Rules Are Important Step for the Safety and Quality of Dietary Supplements
Aug. 12, 2003--Rockville, Md. - The United States Pharmacopeia (USP) commended the U.S. Food and Drug Administration’s (FDA) efforts in issuing proposed rules covering current good manufacturing practices (cGMP) for the manufacturing and packaging of dietary ingredients and dietary supplements. USP believes the proposed rules are a step forward for the dietary supplement industry and should, when final, help ensure the quality and safety of dietary supplements and greatly benefit consumers and the industry.
USP’s comments reflect its extensive experience in developing monographs for dietary supplements and its experience with its Dietary Supplement Verification Program (DSVP). 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, which appear in the United States Pharmacopeia and National Formulary (USP–NF). These texts are the official compendia of the United States and are recognized as such by the Dietary Supplement Health and Education Act (DSHEA) of 1994.
USP’s recommendations are summarized below:
Scientifically Valid Procedures
USP establishes scientifically valid procedures in the USP–NF, and encourages the FDA to include these procedures by adding a definition for the term, “scientifically valid.” The failure to acknowledge these procedures as scientifically valid would be inconsistent with the law as the law regarding dietary supplements recognizes the specifications, i.e. tests, procedures and acceptance criteria, of an official compendium (the USP–NF).
USP supports the proposal requiring criteria for selecting reference materials within laboratory operations. The use of reference materials is an integral part of ensuring the identity, purity, quality, strength and composition of a dietary supplement and/or dietary ingredient. USP also supports the proposed rule’s recommendation for the use of compendial standards. As the nation’s official compendia, USP provides official USP Reference Standards for use when testing materials according to compendial procedures.
Dissolution and Disintegration
USP also recommends that the proposed rule contain dissolution or disintegration requirements for dietary supplements. USP believes such requirements are important tools to establish the quality of dietary supplements. USP currently requires such testing as part of its DSVP program.
USP recommends that the FDA—like USP—require expiration dating. Without expiration dates, manufacturers cannot possibly ensure the appropriate potency or strength of the dietary supplement for the product’s “shelf life.”
Proposed regulations require that when no scientific procedure is available testing must be completed on each lot of components, dietary ingredients, or dietary supplements. USP suggests that the FDA consider modifying the amount of testing of each ingredient based on the use of a certificate of analysis. This degree of testing may take into account the past quality history of the supplier and the type of ingredient (e.g., vitamin, mineral, or botanical).
USP believes that the rule should be expanded to exclude placing on labels statements such as the dietary supplement “is produced using good laboratory practices” or “is produced using good practices” or “is produced in compliance with USP good manufacturing practices.” These or similar statements currently appear on dietary supplement labels and may be misleading.
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 the DSVP mark, which helps to 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 that desire 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.
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USP—Advancing Public Health Since 1820
The United States Pharmacopeia (USP) is a nonprofit, nongovernmental, standard-setting organization that advances public health by ensuring the quality and consistency of medicines, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements. These standards, which are recognized worldwide, are developed by a unique process of public involvement 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 about USP and its four public health programs, visit www.usp.org/e-newsroom.