For decades, pharmaceutical companies and conventional medicine have mounted an attack on dietary supplements. The narrative has been along the lines that pharmaceuticals represent the highest standards for quality, while dietary supplements are not regulated and can be outright dangerous! I will analyze this elitist proclamation.
The belief that pharmaceuticals represent the highest quality standards is challenged by recent and past events. For example, 140,000 bottles of the widely used cholesterol-lowering drug Atorvastatin (Lipitor) have been recalled. The recall is due to the tablets not meeting dissolution specifications. In other words, the tablets do not break down in the digestive tract and pass through without being absorbed. The reality is that there are many FDA drug recalls every month. The FDA also issues recalls of dietary supplements and foods. According to research published in the Journal of Pharmaceutical and Biomedical Analysis, the FDA recalled an average of 330 drugs per year between 2012 and 2023. Each recall involves an average of 400,000 product units. The most frequent cause for the recalls was impurities and contaminants! Moreover, recalls of pharmaceuticals that caused serious health problems or death accounted for 14% of the recalls. Relative to pharmaceuticals, deaths from dietary supplements are uncommon.
Contrary to what the media and certain medical organizations report, the FDA does regulate dietary supplements. The FDA’s own website states: “Dietary supplements are regulated by the FDA as food, not as drugs”.
The FDA requires U.S. supplement manufacturers to register before they can begin manufacturing. Moreover, the FDA acknowledges its oversight responsibility for dietary supplements in more detail with the following statement:
FDA’s role in regulating dietary supplements includes (among other things) inspecting dietary supplement manufacturing establishments, reviewing new dietary ingredient (NDI) notifications and other regulatory submissions for dietary supplements, investigating complaints, monitoring the dietary supplement marketplace, examining dietary supplements and dietary ingredients offered for import to determine whether they meet U.S. requirements, and reviewing adverse event reports from firms, consumers, and health care providers to identify products that may be unsafe.
The FDA requires manufacturers of foods and dietary supplements to follow the Current Good Manufacturing Practices (cGMP). The cGMPs are standards that manufacturers must follow to ensure the quality of dietary supplements and their labeling. This requires testing dietary supplements for purity and potency before release to the market and maintaining written records of the testing. The FDA conducts on-site inspections of supplement manufacturers' facilities. The main company I use to manufacture Stengler Health Products has undergone numerous audits and passed with flying colors each time.
The Federal Trade Commission (FTC) works with the FDA to oversee advertising claims of dietary supplements. The FTC website states:
“The Federal Trade Commission’s broad mandate is to prevent 'unfair or deceptive acts or practices.” That includes making sure the information marketers provide about the benefits and safety of dietary supplements and other health-related products is accurate so consumers can make informed decisions”.
Therefore, dietary supplements are regulated by two oversight agencies: the FDA and the FTC.
There can be problems with dietary supplements on the market, just as there can be with foods and pharmaceuticals. The reasons can include unethical manufacturers or honest mistakes in the manufacturing process. The main issue is the vast number of companies selling online that may not adhere to regulations until they are caught. There are bad players in all areas of business.
However, the claim that dietary supplements are unregulated is “fake news”. So, the next time any doctor or person states that supplements are not regulated, you can inform them that they are uninformed and that they ARE regulated by the FDA and FTC.
Ghijs, S., Wynendaele, E., & De Spiegeleer, B. (2024). The continuing challenge of drug recalls: Insights from a ten-year FDA data analysis. Journal of pharmaceutical and biomedical analysis, 249, 116349. https://doi.org/10.1016/j.jpba.2024.116349
Health Products Compliance Guidance. (2022, December 20). Federal Trade Commission. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance
Powel, J. (2025, October 23). Over 140,000 bottles of cholesterol medication recalled. See affected products. USA TODAY. https://www.usatoday.com/story/money/2025/10/23/generic-statin-atorvastatin-calcium-recall/86861216007/
Program, H. F. (2024, February 21). Questions and answers on dietary supplements. U.S. Food And Drug Administration. https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements
