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 products before they are distributed.
It also includes requirements for record keeping and handling consumer complaints.
Dr. Sidney Wolfe, who has testified before Congress on problems with dietary supplements, said the new rule does not ease his concern that unsafe supplements are too easy to bring to market.
"You still don't have to show the product is safe. You don't have to prove it works," said Wolfe, director of Public Citizen's Health Research Group.
Consumers Union, publisher of Consumer Reports
, called the rule a good step toward improving consistency in the ingredients that go into supplements.
"However, consumers still have no idea if a given product works, or whether it is dangerous," said Janell Mayo Duncan, senior counsel for Consumers Union.
Congress limited the Food and Drug Administration's oversight of vitamins and other dietary supplements in 1994. The new rule is a product of that law, meaning that the rule took nearly 13 years to develop.
Under the old regulations, supplements were governed by the same rules that applied to producing foods, such as cans of soup.
"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.