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Quality Assessment Programs for Dietary Supplements

Assistant Clinical Professor, Department of Family Medicine, University of Colorado, Denver, CO; Vice President of Medical Outreach, Focus on the Family, Colorado Springs, CO

Dónal P O'Mathúna, PhD MA

Professor of Bioethics and Chemistry, Mount Carmel College of Nursing, Columbus, OH

Reprints: Walter L Larimore MD, Focus on the Family, 8605 Explorer Dr., Colorado Springs, CO 80920-1051, FAX 719/548-4525, E-mail larimowl{at}fotf.org

BACKGROUND: In the US, consumers and healthcare professionals have been forced to depend on self-regulation by the dietary supplement industry for product quality, consistency, potency, and purity, a system that has yielded mixed results at best.

OBJECTIVE: To characterize the current state of product quality verification in the dietary supplement industry and review recent developments and future plans to improve supplement safety and regulation.

METHODS: Studies describing the quality of dietary supplements are reviewed, along with recent Food and Drug Administration (FDA) plans to improve supplement regulation. Several independent dietary supplement quality certification programs are described and evaluated.

RESULTS: Quality control standards for dietary supplements run the gamut from good to nonexistent. Contamination, false labeling, and incomplete labeling are not uncommon problems — as are significant discrepancies in disintegration, dissolution, and in vitro release characteristics of various dietary supplements. The need for improved regulation has led to plans for increased FDA involvement through enforcement of good manufacturing practices and truths in labeling. Meanwhile, independent product certification companies have emerged and provide some reassurances; however, they possess several limitations as well.

CONCLUSIONS: Until proposed FDA initiatives are finalized and implemented, certification programs can help provide assurances of safety and assist in product selection. Although they do not testify to effectiveness (and may even inadvertently mislead some consumers), certification programs may help curb what has been called "the Wild West nature of the dietary supplement industry."

Key Words: certification, dietary supplement, quality assurance, quality control

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