OMG and Ugh.
In 1994 the U.S. Congress passed the Dietary Supplement Health and Education Act, which prohibited the Food and Drug Administration and other branches of the federal government from regulating products labeled as food supplements. All that was required from supplements manufacturers to ensure their products were not harmful was a promise that they weren't. Note that in 1906 Congress passed, and in 1938 amended, The Pure Food and Drugs Act, which gave rise to the Food and Drug Administration to ensure the safety of products sold as foods or medicines. Without the FDA, anyone could put just about anything in a bottle or package and sell it as a food or medicine, and today some dietary supplement manufacturers do just that.
Although the it can't regulate products sold as dietary supplements, the FDA tracks potentially dangerous ones through its Tainted Products Marketed as Dietary Supplements_CDER database . Earlier this year researchers reported that between 2007 and 2016 the FDA identified 746 brands of supplements that were adulterated with prescription, approved-and-then-banned, or never-approved drugs, 45% of them for "sexual enhancement," 41% for weight loss, 12% for muscle building, and the rest for various reasons. Each year an estimated 23,000 emergency department visits in the United States are attributed to dietary supplements.
When it spots a tainted dietary product, either through its own monitoring or that from outside laboratories, the FDA usually asks the responsible manufacturer to recall the product from the market. If the manufacturer agrees to the recall, the FDA generally publicizes the recall through its website, public announcements, and email alerts. Unfortunately, not every consumer who needs to know about a recall gets informed of it. Furthermore, some businesses ignore or refuse the FDA notice to recall a product. In the most recent report (cited below), only 360 of the 746 adulterated products were recalled. When a refusal occurs, the FDA can issue a warning letter and mandate a recall, but it rarely does. The agency can also send the issue to the Department of Justice, which is almost never does.
In the past, the FDA's response to its apparent lackluster defense of the public health from unscrupulous and dangerous product manufacturers has been to blame Congress for lack of financial support for both laboratory and enforcement staff and for not giving the agency the necessary enforcement tools to remove dangerous supplements from the market. This particular blame-dance has been going on for over two decades. If you are a consumer of dietary supplements pitched for either sexual enhancement, weight loss, sports performance, or anything else, you would be well-served to check out the FDA's "Tainted Products List" and do a thorough internet search for information about potential toxicity and efficacy.
* Tucker, J. et al (2018). Unapproved Pharmaceutical Ingredients Included in Dietary Supplements Associated With US Food and Drug Administration Warnings. JAMA Netw Open. 2018;1(6):e183337. doi:10.1001/jamanetworkopen.2018.3337. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496
* Cohen, P.A. (2018). The FDA and Adulterated Supplements—Dereliction of Duty
JAMA Network Open. 2018;1(6):e183329. doi:10.1001/jamanetworkopen.2018.3329
* FDA Safety Information. https://www.fda.gov/Safety/default.htm
Eric Golany, PhD is a JOnes & Bartlett Learning author. For more information on healthy living check out his latest text, Health & Wellness, Thirteenth Edition.