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Patricia O'Connell
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Sonali Gunawardhana Warns Food Industry of Changing FDA “Landscape”

Food Chemical News
April 12, 2013

Wiley Rein attorney Sonali P. Gunawardhana was invited to participate in the Grocery Manufacturers of America’s (GMA) Science Forum on April 3, and delivered an eye-opening speech about U.S regulators’ expanding oversight of the food industry. Her remarks garnered a “Quote of the Week” recognition from Food Chemical News.

The two-year-old Food Safety Modernization Act (FSMA) “changed the landscape” for the U.S. Food and Drug Administration (FDA), she told industry leaders during a panel discussion at the annual gathering in Washington. Ms. Gunawardhana served as regulatory counsel in the FDA’s Center for Food Safety and Applied Nutrition before joining Wiley Rein’s Food & Drug Law Practice last year.

Her presentation prompted Food Chemical News to publish an April 5 article that focused on her warning that the 2011 law will change the FDA’s “generally recognized as safe” (GRAS) program. The law gave FDA inspectors new authority to obtain documents used by food manufacturers to determine that certain ingredients in their products meet the agency’s GRAS standards.

“You're actually going to have to have a lot of records,” Ms. Gunawardhana said. FSMA “basically said the agency has the right to come, especially when there's an emergency situation where the agency feels there's a problem, they're going to be able to come in and look at your records, and records you're not used to providing historically.”

Unlike drugs and medical devices—which can’t be marketed in the U.S. without prior approval from the FDA—certain substances can be added to foods without prior FDA clearance, as long as a manufacturer affirms that an ingredient is generally considered to be safe for its intended use.

But a preventive controls rule proposed by the FDA under the 2011 law calls for more scrutiny of companies’ GRAS documents, and could bring the agency’s food-safety oversight more in line with its regulation of drugs and medical devices, Ms. Gunawardhana said.

“How many of you think that you’re moving towards a drug/device approval type of setting?” she asked manufacturers attending the GMA conference, in what was highlighted as the “Quote of the Week” by Food Chemical News. “You are. I hate to break it to you, but you’re moving in that direction.”

“I think the agency is very comfortable in looking at, historically, how drugs and devices have been regulated, and how there's a level of safety there, and they're moving that into the food area,” Ms. Gunawardhana added.

To view the Food Chemical News article on Ms. Gunawardhana’s presentation (“FSMA Could Change Industry Approach to GRAS, Former FDA Attorney Warns”), please click here. (This article was reproduced with permission from Further reproduction without the express written permission of the publisher is prohibited.)