The FDA was formally asked to make such a determination by judge Yvonne Gonzalez Rogers in a July 11 order on a deceptive marketing lawsuit filed by Elizabeth Cox vs Gruma Corp over ‘all-natural’ claims on Mission tortilla chips, which Cox alleged contain ingredients from GE corn.
Rogers, who agreed with Cox that there is a “gaping hole in the current regulatory landscape for ‘natural’ claims and GMOs”, said she was putting the case on ice for at least six months and referring “to the FDA, for an administrative determination, the question of whether and under what circumstances food products containing ingredients produced using bio-engineered seed may or may not be labeled ‘Natural’.”
CFS: ‘Most consumers, if asked, would not consider GE foods as natural’
However, the CFS - which supports organic farming methods - argues that such a determination would violate the Administrative Procedures Act (APA), which requires government agencies to provide a period of public comment.
In a letter to FDA commissioner Margaret Hamburg dated November 4, CFS executive director Andrew Kimbrell and science policy analyst Bill Freese said: “FDA should refrain from defining ‘natural’ in an ad hoc and haphazard manner without first providing to the public notice of the proposed rulemaking and an opportunity to comment.
“In the alternative, if FDA considers it appropriate to define natural without issuing a rule, then it should specifically prohibit labeling GE foods as ‘natural’, added Kimbrell and Freese, who claim that “most consumers, if asked, would not consider GE foods as natural”.
Judge: ‘The FDA is unlikely to respond in a timely manner to any referral from this Court’
Whether the FDA is likely to heed Rogers’ request is anybody’s guess, although several attorneys contacted by FoodNavigator-USA about this issue believe it is very unlikely.
Aside from the question of whether the doctrine of primary jurisdiction should even apply (many judges say the courts are more than capable of determining this issue and don’t need the FDA to weigh in) several judges handling similar cases also believe the FDA lacks the time and resources to step into this particular minefield right now.
For example, commenting on this issue in an August order on a multi-district lawsuit vs Frito-Lay over natural claims, US district Judge Roslynn R. Mauskopf said: “The FDA is unlikely to respond in a timely manner to any referral from this Court.
“The agency would need far more than six months to define the term ‘natural’ or pass on whether foods containing bioengineered ingredients may be labeled as ‘natural’ and would likely open that deliberation to public notice and comment.”
Natural claims and legal confusion
The issue of whether GMOs belong in ‘all-natural’ products - which is at the center of a growing number of proposed class action lawsuits against big food brands - has featured heavily in the debate over GMO labeling, with some state-led labeling initiatives stipulating that products containing GMOs should not be promoted as ‘natural’.
The FDA published non-binding guidance in 1993 saying natural means that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food”.
However, it has not clarified the status of foods containing HFCS, GMOs and a raft of other ingredients that many stakeholders also believe do not belong in a product marketed as ‘natural’.
As for GMOs, the agency says it is “not aware of any data or other information that would form a basis for concluding that the fact that a food or its ingredients was produced using bioengineering is a material fact that must be disclosed [on food labels]. FDA is therefore reaffirming its decision to not require special labeling of all bioengineered foods.” (Click here.)
Click here to read more about natural claims on FoodNavigator-USA.