Is the GRAS Process Broken? – An FDLI Dialogue

In light of recent developments and increasing scrutiny of the GRAS process, our newest Dialogue — Is the GRAS Process Broken?— is both extremely timely and practically important. Join us July 23, 2014, as we discuss what’s working — and what’s not — in the e GRAS notification process. Specifically, recognized experts in the field will explore whether there are holes in the system and the efficacy of the GRAS determination procedures. Speakers will also discuss relevant warning letters issued by FDA March 23, 2014. and compare and contrast GRAS determinations and Food Additive Petitions

when
Wednesday, July 23
10:30 am–3:30 pm

where
Hyman, Phelps & McNamara PC
700 Thirteenth St., NW, Suite 1200
Washington, D.C.

FDA Partner Gary Yingling will speak on the following panel from 12:45 to 2:00 PM:

How should FDA’s Guidance for Industry on GRAS be interpreted, and what will be the effect of pending litigation?

• Is the FDA January guidance a step in the right direction?
• Will the lawsuit filed by the Center for Food Safety against FDA and the GRAS process have an effect on how FDA regulates GRAS going forward?
• Will FDA be required to address the GRAS process in light of the litigation and the 2010 GAO Report finding that the FDA should strengthen its oversight of ingredients determined to be GRAS?

Gary Yingling
Partner, Morgan, Lewis & Bockius LLP

Nicolas Sloss
Assistant Director, Natural Resource and Environment Team, GAO

Mel Drozen
Partner, Keller and Heckman LLP

Moderated by Edward A. Steele, Chairman & CEO, EAS Consulting Group LLC.