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FDA Failing to Test Imported South Asian Herbal Remedies Containing Toxic Heavy Metals

Report ties some herb remedies to toxic metals

By Stephen Smith, Boston Globe Staff | December 15, 2004

South Asian herbal remedies sold next to curry powder and basmati rice in
Boston-area ethnic food markets may contain harmful amounts of lead,
mercury, and arsenic, according to researchers who have analyzed their

The scientists, first alerted to the danger by reports of patients suffering
seizures after taking herbs, discovered that one in five of the imported
products they bought in local shops had levels of heavy metals sometimes
hundreds of times higher than the daily amount considered safe for oral
consumption. The same products are sold nationwide.

The herbal pills, powders, and liquids are a cornerstone in the practice of
Ayurvedic medicine, an ancient holistic system of health that originated in
India and that emphasizes the mind-body connection. It relies on herbs and
oils to treat illness and prevent disease. An estimated 80 percent of
India's 1 billion adults and children use the remedies as a routine part of
health care.

The herbs are not regulated in India, and in this country, unlike
prescription drugs or over-the-counter medicines, the imported products can
be sold without rigorous scientific testing, subject only to the same
standards that apply to food.

The authors of the report on Ayurvedic products called on the US Food and
Drug Administration to test all imported herbal remedies for toxic metals.
Critics of the agency said the Boston findings highlight the need for
tighter regulation of dietary supplements, products containing natural
ingredients that consumers take to enhance health, lose weight, sleep, and
improve sexual performance.

''I absolutely think nothing should be sold without it being tested, and
there should be active regulation of all products that are sold whether
they're natural remedies, over-the-counter, or prescription drugs," said Dr.
Michael Shlipak, a San Francisco researcher who authored a landmark study
detailing the dangers of the herb ephedra. ''It's naive to think there
aren't many dangerous products out there."

But users of the herbs in this country insist that the products are reliable
and that safety concerns reflect bias by Western medical practitioners
against treatments that started in the East.

The Boston study, published in today's Journal of the American Medical
Association, comes amid an unprecedented boom in the use of herbal remedies
-- along with other alternative medical practices -- and a campaign to
validate the safety and effectiveness of those pills and treatments by
government and academic researchers.

In national surveys, 14 to 18 percent of US adults report regularly taking
herbs and other dietary supplements to address everything from flatulence to
hemorrhoids to incontinence.

''We now have roughly one in five adults routinely using herbs and
supplements in the context of their health care, and it's growing," said Dr.
David M. Eisenberg, director of Harvard Medical School's Osher Institute,
which is devoted to testing alternative medical techniques. ''We've also
become increasingly aware that herbs and supplements have the capacity to do
good as well as harm, and that they also have the capacity to interact with
other herbs and drugs."

That has become increasingly evident to doctors, nurses, and disease
trackers as reports have trickled in about cases of lead poisoning linked to
Ayurvedic medications. In July, the US Centers for Disease Control and
Prevention issued a detailed account of such cases, reporting that a dozen
bouts of lead poisoning had been blamed on Ayurvedic remedies from 2000
through 2003.

One of those cases was in Massachusetts.

A middle-age man showed up at a Boston hospital in 2002 suffering seizures.
Doctors were baffled. After running a battery of tests, they concluded that
he had lead poisoning.

''The next obvious question is, why does he have lead toxicity?" said Dr.
Robert B. Saper, lead author of the study published today. ''They asked him:
'Do you work with paint?' Finally, it was posed to the person whether he was
taking anything other than conventional medicine. Lo and behold, he was
taking an Ayurvedic herbal medicine product for the last six years to treat

The man, who had taken herbal tablets called Guglu, recovered. But in a
textbook example of how clinical medicine can give birth to scientific
research, Saper, then a fellow at the Osher Institute and now a Boston
University researcher, heard about the case from colleagues and decided to
study the presence of heavy metals in medicinal herbs. In high enough
concentrations, such metals can result in serious complications -- including
convulsions, nausea, and vomiting.

>From spring through fall 2003, Saper purchased 70 herbal medicine products
imported from South Asia at 30 stores in the Boston area. The researchers
did not examine Ayuverdic herbs made in this country.

Samples were tested at a lab run by the US Environmental Protection Agency,
with scientists hunting for the presence of possibly harmful amounts of
lead, mercury, and arsenic. The finding: Fourteen of the herbal treatments
-- 20 percent -- contained at least one of these heavy metals in unsafe

Researchers can't say for sure how the metals got there. Theories range from
contamination during production to plants grown in tainted soil. But there
also are suggestions in Ayurvedic textbooks that some metals may be added
intentionally, valued for their reported healing potential.

That is a possibility that does not alarm Subhash Sehgal, a Newbury Street
gallery owner who has taken Ayurvedic medicines for most of his 53 years and
insists they do not contain toxic levels of metal.

To maintain his health, he eats bread each day that he coats with a gelatin
called chayanprash, which is said to contain more than 12 herbs. ''It has
been used for thousands of years, and we have never doubted it," he said.
''These are ancient ways to take care of your body."

A 1994 federal law prohibited the FDA from regulating dietary supplements
like prescription drugs, setting a high standard before such a product can
be taken off the market. An FDA official said the agency could not comment
on the Boston study until it receives all the data, but added that
regulators are already working to more aggressively target supplements that
have been shown to pose serious risk to consumers. Nearly a year ago, the
FDA moved to ban ephedra, an herb that had been used by elite athletes to
enhance performance by strengthening their muscles and by dieters to speed
weight loss. Studies blamed the herb for 155 deaths.

Saper advised patients taking imported Ayurvedic herbs to alert their
doctors and consider testing for toxic substances.

Michael McGuffin, president of the American Herbal Products Association,
urged consumers not to lump domestically produced Ayurvedic herbs with
imported products. ''And it's certainly too broad," McGuffin said, ''if it's
read as a condemnation of all herbal products."

Stephen Smith can be reached at
© Copyright 2004 The New York Times Company