# Magazine's Supplement Tests Point Up Lack of Regulation



## JeanG (Oct 20, 1999)

This is from a Sept. 22 article in webmd.com . The url for this article is: http://my.webmd.com/content/article/1728.61632 Magazine's Supplement Tests Point Up Lack of Regulation Important Health Issue Has Been Overlooked in Presidential Race Editorial Comment by Wayne L. Pines WebMD Washington Columnist Reviewed by Dr. Dominique S. Walton Sept. 22, 2000 (Washington) -- As a person who believes the buyer should always beware, but shouldn't always have to, I am upset by the current issue of Consumer Reports. The magazine, best known for testing cars, has now begun using independent labs to test herbal supplement products. In doing so, it is tackling an important health issue that has not been addressed by any of the presidential candidates or their parties' platforms -- an issue that's not at the top of anyone's political agenda. So it's not Consumer Reports I'm upset with. I presume the magazine is conducting legitimate independent tests of the herbal products on the market, and that its medical experts are acting scientifically and in good faith. I'm upset because the system by which health care products are regulated in this country seems to have broken down when it comes to herbal supplements. In its September issue, the magazine reports on its tests of 13 saw palmetto supplements. Saw palmetto is used in Europe and, increasingly, in the U.S. by men with benign prostatic hyperplasia (BPH) a common, age-related condition in which the prostate enlarges, often making urination difficult. Two things in particular about this article bother me: Consumer Reports found that five of the 13 saw palmetto products it tested did not deliver enough of the herb to treat BPH. One product delivered only 10 percent of the dosage recommended by Consumer Reports. These five defective products were purchased off the shelf and presumably have been used by thousands of Americans. The appropriate "dose" of 320 mg per day was based on an evaluation by Consumer Reports' own medical experts, based on their reading of the published literature on saw palmetto. They determined that 320 mg per day of the extract "might be worth trying for some men with mild symptoms" of BPH. Imagine if a magazine were to report that it had tested antibiotics purchased with prescriptions from pharmacies and found that five in 13 were sub-potent and unable to kill bacteria. Or if a magazine were to find that five of 13 aspirin products purchased off the shelves across the country weren't strong enough to work. Such findings would undermine our confidence in our medicine supply. It's the appropriate responsibility of the federal government, in this case the FDA, to assure the safety and quality of products sold for health care purposes. For herbal medicines, the FDA is not doing the job. So it's left for Consumer Reports to not only discover that some saw palmetto products are subpotent, but to figure out from the medical literature (not from actual medical tests) what an appropriate effective dose might be. Do I blame the FDA? No. The FDA's hands are tied by legislation Congress passed in 1994 that prohibits it from acting against dietary supplement products unless they are shown to cause harm. This law led to a surge in dietary and herbal products in pharmacies and grocery stores. It also allowed products to be marked with certain claims of effectiveness without scientific proof. The FDA is now working to establish manufacturing standards for these products. The FDA is frustrated by the legislation. We live in a land in which, thanks to consumer-protection laws and federal regulation, we take for granted that our foods will be safe and our drugs and medical devices will be of high quality, with scientific evidence supporting any therapeutic claims that are made. With dietary and herbal supplements, what we learn from the Consumer Reports article is that we can't take anything for granted. The herbal supplement industry has protectors in Congress who have created a situation where buyers really need to beware. And the status quo will remain until someone is harmed, or until the majority of members of Congress come to their senses and make sure that consumers are protected from mislabeled or poorly made health care products. Wayne L. Pines, WebMD's Washington columnist, is a former associate commissioner and chief spokesman of the Food and Drug Administration. The opinions expressed in this article are not necessarily those of WebMD.


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## Mike NoLomotil (Jun 6, 2000)

Good post.Key phrase that is has been at the root of problems on the FDA side (at least most recently):----------------------------The FDA's hands are tied by legislationCongress passed in 1994 that prohibits it from acting against dietarysupplement products **unless they are shown to cause harm**. ---------------------------**And who is going to invest in this in the private sector? And since the agency has no funding to do so...consumers must rely on CU and other consumer groups to crack open such things.Symptomatic of the probelsm with the regulatory environment and sturcture in thsi country at this time...USDA regulates an industry it is in bed with (shares patent rights to GM food technologies with certain manufacturers...no one seems to be able to do anything about this conflict of interest, and the lawsuits will probably be "in discovery" for the next 5 years; EPA often seems to protect the rights of the polluters as opposed to the rights of the citizens...there is an active case of that in a local town her in FLA right now....).MNL


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