Paper calls for regulation of dietary supplements
The past year or so has seen many recalls and warnings about dietary supplements that include ingredients not found on the label that could be potentially dangerous, have high amounts of drugs that haven’t been approved or shouldn’t be used without a prescription, or for other potential health problems.
A commentary in the New England Journal of Medicine lays out the problems with over-the-counter supplements, particularly those sold for weight loss, whether sold in stores or online.
The scope of the problem
Pieter A. Cohen, M.D., writes in an article titled “American Roulette” that an estimated 15 percent of Americans have used over-the-counter supplements that are marketed as being helpful for weight loss. But most people don’t understand that those products aren’t regulated by the Food and Drug Administration for safety or effectiveness.
Cohen cites a 2002 poll that found a majority of consumers thought such pills were regulated by a government agency, and two-thirds thought the labels of such products were required to include warnings about potential risks and side effects.
In addition, a survey of medical residents found that one-third of respondents thought over-the-counter supplements were regulated by the FDA, and most of them didn’t know that adverse reactions to such pills should be reported to the agency.
Why pills aren’t regulated
The trouble goes back to 1994 and the passage of the Dietary Supplement Health and Education Act. Before that legislation was passed, herbal remedies were considered food additives that were regulated, with manufacturers having to prove the safety of their products before they were marketed.
Now that such preparations are considered dietary supplements rather than food, they are presumed to be safe and there is very little oversight in the market. That’s a problem, because when scientists do look at these products, they often find compounds that aren’t listed on the label that are potentially dangerous, as well as bacteria, toxic plant material, heavy metals and other contaminants.
Supplement makers often change the chemical structure of known drugs slightly in an attempt to slip past what little screening these pills do receive.
The potential dangers of these products are hard to overstate. One FDA analysis found a stimulant, sibutramine, in a product at three times the recommended maximum dose. Other drugs found in the pills that aren’t on the labels could lead to dependence, suicide, dehydration, liver damage and other health problems.
The paper concludes that doctors should be sure to ask patients if they are taking any over-the-counter dietary supplements in case their health problems might be caused by an unrecognized ingredient in the product or an interaction with another drug the patient is taking.
It also suggests quite wisely that Congress ought to give the FDA authority over these drugs and put a mechanism in place to make sure products are safe before they hit the market.
(By Sarah E. White for CalorieLab Calorie Counter News)
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Paper calls for regulation of dietary supplements
