USP Launches Dietary Supplement Certification Program
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 ingredientsincluding the amount and strengthdeclared on the products 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 manufacturers quality systems, and quality control and reviews of manufacturing data. Manufacturers must also agree to comply with The United States Pharmacopeia and The National Formularys (USP-NF) general chapter on acceptable practices for manufacturing nutritional supplements and FDAs "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 nations 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.