• FDA import alert is in response to U.S. budget bill last year
  • Ban is in effect until FDA issues labeling guidelines

Genetically engineered salmon, called “Frankenfish” by critics, have been banned from sale in the U.S. just months after being initially approved by regulators as the first such modified animals for human consumption.

The Food and Drug Administration issued an import alert on Friday, saying the salmon won’t be allowed to be sold until the agency publishes final labeling guidelines, a process that typically takes years. The ban also applies to food made from the fish.

In November, the FDA cleared AquaBounty Technologies Inc. to begin marketing its AquAdvantage Salmon, which have added genes that help them grow faster. The agency’s new restriction is in response to a budget bill signed into law on Dec. 18. The law says the FDA has to issue the new guidelines before the fish can be sold, according to the import alert.

Intrexon Corp. holds a 58 percent stake in AquaBounty. Intrexon fell 6.4 percent to $27.15 at 11:59 a.m. in New York. AquaBounty said it won’t be affected by the change.

“The decision has no impact on AquaBounty’s operations as we are not currently importing our salmon into the U.S.,” said Chief Executive Officer Ronald Stotish. The fish are grown in tanks at facilities in Canada and Panama.

Alaska Opposition

Senator Lisa Murkowski, a Republican from Alaska, has threatened to hold up the nomination of Robert Califf to serve as the new FDA commissioner over the fish labeling issue.

“This is a huge step in our fight against ‘Frankenfish,’” Murkowski said in a statement Friday. “I adamantly oppose the FDA’s misguided decision to allow GE salmon to be placed in our kitchens and on our tables, and I firmly believe that mandatory labeling guidelines must be put in place as soon as possible so consumers know what it is they are purchasing.”

Alaska’s Bristol Bay is the world’s largest sockeye salmon fishery, according to the state.

Under the FDA’s draft guidelines, companies that make products with genetically engineered salmon have the choice to label it as such. If consumers want to avoid it, they can choose wild-caught salmon, the FDA said when it approved AquAdvantage’s fish.

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