FDA Issues GMPs for Nutritionals

"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 commissioner of Food and Drugs Andrew C. von Eschenbach, MD. "In addition, as a result of recent amendments to the Federal Food, Drug, and Cosmetic Act, by the end of the year, industry will be required to report all serious dietary supplement-related adverse events to FDA."

Added Robert E. Brackett, PhD, director of FDA's Center for Food Safety and Applied Nutrition: "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." The agency wants to eliminate "improper packaging and labeling."

The final CGMPs are effective starting August 24, 2007. A three-year phase-in for small businesses is intended to ease compliance for companies with limited resources. "Companies with more than 500 em­ployees have until June 2008 to comply, companies with less than 500 em­ployees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations," FDA explained in its announcement.

FDA is soliciting comment from the public on the interim final rule. The 90-day comment period ends on September 24, 2007. Comments may be addressed to the Division of Dockets Management Branch at www.fda.gov/dockets/ecomments.


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