The Food and Drug Administration announced Friday that all manufacturers of herbal pills, vitamins and any dietary supplements now have to test all the ingredients in their products.
The new rule will be phased in as the federal regulations have allowed supplements that were contaminated and those that did not contain the ingredients that the label claimed.
Last year it was found that some supplements contained an active ingredient that is used in prescriptions for erectile dysfunction. Also in the past supplements have been found that do not have the levels of Vitamin C or Vitamin A that the labels claimed.
The FDA would consider the products adulterated or misbranded if they do not contain the ingredients that are claimed to be in the product. The agency can tell the manufacturer to remove an ingredient that is not claimed or to revise their label. The FDA can also seize the product and file a lawsuit or seek seek criminal charges.
The dietary supplement business is a $22 billion industry
According to Steve Mister, president and CEO for the Council for Responsible Nutrition most companies already test raw ingredients once they come into the plants.
"This raises the bar so that all have to comply," Mister said
.
The new rule will take effect on Aug.24. To give smaller manufacturers time to comply there is a three year phase-in. All domestic and foreign companies
must comply with the new ruling.
There are also requirements for keeping records and how to handle complaints by customers.
It has taken about 13 years to develop the new rule.
"The final rule will help ensure that dietary supplements are manufactured with controls that result in a consistent product free of contamination, with accurate labeling," said Dr. Robert E. Brackett, director of FDA's Center for Food Safety and Applied Nutrition
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