The Proxmire Amendment May Be the Most Anti-Science Law Ever Passed. It's Still in Effect Today.
Earlier this year, testing conducted by the New York State attorney general's office revealed that four out of every five herbal supplements sold at GNC, Target, Walgreens, and Walmart did not contain any of the herbs advertised on their labels. Instead, the products were filled with things like powdered rice, asparagus, garlic, and radish.
The damning discovery left some wondering, "Where was the FDA? Shouldn't they prevent this sort of wrongdoing?"
The disconcerting answer is that the FDA was doing precisely what Congress permits them to do: absolutely nothing. That's right, according to current law, the FDA is essentially prevented from regulating the supplement industry unless there's clear evidence that one of their products is harmful to consumers.
For this sorry state of affairs, you can thank what may be the most influential anti-science legislation ever passed in American politics: the Vitamin-Mineral (Proxmire) Amendment to the Federal Food, Drug, and Cosmetic Act. Journalist Catherine Price succinctly summed up the law's effects in her new book Vitamania:
"Enacted on April 23, 1976... the amendment made it illegal for the FDA to ever establish standards for supplements, classify them as drugs, or require that they only contain useful ingredients. It forbade the FDA from ever setting limits on the quantity or combination of vitamins, minerals, or other ingredients that a supplement could contain, unless the FDA could prove that the formulation was unsafe."
The amendment's primary architect and namesake, long-serving Wisconsin senator William Proxmire, whose patented Golden Fleece Award for wasteful government spending frequently -- and many say unfairly -- targeted basic scientific research, touted the legislation as a win for consumer freedom, guaranteeing access to health-giving vitamins, minerals, and supplements. FDA commissioner Alexander Schmidt called the amendment "a charlatan's dream."
Schmidt's assessment turned out to be correct. Basically unrestricted, the supplement industry saw their sales boom, and their political power grow. In 1994, with key support from Republican Senator Orrin Hatch and Democratic Senator Tom Harkin, the industry helped author the Dietary Supplement Health & Education Act, more commonly known as DSHEA. The law added insult to the injury inflicted by the Proxmire Amendment. DSHEA once and for all removed the FDA's middling power to review and approve dietary supplements before they hit the market. Moreover, manufacturers were permitted to make unproven claims about the effect of their products on the structure or function of the body.
Largely thanks to Proxmire and DSHEA, the supplement industry has ballooned to roughly $30 billion in revenue today, with more than 85,000 products on store shelves worldwide. The vast majority of them do not improve health in any way. Even vitamin and mineral supplements, by far the most popular with consumers, don't seem to have much effect, if any, on a variety of health outcomes, including bone density, cancer, cardiovascular disease, or mortality.
A lack of effect, either positive or negative, is a key reason why Proxmire and DSHEA have remained laws of the land. Most dietary supplements aren't harmful; they're just useless. Evidence-based claims of ineffectiveness are easily drowned out by unbelievable anecdotes and flashy marketing. Unfortunately, unless news of widespread supplement industry abuses or dangerous supplements grows to a clamor, it's unlikely that politicians will place the supplement industry under evidence-based regulation.