In a much anticipated letter response, FDA has officially declined the opportunity to administratively determine whether foods containing bioengineered ingredients may be labeled as “Natural,” “All Natural” or “100% Natural,” and more generally, declined the opportunity to define “Natural” in the context of food labeling.
The issue stems from an influx of litigation involving alleged false advertising of food products making a variety of “Natural” claims, where no official federal law, rule, or regulation defines the term “Natural.” Three separate US District Court cases – Cox v. Gruma Corp. (N.D. Cal.), Barnes v. Campbell Soup Co. (N.D. Cal.), and In re General Mills, Inc. Kix Cereal Litigation (D.N.J.) – referred the issue to FDA on primary jurisdiction grounds for FDA’s determination as to whether food products containing corn from genetically modified seeds could be labeled “Natural.”
As stated in FDA’s January 6 Letter, despite significant push from industry and consumer groups alike, FDA declined to allocate its resources “at this time” to make a determination regarding whether and under what circumstances food products containing genetically engineered ingredients may be labeled “Natural.”
Cox, Barnes and Kix Cereal referrals
Of the multitude of “Natural” cases around the country, three separate 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.) – referred the issue of whether foods containing bioengineered ingredients may be labeled as “Natural,” “All Natural” or “100% Natural.”
In Cox, the plaintiff alleges that various Gruma tortilla products making “All Natural” claims are false and misleading when the products contain genetically modified organisms (GMOs), and more specifically, GMO corn grown from bioengineered, genetically modified seeds.
Similarly, in Barnes, the plaintiffs allege that various Campbell’s 100% Natural Vegetable Soup products are false and misleading when the soups contain GMO corn.1
In Kix Cereal, the plaintiffs allege false advertising of Kix cereal for making “All Natural Corn” statements when the cereal allegedly contains unnatural GMO corn.
Both the Cox and Barnes courts granted the respective defendants’ primary jurisdiction arguments and stayed those cases for six months pending FDA’s response to its referrals; the Kix court referred the issue to FDA and administratively terminated the case until FDA responded to one of the pending “Natural” referrals.2
In granting the respective primary jurisdiction arguments, all three courts held that determining whether foods containing GMOs can make “Natural” claims is an issue best determined by FDA expertise. In the context of GMO foods making “Natural” claims, no federal law, regulation or other requirement requires special labeling of bioengineered ingredients as not “natural.”
While FDA has issued a non-binding guidance defining “Natural” to mean “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,”3 FDA has not finalized a definition for “Natural” and has not instituted a requirement for disclosing GMOs as “unnatural.” As indicated by Cox, given the broad authority granted to FDA through the FDCA and NLEA regarding labeling, the courts held that deferral to FDA would avoid “usurping the FDA’s interpretive authority” and “undermining, through private litigation, the FDA’s considered judgments.”4
Other “Natural” cases
Important to note is the narrow issue referred to FDA in the Cox, Barnes and Kix line of cases. Each of these cases’ referrals specifically asks FDA to administratively determine only whether foods containing GMOs may be labeled as “Natural.”
This isolated attack on “Natural” claims is one of multiple “All Natural” challenges employed by plaintiffs, and the only “Natural” challenge referred to FDA. That is, plaintiffs in other “Natural” cases have also alleged false advertising of “Natural” claims against foods containing artificial or synthetic ingredients5, and where highly processed ingredients or processing methods allegedly render foods unnatural.6 At least one court addressing “Natural” claims in the non-GMO context has distinguished primary jurisdiction arguments on that point, noting that the only “Natural” cases referred to FDA on primary jurisdiction grounds involve the narrow issue of whether foods containing GMOs may be labeled “Natural” 7and that the vast majority of Natural cases have declined primary jurisdiction.
FDA’s January 6 Response Letter
In responding to the three case referrals in its January 6, 2014 Letter, FDA ultimately declined “to make a determination at this time regarding whether and under what circumstances food products containing ingredients produced using genetically engineered ingredients may or may not be labeled ‘natural.’”8 In reaching its conclusion, FDA pointed to a variety of concerns. As a primary matter, FDA defers to higher priority matters to occupy its limited resources, such as issues involving food safety, issues with direct health impacts (including partially hydrogenated oils), outbreaks of food-borne illnesses and overseeing the safety of imported foods. See the Letter here.
