Makers of dietary supplements for the first time will have to identify and test all the ingredients in their products, the Food and Drug Administration said yesterday.
The FDA yesterday released a new rule establishing manufacturing procedures, such as quality-control procedures, designing and constructing manufacturing plants and testing ingredients. The rule applies to all domestic and foreign companies that manufacture, package and label supplements for sale in the United States.
“This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label,” said FDA Commissioner Andrew von Eschenbach.
Dietary supplements — multivitamins, minerals and herbs — are a $22 billion-a-year industry. Supplements are marketed for a broad array of uses, such as athletic-performance boosters, weight loss and treatments for anxiety.
The regulation will be implemented over three years beginning Aug. 24 with large businesses having to comply in the first year and smaller business allowed to take the entire three years to come into compliance.
The aim of the new regulation is to ensure that incorrect levels of vitamins or blatantly wrong ingredients do not show up in the products. Last year, the agency found that some supplements, such as those used for erectile dysfunction, used undeclared active ingredients. The FDA also has found supplements that didn’t contain the levels of vitamin C or vitamin A that were claimed by the manufacturer.
Under the old regulations, supplements were governed by the same rules as food products.
The industry reacted favorably to the new rule, which has been pending for more than three years and took more than 13 years to develop. Congress told the agency in 1994 it must issue a regulation tightening federal safety standards on dietary supplements.
“We are optimistic that these new dietary supplement good-manufacturing practices will enhance consumer confidence in these popular products by raising the bar on production standards,” said Steve Mister, president of the Council for Responsible Nutrition, the industry’s leading trade association.
“I’m sure we won’t agree with everything in the rule, but we are pleased that the new good-manufacturing practices are here as it’s a step forward for our industry.”
The final regulation also includes requirements for record keeping and handling consumer complaints.
Consumer advocacy groups reacted more tepidly to the FDA’s new standard.
“This new rule requires dietary supplement makers follow procedures to ensure that their products contain the type and amount of ingredients on the label. However, consumers still have no idea if a given product works, or whether it is dangerous,” said Janell Duncan, senior counsel for Consumers Union.
Ms. Duncan pointed out that unlike prescription drugs, dietary supplements are not required to be proven safe and effective before being marketed.
“In large part, it is still ’buyer beware’ for consumers of dietary supplements because manufacturers are not required to list known health risks for their products, or make sure that they are safe or effective,” she added.
Further safety measures are on the way as Congress recently passed legislation requiring makers of dietary supplements to report all serious negative side effects to the FDA. That law will go into effect by the end of the year.
Please read our comment policy before commenting.