The Shocking TRUTH About Dietary Supplements in the US

Dr. Stengler: The FDA recalled an average of 330 drugs per year between 2012 and 2023. Each recall involves an average of 400,000 product units, and the most frequent cause for the recalls was impurities and contaminants.

I'm Dr. Mark Stengler. I've researched and written 20 books on nutrition and functional medicine, and I've been practicing as a medical doctor for 30 years. For decades, pharmaceutical companies and conventional medicine practitioners have mounted an attack on dietary supplements. The narrative has been something like this: that pharmaceuticals represent the highest standards for quality, while dietary supplements are not regulated and can be outright dangerous. I'll analyze this proclamation that we often hear.

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, also known as Lipitor, have been recalled in recent times. The recall was 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 food, so it's not just drugs.

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, and the most frequent cause was impurities and contaminants. Moreover, recalls of pharmaceuticals that cause serious health problems or death accounted for 14% of the recalls. Relative to pharmaceuticals, deaths from dietary supplements are very uncommon.

Contrary to what the media and certain medical organizations report, the FDA does regulate dietary supplements. The FDA's own website states that dietary supplements are regulated by the FDA as food, not as drugs. The FDA requires US supplement manufacturers to register before they can begin manufacturing. The FDA acknowledges its oversight responsibility for dietary supplements in more detail, stating that its role includes, among other things, inspecting dietary supplement manufacturing establishments, reviewing new dietary ingredient notifications and other regulatory submissions, investigating complaints, monitoring the dietary supplement marketplace, examining dietary supplements and ingredients offered for import to determine whether they meet US requirements, and reviewing adverse event reports from firms, consumers, and healthcare providers to identify products that may be unsafe.

The FDA requires manufacturers of foods and dietary supplements to follow current Good Manufacturing Practices, often referred to as GMP. The GMPs are standards manufacturers must follow to ensure the quality of dietary supplements and their labeling, requiring testing for purity and potency before release to 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 many audits where the FDA comes in, analyzes how they're doing things, and tests the records — and they have passed with flying colors each time.

What about the FTC's role? The Federal Trade Commission works with the FDA to oversee advertising claims of dietary supplements. The FTC website states that its broad mandate is to prevent unfair or deceptive acts or practices, which 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.

Now, there can be problems with dietary supplements on the market, just as there can be with foods and pharmaceuticals — it can happen in all three categories, and it does. The reasons can be unethical manufacturers or just honest mistakes in the manufacturing process; no business is perfect. The main issue is the vast number of companies selling supplements online that may not adhere to regulations until they are caught. There are bad players in all areas of business — foods, supplements, pharmaceuticals, and many other categories. However, the claim that dietary supplements are unregulated is really 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 supplements are regulated by the FDA and FTC. I hope you found this video helpful, and make sure to hit the like button and subscribe.

‍