products is granted through USP's voluntary Dietary Supplement Verification Program (DSVP) and indicates that the product and its manufacturing facility passed certain quality control tests.

"It's a rigorous program," said USP chief operating officer John T. Fowler during a press conference. "It's not a rubber-stamp program."

V. Srini Srinivasan, vice president of the DSVP program, said the testing process ensures that the product has been manufactured properly and contains the ingredients listed on the label at their declared amounts and strengths. The testing also ensures that a product conforms with the relevant specifications for dissolution and does not contain too many contaminants.

But DSVP certification does not guarantee that a product is safe or effective. Some consumer groups have expressed fears that the public could misinterpret the certification mark as a guarantee that a product works safely and as advertised.

To address this concern, USP's Fowler said that verifying safety and efficacy claims is "not an appropriate role for USP" and should instead be addressed by consumers in consultation with their health care providers.

"Our real emphasis is on the quality of the ingredients," Fowler explained.

So far, four dietary supplement manufacturers have submitted products for DSVP certification, the cost of which is borne by the firms. Most of the products that have earned certification are sold under the Nature Made or Kirkland brand, which together, Wailes said, account for about 20 percent of the dietary supplement market and 30 percent of sales of vitamin and mineral products.

Srinivasan noted that USP has recently received several botanical supplement preparations and nonbotanical products, such as glucosamine and chondroitin, for evaluation by the DSVP program.