Brian Sylvester spoke with Law.com about the FDA’s proposed rule requiring companies to disclose substances they determine are “generally recognized as safe” (GRAS). Brian noted potential legal challenges, as the FDA previously maintained that it lacked authority to mandate GRAS notices, and predicted that parts of the proposal may not survive in their current form. Still, he said the rule “starts a conversation about how the FDA can play a greater role in the GRAS framework in terms of achieving its goal of transparency.” Brian advised companies to inventory their self-GRAS uses and assess whether their determinations could withstand regulatory scrutiny.
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