Looking to enhance health or increase the total intake of a particular nutrient?  In addition to adjusting diet, one may consider taking a dietary supplement.  A dietary supplement is an edible product containing a substance intended to add further nutritional value to one’s own diet. (Milenovich, 2017).  Examples of supplement ingredients may include micronutrients, botanicals, amino acids, and probiotics. Americans have been taking supplements since the first ‘Vital amine’ was isolated in 1926. (Mozaffarian, 2018) To date, nearly 75% of all Americans take supplements (Welch, 2024).  The Food and Drug Administration (FDA) monitors the dietary supplementation marketplace. The FDA’s position is to: set guidelines for companies to follow, investigate claims of complaints concerning the safety of the nutrient, and inspect facilities to ensure they are meeting manufacturing requirements. (Rawson, 2020) U.S. Dietary Supplement Health and Education Act (DSHEA) was established in 1994 to clarify regulations between a dietary supplement and a drug. (Rawson, 2020) The law defined dietary supplements as a food, rather than a drug. This meant that dietary supplements were now categorized as a food product, subjected to food regulations.  

In addition to outlining a legal definition of dietary supplements, DSHEA also outlined labeling, packaging, and storage protocols of supplements. (Rawson, 2020 ) As of 2024, DSHEA requires companies to provide: labels that contain the quantity of an ingredient; nutritional information, including blends; listed ingredients according to weight; safety information; as well as business information. The FDA refers to this guidance as Good Manufacturing Practice (GMP(Welch, 2024). GMP is a strength of the FDA process. With these guidelines set in place consumers can make informed decisions when purchasing dietary supplements. 

Other strengths of the FDA process are the safety reviews of new ingredients, new product testing, and examination of imported substances.Although the FDA employs guidance, challenges remain. For example, the effectiveness of dietary supplements is not required by law. Thus, the average consumer may have difficulty discerning the efficacy of a supplement and its claims. Legally, supplements can make ‘structure-function’ claims such as ‘contains calcium to fortify bones,’ but may not make a claim that a product may cure, diagnose, or treat a disease. (Stephenson, 2022) In addition to the effectiveness of a claim, another challenge is the lack of systematic process of the FDA.  There are over 100,000 different products sold today(Welch, 2024), and with the FDA’s subsequent role to a dietary supplement’s introduction to the market, the FDA relies on a company’s honesty of a product which also raises safety concerns. 

In sum, people have been using dietary supplements for decades. Although improvements have been made by the US government over the years, regulating the validity of claims, as well as FDA systematic policy, is recommended. Products ought to be subjected to 3rd party evaluation prior to being sold to the public, ensuring consumer safety.

References

Bailey, R. L. (2018). Current regulatory guidelines and resources to support research of dietary supplements in the United States. Critical Reviews in Food Science and Nutrition, 60(2), 298–309. https://doi.org/10.1080/10408398.2018.1524364

‌Milenkovich, N. (2017). Dietary supplements: an FDA primer. Drug Topics, 161(1), 29.

Mozaffarian, D., Rosenberg, I., & Uauy, R. (2018). History of modern nutrition science implications for current research, dietary guidelines, and food policy. BMJ, 361, k2392. https://doi.org/10.1136/bmj.k2392

Rawson, E. S., J. David Branch, & Stephenson, T. J. (2020). William’s Nutrition for Health, Fitness & Sport.

Stephenson, T. J., Sanctuary, M. R., & Passerrello, C. W. (2022). Human nutrition : science for healthy living. Mcgraw Hill.

‌FDA’s Regulation of Dietary Supplements with Dr. Cara Welch. (n.d.). Www.youtube.com. Retrieved May 11, 2024, from https://www.youtube.com/watch?v=H19qtWfclBY&ab_channel=U.S.FoodandDrugAdministration

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