If a weight-loss supplement does contain an undeclared active
pharmaceutical, the F.D.A. considers the product to be an illegal,
unapproved drug. Doctors said undeclared drugs could cause problems on
their own, like elevated blood pressure or seizures, could have toxic interactions with other medications people take and
could make it difficult for physicians to diagnose patients.
As the F.D.A. continues to investigate, many questions remain to be
answered – including who put the drugs in the pills and who knew about
it. Some doctors and other experts say the F.D.A. inquiry raises a
larger issue: Whether the regulations governing dietary supplements
leave consumers who take so-called natural weight-loss supplements to
unknowingly play Russian roulette with their health.
Enacted in 1994, the main law on dietary supplements gives the
F.D.A. jurisdiction only after the products go on the market. Rather
than reviewing the supplements and approving them for sale, as the
agency does with drugs, the F.D.A. is limited to spot-checking
manufacturers and distributors, and testing products already on store
shelves. Even the F.D.A. acknowledges there may be hundreds of other
drug-contaminated weight-loss supplements for sale that the agency does
not have the resources to identify.
Even when the agency identifies contaminated products, however, it does
not have the ability to remove the pills from stores, because it is
initially up to companies to recall their products. Eventually, though,
if contaminated products stay on the market, the F.D.A. can seek
injunctions, seize products or file criminal charges.
As of Monday, the American distributors behind only three of the
brands named by the F.D.A., including StarCaps, had recalled their
tainted pills. Meanwhile, Web sites like
continue to sell a variety of the other brands, including 3X Slimming Power and Imelda Perfect Slim.
A full list of the tainted pills and other details are available on the F.D.A.’s Web site,
. An agency spokeswoman said people who want to report problems with the pills could call 1-800-FDA-1088.
“I used to think weight-loss pills were just fancy placebos,” said
Dr. Pieter Cohen, a general internist at the Cambridge Health Alliance
public hospital system in the Boston area. Over the last few years, he
said he had treated many patients who took tainted weight-loss pills
and came in complaining of chest pains and heat palpitations. “I think doctors need to be a lot more thoughtful – whether patients
are buying from local health food stores, off the Internet, or from
friends.”
A truck driver who is one of Dr. Cohen’s patients said he lost 20 pounds by taking what he thought were natural diet  pills imported from Brazil. Unaware that the pills contained high doses of an amphetamine as well as an antidepressant, the man said he nearly lost his trucking license after he did not pass a drug test at work.
“I failed the drug test and found out the hard way,” said the truck
driver, 42, who for privacy reasons did not want his name used. His
trucking license was suspended for six weeks, but he is now back at
work.
Of the nearly $24 billion spent on dietary supplements in this
country in 2007, about $1.7 billion went for weight-loss pills,
according to Nutrition Business Journal, a market research firm. About
15 percent of American adults said they had used weight-loss
supplements and the majority failed to inform their doctors about it,
according to a phone questionnaire of 9,500 adults conducted by
researchers at the Centers for Disease Control and Prevention in Atlanta, Georgia.
Steven M. Mister, the president of the Council for Responsible
Nutrition, a trade group whose members include ingredient suppliers and
makers of dietary supplements, said that the majority of weight-loss
supplements were safe. The F.D.A., he said, is mainly citing obscure
imported brands.
A half-dozen experts interviewed for this article, including
government scientists, health activists, doctors and a professor of
pharmacy, said that even mainstream natural weight-loss supplements
that did not contain hidden drugs could be risky. And they questioned
whether such supplements could have any significant effect on weight.
“Whether they have the ability to help people keep the weight off in
the long term is unknown,” said Dr. Paul Coates, the director of the
Office of Dietary Supplements at the National Institutes of Health (NIH)
in Washington, D.C. He added that even seemingly inert herbs can cause
biological changes. “Anything biologically active may turn out to have
a risk for somebody.”
Consider ephedra, an herbal stimulant that gained popularity as a
weight-loss supplement in the 1990s – until hundreds of people reported
ephedra-related problems including heart attacks, seizures and even
deaths. The F.D.A banned the use of ephedra in supplements in 2004.
Last year, the F.D.A. adopted new “good manufacturing practices”
rules that require makers of dietary supplements to test the purity of
each ingredient and the final product. Another new statute, which went
into effect in December 2007, requires manufacturers to notify the
F.D.A. of any reports of serious health problems caused by the pills.
“The law adequately protects consumer health because it does have
the monitoring system in place,” said Mister, of the industry trade
group.
Dr. Sidney W. Wolfe, the director of the health research division of the consumer advocacy group Public Citizen, said the regulations did not go far enough. Just because something is
uncontaminated does not mean it is safe, he said. For example, Dr.
Wolfe said he was concerned about bitter orange, a natural stimulant similar to ephedra that is widely used in weight-loss supplements.
So far no one has taken responsibility for the undeclared drugs in the pills.
StarCaps, the best known of the brands cited, gained a large
following through celebrity endorsements and articles in glossy
magazines like People. A billboard featuring the company’s founder and proprietor, Nikki Haskell, stood for years above Sunset Boulevard in Hollywood.
After reports surfaced late last fall that StarCaps contained
bumetanide, a potent diuretic that was not included on StarCaps’
ingredients list, the Vitamin Shoppe and GNC pulled StarCaps from their
shelves, according to e-mail messages from the companies in reply to a
reporter’s questions. Asked how GNC ensured the safety of such
supplements, a spokeswoman wrote, “Like any retailer, we rely on
warranties supplied by manufacturers of any third-party product.”
Last fall, Jackson and several other National Football League players
who said they had taken StarCaps failed a drug test when they tested
positive for bumetanide. The drug, which can mask steroiduse, is on the list of substances banned by the league.
Now, Jackson has filed a class-action suit against Haskell and the stores where he said he purchased StarCaps, including the Vitamin Shoppe and GNC.
Haskell said she had been shocked to learn from the news that
her product contained the diuretic. Over the last 25 years, she said
she had sold several hundred thousand bottles of StarCaps and had never
before received a complaint. She voluntarily recalled the products.
“I was completely devastated and remain devastated,” said Haskell.
You can read this article by New York Times writer
Natasha Singer, reporting from New York City, N.Y., in context here: