FDA Moves On Dietary Supplements

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http://www.washingtonpost.com/wp-dyn/articles/A59391-2003Mar7.html

 

FDA Moves On Dietary Supplements

Agency to Oversee Herbal Remedies

 

By Rob Stein

Washington Post Staff Writer

Saturday, March 8, 2003; Page A01

 

The federal government yesterday proposed that vitamins and herbal remedies

for the first time be subject to regulations governing how they are

manufactured and labeled.

 

The Food and Drug Administration unveiled a long-anticipated set of rules

designed to ensure that dietary supplements are produced in clean plants,

are genuine and remain untainted with contaminants.

 

" Millions of Americans use dietary supplements, and we owe it to them to

ensure that they are getting the products they're paying for, " said Health

and Human Services Secretary Tommy G. Thompson.

 

The rules on dietary supplement manufacturing would be similar to those

governing packaged foods. In addition to quality and cleanliness, they would

set standards for inspections and record-keeping. The estimated 1,000

supplement manufacturers would also have to ensure that their products

contain the ingredients and strength specified on the label.

 

The proposal would not require that the supplements be proved safe and

effective, as drugs must be.

 

The move came in response to a number of cases in which dietary supplements

were found to contain compounds other than those stated on the label, at at

different dosages or contaminated with potentially dangerous substances,

such as pesticides, bacteria and even lead and glass, officials said.

 

" In many ways, the dietary supplement market was a buyer-beware market, "

said FDA Commissioner Mark B. McClellan during a briefing for reporters.

 

Under the proposal, " FDA could remove products from the market if they are

adulterated, or contain subpotent or superpotent levels, or the wrong

ingredients or contaminants, " McClellan said.

 

The proposal will be subject to public comment for three months before

taking effect, probably sometime next year, McClellan said. Large

manufacturers would have to comply immediately, and smaller companies would

have as many as three years.

 

The announcement was praised by representatives for the dietary supplement

industry, who said many companies already follow similar guidelines

voluntarily.

 

" The industry has been asking for this rule for a long time, and we're

extremely pleased that it's finally here, " said David R. Seckman, executive

director and CEO of the National Nutritional Foods Association, an industry

group.

 

Consumer advocates welcomed the announcement as well, but criticized the

plan as not going far enough, especially in not requiring that supplements

be proved safe and effective.

 

" Many dietary supplement products are more akin to medicine than a processed

food product. Pharmaceuticals are manufactured to higher-quality standards

than frozen green beans, " said Bruce Silverglade of the Center for Science

in the Public Interest. " The dietary supplement industry has portrayed good

manufacturing standards as ensuring safety and effectiveness. "

 

Federal officials said they were going as far as they could under current

law to protect consumers while still making such products widely available.

Because of the unusual nature of dietary supplements, the regulations are

akin to a mix of the rules used for foods and over-the-counter drugs such as

aspirin, McClellan said.

 

" We are doing everything we can within the law to make sure Americans get

accurately labeled and safe dietary supplements, " McClellan said.

 

Herbal remedies have been the focus of controversy for more than a decade.

Under a 1994 federal law, supplements were free to be sold with little

oversight, including any requirement that they be proved safe or effective

or even that they actually contain the compounds they claim.

 

The dietary supplement market exploded in the United States, with firms

aggressively marketing products ranging from everyday nutrients like calcium

to exotic substances such as cat's claw, an herb from the Peruvian

rainforest purported to help alleviate ailments including AIDS, cancer,

arthritis and diabetes.

 

Millions of Americans now regularly consume St. John's wort to ward off

depression, echinacea to boost their immune systems, ephedra to lose weight,

ginkgo to boost brain power and ginseng to increase their vitality. The U.S.

dietary supplement market is estimated to be about $19 billion.

 

While some products have been shown to clearly have health benefits, the

booming industry has also had a number of health disasters. Ephedra, also

known as ma huang, has been linked to heart attacks.

 

The federal government last week moved to require tough new warning labels

about its use after the supplement was suspected of contributing to the

death of Orioles pitching prospect Steve Bechler. Other products have been

found to interfere with AIDS treatments and cancer therapies. Still others

were found to be tainted with dangerous substances.

 

Since 1993, the FDA has received about 7,000 reports of people suffering

adverse reactions as a result of using supplements, including 1,214 such

reports last year, the agency said.

 

© 2003 The Washington Post Company