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FDA OKs Dietary Supplement Regulations

Companies Left to Set Their Own Testing Standards
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WebMD Health News
Reviewed by Louise Chang, MD

June 22, 2007 (Washington) -- Manufacturers of dietary supplements such as vitamins, minerals, and herbs will have to test their products for purity under new regulations finalized by the FDA Friday.

Much of the testing is left to the discretion of companies, and the agency said it would not inspect all manufacturing plants to monitor compliance. But the rule for the first time compels supplement makers to confirm that what’s in the bottles they sell matches what’s on the labels.

“Consumers should have confidence in the purity of the dietary supplements they purchase,” says Robert Brackett, PhD, director of FDA’s Center for Food Safety and Applied Nutrition.

The rules are set to be phased in over the course of several years. Large companies must comply by next summer, while firms with less than 200 workers have until June 2009. Small companies with 20 employees or less have until 2010.

After those dates, companies will have to test their products for purity and also confirm that the strength of products matches what’s on the label.

‘Flexible’ on Testing

But officials said they would be “flexible” on how companies test their products. “We leave it to the firm to have a scientifically valid testing program,” says Vasilios Frankos, PhD, director of the agency’s office of dietary supplements.

Brackett said the agency would inspect some manufacturing plants to make sure they’re complying with the rules. Companies tagged for unsafe practices in the past would be inspected more frequently. “Others that have shown a good record in the past could probably expect to be inspected less often,” he says.

The rules sparked protest from the FDA watchdog group Public Citizen. The law calling for the regulations has been on the books since 1994. Sidney Wolfe, MD, the group’s health director, called it “baffling” that it took the agency 13 years to finalize the rules.

“Even with these new manufacturing practices, there will be no assurance that dietary supplements work or are safe,” he says.

That’s largely because, unlike pharmaceutical manufacturers, dietary supplement makers are not required by law to prove their products are safe or effective.

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