Feds Call for Tighter Control Over Nutritional Supplements

April 17, 2001
The New York Times
Tighter Rules Are Sought for Dietary Supplements
By ROBERT PEAR

WASHINGTON, April 16 Federal investigators called today for much more
stringent regulation of dietary supplements, saying current standards and
their enforcement were grossly inadequate and allowed safety problems to go
unchecked.

In the final draft of a new report, the acting inspector general of the
Health and Human Services Department said manufacturers of dietary
supplements, the supplements themselves and their ingredients should be
registered with the government.

The investigators said the Food and Drug Administration lacked the most
basic information needed to analyze reports of illness and injury associated
with dietary supplements, which include vitamins and minerals, herbal
products, amino acids and some sports nutrition products. Manufacturers of
supplements are not required to report such "adverse events" to the
government, as makers of prescription drugs must do.

In many cases, the investigators said, federal officials could not determine
the ingredients and could not identify or locate the maker of products
suspected of harming users.

The study, to be issued later this month, said: "F.D.A. was unable to
determine the ingredients for 32 percent (1,153 of 3,574) of the products
mentioned in adverse event reports. F.D.A. does not have the product labels
for 77 percent of the products mentioned in reports. F.D.A. was unable to
determine the manufacturer for 32 percent of the products involved in
reports."

The acting inspector general, Michael F. Mangano, said more than 100 million
Americans were taking dietary supplements. The industry estimates that
retail sales total nearly $15 billion a year.

The report said manufacturers should be required to notify the government
when they receive reports of an illness or injury that may be associated
with dietary supplements.

Though many dietary supplements are beneficial, the study said, some carry
risks. Ginkgo biloba, often taken to enhance memory, "can lead to excessive
bleeding and, in some cases, stroke," the study said. High doses of vitamin
A in pregnancy can lead to birth defects, it said.

Just last week, the government advised consumers to stop using herbal
remedies that contain Aristolochia, also known as Virginia snakeroot. The
F.D.A. said some users had developed permanent kidney damage and cancers of
the urinary tract.

Joseph A. Levitt, director of the Center for Food Safety and Applied
Nutrition at the F.D.A., called the inspector general's report "very
helpful." In an interview, Mr. Levitt said the agency had a plan for
improvements. But Mr. Levitt said the agency would need perhaps $1 million
to $2.5 million to get started.

The F.D.A. can seize products, issue warnings, request recalls and order
manufacturers to put more information on product labels. But from January
1994 to June 2000, investigators said, the government took only 31 such
actions to protect users of dietary supplements.

Healthy consumers take dietary supplements to increase energy, strengthen
their immune systems, prevent memory loss, build muscle mass or lose weight.
Sick people use them as an inexpensive alternative to some prescription
drugs.

Dietary supplements are loosely regulated under a 1994 law. Manufacturers do
not have to obtain government approval before marketing such products. The
F.D.A. relies mainly on reporting of "adverse events" to pinpoint safety
problems.

But the inspector general said the food and drug agency learned of only a
tiny fraction of the events. The reporting of injuries to the government is
voluntary, the study said.

A spokesman for the American Herbal Products Association, a trade group for
the industry, said it opposed mandatory reporting of injuries and illnesses
because there was "no public health need."

The Council for Responsible Nutrition, which represents manufacturers of
dietary supplements, said the new study painted "a biased picture of the
industry," understating the benefits of supplements.

Annette Dickinson, the council's vice president for scientific and
regulatory affairs, said, "We are open to discussion of mandatory reporting,
at least for serious adverse events that present an actual risk of harm to
the consumer." But she said vitamins had been safely used for many years
without problems.

Anthony L. Young, general counsel of the American Herbal Products
Association, said: "The F.D.A. does not evaluate the reports it receives.
It's not using the existing tools. You don't set up a huge registration
system just because the F.D.A. doesn't choose or want to enforce a law
that's been on the books for years."

The inspector general's report said the F.D.A. had not established "good
manufacturing practices" to control ingredients used in dietary supplements.
As a result, it said, the government "cannot assume that products contain
what is listed on their labels, in the quantities listed."

Ms. Dickinson and Mr. Young said the industry supported federal efforts to
define good manufacturing practices.

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