September 17, 2010
Data Suggests Increased Allergy Risk; FDA Needs Much More Data Before Approval
Yonkers, N.Y.—Consumers Union (CU), the nonprofit publisher of Consumer Reports, reviewed FDA’s appraisal of some of the safety issues associated with AquAdvantage salmon, which has been genetically engineered (GE) to reach mature size more quickly, and concluded that the salmon has not been shown to be safe. The Veterinary Medicine Advisory Committee (VMAC) is scheduled to meet to and decide whether the Food and Drug Administration (FDA) should approve the application September 19-20. Dr. Michael Hansen, senior scientist at CU, will appear at the meeting on Monday, September 20 at 3:00 p.m. A copy of his comments can be found at: http://www.consumersunion.org/pdf/CU-comments-GE-salmon-0910.pdf
“FDA should be especially cognizant of the scientific quality of the data and the rigor of the analysis needed to do a proper safety assessment of GE animals in this case, since it is the first genetically engineered animal FDA has had to consider,” Dr. Hansen states in his comments. “Unfortunately, the evidence of FDA’s evaluation of the AquAdvantage salmon suggests that FDA has set the bar very low. This analysis does not conform to FDA standard for assessment of a New Animal Drug (NAD).”
FDA requires New Animal Drugs to be shown to be safe for animals, humans and the environment. Dr. Hansen notes that this has not been shown for the GE salmon. “The data presented, although woefully incomplete, do raise a potential serious human health issue—that of increased allergenicity. If this product (GE salmon) does increase the allergenic risk, it should not be approved. Data from a mere six salmon, which is all FDA presents, is not sufficient nor rigorous enough to conclude that no problem exists,” he comments.
CU is particularly concerned that this salmon may pose an increased risk of severe, even life-threatening allergic reactions to sensitive individuals. Finfish are one of the eight major allergy-causing foods. This salmon could make the problem worse. Instead of approving this product, FDA should be requiring studies with data from many more engineered fish, not the tiny sample of six fish on which it currently bases its conclusions.
CU previously sent a letter to FDA expressing concern about the FDA review process of AquAdvantage’s application for approval of GE salmon, which would be the first GE animal approved for human consumption. CU’s letter states that the current 14-day review period on the safety assessment of the GE salmon, ending next Monday September 20, is far too short. CU also criticized the current composition of the VMAC, announced last week, as lacking experts in food allergies, hormonal effects, and fish ecology. A copy of the letter can be found at: http://www.consumersunion.org/pub/core_food_safety/016884.html