Plaintiffs have made food labeling class actions a rapidly-growing field in recent years, particularly in the Northern District of California. They typically rely on California’s regimen of consumer fraud statutes when bringing those claims. California also has Proposition 65, which requires labeling of substances that a state agency concludes may cause cancer or birth defects. The threshold for labeling is quite low, meaning that even the most mundane items often include—or should include—warnings. Indeed, plaintiffs recently have used the “lack” of a Proposition 65 label on food products as a basis for consumer fraud and other claims even though the Food and Drug Administration finds no health risk from the relevant ingredient and already dictates labeling requirements regarding the ingredient. Such lawsuits are irreconcilable with the purpose of federal food labeling requirements.

Proposition 65 And Its Relationship To 4-MeI In Beverages.

In the past year, interest has grown in 4-methylimidazole (“4-MeI”) and its possible link to cancer. 4-MeI is formed as a byproduct in some foods and beverages as part of the cooking process. It also forms in trace amounts when manufacturing certain types of caramel coloring frequently used in some dark beverages, such as cola and dark beer.

At this point, it is useful to address some of the science regarding 4-MeI. A 2007 study by the National Toxicology Program (“NTP”) seems to be the genesis of this recent concern. That study did not find any increased cancer risk in rats exposed to high doses of 4-MeI but did see an increased rate of lung tumors in mice. In broad strokes, a human would need to drink approximately 300 cans of soda every day for two years to consume the same amount of 4-MeI given to the mice and rats in the NTP study. The FDA has monitored available data and states on its website: “Based on the available information, FDA has no reason to believe that there is any immediate or short-term danger presented by 4-MeI at the level expected in food from the use of caramel coloring.” The FDA is currently reviewing “all available data on the safety of 4-MeI,” but “is not recommending that consumers change their diets because of concern about 4-MeI.”

Much of the interest and litigation activity arose after Consumer Reports published an article in February 2014. Consumer Reports noted that its tests showed that customary servings of some popular soft drinks contain 4-MeI above the limits set by the California Office of Health Hazard Assessment (“COHHA”) under Proposition 65. That law requires labeling substances that COHHA concludes have a 1 in 100,000 chance of causing cancer or birth defects. That list of substances is quite long and includes things such as “Salted fish, Chinese-style,” “Oral contraceptives,” and “Alcoholic beverages, when associated with alcohol abuse.” Under the law, substances with more than 29 micrograms (a microgram is one-millionth of a gram) of 4-MeI must have a warning label; this means that COHHA believes that one excess cancer case will arise per 100,000 people exposed to more than 29 micrograms of 4-MeI daily for a lifetime.

Putative Class Actions Regarding 4-MeI.

Class actions against Pepsico and Goya Foods soon followed the Consumer Reports article. The article identified those companies’ products as having more than 29 micrograms of 4-MeI per serving. We now have inconsistent rulings in those cases. The most recent decision in the Goya Foods matter, moreover, shows how difficult it can be when a court may not understand the underlying science.

Riva: There is not Sufficient Exposure to or Toxicity of 4-MeI in These Drinks.

In Riva v. Pepsico, Inc., No. C-14-2020-EMC (N.D. Cal. Mar. 4, 2015), the court granted a motion to dismiss with prejudice. That decision addressed a putative medical monitoring class action in which the named plaintiffs alleged that consuming Pepsi products caused them to experience an increased risk of bronchioloalveolar cancer. Those plaintiffs cited the NTP report in their amended complaint, so the court analyzed that report closely. First, even the NTP report concludes that the amounts of 4-MeI ingested from such beverages may not be significant. Absent sufficient exposure for 4-MeI from consuming Pepsi products, those plaintiffs could not establish a credible risk of cancer from that consumption. The court was also reluctant to apply the NTP study to humans because it only found an increased risk of cancer in mice; that study implied that any effect may be species specific because rats did not experience a similar increase in that type of cancer. As the NTP study recognized, various species absorb, distribute, metabolize, and excrete the substance differently. Of course, it was also difficult to conclude that humans would be exposed to 4-MeI at the same level as the mice in the NTP study (i.e., approximately 300 cans of soda per day). Moreover, because so many different products contain 4-MeI, those plaintiffs did not establish that consuming Pepsi products (as opposed to consuming other products) would have been the source of any alleged increased risk of that cancer.

Stated more simply, what does Riva mean? That court concluded that the study the plaintiffs relied on does not establish a significant risk of increased cancer from normal human consumption of beverages with 4-MeI. As we are about to see, however, a judge in the Southern District of California recently concluded that it was plausible that a different manufacturer misled consumers by not including a Proposition 65 warning on its beverages. So we have one judge finding that no increased health risk exists that would warrant medical monitoring but a second judge ruling that it may amount to consumer fraud to fail to warn consumers of this same “risk.”

Cortina: Manufacturers may Need to Include Proposition 65 Warnings on Products With 4-MeI.

