FDA OKs Dietary Supplement Regulations

Companies Left to Set Their Own Testing Standards

Reviewed by Louise Chang, MD on June 22, 2007
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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.


The most famous case of dietary supplements being pulled off the market came in 2004 when diet supplements containing ephedra and related compounds were banned by the FDA.

The drug has been linked to cardiovascular problems including heart attacks and was thought to be associated with dozens of deaths.

The Council for Responsible Nutrition, one of the supplements industry’s main lobbying groups, praised the FDA’s new rules.

“We are optimistic that these new dietary supplement [good manufacturing practices (GMPs)] will enhance consumer confidence in these popular products by raising the bar on production standards, helping ensure quality, and leveling the playing field for all dietary supplement companies,” Steve Mister, the group’s president and CEO, says in a statement.

“I’m sure we won’t agree with everything in the rule, but we are pleased that the new GMPs are here as it’s a step forward for our industry,” he says.

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SOURCES: Robert Brackett, PhD, director, FDA Center for Food Safety and Applied Nutrition. Vasilios Frankos, PhD, director, office of dietary supplements, FDA. Sidney Wolfe, MD, director, Public Citizen’s health research group. Steve Mister, president and CEO, Council for Responsible Nutrition.

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