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

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.

Estimation of Total Usual Dietary Intakes of Pregnant Women in the United States

“…This study indicates that dietary supplements appear to help pregnant women meet recommendations to increase intake of some key nutrients, and that most pregnant women take a dietary supplement. Although inconsistent definitions of multivitamin-mineral dietary supplements exist, 58,59 most dietary supplements consumed during pregnancy include folic acid and iron. 8,12 The number of nutrients and the amounts provided by prenatal supplements vary markedly depending on whether the product was obtained via a prescription or over the counter.…”

An Approach to Investigate Content-Related Quality of Nutraceuticals Used by Slovenian Consumers: A Case Study with Folate and Vitamin D Supplements

“…Quality control is also crucial for both production and shelf life; however, the laboratory quantification of certain constituents can be challenging [24][25][26][27][28]. The bioavailability of ingredients used in food supplements and their interactions also need to be considered, but this area is commonly overlooked and very challenging to regulate [29].…”

Menaquinone 7 Stability of Formulations and Its Relationship with Purity Profile

“…In the dietary supplement industry, GMP regulations were promulgated by the FDA almost a decade ago (21 CFR Part 111) [ 25 ], however, according to recent results of FDA GMP inspections [ 26 ], several manufacturers do not fully comply with cGMPs, often due to lack of specifications for ingredients and finished products. The consequences of the presence of unknown components in the finished products should not be underestimated, since they could influence the stability of the formulation and, most importantly, their safety is not guaranteed due to the absence of appropriate toxicity tests [ 27 ].…”