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2/5/2002

USP Launches Dietary Supplement Certification Program

Donna Young

A little more than a year after announcing plans to initiate a certification program for dietary supplement products, the United States Pharmacopeia (USP) is making its Dietary Supplement Verification Program (DSVP) certification mark available to manufacturers to place on container labels.

USP established the program, which had undergone pilot testing in 2001 and was launched last November, to evaluate and confirm the contents of dietary supplement products, the manufacturing processes of firms, and their compliance with purity standards. DSVP does not address health or other claims offered by the manufacturer.

There are no federal regulations that establish a minimum standard of practice specifically for manufacturing dietary supplements, according to FDA. Manufacturers are responsible for establishing guidelines to ensure that dietary supplement products are safe and contain the ingredients listed on the labels.

USP said the DSVP verification mark will help assure consumers, health care professionals, and retail distributors that the product contains the ingredients—including the amount and strength—declared on the product’s label.

FDA regulations require that the label on a dietary supplement container include a descriptive name of the product stating that it is a supplement; the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents.

USP said it will issue its verification mark to companies that submit their products for evaluations based on laboratory testing of product samples and regular monitoring, audits of manufacturer’s quality systems, and quality control and reviews of manufacturing data. Manufacturers must also agree to comply with The United States Pharmacopeia and The National Formulary’s (USP-NF) general chapter on acceptable practices for manufacturing nutritional supplements and FDA’s "Advance Notice of Proposed Rulemaking" for good manufacturing practices.

The Dietary Supplement Health and Education Act (DSHEA), signed into law by President Bill Clinton in 1994, named USP-NF as the nation’s official compendium for standards on dietary supplements. Before then, dietary supplements were subject to the same regulatory requirements as were other foods. DSHEA amended the Federal Food, Drug, and Cosmetic Act.