Court Expresses Doubt on FDA’s “Good-Faith Efforts” to Define “Natural”
A New York federal court has issued a decision seemingly aiming to spur action from the U.S. Food and Drug Administration (FDA), which has purportedly exhibited “no discernible activity” to establish a definition of “natural.” In re Kind LLC “Healthy and All Natural” Litig., No. 15-2645 (S.D.N.Y., entered March 2, 2018). Kind LLC previously filed motions to dismiss or stay claims in multidistrict litigation alleging that its labeling was false and misleading. After allowing stays, the court has indicated that it might proceed with the case without waiting for input from FDA or the U.S. Department of Agriculture (USDA) on the definitions of “healthy” and “natural.”
The court first found that the consumers’ challenge to Kind’s claim that its products are made without genetically modified organisms (GMOs) was not preempted by the National Bioengineered Food Disclosure Standard, holding that the relevant state consumer-protection statutes “do not impose a GMO standard or requirement. Those statutes only provide remedies for representations that are untrue or misleading . . . [the plaintiffs] simply want to ensure that Kind’s labels are truthful.”
Kind argued for a stay for the “non-GMO” claim because USDA’s deadline to set GMO standards is July 2018. The court found “no doubt that a national GMO standard will be relevant to many of the underlying issues in this action. If the USDA successfully formulates that standard by July 2018, the parties may likely rely on it to strengthen their claims or defenses. Beyond that, however, a GMO standard will not conclusively shed light on whether a reasonable consumer would have been deceived by KIND’s representation that its products were GMO free.” The court stayed the “non-GMO” claims until August 15, 2018, to allow parties to review the scheduled July determinations.
The court then turned to the stay granted to the plaintiffs’ “natural” labeling claims, noting that it originally stayed the claims in September 2016 because the “FDA rulemaking process should run its course.” The court also noted that the public comment period on “natural” labeling ended in May 2016—but “[s]ince then, the FDA has gone quiet.” The court then pointed to a July 2017 House Committee on Appropriations report on a bill that would, if passed, trigger a 60-day period in which FDA would be required to announce “the actions and timeframe” for defining “natural.” Congress has not passed the bill, the court stated, and FDA might set a years-long timeframe, leaving “this case in judicial purgatory for an indefinite period of time.”
After two years, the court found, “the pace of the FDA’s process is still unclear. There is no indication whether the FDA is earnestly working toward a uniform ‘natural’ standard, or whether it has shelved that effort.” The court indicated that it would continue the stay on the “natural” claims but “limit its duration through the date on which the USDA is expected to define and promulgate the ‘non-GMO’ standard.” Because the parties agree that the claims should not be litigated separately, the court found August 15, 2018, to be a “sensible benchmark from which it can reassess whether a stay over both claims is proper.”
The court concluded its opinion by warning that the primary jurisdiction doctrine “relies on the timely and good-faith efforts of regulatory agencies in addressing issues within their domain . . . this Court cannot sit idly by on an illusory assurance that something is likely to happen.”