At the Food and Drug Law Institute’s Annual Conference, Brian Sylvester provided a clear-eyed assessment of the evolving debate over FDA oversight of food chemicals and the future of the GRAS framework. He emphasized that FDA already retains meaningful enforcement authority under the existing statute, including the ability to act against adulterated food in commerce, underscoring that the current framework is not without regulatory teeth. At the same time, Brian identified a key legal constraint on reform efforts: absent congressional action, it remains uncertain how FDA could mandate GRAS notifications in a manner consistent with the Federal Food, Drug, and Cosmetic Act. His remarks framed the central tension in the policy debate—balancing calls for increased oversight with the statutory limits on agency authority.
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