Thanks, Congress, for making bull testicles available as a dietary supplement!
On October 21, 1993, there was a hearing before the U.S. Senate Committee for Labor and Human Resources, with the long-winded title:
Examining How the Federal Government Should Regulate the Marketing and Use of Dietary Supplements and Related Measures, Including S. 784, To Strengthen Federal Standards with Respect To Dietary Supplements.
S. 784, sponsored by Sen. Orrin Hatch, would eventually be enacted as the Dietary Supplement Health and Education Act of 1994 (DSHEA).
I discovered this bit of Congressional theater when doing research for my recent talk at NECSS. Scott Gavura and I joined forces to present “Natural Disaster: Dietary Supplements.” Scott focused on pharmacology, while I talked about FDA regulation of dietary supplements (or lack thereof). Thanks to him, I now have a rudimentary knowledge of pharmacokinetics, the science behind how a drug or supplement works (or doesn’t) in the body. If you haven’t read his post from last week explaining this, and more, you should.
Reading the lengthy hearing transcript (well, ok, a lot of it) confirmed my suspicions that the fix was in even before the gavel went down to begin the hearing. What I had not realized was, at least according to some proponents of DSHEA, part of the deal was that consumers would have access to accurate information backing efficacy claims made for supplements and their safety. Nor had I realized that the weaknesses of DSHEA, which have become painfully obvious in the 20-plus years since the law was passed, were anticipated from the get-go and that Congress was well-informed of what they were. Finally, I was not previously aware of the provenance (shall we say) of the “experts” asked to testify at the behest of Sen. Hatch.
First, let’s set the stage on which this drama plays out, according to two excellent books on dietary supplements, Natural Causes and Vitamania. In 1991, Congress passed the Nutrition Education and Labeling Act (NELA). Most famously, NELA, for the first time, required that all foods bear the now-familiar nutrition label. It also required that any health claims made for foods be backed by “significant scientific agreement.” Rep. Henry Waxman and others wanted the same standard applied to dietary supplement health claims. After all, if food companies had to meet a certain standard to make health claims for, say, calcium in their products, why shouldn’t claims for the health benefits of calcium in dietary supplement form be held to the same standard? But the supplement industry knew it couldn’t survive under such stringent rules and Sen. Hatch made sure it didn’t happen. All parties agreed to let the FDA decide what standard should be required of supplement health claims and left it at that. (more…)