Food Drug and Cosmetic Act

Plaintiffs’ lawyers love to challenge products labeled as “natural,” with hundreds of false advertising class actions filed in just the last few years. Recently, in Astiana v. Hain Celestial (pdf), the Ninth Circuit reversed the dismissal of one such class action, and in doing so, addressed some key recurring arguments made at the pleading stage in litigation over “natural” labeling.

The Hain Celestial Group makes moisturizing lotion, deodorant, shampoo, conditioner, and other cosmetics products. Hain labels these products “All Natural,” “Pure Natural,” or “Pure, Natural & Organic.” A number of named plaintiffs, including Skye Astiana, filed a putative nationwide class action, alleging that they had been duped into purchasing Hain’s cosmetics. According to plaintiffs, those cosmetics were not natural at all, but allegedly contained “synthetic and artificial ingredients ranging from benzyl alcohol to airplane anti-freeze.” Astiana claimed that she likely would not have purchased Hain’s cosmetics at market prices had she been aware of their synthetic and artificial contents. As is typical in such cases, she sought damages and injunctive relief under a variety of theories: for alleged violations of the federal Magnuson-Moss Warranty Act, California’s unfair competition and false advertising laws, and common law theories of fraud and quasi-contract.

The district court dismissed the entire case in deference to the “primary jurisdiction” of the U.S. Food and Drug Administration over natural labeling of cosmetics. On appeal, the Ninth Circuit made two important rulings to which defendants in “natural” litigation should pay special attention:

Primary Jurisdiction

Federal regulators have (with a few limited exceptions not relevant here) declined either to adopt a formal definition of the term “natural” or to regulate that term’s use on cosmetics or food labels. But both plaintiffs and defendants have pointed to informal FDA statements and letters on the subject to advance particular litigation positions. For example, in this case, Hain invoked the prudential doctrine of primary jurisdiction to argue that a case challenging labeling statements cannot go forward because the FDA, not the courts, must determine in the first instance what the challenged labeling statement means and how it should be used. (Indeed, as we have previously discussed, the primary jurisdiction doctrine has led more than a dozen courts to stay false advertising cases in which plaintiffs allege that the ingredient name “evaporated cane juice” is misleading.)

Critically for other defendants intending to invoke primary jurisdiction in the future, the Ninth Circuit concluded that the district court had not erred in concluding that the doctrine applied. Rather, the district court’s error was only in dismissing the case rather than staying it. As the Ninth Circuit explained, “[w]ithout doubt, defining what is ‘natural’ for cosmetics labeling is both an area within the FDA’s expertise and a question not yet addressed by the agency,” and “[o]btaining expert advice from that agency would help ensure uniformity in administration of the comprehensive regulatory regime established by the [Food Drug and Cosmetics Act.]” Significantly, as the Ninth Circuit noted, the FDA had shown “reticence to define ‘natural’” at the time Hain invoked the doctrine with respect to food labels, in light of competing demands on the agency, and there is no reason to believe the FDA is on the verge of rulemaking on ‘natural’ labeling. But that was not a reason to bar the doctrine’s application.

That said, when, as in Astiana, additional judicial proceedings are contemplated once the FDA completes its work, the Ninth Circuit held that the case should be stayed rather than dismissed. And on that basis, the Ninth Circuit reversed the district court’s dismissal. Whether the Astiana decision supports primary jurisdiction arguments outside the context of “natural” labeling on cosmetics—such as ‘natural’ statements on food labels—remains to be seen. But as we read it, the court’s core holding would seem to have broader application.

Express Preemption

Hain separately argued that the FDCA expressly preempted the plaintiffs’ claims challenging the use of the term “natural.” But because there are no regulations defining ‘natural’ or its use on cosmetics labels, the Ninth Circuit disagreed, concluding that neither plaintiffs’ claims nor their requested remedy would impose requirements different from the (non-existent) federal rules on “natural” labeling. The Court did not find persuasive Hain’s argument that the FDA’s conscious decision not to define or regulate the term “natural” supports express preemption. That said, in other settings, including in “natural” cases, defendants may still find it appropriate to point out that the FDA (or another agency) has made a conscious decision not to regulate, and that such a decision should be entitled to deference and respect, or should be taken into account in assessing whether plaintiff has stated a claim.

