By claiming on the label that their product is “natural”, manufacturers have helped themselves to 40 billion of consumer dollars each year, this claim being second most lucrative only to labeling products based on their fat content.

While certain informative labeling serves a truly important function - helping consumers with celiac disease or with milk or peanut allegories to select products that are gluten, lactose, and peanut free - the word “natural” on a food label, while clearly comforting to consumers looking to make smart choices about their consumption, has no agreed-upon meaning.  The FDA has so far declined to define what it means for a food to be “natural,” and, since 1993, its only non-binding guidance on the meaning of “natural” has been “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.”  58 Fed. Reg. 2303, 2407 (January 6, 1993). But, this rather unhelpful definition may soon be changing as a result of the FDA’s recent request for comments on use of the term “natural” on food labeling.

This development is likely a response to the recent wave of litigation involving false advertising claims based on the presence of bioengineered ingredients (genetically modified organisms - GMOs - such as corn grown from bioengineered seeds) in foods labelled “natural.”  Courts have had an easier time finding that artificial ingredients such as the Sodium Acid Pyrophosphate (“SAPP”) most likely ran afoul of the 1993 guidance and allowed false advertising claims based on presence of such ingredients in foods labelled “natural” proceed passed motions to dismiss.  E.g. Musgrave v. ICC/Marie Callender’s Gourmet Prods. Div., No. 14-cv-02006 (N.D. Cal. Feb. 5, 2015).  But GMOs have presented a more formidable challenge.  For example, in a trio of cases - Cox v. Gruma Corp., No 12-06502 (N.D. Cal.), Barnes v. Campbell Soup Co., No. 12-05185 (N.D. Cal.), and In re General Mills, Inc. Kix Cereal Litigation, No. 12-00249 (D.N.J.) - courts found it impossible to determine without FDA’s guidance whether GMOs fell into the category of “artificial or synthetic” products described in the 1993 guidance.  The Cox, Barnes, and Kix Cereal courts then stayed or administratively dismissed the complaints and referred the question of whether foods containing GMOs can be labeled “natural” to the FDA - the entity the courts agreed had primary jurisdiction over this question.  In the January 6, 2014 letter to the judges the FDA, however, “respectfully” declined to define “natural.”  The FDA did indicate that if it were inclined to provide an actual definition beyond the 1993 guidance, it would not comment in the context of lawsuit, but “would likely embark on a public process such as issuing a regulation or formal guidance.”  Even before the FDA sent its letter, however, many courts had pessimistically predicted this result and declined defendants’ requests to stay or dismiss cases until the FDA weigh in on the definition of “natural.”  E.e. Gedalia v. Whole Foods Mkt. Servs., Inc., No. 4:13-CV-3517 (S.D.Tex. 2014) (“deference to the FDA would likely be unfruitful due to the agency’s long-standing reluctance to officially define the term ‘natural.’”)

Now through February 10, 2016, anyone with an opinion can weigh in on whether: (1) it is even appropriate to define the term “natural,” (2) if so, how the FDA should define “natural,” and (3) how the FDA should determine appropriate use of the term on food labels.  In asking for the guidance, the FDA itself recognizes that the policy it expressed through the 1993 guidance does not address food production or processing methods, such as use of pesticides in growing the food, or the use of thermal technologies, pasteurization, or irradiation in food manufacturing, or whether the term “natural” should indicate any nutritional or health benefits.

With respect to the contentious issue of GMOs, it is likely that two lines of thinking will dominate the conversation of whether any degree of gene modification would allow for a food to still be labelled “natural.”  Some will advocate the position that any modifications, even those that merely enhance or suppress certain existing genetic characteristics of a plant or an animal, would cause the food to be excluded from the “natural” category.  Others will argue that only the process by which genes from the DNA of one species are extracted and artificially forced into the genes of an unrelated plant or animal would make the food “unnatural.”  The purist - no genetic tinkering of any kind - position skirts the fact that in “natural” breeding practiced by those who do not manipulate genes through irradiation or use of agrobacterium, plants and animals are cross-bred mixing whole strands of DNA and swapping many genes at once in the hopes of getting a new interesting combination of useful traits.  This approach is messier and can be nearly as rife with “dangers” of undesirable and potentially harmful genes getting turned on in the process.

It remains to be seen whether the FDA’s newest effort will make it any easier to know when it is proper to label a food “natural”. That it was willing to take a position on the issue, especially in light of the rising number of consumer fraud food labeling class actions, is certainly encouraging.  But, given the ongoing revolutions both in science and in the public’s perception of what constitutes “natural,” it is hard to see this as much more than an attempt to not fall too far behind.