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It’s a food and beverage manufacturer’s nightmare: the headline on People Magazine’s website announces you were sued in a class action because your always 100% natural sparkling water allegedly contains an ingredient used in cockroach insecticide. It’s an all-too-common nightmare for companies that market all natural food and drinks.

The heart of the claims in Rice v. National Beverage Corp​, brought in Chicago on October 1, is that LaCroix’s ‘all natural’ advertising allegedly misleads consumers because the seltzers contain four ingredients the FDA has “declared … to be synthetic.”

But in its statement refuting these allegations, National Beverage says LaCroix’s natural flavors are “derived from the natural essence oils from the named fruit used in each of the flavors,” and contain no artificial ingredients.

Class action litigation abounds because the FDA has yet to define ‘natural,’ despite having considered doing so twice. Nearly 30 years ago, in 1991, the FDA proposed defining the term and solicited comments on whether a product labeled ‘natural’ should be considered misbranded if it had been more than minimally processed or contained any artificial or synthetic ingredients, such as food and color additives. More recently, in November 2015, it solicited comments on use of the term ‘natural’ but has yet to release any proposed rule.

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An unidentified FDA spokesperson told Today.com in response to a request for comment on this case that while the FDA has not formally defined ‘natural,’ it expects the term “to mean 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 that food.”

Despite this will-they-or-won’t-they history, FDA commissioner Dr. Scott Gottleib told the audience in his March 29, 2018 speech to the National Food Policy Conference that his agency would “have more to say on the issue soon.”  “Like other claims made on products regulated by FDA​,” he continued, “We believe the ‘natural claim’ must be true and based in science.” We can expect the FDA ultimately to employ evidence-based criteria informed by public health concerns.

All four ingredients in the lawsuit can be naturally occurring

Rice’s lawsuit claims that the chemical compounds ethyl butanoate, limonene, linalool, and linalool propionate “are synthetically created and added to consumable goods to make those goods taste or smell a certain way.​” In fact, limonene and linalool are on an FDA list of “synthetic flavoring substances and adjuvants that are generally recognized as safe for their intended use, within the meaning of section 409 of the [Federal Food, Drug, and Cosmetic] Act.” ​ 21 C.F.R. § 182.60. But all four ingredients can be naturally occurring:

• Ethyl Butyrate is present in many fruits, including apple, apricot, banana, plum, and tangerine. It can be used as a flavoring ingredient and can be synthesized by reacting ethanol and butyric acid.
• Limonene is a major component of citrus (e.g. ​lemon, orange) oil.
• Linalool is a naturally-occurring chemical found in many flowers and spice plants.
• Linalool propionate is found in ginger.

Without clearly alleging it, Rice’s lawsuit suggests that these substances said to be in LaCroix’s seltzer water were synthetically created rather than taken from the plants in which they occur naturally.

National Beverage denies this, but even if proved, the suit would turn on the legal question whether a food or beverage can be ‘all natural’ if it includes synthetically created ingredients that are bio-identical to those naturally occurring in fruits and other plants.

A guiding principle in label-claims litigation is that consumers consider ‘well-known facts of life’ in making their purchases and do not assume things about products beyond the literal statements made that are contrary to well-known facts. For example, in Henderson v. Gruma Corp.​, a California federal court dismissed consumer fraud claims against a product made ‘with Garden Vegetables’ and ‘authentic tradition’ because it contained vegetables that could be grown in a garden. But the ‘all natural’ claims survived.

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Narrower claims of ‘natural fruit flavors’ or the depiction of fruit on a label have not been found to be misleading, even when the product fails to contain actual fruit, because FDA regulations permit them as indicative of a product’s ‘characterizing flavor.’ See​ McKinnis v. General Mills, Inc.​, 2007 WL 4762172, at *3 (C.D. Cal., Sept. 18, 2007) (citing 21 C.F.R. § 101.22(i)). This shows the value of a formal FDA rule.

This isn’t really about cockroach insecticide…

At this early stage of the Rice​ case, the court can dismiss it only if it concludes based on the allegations in her lawsuit that no reasonable consumer could be deceived by LaCroix’s ‘All Natural’ or ‘always 100% natural’ claims. While courts sometimes dismiss cases under this standard, sometimes they find the label’s or website’s claims raise factual issues that cannot be resolved on a motion to dismiss but require evidence to be developed later in the case.