After the oral argument in POM Wonderful LLC v. Coca-Cola Co. (pdf), No. 12-761, the Supreme Court appeared all but certain to allow competitors to sue for false advertising under the Lanham Act over labels of FDA-regulated food products.  Food manufactures have been waiting to see just how broad the ruling would be and whether it would affect the onslaught of consumer class actions challenging food and beverage labels.  The wait is over, and the POM v. Coke decision, while effecting a dramatic change in competitor actions, should have little impact on consumer class actions.

As described by the Supreme Court, here are the facts of the case:  POM markets a juice product labeled “Pomegranate Blueberry 100% Juice,” which consists entirely of pomegranate and blueberry juices.  Coke (under its Minute Maid brand) markets “Pomegranate Blueberry Flavored Blend of 5 Juices,” a competing product that contains 99.4% apple and grape juices, with pomegranate, blueberry, and raspberry juices accounting for the remaining 0.6%.  The label on the Minute Maid product features a picture of all five fruits and the words “Pomegranate Blueberry” in a larger font than the words “Flavored Blend of 5 Juices.”  Significantly, the Minute Maid label complies with the technical labeling rules set out in the federal Food, Drug, and Cosmetic Act (FDCA) and FDA’s related regulations for naming a flavored juice blend.

POM alleged that Coke’s product name and label violate the Lanham Act’s false-advertising provision because (according to POM) consumers will be fooled into thinking there is more pomegranate and blueberry juice in the product than there really is.  The district court and Ninth Circuit rejected the Lanham Act claims, accepting Coke’s argument  that because juice labeling is pervasively regulated by FDA, applying generalized principles of false advertising under the Lanham Act would destroy the uniform, national labeling standard announced by the agency under the FDCA.  As the Ninth Circuit put it, “the FDCA and its regulations bar pursuit of both the name and labeling aspect” of the Lanham Act claim because allowing the claim would “undermine the FDA’s regulations and expert judgments” about how juices may and should be included in the product name.

The Supreme Court unanimously reversed the Ninth Circuit’s decision in an opinion by Justice Kennedy.  In analyzing whether one federal statute (the FDCA) precludes a remedy available under another (the Lanham Act), the Court ruled that the FDCA and Lanham Act can be harmonized because they are “complementary and have separate scopes and purposes” and—unlike FDCA’s express preemption of state-law claims—neither statute “discloses a purpose” by Congress to bar competitor suits like POM’s.  (A more detailed discussion of the Court’s opinion is available here.)  Notably—although the Court repeatedly tells us that the FDCA and Lanham Act can get along—the opinion never actually does the hard work of harmonizing Coke’s compliance with the FDCA’s detailed rules for naming flavored juice blends with POM’s theory of liability challenging the FDCA-compliant name under a generalized theory of false advertising.

By contrast with competitor lawsuits, the Court’s decision should have virtually no impact on food labeling consumer class actions.  While the Court expressed the view that consumers will be indirect beneficiaries of competitor Lanham Act claims over allegedly misleading labels, it made clear that its decision does not address or alter the interplay between state consumer protection laws or consumer suits and the FDCA.  In other words, the decision does not in any way undermine preemption principles that would apply to state-law claims challenging labels regulated by FDA.  That’s important not just for food companies facing consumer class actions, but also to avoid a problem the Court specifically recognized in its decision: the “disuniformity that would arise from the multitude of state laws, state regulations, state administrative agency rulings, and state-court decisions that are partially forbidden by the FDCA’s pre-emption provision.”  Though the Court correctly recognizes the resulting chaos if each state could impose non-identical labeling requirements, it characterizes the potential disuniformity from the potential tension between the FDCA and the Lanham Act a result that Congress envisioned.

