AquaBounty Technologies’ path to the U.S. market for its genetically engineered (GE) salmon has been a long one. In 2015, the FDA approved AquaBounty’s application to create and farm its GE salmon (trade name, AquAdvantage)...more
L E G I S L A T I O N , R E G U L A T I O N S & S T A N D A R D S - FDA Issues Guidance On “Potassium Chloride Salt” - The U.S. Food and Drug Administration (FDA) has issued draft guidance for industry on the use of...more
As plant-based beverages appear on more store shelves, the definition of “milk” has become the center of a dispute involving legislatures, regulators, litigators and industry groups. Shook Partners Katie Gates Calderon and...more
GE Salmon Bill Introduced in U.S. Senate - A bipartisan group of U.S. senators has introduced a bill that would require labeling of genetically engineered (GE) salmon and independent scientific review of the U.S. Food and...more
The Senate Appropriations Committee is looking to tinker with the Food and Drug Administration’s rulemaking agenda through its fiscal year 2017 funding bill for the Department of Agriculture and FDA (S. 2956). Passed...more
FDA Approves First Genetically Modified Food-Producing Animal - On November 19, 2015, the United States Food and Drug Administration (FDA) approved a new animal drug application (NADA) that authorizes the marketing of...more
Reversing course from the end of 2015, FDA recently announced an import ban on genetically engineered (GE) salmon until such a time as comprehensive labeling guidelines are introduced. Despite FDA’s approval of GE salmon in...more
On January 12, 2016, the Senate Health, Education, Labor, and Pensions (HELP) Committee unanimously approved the President’s nomination of Dr. Robert Califf as the next commissioner of food and drugs. (Senator Bernie...more
The past few weeks have seen significant action within the Food and Drug Administration (FDA) on food safety, labeling, and nutrition issues. With the release of three final rules on Food Safety, approval of the first...more
Last week will undoubtedly be marked in the annals of Food and Drug Administration history as an important milestone for the Agency. On November 19, 2015, FDA approved the first genetically engineered (GE) animal intended for...more