Dietary supplements are a $28 billion dollar business in America. Thanks to 1994′s Hatch Act, the Dietary Supplement Health and Education Act (DSHEA), pushed through Congress and released upon a then-unprotesting public by Utah’s Sen. Orrin Hatch (R-UT), substances which may be benign, toxic, and everything in between, as long as they are sold as “dietary nutritional supplements,” get a virtual free pass.
According to Dr. George Lundberg, member of the Institute of Medicine and former Editor-in-Chief of the Journal of the American Medical Association (JAMA), manufacturers of supplements can make “structure-function” claims, such as “supports sexual health,” but not actual health claims (which the FDA defines as proof that the substance can be used to diagnose, treat, cure or prevent any disease).
Part of the law mandates that ingredients brought to market after 1994, so-called “novel” ingredients — and only those — be shown to have passed safety tests. Older ingredients got “grandfathered” in without the need to be proven either safe or effective. There have been approximately 51,000 new ingredients brought to market since DSHEA passed, of which about 0.3% — that’s not a misprint, 170 out of 51,000 — have documented safety tests.
Unfortunately, consumers are often under the impression that substances called “natural” must be safe and that includes vitamins, minerals, potions, herbals, biologicals, etc. If a shopper has a question about the efficacy or danger of a supplement, they may simply ask the health-food store employee who is not required to have any kind of credentials.
According to Dr. Lundberg, “We Americans, so concerned about minute amounts of this or that chemical in our food and water, and ready to challenge our board-certified internist on treatment decisions, gobble down supplements with alarming obliviousness to their potential dangers and denial of the overwhelming absence of evidence of benefit.”
A “Perspective” article in a recent New England Journal of Medicine by Dr. Pieter Cohen called for a tightening — no, not even that, merely actually enforcing the law as written — by having the FDA demand that, instead of pleading with, the supplement manufacturers supply the agency with at least the legal minimum of data on their products’ safety.