Web Date: July 2, 2007
FDA Finalizes Rules For Dietary Supplements
Domestic and foreign manufacturers of vitamins, herbs, and other dietary supplements must follow new standards to show that their products are labeled properly and are not contaminated. On June 22, FDA officials announced new standards for testing the purity, strength, and composition of all supplements.
"This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the new products they purchase contain what is on the label," says FDA Commissioner Andrew C. von Eschenbach. Supplements have always been regulated as a category of food, not as drugs.
The standards lay out good practices to ensure quality during manufacturing, labeling, and storage of dietary supplements. They list requirements for quality-control procedures, the design of manufacturing plants, and testing of ingredients and final products. They take effect for large plants in June 2008 and for small companies in June 2010. Furthermore, because of recent amendments to the federal Food, Drug & Cosmetic Act, manufacturers in this $21 billion dietary supplement industry will be required to report adverse events caused by their products.
The power to establish the new manufacturing standards was granted in a 1994 federal law, but some critics say the new rules do not do enough to ensure safety. "Today's final rule on Good Manufacturing Practices is an example of better late than never. But the requirements do not appear to go as far as they could have," notes Sen. Richard J. Durbin (D-Ill.).
Under the rules, FDA will be able to inspect manufacturing plants for compliance. Companies must keep records showing that supplement ingredients have been tested, but they do not have to submit these records to FDA. Supplement makers are responsible for devising scientifically defensible tests for the purity of ingredients, the agency says.
FDA plans to inspect some of the plants, but it does not have additional money for enforcement. Resources will be shifted according to the risk posed by the manufacturers, says Robert E. Brackett, head of the agency's Center for Food Safety & Applied Nutrition. If a company violates the rules, FDA could fine the firm or ask it to voluntarily withdraw a product.
"Even with these new manufacturing practices, there will be no assurance that dietary supplements work or are safe," says Sidney Wolfe, director of the Health Research Group at Public Citizen, a nonprofit public interest organization. He urges Congress to address "this enormous deficiency in the law."
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