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.