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US FDA Wants Vitamin Manufacturers to Test All Ingredients

Dietary supplements pills, liquids or other products are a $22 billion industry in the US. But it is not exactly well-regulated.

But now, addressing concerns over the ingredients that go into the making of these supplements, the Food and Drug Administration has announced that it is phasing in a new rule making for mandatory tests of all ingredients by the manufacturers themselves.

Frequently it has been pointed out that in many cases these supplements contained contaminated ingredients. Also there are occasions when ingredients listed on the label are not actually present in the final product.

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.

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 pro
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