FDA to Demand Supplement Makers to Vouch for Contents

updated 11/16/2006

by Alicia Ault

WASHINGTON (Reuters Health) - The U.S. Food and Drug Administration (FDA) on Friday proposed to require dietary supplement makers to prove their products contain the ingredients listed, and in the right strength, and that they don't harbor impurities. "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," said Dept. of Health and Human Services Secretary Tommy Thompson in a statement. The rule is the latest in a series of steps being taken by HHS to make sure that dietary supplement product information is accurate, said FDA Commissioner Mark McClellan.

Consumer advocate Dr. Sidney Wolfe said the rule may make products only slightly safer by ensuring that there is not twice as much in a bottle as stated. However, he said it still won't address what he calls the biggest flaw in the dietary supplement law--that companies aren't required to conduct pre-market safety and efficacy studies. "Most of the people who've gotten in trouble with ephedra or other dietary supplements haven't gotten in trouble because there's more there, it's because products are inherently dangerous or ineffective," said Wolfe, president of Public Citizen's Health Research Group.

In 1994 the FDA was given the power to ensure safe manufacturing and proper labeling of supplements, but is just now issuing the rule that spells out how it will do so. The proposal won't go into effect for at least a year, which means consumers won't see changes soon. But McClellan said he expects some manufacturers to start complying with the requirements before they become law, saying that many have asked for rules that set a "level playing field."

McClellan also said he does not expect opposition. "I think this proposal, the way we've designed it, is going to have broad support," he said in a briefing. "I am confident we are going to be able to follow through on this--this is something the public wants."

Private lab tests have found that five of 18 soy or red clover-containing products had only 50 percent to 80 percent of the listed amount of isoflavones, he said. The agency also knows of one company that recalled supplements because of lead contamination, and another that recalled a supplement that contained only 35 percent of the folic acid listed on the label--worrisome to women relying on the product to help prevent birth defects.

The new rule would help prevent these potentially dangerous problems by giving the FDA power to oversee construction of plants, establishment of quality control procedures and send inspectors into plants to test raw ingredients and finished products for strength and contaminants, said McClellan. If products or procedures aren't in line with FDA rules, the agency would warn the company to comply and, eventually, force a recall or shutdown. McClellan said the agency had enough money and manpower to make sure the estimated 1,000 dietary supplement makers comply with the new rule.

The proposal would also apply to companies that manufacture products outside the U.S. and import them for sale, and to those that import raw ingredients, said Joseph Levitt, director of FDA's Center for Food Safety and Applied Nutrition.

One industry trade group, the Washington DC-based Consumer Healthcare Products Association, said it welcomed the FDA proposal. "We think this will provide consumers with a lot more confidence in the products they are taking," said Donna Edenhart, a CHPA spokeswoman. Most CHPA members are larger companies that also manufacture pharmaceuticals and are accustomed to abiding by FDA manufacturing rules.

Under the FDA proposal, smaller supplement makers would have three years to get into compliance.

The public has 90 days to comment on the proposal. The agency will analyze the comments, and hopes to issue the final rule within a year, McClellan said.

© Reuters 2002. All rights reserved.

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