In response to a Congressional directive buried in the 2016 Consolidated Appropriations Act (“the Appropriations Act”), FDA issued an Import Alert targeting “[a]ny shipment of suspected or known GE salmon or product composed in whole or in part of GE salmon” for further evaluation. The Appropriations Act, at section 761, purports to prohibit FDA from admitting such products during fiscal year 2016 “until FDA publishes final labeling guidelines for informing consumers of such content,” and further directs FDA to “develop labeling guidelines and implement a program to disclose to consumers whether salmon offered for sale to consumers is a genetically engineered variety.”
Ominous as it may sound for a would-be importer of GE salmon, the immediate impact of FDA’s Import Alert is negligible. As well known to all the participants in this long-running drama, AquaBounty Technologies, Inc. – the unstated target of the Congressional directive and the Import Alert – won’t have any GE salmon ready for market during fiscal year 2016.
As to the Congressional directive to publish “final labeling guidelines,” FDA previously issued draft guidance providing for voluntary labeling of GE salmon, consistent with the agency’s conclusion that there is no material difference between food derived from AquAdvantage salmon and its conventional counterpart (see our prior posting here). To the extent that Congress is directing FDA to require such labeling, FDA could do so only by changing its conclusion regarding materiality, or changing its longstanding interpretation of that concept as embedded in § 201(n) of the FDC Act. The first course of action would appear to lack a scientific basis, and the second would have significant implications that go beyond food labeling and extend to labeling of other FDA-regulated product categories, including drugs and medical devices.
Given the wording of the Appropriations Act, it appears that FDA could finalize the draft GE salmon labeling guidance in its current form. The Appropriations Act does not explicitly direct that labeling be mandatory, nor does it provide a statutory basis for FDA to impose such a requirement. Congress knows how to write legislation to that effect; to wit, Congress has attempted and failed no less than eight times since 2010 to pass such legislation (here, here, here, here, here, here, here, and here).
In summary, this is but one more play in a playbook evidently intended to derail the domestic marketing of GE salmon by any means – even means that are highly implausible. The signal sent to a company that is considering developing a food derived from a GE animal can hardly be encouraging. Simply put, meeting the rigorous scientific and regulatory criteria established by FDA might not be the most significant or unpredictable barrier to success.