Biotech Opponents Argue that GE Foods are Materially Different from Conventional Food

October 12, 2011

By Riëtte van Laack

On October 4, 2011, the Center for Food Safety (“CFS”) announced the filing of what it touts as “a groundbreaking new legal petition” with FDA, demanding that FDA issue regulations that require the labeling of all food produced using genetic engineering.  CFS filed the petition on behalf of the Just Label It campaign.  Co-petitioners include various food companies, organic trade organizations, and other biotechnology opponents.

According to Petitioners, the differences between genetically engineered (“GE”) and conventionally produced foods are material, and lack of labeling that discloses that a food is GE is misleading to consumers.  Petitioners ask that FDA issue regulations that define GE as “a process that alters an organism at the molecular or cellular level by means that are not possible under natural conditions or processes . . . exclud[ing] modification that consists exclusively of breeding, conjugation, fermentation, hybridization, in vitro fertilization, or tissue culture.”  The label of a GE food would be required to indicate which ingredients are genetically engineered and include a notice “GENETICALLY ENGINEERED” followed by a statement “UNITED STATED GOVERNMENT NOTICE: THIS PRODUCT WAS PRODUCED USING GENETIC ENGINEERING.” 

Under FDC Act sections 403(a)(1) and 201(n), a food is misbranded if its labeling is false or misleading in any particular, including by virtue of failing to disclose facts material with respect to the consequences which may result from use of the food under customary or usual conditions of use.  In 1992, FDA issued a policy which states in part that bioengineered foods as a class are not materially different from conventional foods, and thus there is no basis to require labeling that specifies their method of production (FDA prefers the term “bioengineered” to GE).  FDA adhered to this position in a draft guidance on voluntary labeling of bioengineered foods issued in 2001. FDA’s current approach is to consider whether such labeling is required on a case-by-case basis.  The Agency operates a voluntary consultation program for bioengineered foods under which the agency considers numerous characteristics in its evaluation of potential differences between bioengineered and conventional foods.

According to Petitioners, "[t]he agency severely constricted what it called 'material,' limiting it to the ability of a change to be tasted, smelled, or known through the other senses.”  Petitioners assert that “whether the FDA believes that GE foods are ‘of the same or equal quality’ as their conventional counterparts is irrelevant to the question of whether it is misleading to label GE foods the same as conventional foods.  The proper focus is whether consumers are deceived and whether their right to know is abridged.”

Petitioners cite FDA’s regulations mandating labeling of irradiated foods and identification of the food source of hydrolyzed protein as precedents for FDA’s authority to mandate labeling based on production processes, even if those processes do not measurably affect the sensory and performance characteristics of the food. Moreover, citing the U.S. Court of Appeal for the Sixth Circuit decision in IDFA v. Boggs, petitioners argue that a difference does not need to be measurable; FDA may require labeling merely because conventionally produced food have a demonstrable history of safe use and there is a lack of history of safe use for GE foods.  Petitioners also mention the patentability of GE foods as evidence that GE foods are novel and cannot be equivalent to (i.e., are materially different from) conventional foods.

In light of FDA’s stance on labeling of bioengineered foods, its current strategic priorities, and its limited resources, it appears unlikely that the Agency will initiate rulemaking to mandate such labeling in the near future.  Meanwhile, Just Label It advises consumers who want to avoid bioengineered foods to “[l]ook for the USDA Organic seal and buy organic – The National Organic Standards prohibit the use of genetic engineering.”