At my panel on eco-labeling yesterday, I engaged in a fascinating discussion with fellow panelist from Consumers Union (the nonprofit publisher of Consumer Reports) about whether the FDA has the authority under the Food, Drug and Cosmetic Act to require mandatory labeling on of genetically modified foods.  My initial answer is no.  It is my understanding that no federal law requires mandatory labeling of GM foods, and that the FDA will only require labeling if a health safety issue arises which the FDA has not determined to be the case for current GM foods (in which case the GM food will likely not be approved for use in the first place).  Here’s a nice article in the Post which lays it out in lay terms.

More litigation over genetically modified food is sure to arise within the next few years. Currently, the FDA is reviewing whether to approve genetically modified salmon as safe for human consumption, and salmon may change this whole debate from a political and public awareness standpoint (which GM alfalfa and sugar beets have failed to do).[1]  The farm-grown salmon contain an extra growth hormone gene that allows them to grow to a marketable size twice as fast as a conventional fish.[2] FDA analysis will primarily focus on whether genetically modified salmon are safe compared to conventional salmon, yet the ecological consequences of allowing genetically modified salmon on the market remain unclear.[3] It is clear that if these salmon do become the first genetically modified animal to enter the American food supply, they will likely pave the way for other genetically modified animals to enter the market.

What is interesting, is that while FDA, in my view, will not require labeling of GM foods in general,  salmon may create an opening for labeling if the FDA can be convinced that it is a GM food not “substantially equivalent” to a food product already in the human food supply (non-GMO salmon).[4]  What’s also unusual is that the FDA may attempt to stop ‘GM-free’ labels due to the difficulty of proving some contains absolutely no GM traits; though I imagine companies could say something like ‘not made through bioengineering.’  What is clear is that these are some initial views of mine, and I really need to sit down and do some serious statutory interpretation; especially on the narrow issue of whether the FDA could require labeling of some GM foods in some circumstances, and whether GM fish and meats could fit any such circumstances.


[1] Andrew Pollack, Panel Leans in Favor of Engineered Salmon, N.Y. Times, Sept. 20, 2010, http://www.nytimes.com/2010/09/21/business/energy-environment/21salmon.html.

[2] -“FDA regulates GE animals under the new animal drug provisions of the Federal Food Drug and Cosmetic Act (FFDCA or the Act), 21 USC 321 et seq., and the National Environmental Policy Act (NEPA). Section 201(g) of FFDCA defines drugs as “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” The rDNA construct in the resulting GE animal is thus a regulated article that meets the drug definition; the GE animal itself is not a drug. As a short-hand, the agency sometime refers to regulating the GE animal. All GE animals are captured under these provisions, regardless of their intended use.”  http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf.

[3]  This document concludes both safe for food eating purposes and argues safe for env purposes.  http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/VeterinaryMedicineAdvisoryCommittee/UCM224762.pdf.

[4] Mary Jane Angelo, Regulating Evolution for Sale: An Evolutionary Biology Model for Regulating the Unnatural Selection of Genetically Modified Organisms, 42 Wake Forest L. Rev. 93 (2007).

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