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June 7, 2000 (Washington) -- The herbs and supplements that promise everything from improved mood to a better sex life may actually be dangerous substances that government health officials choose to ignore. That harsh assessment comes from former FDA Commissioner David Kessler, MD.
"Congress has shown little interest in protecting consumers from the hazards of dietary supplements, let alone from the fraudulent claims that are made. ... Nor does the public understand how potentially dangerous these products can be," writes Kessler in an editorial appearing in the June 8 edition of The New England Journal of Medicine (NEJM).
Kessler says in the editorial that Congress needs to change the controversial Dietary Supplement Health and Education Act of 1994 (DSHEA), which he says has allowed the $15 billion dollar supplement industry to escape regulation.
What sparked Kessler's comments is a European study, also appearing in the same issue of the NEJM, on a Chinese herb called Aristolochia fangchi. According to the researchers, many of those who took the product to lose weight paid a high price in terms of kidney damage.
The scientists evaluated over 100 patients with kidney problems who had taken the suspect herb. Forty-three of them experienced kidney failure, and because of concerns over the possibility the supplement might cause kidney or bladder cancer, 39 of these individuals had their injured kidneys removed.
Kessler makes the point that problems related to Aristolochia have been on the rise since the '90s, when women taking it in a Belgian clinic began to experience kidney disorders. While it's not clear there have been similar issues in the U.S., Kessler wrote that he was able to buy the herb in this country and chided the FDA for its failure to respond.
"As of this writing, the FDA has yet to act, though it is likely that the agency will take some action in the very near future," wrote Kessler. In fact, the FDA beat Kessler to the punch, if only by a week.
Last week, the agency sent out a letter to doctors about Aristolochia botanicals, saying that they should be discarded by those who prescribe them. Physicians were also asked to inquire if their patients who were experiencing kidney problems had previously taken these supplements. In addition, the FDA said the herbs had caused cancer in animals and might also trigger the disease in people.
However, Kessler was clearly aiming beyond the grave medical problems linked to these Chinese herbs. He was citing them as an example of why he thinks the current system is broken and needs to be fixed.
He also points out that, unlike drugs, dietary supplements don't have to be shown to be safe and effective before being put on the market.
Officials with groups who represent the supplement industry have a very different view of the situation. They point out the vast majority of their products have been safely used for thousands of years.
"The real crux of the problem about DSHEA is that the FDA doesn't really exert its regulatory authority anywhere near the extent to which it can," John Cardellina, PhD, vice president of botanical science for the Council of Responsible Nutrition, tells WebMD.
R. William Soller, PhD, a senior scientist for the Consumer Healthcare Products Association, agrees. "DSHEA does not take away any enforcement authority from FDA to ensure that dietary supplements are free from contaminants found to cause rare health problems," he says.