'Natural' Claims: FDA Requests Comments on Use of the Term 'Natural' on Food Labeling

For years, class action litigation has raged over advertisements claiming that foods are "natural." Seizing on ambiguity in the public's understanding of that term, the plaintiffs' bar has rushed to fill a void left by regulators, who have thus far refrained from offering a standard definition. The U.S. Food and Drug Administration (FDA) has repeatedly declined to wade into the controversy. On Tuesday, however, the agency finally responded to "consumers who have requested that the FDA explore the use of the term 'natural.'" Acknowledging "the changing landscape of food ingredients and production," the agency announced that beginning on November 12, it will accept public comments on use of the term in labeling of human food products.

FDA has long observed that defining "natural" from a food science perspective is difficult. It has said that it would not expect "natural" foods to contain synthetic or artificial ingredients that would not normally be expected to be present in the product, 58 FR 2302 at 2407, but it has consistently declined to issue regulations setting forth a formal definition.

As recently as January 2014, FDA refused a request from a federal court to formalize its policy on "natural" foods. The agency said it was hesitant to define "natural" due to the broad policy implications of such a move. While acknowledging that both it and USDA had considered the issue, FDA declined to take it up in the context of litigation between private parties, explaining that:

Any definition of "natural" on food labeling has implications well beyond the narrow scope of genetically engineered food ingredients about which the Court referral pertains. For example, if the agencies were to define the term, they would likely need to consider among other things: relevant science; consumer preferences, perceptions, and beliefs; the vast array of modern food production technologies in addition to genetic engineering [ ]; the myriad food processing methods [ ]; and any strictures flowing from the First Amendment.

With its announcement on Tuesday, FDA acknowledged that it could no longer ignore the issue. It explained that its earlier policy "was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods." It further added that existing policy "did not consider whether the term 'natural' should describe any nutritional or other health benefit." FDA's decision to take up the issue comes in response to Citizen Petitions requesting the agency define the term or even ban its use on food labels altogether. Some, like the Grocery Manufacturers Association, have asked for regulation declaring that terms like "Natural," "All Natural," "100 percent Natural," "From Nature," "Naturally Grown," or "Naturally Sourced" may be used with the name of the food product or elsewhere on food labels even if the food contains an ingredient derived from biotechnology. With FDA's decision to open the floor to public comment, all of these options are now on the table.

Implications for Current Litigation

Where there is a possibility of FDA or other agencies taking a position on labeling statements subject to litigation, courts are often willing to wait for the agency to act before allowing cases to move forward. The primary jurisdiction doctrine gives courts the option to stay proceedings or dismiss complaints without prejudice pending the resolution of an issue by a regulatory body. Food manufacturers defending class actions have thus argued that courts should stay or dismiss litigation until FDA or other relevant agencies have had the opportunity to weigh in. For example, in 2013 courts stayed litigation involving whether the phrase "evaporated cane juice" was deceptive when FDA reopened the comment period for draft guidance evaluating use of the phrase. They did so again in 2015 when FDA said it planned to revisit the draft guidance.¹

Conversely, because of FDA's previously stated unwillingness to define the term "natural," and with no pending rulemaking, courts have found no basis to stay or dismiss "natural" claims.² FDA's announcement that it will move forward and examine the meaning of "natural" is thus significant as it may change courts' thinking. Defendants will need to consider whether to ask courts to defer to FDA's expertise and stay current lawsuits until FDA acts. Regardless of FDA's ultimate decision about the term "natural," staying current litigation while the agency considers the term and its appropriate use may, in the long run, create consistency and clarity in a landscape that is currently unpredictable and confusing.

Comment Period

FDA has requested information pertaining to questions including but not limited to:

• Whether the term "natural" should be defined;
• If yes, how should "natural" be defined; and
• How should the term "natural" be used on food labels.

Members of the food industry are encouraged to participate in this process by submitting comments for FDA's consideration. Makers of other FDA-regulated products, such as cosmetics and OTC drugs should also consider whether to participate, as any FDA pronouncement could prove to be very influential on their own labeling and advertising as well.

The comment period begins on November 12, 2015 and ends on February 10, 2016. Attorneys from Crowell & Moring are monitoring these activities, and are available to provide legal guidance on its possible impacts and solutions for your business.

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¹ Reese v. Odwalla Inc., et al., Case No. 4:13-cv-00947 (N.D. Cal.) (Finding the FDA's recent decision to re-open comments on its 2009 draft guidance on ECJ could have a direct bearing on the lawsuit," and explaining that "[t]he FDA's action clearly indicates that the agency is exercising its authority in this area ... any final pronouncement by the FDA in connection with that process almost certainly would have an effect on issues in litigation here."); Swearingen et al. v. Santa Cruz Natural Inc., Case No. 3:13-cv-04291 (N.D. Cal.)  (Granting the plaintiffs' motion to stay the litigation, pending FDA's finalization of the draft ECJ guidance).

² See e.g., Janney v. General Mills, 944 F. Supp.2d 806, 814-15 (N.D. Cal.) ("Nevertheless, in repeatedly declining to promulgate regulations governing the use of 'natural' as it applies to food products, the FDA has signaled a relative lack of interest in devoting its limited resources to what it evidently considers a minor issue, or in establishing some 'uniformity in administration' with regard to the use of 'natural' in food labels.); Ham v. Hain Celestial Grp. Inc., Case No. 3:14-CV-02044 (N.D. Cal.) (Refusing to stay the case and noting that there was "no evidence that the FDA intends to define the term 'natural' or 'all natural.' On the contrary, the evidence in the record suggests that the FDA has no imminent plans to do so.")