Magazine article Drug Topics

Watch for New Seals of Approval on Dietary Supplements

Magazine article Drug Topics

Watch for New Seals of Approval on Dietary Supplements

Article excerpt

The United States Pharmacopeial (USP) Convention is launching a dietary supplement verification program that will enable dietary supplement manufacturers to sport a verification mark on their products' labels.

According to a USP spokesman, this mark will indicate to consumers, practitioners, and retailers that the product contains the dietary supplement ingredients in the designated amount, meets acceptable limits of undesirable elements, and is manufactured appropriately.

"In the past couple of years, there has been confusion at the consumer level in differentiating quality dietary supplements from the ones that are not meeting quality standards. Lots of questions have been raised regarding the purity and quality standards, label accuracy, safety, and efficacy of these products," said Forouz Ertl, v.p. of USP's dietary supplement verification program.

Noting that USP began to work on establishing the program more than a year ago, Ertl said that a pilot phase of the program was launched a few months ago. During the pilot, USP evaluated eight products from the following four dietary supplement manufacturers: Leiner Health Products, Pharmavite, Rexall Sundown, and Perrigo.

The verification program is voluntary and open to all dietary supplement manufacturers in the United States. Manufacturers will be required to sign a licensing agreement with USP, but USP would not disclose the fees they will be charging companies.

"We ask the manufacturers to give us documentation-to establish the fact they already have a quality standard system in place," Ertl said. "If they can't establish their quality standards to us, the company will not qualify for our program. After we qualify the company, we go through product qualification. We ask for documentation specific to every product the firm wants us to certify. We arrange for a Good Manufacturing Practice [GMP] audit of their facility to be conducted by USP. …

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