- The Washington Times - Friday, March 7, 2003

WASHINGTON, March 7 (UPI) — The Food and Drug Administration proposed new production standards Friday for dietary supplements that will for the first time require manufacturers to ensure their products are free of contaminants and post labels identifying the ingredients and amounts of supplements.

"This proposed regulation would require that dietary supplements provide accurate information on the type and amount of ingredients they contain and that dietary supplements are produced using safe methods," said FDA Commissioner Dr. Mark McClellan, in announcing the new standards.

Current U.S. law does not require specific manufacturing standards for dietary supplements, which include vitamins, herbals and amino acids.

The regulations, which could go into effect in 2004, establish production standards requiring supplements and ingredients to be free of contaminants or impurities. In addition, manufacturers must ensure labels accurately reflect the levels of active ingredients and other components of their products.



"Americans must have confidence that the dietary supplements they purchase are not contaminated and that they contain the dietary ingredients and the amounts claimed on the labels," Health and Human Services Secretary Tommy Thompson said in a statement. "Millions of Americans use dietary supplements, and we owe it to them to ensure that they are getting the products they're paying for."

Under the proposed regulations, products found not to contain dietary ingredients as listed on labeling would be considered adulterated. The FDA "could remove them from the market and take action against the manufacturer," McClellan said.

He cited cases in which dietary supplements had to be withdrawn from the market after they were found to contain impurities "such as bacteria, glass or lead."

In addition, a number of analyses have shown dietary supplements often contain less or more active ingredient than what their labels purport, he said. In one instance, a folic acid supplement, which can reduce the risk of having a baby with neural tube defects, "contained only 35 percent of the amount of folic acid claimed on the label," the FDA said.

The regulations, which would apply to all dietary supplements, are part of the FDA's effort to ensure both the quality of these products and that their labels contain accurate information for consumers, McClellan said.

Last week, the agency proposed new warning labels for products containing ephedra —an ingredient found in many supplements that has been associated with death and other health problems.

McClellan noted the proposed regulations do not indicate the FDA endorses dietary supplements' safety or effectiveness. "This is not about safety and effectiveness of products … This is universal standards so consumers can know what's on the label is what's in the product," he said.

Dietary supplement manufacturers welcomed the new regulations.

"We are delighted that this happened," John Hathcock, vice president of scientific and international affairs of the Council for Responsible Nutrition, a group representing dietary supplement manufacturers, told United Press International.

Hathcock said accurate labeling already is legally required and most manufacturers already comply but "we know there are some … out there who need to be brought into line and this should do it."

Some manufacturers already have in place more stringent manufacturing standards than the FDA will require under these new regulations, he added.

One category of dietary supplements might be more difficult to certify, in terms of levels of active ingredients listed on their labels, Hathcock said. Herbal products are derived directly from plants and therefore levels of active ingredient can vary from one plant to the next. Still, he noted, "Compliance with them is by no means impossible."

McClellan said the manufacturing standards would also aid researchers attempting to determine whether certain supplements have health benefits.

Dr. Stephen Straus, Director of the National Center for Complementary and Alternative Medicine at the National Institutes of Health, agreed.

"Since credible research studies cannot be performed using many of the current, highly variable products, these practices will also speed our ability to provide the public with more definitive data about the safety and effectiveness of popular dietary supplements," Strauss said in a written statement.

The agency will take comments from the public, manufacturers and other interested parties for 90 days before issuing the final version of the regulations, McClellan said. He added he expects many manufacturers likely will comply voluntarily before the regulations go into effect.

Hathcock agreed that was likely. "We expect our (member) manufacturers to quickly get into compliance mostly before the actual legal compliance date," he said.

Smaller manufacturers would be given a period of three years to comply with the regulations, McClellan said.

Hathcock said small manufacturers could get into compliance just as fast as larger makers and he did not "see an immediate rationale for the time differential."

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