They are almost universally perceived by Americans as natural, safe and non-drugs, but in reality, dietary supplements may or may not be natural, and many of them are, in fact, drugs. And ironically, despite the constant media attention and public concern over the safety of prescription drugs, according to a recent study, supplements are also responsible for more than half of all drug recalls.
A group led by Dr. Ziv Harel, of St. Michael's Hospital in Toronto, reported in a Research Letter published online in JAMA Internal Medicine that FDA data showed 51 percent of Class I recalls (the most serious class) over a 9-year period were adulterated dietary supplements, many used for either sexual-enhancement, body-building, or weight-loss aids.
The authors urge that more be done to regulate this industry through more stringent enforcement and a standard of regulation similar to that for pharmaceuticals.
In an editorial note, Dr. Mitchell Katz said it s likely that the number of recalls grossly underestimates the number of products on sale with unapproved ingredients. Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health.
ACSH s Dr. Josh Bloom, a longstanding and vocal critic of the supplement industry, couldn t agree more. He says, The Dietary Supplement Health and Education Act of 1994 was pushed through Congress by Senator Orin Hatch (whose state, Utah is the home to many supplement manufacturers). He adds, this law provided an artificial and completely non-scientific provision where supplements could avoid FDA approval procedures but including certain disingenuous and intentionally confusing wording on the label of the bottle.
And it works the dietary supplement is a $20 billion industry, which constantly offers a stream of new products none of which go through FDA approval process.
Indeed, 89 percent of supplement recalls occurred after 2008, and all of them were due to unapproved (and wrong) drug ingredients something that a pharmaceutical company would never even try, let alone get away with.
You can read Dr. Bloom s 2102 American Spectator op-ed entitled "When is a Drug a Drug?' here.