News & Analysis as of

GRAS Regulatory Requirements Regulatory Oversight

Beveridge & Diamond PC

FDA Targets Food Chemicals: New BHA Reassessment, “No Artificial Colors” Enforcement Discretion, and a Potential GRAS Overhaul

Beveridge & Diamond PC on

The U.S. Food and Drug Administration (FDA) continues to advance the Trump administration’s Make America Healthy Again (MAHA) priorities by increasing scrutiny of chemicals in the food supply and accelerating the shift away...more

The Food Lawyers ®

FDA’s Focus on Self-Affirmed GRAS: Regulatory Recalibration and Practical Implications

The Food Lawyers ® on

The U.S. Food and Drug Administration (FDA) has signaled renewed regulatory focus on the long-standing practice of “self-affirmed” GRAS determinations....more

Wiley Rein LLP

Reforming GRAS: Digesting the Proposed “Better Food Disclosure Act” (S. 3122)

Wiley Rein LLP on

Senator Roger Marshall (R-KS) introduced much-anticipated legislation this month that seeks to reform the process by which “generally recognized as safe” (GRAS) substances are assessed by the U.S. Food and Drug Administration...more

Morgan Lewis

HHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now

Morgan Lewis on

Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human...more

Ice Miller

RFK Jr. Calls to End the Self-Affirming GRAS “Loophole”

Ice Miller on

Through an Order that the Secretary of the U.S. Department of Health and Human Services (HHS) Robert F. Kennedy Jr. (RFK) called an act of “radical transparency,” the U.S. Food and Drug Administration (FDA) has been directed...more

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