August 22nd, 2011 by Steve Novella, M.D. in Health Policy, Opinion
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In 1994 Congress (pushed by Senators Harkin and Hatch) passed DSHEA (the Dietary Supplement Health and Education Act). As regular readers of SBM know, we are not generally happy about this law, which essentially deregulated the supplement industry. Under DSHEA supplements, a category which specifically was defined to include herbals, are regulated more like food than like medicinals.
Since then the flood-gates opened, and there has been open competition in the marketplace for supplement products. This has not resulted, I would argue, in better products – only in slicker and more deceptive claims. What research we have into popular herbals and supplements shows that they are generally worthless (except for targeted vitamin supplementation, which was already part of science-based medicine, and remains so).
A company can essentially put a random combination of plants and vitamins into a pill or liquid and then make whatever health claims they wish for their product, as long as they stay within the “structure-function” guidelines. This means they Read more »
*This blog post was originally published at Science-Based Medicine*
August 13th, 2011 by David Kroll, Ph.D. in Health Policy, Opinion
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A rumble of discontent is being heard across the dietary supplement industry since a draft guidance document was published last month by the US Food and Drug Administration. In response to the FDA Food Safety Modernization Act signed into law in January by President Obama, the FDA was required to produce documents requiring dietary supplement and foods companies to submit safety information on any new dietary ingredient (NDI) placed into products after 1994.
The guidance document is open for comments from industry but, when issued, a final rule will require dietary supplement products to file a claim of a New Dietary Ingredient (NDI) for any supplement component that was not part of the diet before 1994. What seems to be riling up the industry is that any change in supplement composition after 1994 will require filing of a NDI disclosure. That is, if you as a manufacturer add more DHA to your fish oil supplement, you have to file a NDI notification.
Stepping back, the goal of the FSMA makes perfect sense: Read more »
*This blog post was originally published at Science-Based Medicine*
July 5th, 2011 by David H. Gorski, M.D., Ph.D. in Health Policy, Opinion, Quackery Exposed
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The weakness and ineffectiveness of the law in the U.S. regulating dietary supplements has been a frequent topic here on Science-Based Medicine, including the continued failure of efforts to address the serious shortcomings of current law and the illogic at its very heart. Indeed, over the last decade or so that I’ve paid attention to relevant issues regarding supplements continually amazed at how much supplement manufacturers can get away with and for how long. For example, one of the most recent atrocities against science occurred when Boyd Haley, disgraced chemistry professor at the University of Kentucky and prominent member of the mercury militia wing of the anti-vaccine movement, tried to sell an industrial chelator as a dietary supplement to treat autistic children. True, that was too much even for the underfunded, undermanned FDA to ignore, but it was amazing how long he got away with it. Apparently it takes someone trying to market a chemical compound that can’t by any stretch of the imagination be characterized as a “nutrient” or “food” to be so obviously against even the travesty of a mockery of a sham of a law regulating supplements (the Dietary Supplement Health and Education Act of 1994, or the DSHEA) that the FDA could take action.
Of course, here at SBM, we’ve written numerous posts on the shortcomings of the DSHEA. Basically, this law created a new class of regulated entities known as dietary supplements and liberalized the sorts of information that supplement manufacturers could transmit to the public. The result has been this:
It [the DSHEA] also expanded the types of products that could be marketed as “supplements.” The most logical definition of “dietary supplement” would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients. Although many such products (particularly herbs) are marketed for their alleged preventive or therapeutic effects, the 1994 law has made it difficult or impossible for the FDA to regulate them as drugs. Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.
One might wonder how such a bad law could survive for so long (seventeen years now), but it has its defenders. One man, in particular, defends the DSHEA against all regulatory threats, Read more »
*This blog post was originally published at Science-Based Medicine*
March 30th, 2011 by Harriet Hall, M.D. in Opinion, Quackery Exposed
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David Kroll’s recent article on thunder god vine is a great example of what can be learned by using science to study plants identified by herbalists as therapeutic. The herbalists’ arsenal can be a rich source of potential knowledge. But Kroll’s article is also a reminder that blindly trusting herbalists’ recommendations for treatment can be risky.
Herbal medicine has always fascinated me. How did early humans determine which plants worked? They had no record-keeping, no scientific methods, only trial and error and word of mouth. How many intrepid investigators poisoned themselves and died in the quest? Imagine yourself in the jungle: which plants would you be willing to try? How would you decide whether to use the leaf or the root? How would you decide whether to chew the raw leaf or brew an infusion? It is truly remarkable that our forbears were able to identify useful natural medicines and pass the knowledge down to us.
It is equally remarkable that modern humans with all the advantages of science are willing to put useless and potentially dangerous plant products into their bodies based on nothing better than prescientific hearsay. Read more »
*This blog post was originally published at Science-Based Medicine*
February 24th, 2011 by Harriet Hall, M.D. in Health Tips, Research
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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.
Food, Medicine, or Something In Between?
The FDA regulates foods and has been instrumental in improving the safety of our food supply. It regulates prescription and over-the-counter medications, requiring evidence of effectiveness and safety before marketing. Surveys have shown that most people falsely assume these protections extend to everything on the shelves including diet supplements, but they don’t.
Under the 1994 Diet Supplement Health and Education Act (DSHEA), a variety of products such as vitamins, minerals, herbs and botanicals, amino acids, enzymes, organ tissues, and hormones can evade the usual controls if they are sold as diet supplements. Under the DSHEA, the manufacturer doesn’t have to prove to the FDA that a product is safe and effective; it is up to the FDA to prove that it isn’t safe, and until recently there was no systematic method of reporting adverse effects (required reporting is still limited to serious effects like death).
So far the FDA has only managed to ban one substance, ephedra, and it took the death of a prominent sports figure and considerable skirmishing with the courts to accomplish that. Independent lab tests of diet supplements have found a high rate of contamination (with things like heavy metals and prescription drugs) and dosages wildly varying from the label. A striking example was Gary Null’s recent poisoning with vitamin D from one of his own products which contained 1,000 times the intended amount.
The FDA has issued rules on good manufacturing practices, but standardization is not required and it remains to be seen whether the new rules will effectively improve product quality. Read more »
*This blog post was originally published at Science-Based Medicine*
