Friday, October 17, 2025

Supplement Update: Buyer Beware!

I ran across this recently: "The Food and Drug Administration is advising consumers not to purchase or use PAIN FLEX, a product promoted and sold for joint pain on various websites, including Amazon.com and possibly in some retail stores...FDA laboratory analysis confirmed that PAIN FLEX contains dexamethasone [a steroid] and methocarbamol [a muscle relaxant, emphasis mine] not listed on the product label." (FDA Aug. 22, 2025)

People are interested in self-care, and I do applaud when folks take an interest in promoting their own health through active means. On the other hand, stories like this remind us that "do-it-yourself" self-care comes with certain hazards. 

In 1994 Congress passed the Dietary Supplement Health & Education Act or DSHEA, which firmly established that Americans are free to use dietary supplements like nutritional supports, herbal remedies, and related products for their own health. DSHEA prohibits the FDA from removing such products from the market unless significant safety issues have emerged. The burden of proof of harm is on the FDA. They usually try to get a voluntary recall when a problem is found. For manufacturers, they are to refrain from stating that these products cure or improve specific health problems unless evidence for such has been reviewed by the FDA. Otherwise, it's a free market.

There's no specific count available, but the FDA has only forced withdraw of a small number of products since the law wen into effect. Ephedrine alkaloids (from Ephedra sinica) and DMAA (1,3-dimethylamylamine), an amphetamine derivative, both used in weight loss/body-building supplements, caused heart problems, strokes, seizures, and sometimes death; and tianeptine, an unapproved drug advertised for memory problems, was found to cause addiction, anxiety, seizures, and withdrawal symptoms. Both were removed by order. (Ephedra as the raw herb remains available to practitioners of traditional Chinese medicine.)

This is only the latest case of supposedly "safe" products being adulterated with drugs. DIY-ers would be wise to consder that the FDA doesn't get to regulate the quality and purity of dietary supplements. It can be hard to know what's safe, but consider that professionals often go to some lengths to source supplements from reputable sources, in which supplement purity may be traced to laboratory assays. For some people, the modest additional expense doesn't seem worth it. Stories like this one may caution otherwise!

Caveat emptor: "Let the buyer beware."

(Bene vale: "Be well!")

E.D.

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