GMP Interim Final Rule Sets Bar High For 100% Testing Exemption – Experts
This article was originally published in The Tan Sheet
Firms "rarely" will meet the scientific rationale FDA included in an interim final rule to substantiate petitions for exemption from 100 percent ingredient identity testing required in the dietary supplement good manufacturing practices, according to food and drug law expert Scott Bass
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Some smaller dietary supplement firms could need support from the industry and flexibility from FDA to pay for complying with good manufacturing practices and still keep their doors open
The Consumer Healthcare Products Association requests a 60-day extension to the comment period for FDA's interim final rule on a petition to request exemption from 100% identity testing of dietary ingredients in a letter to FDA Aug. 9. "CHPA and its members feel that additional time is needed to adequately respond to the Federal Register notice," the association notes. The IFR was published June 25 and will be effective Aug. 24 (1"The Tan Sheet" July 23, 2007, p. 3). In a separate same-day filing, the trade group also requests a 60-day extension of the comment period for FDA's draft guidance for industry on an evidence-based review system for the scientific evaluation of health claims. The group feels "additional time is needed to adequately prepare" its comments; if the agency grants CHPA's request, the new comment deadline would be Nov. 6...
The dietary supplement good manufacturing practices final rule provides "a very flexible framework for required testing," said Vasilios H. Frankos, director of the dietary supplement programs division for FDA's Center for Food Safety and Applied Nutrition