FDA OKs Dietary Supplement Regulations
Companies Left to Set Their Own Testing Standards
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
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
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
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
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