Whether the Court was right or wrong about that, one thing is clear:  In creating food labels, food companies should consider not only what the FDCA and federal regulations say, but also analyze the potential risks of competitor lawsuits under the Lanham Act.  We will have more to say about these issues on a webinar tomorrow; interested clients or friends of the firm may register for the webinar here. 

 

 

The plaintiffs’ bar continues to file consumer class actions challenging food and beverage labels en masse, especially in the Northern District of California—also known as the “Food Court.” One particular line of cases—at least 52 class actions, at last count—targets companies selling products containing evaporated cane juice. The battle over evaporated cane juice has become the latest front in the war over whether federal courts should apply the primary-jurisdiction doctrine and dismiss or stay food class actions while awaiting guidance from the federal Food and Drug Administration.

In these cases, plaintiffs allege that the term “evaporated cane juice” is misleading because (in their view) it disguises the fact that the ingredient is a type of “sugar”; they contend that the ingredient  should be identified as “sugar.” Their theory rests almost entirely on a draft guidance that the FDA issued in 2009, in which the agency proposed the ingredient be called “dried cane syrup” (notably, not “sugar”), and invited public comment on the issue. That guidance suggested that the name “evaporated cane juice” not be used because it suggests the ingredient is a juice.

In response to these lawsuit, many defendants have emphasized that the FDA’s 2009 guidance not only is non-binding, but that the existence of the guidance establishes that the FDA is examining the precise issue underlying plaintiffs’ theory of liability. Accordingly, defendants argue, courts should let the agency finish its work. Or, put another way, because the federal Food, Drug, and Cosmetic Act squarely authorizes the FDA to regulate the names of ingredients as part of its power to prescribe uniform national standards for food labels, the issue is within the FDA’s “primary jurisdiction.” Thus, as we have contended in advancing the primary-jurisdiction argument, the issue should be decided by an expert agency, not via litigation brought by profit-motivated consumer class action lawyers.

How have these arguments fared? Because the FDA did not take action for over four years after issuing the 2009 draft guidance, plaintiffs had a great deal of success in convincing courts that the FDA was not actively addressing the evaporated-cane-juice issue further and therefore that applying the primary-jurisdiction doctrine was inappropriate.

All that changed in March 2014, when the FDA published a notice in the Federal Register reopening the comment period on the 2009 draft guidance and emphasizing that it has “not reached a final decision on the common or usual name for” evaporated cane juice and that it “intend[s] to revise the draft guidance, if appropriate, and issue it in final form.” [Our firm recently filed a comment with the FDA on this issue.]

As if a light had been switched on, virtually every court to consider the issue since the March notice—at least 10 class actions so far—has ruled in favor of deferring to the FDA’s primary jurisdiction in evaporated-cane-juice cases. This overwhelming trend is welcome news.

But from our perspective, the fact that the FDA recently reiterated its interest in this area should not have been necessary to trigger the primary-jurisdiction doctrine. Indeed, even before the March 2014 notice, the question of the proper labeling of evaporated cane juice was one within the primary jurisdiction of the FDA, as at least one court recognized.

To be sure, as one judge has put it, whether the FDA (or another regulatory agency) “has shown any interest in the issues presented by the litigants” appears to be an “unofficial fifth factor” that influences courts grappling with whether primary jurisdiction should be applied in a given case. Greenfield v. Yucatan Foods, L.P., — F. Supp. 2d –, 2014 WL 1891140, at *4-5 (S.D. Fla. May 7, 2014). But this “unofficial fifth factor” is neither necessary nor part of the four, well-recognized factors for applying primary jurisdiction: “(1) [a] need to resolve an issue that (2) has been placed by Congress within the jurisdiction of an administrative body having regulatory authority (3) pursuant to a statute that subjects an industry or activity to a comprehensive regulatory authority that (4) requires expertise or uniformity in administration.” Clark v. Time Warner Cable, 523 F.3d 1110, 1115 (9th Cir. 2008).

