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FDA Places Ban on Import of GE Salmon

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 November 2015, the agency appears to have bowed to congressional pressure and placed a hold on the importation of the AquAdvantage Salmon pending resolution of the labeling guideline controversy.  It is worth noting, however, that the GE salmon’s producer, AquaBounty Technologies, is not ready to import or distribute the product so the FDA import ban is not expected to have an effect on the company’s current operations.

As discussed in our explanation of the FY2016 Appropriations Package, at the end of 2015 Congress attempted to negate FDA’s approval of, and related actions on, GE salmon with a  provision that forbids the agency from allowing the introduction into interstate commerce of any food that contains the approved AquAdvantage GE salmon until it publishes final, mandatory labeling guidelines to inform consumers about the GE content of such foods.  Currently, FDA’s draft labeling guidance on GE salmon, and FDA’s policy for labeling GE-derived foods more generally, does not mandate any label statements, but rather offers advice and examples of how to make voluntary label claims that are not potentially false or misleading to consumers.

The issue was further complicated in January, when it became clear that the nomination of Dr. Robert Califf, President Obama’s choice as the next Commissioner of Food and Drugs, would be held up until Senators receive assurance from FDA that the agency will require mandatory labeling for GE salmon when it becomes commercially available (among other, non-food-related reasons that Dr. Califf’s nomination is being delayed). This charge was led by Senator Murkowski (R-AK), who has expressed concerns about the safety of GE salmon and has applauded FDA’s decision to ban the imports as a victory for consumers.

Katherine Fox is co-author of this article. 

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About this Author

Joanna Hawana, Mintz Levin, FDA Lawyer, Clinical Trials & Research Consumer Product Safety FDA Regulatory Health Care Compliance, Fraud & Abuse, and Regulatory Counseling Health Care Transactional Due Diligence
Of Counsel

Joanne counsels global clients on regulatory and distribution-related considerations to bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized. She also advises on the business impact of new US federal and state actions that affect those regulated products, such as drugs, foods, cosmetics, electronic nicotine delivery systems, and medical devices, including in vitro diagnostics, lab tests, and mobile medical applications. In recent years she has been advising clients in different industries regarding FDA’s approaches to...