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July 21, 2008

GRAS applications and No Questions letters

FDA Law Blog (published by Hyman, Phelps, and McNamara) has an interesting post on GRAS (Generally Recognized As Safe) applications for food ingredients and uses for food ingredients:

FDA GRAS Response Letter Offers No Safe Harbor from FDAAA § 912

In previous postings (here and here), we have observed that § 912 of the 2007 FDA Amendments Act (“FDAAA”), which added the new § 301(ll) prohibition to the FDC Act, could represent a fundamental shift in the dividing line between foods and drugs, and has the potential to deter innovation in the research and development of new food ingredients.  That potential is slowly starting to be realized.  To understand why, a brief recap of the Generally Recognized as Safe (“GRAS”) concept is necessary.

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July 21, 2008 in Ingredients | Permalink

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