LaCroix has already begun to reframe Rice’s ‘cockroach insecticide’ rhetoric. Despite the headlines, the issue is whether a reasonable consumer would be misled to believe LaCroix’s ingredients are natural, not whether LaCroix seltzer water shares a common ingredient with a cockroach insecticide.

Courts have examined similar issues with respect to synthetically created ingredients with naturally occurring analogues. For example, Trader Joe’s and Kashi have been targets of class actions for ‘all natural’ products that allegedly contained synthetically created analogues of naturally occurring vitamins.

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Trader Joe’s was sued over an ‘All Natural’ label on its apple juice, which contained synthetically created, chemically modified, vitamin C—ascorbic acid. Trader Joe’s argued that a ban on ‘All Natural’ labeling for products containing ascorbic acid would, in effect, force manufacturers to imply that ascorbic acid is inferior to naturally occurring vitamin C, which would violate an FDA regulation that forbids state laws from requiring the addition of positive or negative language to a label.

Larsen v. Trader Joe’s Co.​, 917 F. Supp. 2d 1019, 1022-25 (N.D. Cal. 2013). While acknowledging potential market consequences, the court denied Trader Joe’s motion for judgment on the pleadings because it found Trader Joe’s failed to show that the lack​ of ‘All Natural’ on the label suggested inferiority that would violate the federal regulation.

What do reasonable consumers think?

In Garcia v. Kashi Co.​, a Florida federal court found an ‘all natural’ label could “mislead a reasonable consumer into believing that they were buying a product free of GMOs, Pyridoxine Hydrochloride, Alpha-Tocopherol Acetate, Hexane-Processed Soy ingredients and Calcium Panthothenate,​” adopting the plaintiff’s language of referring to vitamins by their chemical names rather than their common ones, ostensibly to make them seem less natural, and denied Kashi’s motion to dismiss.

The court acknowledged that an FDA regulation permitted the vitamin ingredients alleged to be synthetic to be listed by their common names, but found that the ‘all natural’ labeling did not fall within this regulation and allowed the suit to continue.

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The Trader Joe’s ​court said that in removing the prohibition on differentiation between naturally occurring and synthetic vitamins the FDA recognized some value to consumers in knowing whether ingredients are synthetic or naturally occurring. But the FDA did not make such a statement, and its stated purpose in making the change was to clarify language it thought was “easily misinterpreted.”

The FDA has not said whether a ‘natural’ label is misleading if used on a product containing a substance that can be both naturally occurring and chemically synthesized

In 1997, in response to comments, the FDA deleted a section of 21 C.F.R. § 101.9(k)(6) [renumbered as 101.9(k)(4)] that prohibited “any differentiation between added and naturally occurring vitamins​” but retained the preceding language in that section that prohibited “any representation that naturally-occurring vitamins are superior to added or synthetic vitamins.” ​

In doing so, it noted that it would maintain its prior policy​ to allow unrestricted truthful and non-misleading use of ‘natural’ “except for products with added color, synthetic substances, or artificial flavors as provided in § 101.22,​” for which the use of the term ‘natural’ on the label would be considered misleading.

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However, the agency advises that the term ‘natural’ should not be used when referring to a vitamin that is only obtained​ through chemical synthesis (e.g. use of ‘natural vitamin E’ for a product containing dl-alpha tocopheryl acetate).”

The FDA did not say whether a ‘natural’ label is misleading if used on a product containing a vitamin (or other substance) that can be both​ naturally occurring and chemically synthesized. While the FDA noted that there were no restrictions in the regulations regarding identification of the chemical form of the vitamin and that “such identification is helpful on certain nutrients,​” it made no comment about the value of identification of naturally-occurring or synthetic vitamins.

Primary jurisdiction?

While some courts have stayed proceedings until the FDA defines ‘natural,’ others have refused, given the FDA’s long history of considering whether and how to define it but never taking formal action. National Beverage may ask the court to wait in light of Dr. Gottleib’s March 2018 statement that the FDA would “have more to say on the issue soon​,” but there is no guarantee the court will find these recent comments depart from the FDA’s past pattern sufficiently, or are definitive enough, to justify a stay.

Despite National Beverage’s view of the lack of merit in Rice’s claim, and the ubiquity of ‘all natural’ marketing, it’s unsurprising that most defendants have preferred to settle claims rather than fight them to the end.

Until the FDA defines ‘natural,’ the lesson for food and beverage manufacturers is that given consumer demand for natural products, the most effective advertising strategy should be to use language that appeals to consumers but is narrow enough not to appeal to class action lawyers.