News & Analysis as of

GRAS Regulatory Requirements Federal Food Drug and Cosmetic Act (FFDCA)

Vicente LLP

Frequently Asked Questions About Non-Alcoholic Beverage Regulations

Vicente LLP on

THC beverages, zero-proof spirits, dealcoholized wines, non-alcoholic (NA) beer, kava and kratom drinks and functional wellness beverages are filling more shelves than ever at package and liquor stores, groceries, bodegas,...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

Epstein Becker & Green

Eliminating the GRAS Pathway: An Update

Epstein Becker & Green on

Legislation introduced in the U.S. Senate in November, informally called the “Better FDA Act of 2025,” is perhaps a bit misleading. While it involves the Food and Drug Administration (“FDA”), the full title of S....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

Hogan Lovells

Senator Marshall Introduces GRAS Reform Bill

Hogan Lovells on

On November 6, 2025, Senator Roger Marshall (R-KS) introduced the “Better Food Disclosure Act of 2025”, also known as the “Better FDA Act of 2025” (S. 3122) which would reform the Generally Recognized as Safe (“GRAS”) legal...more

Husch Blackwell LLP

Eliminating the GRAS “Loophole”: Implications for Functional Foods and Beverages

Husch Blackwell LLP on

On March 10, 2025, the U.S. Department of Health and Human Services (HHS) announced that U.S. Secretary of HHS Robert F. Kennedy Jr. directed the U.S. Food and Drug Administration (FDA) to explore closing the GRAS...more

Epstein Becker & Green

The End of the Self-Affirmed GRAS Pathway?

Epstein Becker & Green on

On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential...more

Morgan Lewis - Well Done

Chocolate Cicadas and Mealworm Mints: Will FDA Spit Out Guidance for Edible Insects?

The month of May was buzzing with good news for the edible insect industry, but this emerging food trend still faces regulatory uncertainty in the United States....more

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