Agriculture Reference
In-Depth Information
The FDA policy statement asserting this “substantial equivalence”
assumption nevertheless indicates that the agency retains authority to
require that a specific type of GM food be labeled under certain circum-
stances, such as if using the common name of its non-GM food counter-
part would mislead consumers in that it would not adequately indicate
GM-imparted characteristics of the food such as a change in its texture
or taste, or fail to indicate GM-created safety issues such as a new and
unsuspected allergenic hazard. FDA has issued a Guidance for Industry
that outlines how food producers may voluntarily label their products to
indicate its GM content, or conversely to indicate its lack of GM con-
tent. In carefully considered language, the Guidance provides examples
of label wording it would find appropriate for such purposes, wording
that would not mislead consumers or conflict with the agency's assump-
tion about the equivalence of GM and non-GM foods.
42
This contrasts
with the mandatory labeling and traceability requirements for GM foods
in the EU, as discussed in Chapter 3.
FDA has resisted critics who oppose its policies and assumptions
with regard to the GRAS status of GM foods, and the absence of pre-
market review and mandatory labeling. A federal court, petitioned by
a consumer interest group to review and invalidate these agency deter-
minations and policies, denied the group's claims that the FDA had not
followed appropriate regulatory procedures, made arbitrary determina-
tions, and had violated the rights of persons to be able to choose non-GM
foods for religious or other personal reasons. Reinforced by this judicial
affirmation of its policies and practices, FDA has continued to refuse to
modify its regulatory program.
43
As an aside, it should be noted that FDA's regulatory responsibili-
ties also encompass pre-market review of new pharmaceuticals to deter-
mine if they are safe and effective, and that their production process can
42
FDA, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or
Have Not Been Developed Using Bioengineering 2, 4 (2001)
.
43
Alliance for Bio-Integrity v. Dept. Health and Human Services, 116 F.Supp.2d 166
(D.D.C. 2000).
