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  Vol. VI, No. I
  January/February 2003

 Return to
 Pharmacotherapy
 Update Index

 

Dietary Supplements Update:
Seals-of-Approval

There continues to be a consistent use of dietary supplements in the United States. Many consumers, however, do not realize that these products are not standardized or regulated by The Food and Drug Administration (FDA) as prescription and over-the-counter products are. It remains the responsibility of the dietary supplement manufacturer to ensure the quality and consistency of the product. There are, however, no universal standards for maintaining this consistency and, therefore, several groups have begun to test products for quality. Two independent organizations, the U.S. Pharmacopeia (USP) and NSF International, have created fee-for-service certification programs for testing the quality of dietary supplements.

In February 2001, the USP initiated the Dietary Supplement Verification Program (DSVP). This program assesses the quality of dietary supplement ingredients as well as the conformity of the ingredients and product specifications. Health claims of the dietary supplements are not evaluated in this program. Once the USP evaluates and approves the product for quality, a seal is placed on the product. This label specifically indicates that the product has been manufactured in compliance with good manufacturing practices (GMPs), and it also tells the consumer that the product contains the stated ingredients, in amount and strength, and that the product is pure and meets limits for contaminants.

The USP will continue to do random checks to ensure product compliance and maintain certification, while audits of the manufacturing site will also be performed. Two manufacturers, Kirkland and Nature Made, are expected to be the first with DSVP labels by January 2003. NSF International began a certification program in 1999. Similar to the USP program, NSF verifies products for content and label accuracy, monitors for purity and contaminants, audits the manufacturing process, as well as conducts continued surveillance to ensure compliance. NSF also ensures manufacturers follow good manufacturing practices (GMPs) and has already certified over 60 dietary supplements.

A third independent group, ConsumerLab.com, is also testing herbs and supplements for purity, active ingredient content, and consistency. Manufacturers pay ConsumerLab between $2,500 and $4,000 to have their product tested and, if approved, can pay an additional fee for the ConsumerLab (CL) seal-of-approval. Products that pass ConsumerLab's testing will be listed on their website. As of July 2002, 595 products have been tested with 454 passing.

"Seals-of-approval" will assist patients in choosing quality products, however, consumers should be aware that these seals do not indicate an herb or supplement is safe and effective. Therefore, dietary supplements should still be treated with the same precautions as prescription medication and should not be taken without consultation from a physician or other health care professional.

Top Selling Herbs in 2001 ($ in millions)
 Ginkgo $46
 Echinacea $40
 Garlic $39
 Ginseng $31
 Soy $28