For the first time, makers of dietary supplements, including vitamins and herbal pills, will be required to test their products, the Food and Drug Administration said Friday.
Under the Dietary Supplement Health and Education Act, which passed in 1994, supplement makers were told they must be able to substantiate the safety of their ingredients. Now, 13 years later, the FDA's announcement represents the actualization of that requirement.
The agency is phasing in the new rule requiring supplement makers to test the purity and composition of their products. Big companies will have to comply by next June, while small companies have until 2010 to start testing their products.
“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” FDA Commissioner Andrew von Eschenbach said in a statement.
If the FDA discovers that supplements do not contain the ingredients they claim to contain, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove the ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or even seek criminal charges. The FDA has also announced requirements for record keeping and handling consumer complaints.
Some are skeptical and concerned that the guidelines are too general — and too gentle.
Dr. Tod Cooperman, president of ConsumerLab.com, a Westchester, N.Y.-based company that independently evaluates hundreds of supplements and periodically publishes reviews, says the the new standards leave too many important decisions to the manufacturers, such as which type of testing methods are appropriate.
"The problem is manufacturers often rely on tests that aren't very specific and can be tricked," Cooperman said. His lab has found instances of lead contamination and wrong ingredients that manufacturers' own testing methods have not identified. "This won't ensure the quality of supplements, but it may help improve the consistency from batch to batch."
The new rules don't ask companies to do testing to prove any of their health claims. Still, this announcement is largely seen as a step in the right direction.
"Supplements have been an exempt industry, so this is a shift that's important and overdue," said Art Caplan, director of the University of Pennsylvania's Center for Bioethics and an MSNBC.com columnist. "It's not the most vigorous approach but it's better than nothing."
Last year, the FDA found that some supplements contained undeclared active ingredients used in prescription drugs for erectile dysfunction. In the past, regulators found supplements that didn’t contain the levels of vitamin C or vitamin A that were claimed.
Most companies already test their raw ingredients once they come into the plant, said Steve Mister, president and CEO for the Council for Responsible Nutrition, a trade association representing about 65 manufacturers.
“This raises the bar so that all have to comply,” Mister said.
Dietary supplements — pills, liquids or other products people take to improve their diets — are a $22 billion industry.
The Associated Press contributed to this report.