FDA OKs Dietary Supplement Regulations

Companies Left to Set Their Own Testing Standards

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

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

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

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

The rules are set to be phased in over the course of several years. Largecompanies must comply by next summer, while firms with less than 200 workershave until June 2009. Small companies with 20 employees or less have until2010.

After those dates, companies will have to test their products for purity andalso 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 theirproducts. “We leave it to the firm to have a scientifically valid testingprogram,” says Vasilios Frankos, PhD, director of the agency’s office ofdietary supplements.

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

The rules sparked protest from the FDA watchdog group Public Citizen. Thelaw 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 agency13 years to finalize the rules.

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

That’s largely because, unlike pharmaceutical manufacturers, dietarysupplement makers are not required by law to prove their products are safe oreffective.

The most famous case of dietary supplements being pulled off the market camein 2004 when diet supplements containing ephedra and related compounds werebanned by the FDA.

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

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

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

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

Show Sources

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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