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Patricia O'Connell
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Sonali Gunawardhana Discusses Upcoming “Banner Year” for FDA Food Additive Oversight

Food Chemical News
January 8, 2014

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was quoted by Food Chemical News in a January 3 article about the 2014 regulatory outlook for the U.S. Food and Drug Administration’s (FDA) Office of Food Additive Safety.  This may prove to be a “banner year” for the office, according to the article.

Ms. Gunawardhana said a closely watched issue this year will be whether the FDA changes its classification of partially hydrogenated oils (PHOs)—the primary dietary source of artificial trans fats in processed foods.

The FDA made a preliminary determination in November that PHOs are no longer “generally recognized as safe” (GRAS) and should be removed from the food supply.  The agency set a March 8 deadline for comments on its initial proposal in order to collect additional data and gain input on the time needed for manufacturers to reformulate foods that currently contain PHOs.

Any final determination by the FDA that PHOs are no longer generally recognized as safe could affect the availability of products that rely heavily on artificial trans fats, such as cake frosting, Ms. Gunawardhana said.  

“Frosting is shelf-stable for a reason,” and that reason is the use of PHOs, Ms. Gunawardhana said.  “I’m not sure you can use lard or anything else and be shelf-stable.”

She also noted that it would cost the industry a staggering amount of money to reformulate foods that currently contain PHOs.

Ms. Gunawardhana suggested that the FDA might “talk to different groups and take not as drastic a move” as fully revoking the GRAS status of PHOs.

The agency might also revisit the GRAS status of food color additives amid pressure from consumer groups, and may try to collaborate with industry groups to modify the overall GRAS program, she added.