WASHINGTON – For the first time, manufacturers of vitamins, herbal pills and other dietary supplements will have to test all of their products’ ingredients.
The Food and Drug Administration said Friday it is phasing in a new rule designed to address concerns that existing regulations allowed supplements onto the market that were contaminated or didn’t contain ingredients claimed on the label.
Last year, the agency 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.
If, upon inspection, the FDA finds that supplements do not contain the ingredients they claim, the agency would consider the products adulterated or misbranded. In minor cases, the agency could ask the manufacturer to remove an ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or even seek criminal charges.
Dietary supplements – pills, liquids or other products – are a $22 billion industry.
Most companies already test their raw ingredients, 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.
The new rule goes into effect Aug. 24 and will have a three-year phase-in that gives smaller manufacturers more time to comply. Even the largest of the manufactures won’t have to comply until June 2008.
The rule applies to all domestic and foreign companies that manufacture, package and label supplements for sale in the U.S. It requires them to analyze the identity, purity and strength of all the ingredients that go into their products before they are distributed.
It also includes requirements for record keeping and handling consumer complaints.
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