FDA says that the new rules are formulated to address concerns that existing regulations allowed contaminated or unnamed labeled ingredients into the market. The agency found out last year that some supplements contained undeclared active ingredients used in prescription drugs for erectile dysfunction.
The manufacturers who refuse to adhere to the new regulations would have FDA consider their products adulterated or misbranded. If the problem is minor, the agency could ask the manufacturer to remove an ingredient or revise its label. However, if some serious error is committed, FDA could seize the product, file a lawsuit or even seek criminal charges.
According to AP reports, the new rule that applies to all domestic and foreign companies that manufacture, package and label supplements for sale in the U.S., will be applicable from Aug. 24. It will have a three-year phase-in period that gives smaller manufacturers more time to comply and even the largest of the manufacturers won't have to comply until June 2008.
The new rules makes it mandatory for all companies to keep a strict check on 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.
