GM salmon scores another FDA approval
April 27, 2018
By Liza Mayer
AquaBounty Technologies says it has received approval from the US Food and Drug Administration (FDA) to raise AquAdvantage Salmon at its land-based contained facility near Albany, Indiana.
The FDA previously approved AquaBounty’s New Animal Drug Application (NADA) on November 19, 2015, for the production, sale, and consumption of AquAdvantage Salmon in the United States. That approval specified that all production facilities for the product would require separate site-specific approvals. To conform with this requirement, the company submitted a supplementary NADA to the FDA requesting approval to grow AquAdvantage Salmon at its farm site near Albany, Indiana.
The Indiana facility as currently configured has a production capacity of 1,200 tons per year and was designed to allow significant expansion.
But while AquaBounty’s Indiana facility is now approved, it cannot proceed with the commercial production of AquAdvantage Salmon until the FDA issues official product-labeling guidelines.
“We still have work to do before we can start production, but we take great pride in this latest accomplishment,” said CEO Ron Stotish.