The same factors were satisfied in the evaporated-cane-juice context even before the March 2014 notice.  And—speaking more generally—uncertainty over when the FDA will act should not be treated as an invitation for different courts to apply different state laws and develop differing labeling regimes.

Here’s hoping for a few more helpings of primary jurisdiction at the Food Court—and a few more scoops of uniformity and certainty for the food and beverage industry.

It is no secret that many private class actions are filed as follow-on lawsuits to news reports, government investigations, regulatory developments, and identical earlier-filed class actions. But a recent gambit by the plaintiffs’ bar is among the more creative efforts we have seen. Earlier this week, a well-known plaintiffs’ firm filed Dang v. Samsung Electronics Co., in the Northern District of California. The complaint alleges that Apple’s victory over Samsung (at least in part) in certain highly publicized patent infringement actions establishes that Samsung has violated California’s consumer protection law as well as warranty statutes in 49 states and the District of Columbia.

The background of the patent battle between Apple and Samsung is well known, so we mention only a few highlights. In fall 2013, the federal court for the Northern District of California found Samsung liable for infringing several patents relating to Apple’s iPhone. The International Trade Commission also found that certain devices were infringing and precluded Samsung from importing or selling those devices. The same court already has granted partial summary judgment to Apple in a second patent lawsuit targeting additional Samsung devices, with a jury trial set for the end of March. (The battles are not over, to be sure.)

The Dang lawsuit alleges that Samsung induced consumers to purchase its devices by concealing its infringing activities, and that once those activities became known, the resale prices of Samsung smartphones and tablets “dropped dramatically,” injuring consumers and unjustly enriching Samsung. Mr. Dang alleges that “[h]ad [he] known the Product he purchased infringed on the patents held by [Samsung’s] competitor, Apple, he would not have purchased the Product.” He seeks to represent everyone in the U.S. who has purchased one of the allegedly infringing devices since 2008—a proposed class that undoubtedly totals in the millions.

Will Dang become a model for other plaintiffs’ lawyers to follow? The short answer: It depends on whether courts will accept the notion that the alleged infringement harms consumers (as opposed to competitors). Color us skeptical—to put it mildly, we have a number of questions:

  • How plausible is it that the interpretation of complex technology patents matters to consumers when they purchase a product?
  • How many Samsung purchasers even know that there is litigation involving Apple patents, much less the determination of the claims?
  • In light of the Ninth Circuit’s decision in Mazza v. American Honda Motor Co.—a case we have discussed before—what are the chances that a nationwide class could be certified given the variations among state warranty and consumer protection laws?
  • Is it realistic to believe that injury and damages can be proven on a classwide basis?

Nevertheless, it is easy to see why plaintiffs’ lawyers might find these kinds of cases attractive. If the result of a battle between competitors is that a product has been determined to be infringing by a court or agency, that may substantially reduce the work a plaintiffs’ lawyer needs to do to pursue the case. And that lawyer will likely argue that key aspects of liability have already been established before the class action even gets started.

The theory espoused in Dang parallels the strategies used by plaintiffs’ firms in the recent wave of false advertising class actions against food and beverage manufacturers. As we have discussed, many of these lawsuits rely on California’s wholesale incorporation of the federal Food Drug and Cosmetic Act (“FDCA”). Plaintiffs attempt to convert alleged technical violations of FDCA labeling requirements into consumer claims alleging that the mere sale of such products is illegal—without the need to show that class members actually were deceived by or relied on the alleged mislabeling. And most of those lawsuits have landed in the Northern District of California—now known as the nation’s “Food Court.”

It’s no coincidence that the Dang lawsuit was filed in the Northern District of California by two plaintiffs’ firms that are highly active in the Food Court wars. Will plaintiffs’ lawyers next flock to copycat class actions seeking to leverage findings of patent infringement? Stay tuned. We’ll be monitoring the situation.

