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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.