The Shocking TRUTH About Dietary Supplements in the US

Introduction and FDA Recall Context 0:00

The FDA recalled an average of 330 drugs per year between years of 2012 and 2023. Each recall involves an Average of 400,000 product units. The most frequent cause for the recalls was I'm Dr. Mark Stengler. I've researched and written 20 books on nutrition and functional medicine, and I have been practicing as a naturopathic 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 supplement are not regulated

Pharmaceutical Quality Claims Challenged 0:34

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 adervastatin, also known as Lipitor, have been recalled in recent times. The recall is due to the tablets not meeting dissolution specifications. In other words, this means the tablet 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.

FDA also issues recall of dietary supplements and foods, so it's not just drugs. I'll talk more about this in a bit. According to research published in the Journal of Pharmaceutical and Biomedical Analysis, the FDA recalled an average of 330 drugs per year between years

FDA Drug Recall Statistics 1:22

of 2012 and 2023. Each recall involves an averages of 400,000 product units. The most frequent cause for the recalls was impurities and contaminants. Moreover, recall of pharmaceuticals that caused serious health problems or death accounted for 14% of the Now, relative to pharmaceuticals, gastric dietary supplements are very uncommon. So, contrary to what the media and certain medical organizations report, the FDA does regulate dietary supplement. The FDA's own website states, quote, dietary Supplements are regulated by the F.D.A.

as food, not as drugs, unquote. The FDA requires U.S. supplement manufacturers to register before they can begin manufacturing.

Dietary Supplements Are Regulated 2:12

Moreover, the FDA acknowledges its oversight responsibility for dietary supplements in more detail with the following statement. reviewing new dietary ingredient 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, 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, often referred to as GMP.

The GNPs are standards that manufacturers must follow to ensure the quality of dietary supplement and their labeling.

Manufacturing Standards and FDA Inspections 3:08

This requires testing dietary supplements for purity and potency before released to the market and maintaining written records of the testing. the FDA conducts on-site inspections of supplement manufacturers facilities. I know 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, they are testing their records, and they have passed with flying colors each time. But these manufacturing facilities, are audited by the F.D.A.

Now, what about the FTSE's role? Well, the Federal Trade Commission, or the ftse, works with the fda to oversee advertising claims of dietary supplements. The FTC website states in regards to this quote, 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

FTC Oversight of Supplement Advertising 4:03

so consumers can make informed decisions, unquote. So therefore, dietary supplement are regulated by two oversight agencies, The FDA and the FDC. Now there can be problems with dietary supplements on the market just as it can with foods and pharmaceuticals. It can happen in all three categories and it does. Now the reasons for why there could be problem with let's say dietary supplement or foods or drugs are unethical manufacturers or just honest mistakes in the manufacturing process. No business is perfect in what they do.

The main issue is the vast number of companies selling online supplements that may not adhere to regulations until they are caught.

Why Problems Occur and Final Takeaway 4:46

There are bad players at all areas of business. Again, foods, supplements, pharmaceuticals, and many other categories of businesses. 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 the are regulated by the FDA and FTC. I hope you found this video helpful and make sure to hit the like button and subscribe.