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Judge rebuffs lawsuit challenging FDA authority to regulate AquAdvantage GMO salmon as a drug

| | January 15, 2020
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AquaBounty GMO salmon
This article or excerpt is included in the GLP’s daily curated selection of ideologically diverse news, opinion and analysis of biotechnology innovation.

Remember the GMO salmon? It was created by a company called AquaBounty back in 1989 and approved by the Food and Drug Administration in November 2015. It’s sold in Canada under the brand name AquAdvantage, and the first batch intended for the U.S. market is …. expected to come to market in the U.S. sometime [in 2020].

Or not …. There’s a longstanding lawsuit brought by a coalition of salmon industry folks and environmentalists that’s trying to completely overturn the [FDA’s] approval.

Drugs are things that treat diseases and relieve pain. AquaBounty’s DNA construct isn’t administered to a fish per se, and it isn’t curing anything. It’s is reengineering a fish that hasn’t yet begun its life.

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But as [judge Vince] Chhabria explains …. [w]hat matters is how the statute defines it, and the [Food, Drug, and Cosmetic Act] says drugs are, among other things, “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

For the moment …. FDA has the right to regulate genetically altered animals under its pathway for veterinary drugs, the rest of the suit will continue, and a batch of AquAdvantage salmon continue to fatten up down in Indiana.

Read full, original article: GM salmon leaps another legal hurdle. Next up: Another legal hurdle

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