July 21, 2008
GRAS applications and No Questions letters
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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