FDA Offers Extension for Nutraceutical GMPs


Erik Swain

Nutraceutical GMPs will affect packaging as well as manufacturing. Bottles courtesy Matrix Packaging Inc. (Addison IL); closures courtesy Rexam Closures (Mundelein, IL).

FDA has decided to extend the comment period on its proposal to establish good manufacturing practices (GMPs) for dietary supplements.

Comments on FDA's proposed rule, published in the March 13, 2003, Federal Register [68 FR:12157--12263], are now due on August 11, 2003. The agency had initially asked for them by June 11. 

The proposal applies to companies that manufacture, package, or hold dietary supplements. It would require these companies to evaluate the identity, purity, quality, strength, and composition of the ingredients and supplements. The rule calls for industry to manufacture, package, and store supplements in a way that does not adulterate or misbrand them.
The proposal has generated controversy in the supplement industry, parts of which would prefer to see the products regulated more like foods than drugs. Therefore, several industry groups petitioned for an extension of the comment period, so they could conduct the research necessary to provide complete scientific responses. 

On that basis, the agency agreed to a 60-day extension but does not plan to grant any additional time. It wants to finalize a rule as quickly as possible. 
Submit written comments to the Dockets Management Branch (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to www.fda.gov/dockets/ecomments.  

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