USP Welcomes FDA Proposed Rules for Good Manufacturing Practices Rules to Help Assure Consumers Taking Dietary Supplements

Rockville, Md., April 3, 2003—The United States Pharmacopeia (USP) said today that the current good manufacturing practices (cGMP) proposed by the U.S. Food and Drug Administration (FDA) addressing the manufacturing and packaging of dietary ingredients and dietary supplements will greatly benefit consumers and the industry. USP believes the proposed rules are a step forward for the dietary supplement industry, and USP will submit formal comments to this effect to FDA.

USP has set standards for quality, purity, strength, and identity for pharmaceuticals and dietary supplements since 1820. In developing the proposed rules, FDA cited USP’s official manufacturing practices standards for dietary supplements (General Chapter <2750> Manufacturing Practices for Nutritional Supplements), which appear in the United States Pharmacopeia and National Formulary (USP–NF). These are official compendia of the United States and are recognized as such by the Dietary Supplement Health and Education Act (DSHEA) of 1994.

The proposed rules also indicate that manufacturers should use official compendial Reference Standards and compendial validated methods whenever possible when developing and producing dietary supplement products. FDA has the authority to recognize and enforce USP–NF validated methods and reference standards for vitamins, minerals, amino acids, and botanicals. Currently, USP has 155 dietary supplement monographs; an additional 74 monographs are under development. USP also has 102 References Standards for dietary supplements, as well as an additional 41 that are under development. A detailed listing of USP’s monographs and Reference Standards for dietary supplements are listed on the USP Web site, www.usp.org.

The proposed rules also establish limits for microbial contaminants and reference USP–NF General Chapters <2021>, <2022>, and <2023> as the standards for the dietary supplement industry.

USP operates the Dietary Supplement Verification Program (DSVP), which includes adherence to GMPs and evaluates and verifies supplements according to stringent standards for purity, testing for potential contaminants, and accuracy of ingredient labeling. Products that pass DSVP’s rigorous requirements are awarded a mark that helps assure consumers, health care professionals, and supplement retailers that a product:

· Contains the declared ingredients on the product label;
· Contains the amount or strength of ingredients declared on the product label;
· Meets requirements for limits on potential contaminants; and
· Has been manufactured properly by complying with USP and proposed FDA cGMPs.

The DSVP program incorporates not only FDA’s proposed GMPs but also the following more stringent requirements: review of written procedures for quality assurance, expiration dating, and adherence to USP–NF monographs (including dissolution and disintegration standards where applicable). This voluntary program has been embraced by several companies who want a rigorous approach to help ensure the identity, strength, potency, and quality of their dietary supplement products. In fact, manufacturers whose products have passed DSVP’s rigorous requirements are likely to meet or exceed the proposed FDA GMP rules.

For further information about USP go to www.usp.org, or contact USP by sending an e-mail to
[email protected].

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USP—The Standard of Quality

USP is a non-government organization that promotes the public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies. These standards are developed by a unique process of public involvement and are recognized worldwide. In addition, USP has additional public health programs that focus on promoting optimal health care, including the Dietary Supplement Verification Program (DSVP), Health Care Information, and Patient Safety. USP is a not-for-profit organization that achieves its goals through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical industry, and consumer organizations. For more information, visit www.usp.org/e-newsroom.

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