 

The federal Food Drug and Cosmetic Act (“FDCA”)—along with the implementing regulations promulgated by the FDA—sets out a detailed national standard for much of what appears on food and beverage labeling. See 21 U.S.C. §§ 301, et seq.; 21 C.F.R. §§ 101, et seq.; Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170, 1175 (9th Cir. 2012). This national labeling law expressly preempts states from enacting different requirements for labels, including requirements imposed by courts under the guise of redressing a “misleading” or “fraudulent” label. 21 U.S.C. § 343-1; Turek v. Gen. Mills, Inc., 662 F.3d 423, 426 (7th Cir. 2011).

Preemption under the FDCA served as a bulwark against the first wave of false advertising consumer class actions against the food and beverage industry. Most of those complaints essentially attempted to impose state-law labeling requirements that differed from the federal requirements, and courts therefore dismissed the claims as expressly preempted. See, e.g., Turek, supra; Carrea v. Dreyer’s Grand Ice Cream, Inc. (pdf), 475 Fed. App’x 113 (9th Cir. 2012).

In response, the plaintiffs’ bar adapted by refocusing class action litigation on labeling statements that they asserted were not covered by a federal requirement. The hundreds of cases challenging “natural” labeling statements are an example. In most respects, FDA has declined to regulate the use of the term “natural” on food and beverage labels, claiming that, “[f]rom a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer a product of the earth.”  No federal requirement, no preemption of the state-law consumer claims, plaintiffs say.

Moreover, in the last 16 months, the plaintiffs’ bar has debuted a new theory that it hopes will allow them to evade preemption. They rely on California’s wholesale incorporation of the FDCA’s labeling law into the law of California. Cal. Health & Safety Code § 110100. Alleged violations of the FDCA are thus transformed into violations of California’s Sherman Food Drug and Cosmetic Law. And violations of the Sherman law, in turn, may be alleged as predicate acts in support of claims for violation of California’s consumer protection laws, including the Unfair Competition Law (a/k/a Section 17200). Plaintiffs argue that because state law imposes identical requirements to the federal requirements (indeed, the same FDCA requirements), liability under state law is not preempted.

But is indirect enforcement of the FDCA via a “state-law delivery device” compatible with Congress’s refusal to create a private right of action for violation of the FDCA? (California’s Sherman Law also does not allow for private enforcement.) Plaintiffs tried and failed to use a similar strategy in the context of medical devices, which are also governed by the FDCA. Specifically, the Supreme Court has held that Section 337 of the FDCA (the exclusive-enforcement provision) impliedly bars suits by private litigants “for noncompliance with” federal law, and that the express-preemption provision of the Medical Device Amendments preempts any state-law claim if the result of the litigation might be to require (or forbid) any conduct not already required (or forbidden) by federal law. Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 349 n.4 (2001); Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008). Taken together, the exclusive-enforcement and express-preemption provisions

create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted . . .), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted . . .).

Bryant v. Medtronic, Inc. (pdf), 623 F.3d 1200, 1204 (8th Cir. 2010) (emphasis in original).

On our view, Buckman and its progeny bar any state-law claim for which the existence of the federal regulatory scheme is a “critical element.” This implied preemption issue, as applied to food labeling false advertising claims, is currently joined in several pending motions in the Northern District of California. See, e.g., Kane v. Chobani, No. 12-cv-2425 (N.D. Cal), Dkt. No. 97; Trazo v. Nestlé USA, Inc., No. 12-cv-2272 (N.D. Cal.), Dkt. No. 64; Samet v. Procter & Gamble Co., No. 12-cv-1891 (N.D. Cal.), Dkt. Nos. 85, 87; Bruton v. Gerber Prods. Co., No. 12-cv-2412 (N.D. Cal.), Dkt. No. 47.

We expect decisions on these motions in the near future and will blog on the results when decisions are issued.