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Review
. 2020;60(2):298-309.
doi: 10.1080/10408398.2018.1524364. Epub 2018 Nov 13.

Current regulatory guidelines and resources to support research of dietary supplements in the United States

Regan L Bailey  1
Affiliations
Review

Current regulatory guidelines and resources to support research of dietary supplements in the United States

Regan L Bailey. Crit Rev Food Sci Nutr. 2020.

Abstract

The U.S. Dietary Supplement Health and Education Act (DSHEA) established the regulatory framework for dietary supplements as foods through the Food and Drug Administration (FDA). DSHEA outlined the legal definition, labeling requirements, and process for adverse event reporting for dietary supplements. FDA also issued formal guidance on current Good Manufacturing Practice to ensure that processes for preparation, packaging, labeling, and storage of supplements and ingredients are documented and meet specifications to ensure purity, composition, and strength. However, efficacy of dietary supplements is not required under U.S. law. Despite regulations to improve the marketplace, many challenges remain; as a result, the quality and safety of products available can be highly variable, especially for botanical and herbal products. The ability of regulators to successfully carry out their mission is hampered by the sheer number of products and manufacturing facilities and a lack of analytical methods for all ingredients and products in the marketplace, this is especially difficult for herbal and botanical dietary supplements. Safety issues continue to exist such as adulteration and contamination, especially with specific product types (i.e. body building, sexual enhancement). Thus, a need remains for continued efforts and improved techniques to assess the quality of dietary supplements, especially with regard to purity, bioavailability, and safety. This review will highlight the existing American regulatory framework for dietary supplements and will describe the remaining regulatory barriers to ensuring that safe and high-quality dietary supplements are offered in the marketplace.

Keywords: Dietary supplements; good manufacturing practices; quality; regulation; safety.

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References

    1. Agbabiaka TB, Wider B, Watson LK, and Goodman C 2017. Concurrent use of prescription drugs and herbal medicinal products in older adults: A systematic review. Drugs & Aging 34 (12): 891–905. - PMC - PubMed
    1. American Herbal Products Association 2018. Guidance on formulation and marketing of dietary supplements under tha national organic program Silver Spring, MD: American Herbal Products Association.
    1. Andrews KW, Roseland JM, Gusev PA, Palachuvattil J, Dang PT, Savarala S, Han F, Pehrsson PR, Douglass LW, Dwyer JT, et al. 2017. Analytical ingredient content and variability of adult multivitamin/mineral products: National estimates for the dietary supplement ingredient database. The American Journal of Clinical Nutrition 105 (2):526–39. - PMC - PubMed
    1. Andrews KW, Gusev PA, McNeal M, Savarala S, Dang PTV, Oh L, Atkinson R, Pehrsson PR, Dwyer JT, Saldanha LG, et al. 2018. Dietary supplement ingredient database (DSID) and the application of analytically based estimates of ingredient amount to intake calculations. The Journal of Nutrition 148 (8S):1413S–21S. - PMC - PubMed
    1. Anwar M, Law R, and Schier J 2016. Notes from the field: Kratom (mitragyna speciosa) exposures reported to poison Centers-United States, 2010–2015. Morbidity and Mortality Weekly Report 65 (29): 748–9. - PubMed