As to the issue of defining “Natural” itself, FDA acknowledged that there is no formal definition of the term “natural” with respect to foods, but restated its informal policy definition.9 Further, FDA stated that if it “were inclined to revoke, amend, or add to this policy,” it would do so through formal administrative processes rather than private litigation.10
Thus, while FDA rejected the opportunity to define “Natural” as referred via primary jurisdiction means, it does not appear to outright reject the prospect of defining “Natural” at some point. Rather, FDA indicates the appropriate procedure to best address the complexities and concerns at issue would be through the comment and rule making process, which would more fully engage the public and promote transparency. However, FDA makes no promises that it would “revoke, amend, or add to the current policy, or develop any definition at all” even if it did undertake a formal administrative process.11
As to the specific issue on referral – GMO’s in foods making “Natural” claims – FDA acknowledges that “[a]ny definition of ‘natural’ on food labeling has implications well beyond the narrow scope of genetically engineered food ingredients about which the Court’s referral pertains.”12 As discussed above and as evidenced in multiple class actions through the US, whether foods contain GMOs is only one of several attacks on foods that make “Natural” claims. In its January 6 Letter, FDA seems to focus more on the general prospect of defining the term “Natural” in the context of food labeling rather than specifically in the context of foods containing GMOs. The broad language in FDA’s Letter appears to foreclose FDA’s willingness to define “Natural” in any context through primary jurisdiction-based referrals, whether based on foods containing GMOs, foods containing synthetic ingredients, or foods that are highly processed. Again, FDA does not foreclose the possibility of defining “Natural” through an official administrative process13, but does not promise to initiate such proceedings, nor does it promise that undertaking a more formal process would result in a definition.
Back to the state and district courts
The ball is now back in the various state and district courts to undertake resolving challenges to “Natural” claims, where the vast majority of “Natural” cases have yet to reach the merits. The litigation landscape will likely begin to shift as these cases either settle, motion for class certification or continue through discovery in preparation for trial.
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1 Notably, the Barnes court dismissed the plaintiffs’ claims as to Campbell’s 100% Natural Mexican-Style Chicken Tortilla soup on preemption grounds where Campbell’s had to obtain USDA and FSIS pre-approval under the Federal Meat Inspection Act and Poultry Products Inspection Act. Barnes, 2013 WL 5530017, at *5 (N.D. Cal. July 25, 2013). Part of the pre-approval process includes a determination of whether the label appears “false or misleading, 21 U.S.C. § 457, and receiving pre-approval has preemptive effect. Barnes, 2013 WL 5530017, at *5 Therefore, because Campbell’s received federal pre-approval, the Chicken Soup label “cannot be construed, as a matter of law, as false or misleading.” Id.
2 The District of Colorado also stayed Van Atta v. General Mills, No. 12-02815 (D. Colo. July 18, 2013) on primary jurisdiction grounds, but found referral to FDA unnecessary given the GMO-Natural issue had already been referred to FDA by the Cox court.
3 58 Fed. Reg. 2303, 2407 (Jan. 6, 1993).
4 Cox v. Gruma Corp., No. 12-06502, 2013 WL 3828800, at *2 (N.D. Cal. July 11, 2013).
5 See e.g., Bates v. Kashi, No. 11-01967(S.D. Cal.); Thurston v. Bear Naked, No. 11-02890(S.D. Cal.); Brazil v. Dole Food Co., No. 12-01831 (C.D. Cal.); Pelayo v. Nestle, No. 13-05213 (C.D. Cal.).
6 See, e.g., Janney v. General Mills, No. 12-03919 (N.D. Cal.); Martin v. Cargill, No. 13-02563 (D. Minn); In re Simply Orange Juice, MDL No. 2361; In re Tropicana Orange Juice Marketing & Sales Practices Litig., MDL No. 2353.
7 See Janney v. General Mills, No. 12-03919, 2013 WL 5587945, at *4 (N.D. Cal. Oct. 10, 2013).
8 Letter from Leslie Kux, Assistant Commissioner for Policy Food and Drug Administration, to Judges Gonzalez Rogers, White, and McNulty, January 6, 2014 at 3 (“January 6, 2014 FDA Letter”).
9 FDA’s non-binding guidance defines “Natural” to mean “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 (Jan. 6, 1993).
10 January 6, 2014 FDA Letter at 2 & n.1.
11 January 6, 2014 FDA Letter at 2.
12 Of the broader issues beyond GMOs in foods making “Natural” claims, FDA identifies the following factors that would also require consideration: “relevant science; consumer preferences, perceptions, and beliefs; the vast array of modern food production technologies in addition to genetic engineering (e.g., use of different types of fertilizer, growth promotion drugs, animal husbandry methods); the myriad food processing methods (e.g., nanotechnology, thermal technologies, pasteurization, irradiation); and any strictures flowing from the First Amendment.” January 6, 2014 FDA Letter at 2.
13 FDA does acknowledge that the Grocery Manufacturers Association intends to file a citizen petition in early 2014 asking FDA to “issue a regulation authorizing foods containing ingredients derived from biotechnology to be labeled ‘natural.’” FDA similarly responded to that potential petition by indicating a preference for using its administrative process rather than providing a response in the context of private litigation. January 6, 2014 FDA Letter at 2 n.1.