September 12th, 2011 by David Kroll, Ph.D. in News, Research
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As early as 2006, I used to be able to write monthly about US FDA warnings on erectile dysfunction supplements being found adulterated with prescription drugs such as sildenafil, the phosphodiesterase-5 inhibitor found in Viagra. These adulteration episodes raised the question of how many anecdotal reports of herbal products “working” had to do with them containing approved medicines.
So common was this practice that FDA created a site in 2008 that was dedicated to this problem: Hidden Risks of Erectile Dysfunction “Treatments” Sold Online. Indeed, these products were more commonly encountered from online retailers and not in health food stores. Other similar practices include bodybuilding supplement being spiked with anabolic steroids and weight loss supplements being adulterated with sibutramine (formerly Meridia), an anorectant removed from the market last year after showing increased incidence of heart attacks and stroke in patients with preexisting cardiovascular disease.
The herbal industry, led by the American Herbal Products Association (AHPA), aimed to clean up this problem and launched an initiative called, KeepSupplementsClean.org. Spurred by an FDA letter to the industry on 15 December 2010 of increased scrutiny on the adulteration problem, AHPA actually encouraged FDA to 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*
May 25th, 2011 by admin in Health Tips, Research
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An Embarrassment of Riches?
Much has been written here about the dietary supplement business, a multibillion dollar industry with powerful political connections, and about the woeful inadequacy of regulation which allows widespread marketing of supplements without a solid basis in science or scientific evidence.
The veterinary supplement market is a pittance compared to the human market, but still a billion-dollar pittance that is growing rapidly. Unfortunately, the resources available for good quality research in veterinary healthcare are also a pittance, and it is not at all unusual for our pets to suffer, or even be euthanized, as a result of treatable diseases for want of money to pay for needed care. So $1 billion a year spent on nutritional supplements may not be such a good deal if these products don’t effectively prevent or treat disease. Read more »
*This blog post was originally published at Science-Based Medicine*
May 10th, 2011 by RyanDuBosar in News
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About 9% of infants are given dietary botanical supplements or teas as young as 1 month old, prompting government researchers to warn physicians to look for side effects and other health risks.
Supplement use is common. Parents use them to help with fussiness, digestion, colic, and relaxation. Parents like them because there’s no prescription required, they’re traditional to many cultures, and they’re marketed as “natural.”
But, caution the authors of a paper that appeared in the journal Pediatrics, such supplements’ purity and potency are unregulated, they can interact with prescription medicines, they may contain heavy metals or other contaminants, and they may not adapt well to a newborn’s metabolism and body weight.
Supplement use is also common as a cause of emergency room visits. And they’re linked to seizures and death.
Researchers from the Food and Drug Administration and the Centers for Disease Control and Prevention used data from the Infant Feeding Practices Study II, a longitudinal survey of 2,653 women studied from late pregnancy through the first year of the child’s life. The sample was drawn from a nationally distributed consumer opinion panel of healthy adult mothers with healthy term or near-term infants.
*This blog post was originally published at ACP Internist*
May 10th, 2011 by admin in Health Tips, Research
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Calcium is good for us, right? Milk products are great sources of calcium, and we’re told to emphasize milk products in our diets. Don’t (or can’t) eat enough dairy? Calcium supplements are very popular, especially among women seeking to minimize their risk of osteoporosis. Osteoporosis prevention and treatment guidelines recommend calcium and vitamin D as an important measure in preserving bone density and reducing the risk of fractures. For those who don’t like dairy products, even products like orange juice and Vitamin Water are fortified with calcium. The general perception seemed to be that calcium consumption was a good thing – the more, the better. Until recently.
In a pattern similar to that I described with folic acid, there’s new safety signals from trials with calcium supplements that are raising concerns. Two studies published in the past two years suggest that calcium supplements are associated with a significantly increased risk of heart attacks. Could the risks of calcium supplements outweigh any benefits they offer? Read more »
*This blog post was originally published at Science-Based Medicine*
