News & Analysis as of

Genetically Engineered Animals Regulatory Oversight

ArentFox Schiff

FDA Greenlights Commercialization of Gene-Edited Pig Resistant to Devastating Swine Disease PRRSV

ArentFox Schiff on

On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....more

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

Alston & Bird on

Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Morgan Lewis - Well Done

USDA’s Proposal to Take Back Regulatory Oversight of GM Animals from FDA Remains Viable Despite Change in Administration

On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A...more

Morgan Lewis

FSIS Advises on Animal-Raising Label Claims but Issues Still Exist

Morgan Lewis on

The USDA’s Food Safety and Inspection Service (FSIS) updated two labeling guidelines involving animal raising claims in December. Labeling Guideline on Documentation Needed to Substantiate Animal Raising Claims...more

Mintz - Consumer Product Safety Viewpoints

Regulatory Agencies Launch Unified Website for Biotechnology Regulation

In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9,...more

Hogan Lovells

FSIS Issues Updated Labeling Guideline on Statements That Bioengineered or Genetically Modified Ingredient or Animal Feed Were Not...

Hogan Lovells on

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued an updated Labeling Guideline on Statements That Bioengineered or Genetically-Modified Ingredients or Animal Feed Were Not...more

Wilson Sonsini Goodrich & Rosati

FDA Target of Executive Order on Agricultural Biotechnology

In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an...more

Polsinelli

Final Rule Regarding the Labeling of Bioengineered Foods

Polsinelli on

On December 21, 2018, the Agricultural Marketing Service (“AMS”) of the United States Department of Agriculture (“USDA”) issued its long-anticipated final rule establishing requirements for the disclosure of food that is...more

Hogan Lovells

USDA’s AMS Issues Final Rule on National Bioengineered Food Disclosure Standard

Hogan Lovells on

Yesterday the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) released its final rule implementing the National Bioengineered Food Disclosure Standard (NBFDS) passed by Congress in July 2016. In...more

Hogan Lovells

USDA’s AMS Issues Proposed Rule on National Bioengineered Food Disclosure Standard

Hogan Lovells on

On May 3, the U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service (AMS) issued its proposed rule implementing the National Bioengineered Food Disclosure Standard (NBFDS) passed by Congress in July 2016....more

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