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Patricia O'Connell
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Sonali Gunawardhana Discusses FDA Consent Decree on Food Additives Oversight

Food Chemical News
October 30, 2014

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted yesterday in a Food Chemical News article about a consent decree that settled a lawsuit against the Food and Drug Administration (FDA) regarding its oversight of food additives.

The consent decree requires the FDA to release its final rule on the Generally Recognized as Safe (GRAS) food ingredients program by August 31, 2016, according to the article.  The forced final rulemaking does not directly threaten to significantly disrupt the agency’s current GRAS regime, but putting that regime under additional safety scrutiny warns industry to take a close look at the defensibility of existing procedures and to accumulate a record of safety security and to focus on ensuring best science in future reviews, Ms. Gunawardhana said.  “This is a costly endeavor for industry,” she said.

“Should additional and more resource-intensive GRAS reviews be reinstated due to the issuance of the final rule, I believe the agency would then seek to implement user fees or request additional money from Congress be added to its budget for these reviews given the current limitations of the staff,” Ms. Gunawardhana added.  “Should the agency stay with its current regulatory oversight program, the task will fall to industry through qualified scientific experts to evaluate the safety of food ingredients.”