The U.S. Food and Drug Administration (FDA) lifted the import alert allowing AquaBounty to start farming AquAdvantage® Salmon in Indiana facilities. The FDA’s approval of the application related to AquAdvantage Salmon followed a comprehensive analysis of the scientific evidence, which determined that the GE Atlantic salmon met the statutory requirements for safety and effectiveness under the Federal Food, Drug and Cosmetic Act. However, in 2016, Congress directed the FDA not to allow into commerce any food that contains GE salmon until it issued final labeling guidelines informing consumers of the GE salmon content in the food. The FDA complied with this requirement by implementing an import alert in 2016 that prevented GE salmon from entering the U.S.
Sylvia Wulf, Chief Executive Officer of AquaBounty, stated, “we are delighted that the FDA has lifted the import alert, which will allow AquaBounty to begin producing and marketing AquAdvantage salmon in the United States. As the FDA notes in this announcement, our salmon was approved by the agency over three years ago based upon a very comprehensive science-based review process, which established that our salmon was safe, nutritious and environmentally sound and met all other regulatory requirements. We will immediately start the process to import AquAdvantage eggs from our hatchery in Canada to begin grow out at our Indiana facility.”
This decision is an important achievement not just for AquaBounty, but for biotechnology and agricultural innovation in general. As both the FDA and USDA have recognized, animal and plant biotechnology, it will enable the development of innovative and transformational products that have the potential to increase sustainable production of food, enhance human nutrition and help feed a rapidly growing global population.