New Warning About Supplement Sources
B O S T O N, July 26, 2000 -- Dietary supplements, used by almost half of all Americans, often contain raw animal products that may be contaminated with mad cow disease, due to lack of federal oversight, says a Maryland doctor.
Dr. Scott Norton, a Chevy Chase, Md.,-based dermatologist, says he discovered the disturbing news when he took his sons to the local health food store for an “indoor safari ” after their nature hike was rained out.But instead of finding natural herbs and plants on the labels, to his dismay, the former botanist discovered they contained raw animal meats, such as cow thymus, liver and brain.
This finding led Norton to question the source — and safety, in this era of mad cow disease — of the contents of dietary supplements, which industry watchdogs say are largely unregulated by the Food and Drug Administration.
“I was appalled,” Norton says. “If I were given the opportunity to eat brain tissue from an unidentified animal, for an unidentified location, I would decline — and recommend that my family and patients decline, too.”
Norton wrote a letter to the New England Journal of Medicine that was published today sounding the alarm to doctors and consumers.
“We thought the author made some interesting points that ought to be of concern to people who take these products,” says Dr. Robert Utiger, the journal’s deputy editor, who decided to print the striking letter.
No Oversight in Sight Norton points out that although there have been no documented cases of any transmission of bovine spongiform encephalopathy — known as mad cow disease — through dietary supplements, without adequate governmental oversight, the possibility exists.
And several pharmacologists say they don’t find the idea as outlandish as one might think.
“I believe that Dr. Norton has articulated a reasonable concern,” says Jan Engle, professor of pharmacy at the University of Illinois in Chicago. “There is a theoretical risk.”
Bovine Brains Mad cow disease, which has caused the death of more than 50 people in Britian, is thought to be caused by prions, which are unidentified infectious agents that eat away at brain tissue. No cases have been documented in the U.S., largely because the FDA and the U.S. Department of Agriculture have banned the import of beef from affected countries.
But because the FDA doesn’t regulate what goes into dietary supplements, there is no way of assuring that infected meat from overseas is not being used.
“The origin of these products is not controlled,” says Dr. Domenic Sica, professor of medicine and pharmacology at the Medical College of Virginia in Richmond. “Some of this stuff has raw materials imported from outside the U.S. It’s not safe just because a company says it’s safe.”
“There’s so many ways that there are holes,” agrees Dr. Randy Juhl, dean of the school of pharmacy at the University of Pittsburgh. “Such as, if the supplement is imported from another country. And who is looking to see where the dead cows came from? This points out yet another hole in our regulation of dietary supplements.”
Supplements Unsupervised That hole, experts say, has been caused by a 1994 act of Congress that left dietary supplements largely unregulated before they go on the market.
“Companies don’t have to do safety tests,” explains David Schardt, an associate nutritionist with the Center for Science in the Public Interest, a consumer watchdog group based in Washington, D.C. “They’re not allowed to sell products they know are unsafe, but the FDA has to prove they’re unsafe before can pull off. The FDA has the burden of proof.”
“This is another example of the dietary industry selling protects that have potential health risks and eluding safety monitoring,” Norton says. “The industry needs some regulation.” The FDA was preparing a statement in response to the letter at press time.
But so far, the agency has only been concerned with keeping regulated drugs and medical products free of the disease, says Paul Brown, senior scientist at the National Institutes of Health and chairman of the committee monitoring the transmission of transmissible spongiform encephalopathy.
“I would look forward for this issue to be the subject of a meeting for public discussion,” Brown says. “Some of these supplements do use powdered bovine brain. I guarantee you if you used an animal with mad cow disease, it would be infectious.”
Prions Prevailing There is a risk that prions could remain even in supplements that have been processed because they are harder to kill than bacteria and viruses, explains Caroline Smith DeWalle, director of food safety of the Center for Science in the Public Interest.
“We don’t know how to clean up the products to prevent the transmission of mad cow disease,” she says. “There is no safe way to assure the products of these animals aren’t affected.”
But testing these dietary supplements for presence of the disease would be “horrendously expensive” and would not able to pick up the minute traces, anyway, the NIH’s Brown says.
Supplements are ‘Safe’ The letter “falsely impugns the safety of glandular products marketed in the U.S.,” says John Cordaro, president of the Council For Responsible Nutrition, a dietary supplement industry group. “Consumers who value these products can use them in confidence,” he says, because the FDA's “import alert” monitors shipments of cattle products from affected countries and would consider them to be “adulterated.” Only a “tiny proportion” contain glandular ingredients from cows, he adds, and those that do usually come from herds in the U.S.
Indeed, companies like Standard Process, a 70-year old supplement manufacturer based in Palmyra, Wis., which uses cow brains, spleens and livers in some of its products, notes on its Web site that bovine organs come from USDA-inspected facilities, and only from within the United States.
But experts agree there is always a risk of companies either unknowingly or unscrupulously obtaining contaminated cow material.
“I hope these companies are using their heads,” the NIH’s Brown says, “and not the cattle’s heads.”