USP Comments on FDA Dietary Supplement Strategy

The U.S. Pharmacopoeia (USP) has responded to the Food and Drug Administration's (FDA) request for information in developing an overall strategy to achieve effective regulation of dietary supplements. Commenting at FDA's open meeting, Joseph Valentino, J.D., USP's general counsel and senior VP stated, "FDA's overall strategy should ensure the identity, safety, purity, and quality of dietary supplements. This strategy also should ensure consistency and uniformity of product strength and identity, so that consumers can make informed selections among dietary supplements."

Based upon concerns about the quality of dietary supplements, USP has set standards for these products and has developed information on standards. In its comments, USP encouraged the FDA to:

• work with USP to develop standards for botanical and non-botanical dietary supplement products;
• encourage the industry to use these standards, and incorporate them into FDA regulations;
• enforce USP standards and National Formulary (NF) standards to ensure the purity, potency, quality, and most important, the safety of dietary supplements; and
• carefully review product labeling to ensure that labels accurately state compliance with USP or NF standards and do not contain false, meaningless, or misleading statements.

The USP further offered that "USP" or "NF" on a product label would help inform consumers that the manufacturer is meeting quality standards that have been established by an authoritative, credible and federally-recognized standards-setting organization. The organization claims that vague statements such as "standardized" or "meets laboratory standards" offer no such assurance, and may be misleading to consumers.

USP is establishing public standards for botanicals that comprise 90% of U.S. sales. USP also is establishing standards for the major non- botanical dietary supplements on the market. A full copy of the USP's comments is available at www.usp.org or contact USP at: 301-816-8252.