Posts Tagged nutritional supplements

Supplements, Lies, and a Lengthy Transcript

Thanks, Congress, for making bull testicles available as a dietary supplement!

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…)

Posted in: Herbs & Supplements, Legal, Nutrition, Politics and Regulation

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The consumer lab rat: More questions about supplement safety

Laboratory Rats
Do you take a vitamin or dietary supplement? Over half of all American adults do, making this a $30 billion dollar business. Many of us even take supplements in the absence of any clear medical or health need. I’m often told it’s a form of nutritional “insurance” or it’s being taken for some presumed beneficial effect – like Steven Novella outlined in yesterday’s post on antioxidants. We love the idea of a risk-free magic bullet that improves our health and wellness. Especially one that avoids what are presumed to be toxic, unnatural drugs. Supplements are marketed as safe, natural and effective, and there is no question that messaging has been effective.

I used to take supplements. For me it was multivitamins. But as I’ve taken a closer look at the evidence for supplementation, my personal behaviors changed. The primary reason is a lack of evidence. There is no evidence to suggest that vitamins offer any health benefits in the absence of deficiency. The balance of evidence suggests that routine multivitamins are unnecessary for most people. Vitamins should come from your food, not from supplements. More generally, looking at the broader category of supplements that range from probiotics to herbal remedies, there is little evidence to support most of them. With a few exceptions, the research done on dietary supplements is unconvincing and largely negative. If you don’t supplement, you don’t seem to be missing out on any tremendous health benefits.

Going beyond the lack of evidence, there’s an even more compelling need for consumers to be wary of them. The safety of supplements is increasingly being called into question. Evidence has emerged demonstrating that quality standards for supplements sold in many countries are erratic and unpredictable. The root cause seems to be regulatory systems that prioritize manufacturer interests ahead of consumer protection. With supplements, products are effectively being tested for safety after they are marketed, and the consumer is the unwitting research subject. (more…)

Posted in: Herbs & Supplements, Politics and Regulation

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New FDA regulatory role threatens bogus diagnostic tests

lab test
The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it focused on commercial tests kits, which are broadly marketed to laboratories or the public. These tests had to undergo the same pre-market approval process as other medical devices regulated by the FDA, including, in some cases, clinical studies demonstrating that the device is safe and effective for its intended use.

Historically, LDTs were developed by hospitals, researchers and academic medical centers for their own use. That is no longer true. In the past 15 years or so, there has been an explosion in the use of LDTs by commercial labs and biotechnology companies. The FDA now estimates that there are about 11,000 LDTs offered by 2,000 laboratories. One estimate is that the results of clinical lab tests (although not exclusively LDTs) influence 70% of health care decisions. (See the Congressional Research Service Report’s exhaustive analysis of FDA regulation of IVDs and inclusion of LDTs for more on the history and current use of LDTs.)

Do you have any idea whether the IVDs that have poked around in your blood or tissues are FDA-approved or unapproved LDTs? (Does your physician?) Do you know what evidence (if any) there is standing behind these tests? No? Me either. That’s because there is no requirement that anyone give you this information. (more…)

Posted in: Diagnostic tests & procedures, Legal, Medical devices, Naturopathy, Politics and Regulation

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Diet Supplements or Nutritional Supplements: A Ruse by Any Other Name is Still a Ruse

I was surprised to get this e-mail from a reader:

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

My co-bloggers and I have addressed these issues repeatedly. Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again; and maybe by writing this post I can make it easier for new readers to find the information.

Posted in: Herbs & Supplements, Politics and Regulation

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