Author Affiliation: US Pharmacopeial Convention, Rockville, Maryland (rlw@usp.org).
To the Editor: The Commentary by Dr Denham1 noted the public health challenges associated with implementing the Dietary Supplement Health and Education Act of 1994 (DSHEA). Through DSHEA, quality standards of the US Pharmacopeial Convention (USP)—a not-for-profit standards-setting organization for drugs, dietary supplements, and food ingredients—are legally enforceable under the food misbranding provisions of the Federal Food, Drug, and Cosmetic Act for manufacturers who label dietary supplements as complying with the United States Pharmacopeia–National Formulary (USP-NF).2 Manufacturers who do not claim compliance with USP-NF, however, are not required to meet these standards,3 with possible implications for quality.4 For example, USP standards include tests for performance as a means of ensuring adequate release of dietary supplement ingredients from the dietary supplement. Further, USP standards ensure consistency in quality over time between and across dietary supplement products that are marketed under the same name.4
The USP public standards, developed through an open and transparent process by independent experts, provide quality specifications for dietary supplements and help protect consumers. Although these standards may not be mandatory under DSHEA, consumers through their purchasing actions can encourage manufacturers to embrace public quality standards that raise the bar, and the Food and Drug Administration (FDA) also can play a helpful role in encouraging development of and conformance to these standards.
Consumers can educate themselves and help ensure the identity and integrity of dietary supplements by looking for a mark of quality that indicates a manufacturer's voluntary participation in a verification program. Increasing numbers of manufacturers take part in such programs, and they are offered by several sources. Products that pass all verification requirements, including an audit for compliance with good manufacturing practices, product and ingredient testing, and manufacturing document review, can receive recognition (eg, http://www.usp.org/USPVerified).
These voluntary verification programs can advance the global strategy recently announced by the FDA of leveraging public and private resources. Such programs could be part of a risk-based priority inspection regime in which manufacturers who embrace voluntary verification and certification programs become less urgent candidates for inspection, and facilities at higher risk could be targeted for inspection.
Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Williams reported being the chief executive officer at the US Pharmacopeial Convention.
Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature
Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal
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