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Patricia O'Connell
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Sonali Gunawardhana Discusses Draft FDA Guidance on GMO Labeling

September 19, 2013

Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice, was interviewed by Politico for a September 17 article about the labeling of foods containing genetically modified organisms (GMO).

Sen. Elizabeth Warren (D-MA) recently urged the U.S. Food and Drug Administration (FDA) to finalize its 12-year-old draft guidance for companies regarding the use of food labels to indicate whether the products have been developed using bioengineering.  If the draft guidance is finalized, food manufacturers could follow it on a voluntary basis.

Some consumer advocates are concerned that such nonbinding FDA recommendations could be used to preempt mandatory GMO labeling standards enacted by some states, according to the article.  But Ms. Gunawardhana told Politico that type of preemption is unlikely, as guidance documents are considered nonbinding on both the agency and industry; rather, guidance is the agency’s current thinking and/or suggested best practices on a matter.

“It’s not law; therefore anything you put in the guidance documents really can’t stand on its own,” said Ms. Gunawardhana, who served as regulatory counsel in the FDA’s Center for Food Safety and Applied Nutrition before joining Wiley Rein last year.

“The bottom line is that you need a law or some other statutory authority” behind the guidance, she said.