In Cortina v. Goya Foods, Inc., No. 14-CV-169-L(NLS) (S.D. Cal. Mar. 19, 2015), the named plaintiffs alleged several California consumer fraud claims because the defendant did not disclose “material facts about the levels of 4-MeI” in its beverages. In essence, those plaintiffs argued that the beverages must contain a Proposition 65 notice because the caramel coloring adds more than 29 micrograms of 4-MeI to the products. That court rejected a federal preemption argument under the Nutrition Labeling and Education Act of 1990. That federal statute expressly preempts state laws that would impose labeling obligations not imposed by the FDA. Undeniably, federal law requires products with artificial flavoring, artificial coloring, or chemical preservatives to state that fact on the labels. 21 U.S.C. § 343(k). The defendant argued that requiring additional labeling regarding 4-MeI (which arises from caramel coloring) would amount to an additional requirement beyond what federal law requires. The court disagreed, reasoning that the allegations had nothing to do with caramel coloring. “Plaintiffs’ claims are based on a theory of omission—that defendant’s products failed to disclose the presence of substances known to the state to cause cancer.” Apparently, under this reasoning, the state could compel a manufacturer to include a Proposition 65 warning about 4-MeI even though (1) federal law already dictates what a label must state regarding artificial coloring (the source of 4-MeI) and (2) the FDA states on its website that there is no reason to believe of any health risk from consuming foods with 4-MeI.

The Cortina court also refused to defer to the FDA under the primary jurisdiction doctrine. That is a prudential doctrine under which courts will await a regulatory agency’s actions regarding subject matter within the agency’s purview. Such deference seems warranted here because the FDA is reviewing available data regarding the safety of 4-MeI to determine if it should take additional action. Thus, this is not a situation of a defendant arguing hypothetically that a regulatory agency may look at the issue; quite the contrary, the FDA indicates it is actively doing so. Nonetheless, the court will not wait for the FDA’s ongoing review to conclude. Thus, the putative class action will plow forward even though the FDA may soon state that there remains no reason to believe a viable health risk exists.

The Cortina court also concluded that the plaintiffs’ claims were plausible even though the FDA states that there is no reason to believe there is immediate or sort-term danger to consumers. The court latched on to the FDA’s statement that it reached that conclusion “[b]ased on the available information . . . .” The court inferred that meant some limit on the usefulness of the data. Indeed, the court concluded that “it appears that the FDA is saying that it does not know whether, and in what amounts, 4-MeI presents a danger, but is looking into the situation.” That is an untenable interpretation of the FDA’s comments. If that standard were sufficient, any plaintiff could always argue that one more test or one different analysis somehow may reach a conclusion different from what all existing analyses have reached. It will always be possible to suggest that some undefined additional testing should occur. It is not clear on what the FDA could base its statement other than “the available information.” It certainly could not base its conclusion on unavailable information.

These Cases Help Show That Proposition 65 Labeling Of Food Or Beverage Is Untenable.

At this point, we have one federal court in California holding that the science does not suggest any increased risk of cancer to humans from consuming beverages with 4-MeI in anticipated amounts. Because of that lack of risk, there is no basis to order medical monitoring. On the other hand, a different court in California concluded that it may amount to consumer fraud to fail to warn consumers about that same substance.

To be sure, Riva and Cortina present different legal theories—medical monitoring and consumer fraud, respectively. But the underlying premise is fundamentally the same. In Riva, there is no need to test for cancer because 4-MeI does not lead to an increased risk of the disease. In Cortina, however, it is deceptive to fail to warn consumers that beverages contain 4-MeI because that substance ostensibly is linked to an increase risk of cancer. And in both settings, the FDA knows that caramel coloring results in products containing 4-MeI; nonetheless, it permits using that coloring and only requires that the label note the use of “artificial coloring” in those situations.

This morass points to the difficulties that Proposition 65 and questionable science create. The standard for requiring Proposition 65 labeling is quite low—one more cancer in a population of 100,000 over a lifetime of exposure. Put that into perspective. Using the most recent data available from the CDC (2011), the United States saw approximately 67 instances of lung cancer per 100,000 people. Under Proposition 65, a manufacturer must label a substance that, with a lifetime of exposure, theoretically leads to 68 instances of lung cancer per 100,000 people—a 1.5% increase over the expected 67 instances.

Moreover, the science underlying these determinations is not always sound or certainly is questionable in terms of extrapolating to ordinary human exposure. Would anyone really consume 300 cans of soda a day for two years? That is the approximate exposure required to replicate the 2007 NTP study. We know that “‘the dose makes the poison’; this implies that all chemical agents are intrinsically hazardous—whether they cause harm is only a question of dose.” Bernard D. Goldstein and Mary Sue Henifin, Reference Guide on Toxicology, in Federal Judicial Center, Reference Manual on Scientific Evidence 636 (3d ed. 2011). Nonetheless, the reasonableness of the dose doesn’t seem to enter the calculus for these claims. Even the NTP study only found increased incidence of cancer in mice; rats did not show such results. If such differences exist between those species, how can we reliably extrapolate to humans?

This is not an issue the FDA is ignoring. Rather than allow lawyer-driven litigation to proceed, we would be better served to leave these issues to that regulatory body and to real science.

James D. Smith is a partner in the Phoenix office of Bryan Cave LLP.