We’ve got food on our mind.  Last Sunday, the CBS Sunday Morning show ran its food episode, with segments about, inter alia, a little restaurant in the north of England being rated the best in the world, the Martha Stewart and Snoop Dog cooking show, and the rolled ice cream fad (focusing on Sweet Charlie’s in Philly).  And tomorrow, of course, is Thanksgiving.  We’re looking forward to great food on the table and loved ones around it. We wish the same for you.

Today’s case is about food, and about a legal doctrine we like almost as much as turkey and cranberry sauce: primary jurisdiction.  The case is Rosillo v. Annie’s Homegrown Inc., 2017 U.S. Dist. LEXIS 190130 (N.D. Cal. Oct. 17, 2017).  It is yet another case alleging misuse of the term “Natural.”  Does anyone have a clear idea what that word means? Even if you do think you do know what it means, are you confident that your definition is the same as what resides in the head of the person sitting next to you?  Who knows what any given set of jurors will think about this issue?  We need order brought to this chaos.  That order is much more likely to come from the FDA than from random litigation experiments sprinkled around the country.

In Rosillo, the plaintiffs claimed that the defendant’s salad dressings were not natural because they contained xanthan gum, a thickening agent manufactured via fermentation and treated with a byproduct of isopropyl alcohol.  (One plaintiff bought her salad dressing at a Target store, while another bought hers at Whole Foods.  Now that’s varied distribution.). The plaintiffs brought causes of action under California and New York consumer and false advertising laws, as well as for breach of warranty, misrepresentation, and violation of the federal Magnuson-Moss Warranty Act.  The defendants moved to dismiss the actions on the merits and, in the alternative, to stay the action under the primary jurisdiction doctrine in order to permit the FDA to decide the scope of “natural.”  The court issued the stay, so it did not reach the merits.

Primary jurisdiction is a “prudential” doctrine, under which a court determines that an otherwise cognizable legal claim implicates technical policy questions that would benefit by first hearing from the regulatory authority.  The Rosillo defendants premised their stay request on the FDA’s establishment in November 2015 of a docket to consider the use of the term “natural” on food labels.  The FDA invited comments, and extended the period for taking such comments up through mid 2016.  No decision has yet issued.  Meanwhile, lots and lots of cases have been filed against food manufacturers around the country (though especially in California) alleging phony “natural” labels.

The plaintiffs argued against waiting for the FDA because (1) the issue in their cases is whether reasonable consumers were being deceived, which is supposedly separate from whatever the FDA will decide, and (2) it is unclear whether the FDA will ever actually resolve the “natural” issue, especially given the FDA’s “extended silence” since the closing of the comment period.  The Rosillo court disagreed with the plaintiffs.

First, the FDA’s guidance on whether and when companies can call their products “natural” will inevitably be relevant to how reasonable consumers understand the term.  Indeed, the plaintiffs’ complaint cites FDA regulations and pronouncements.  Second, the FDA’s food labeling regulatory framework undeniably is broad and comprehensive.  Third, the Ninth Circuit Astiana case held that the meaning of “natural” is a particularly complicated issue that Congress committed to the FDA.

What about the FDA’s “extended silence”?  The Rosillo court seized upon a recent Congressional appropriations bill report, which commended the FDA for wrestling with the “natural” issue and directing the FDA to report within 60 days “on the actions and timeframe for defining ‘natural’ so that there is a uniform national standard for the labeling claims and consumers and food producers have certainty about the meaning of the term.”  The appropriations bill is pending, so the 60 day clock has not yet commenced.  Nevertheless, the Rosillo court concluded that it is likely that the FDA will address the “natural” issue in a relatively short period of time.

The result is that the Rosillo case is stayed.  The logic of the Rosillo decision should also apply to the vast array of other cases with similar allegations.  Even more important, let’s hope that the FDA will for once and for all resolve the issue and make these disputes and the surrounding cacophony unnecessary.  That outcome would make us thankful.

We depend on young associates to perform most of the legal research that supports the arguments we make on behalf of our clients.  By and large, those associates do an excellent job.  On those rare occasions when we find ourselves grousing about the quality of research, it usually has something to do with reliance on overly-specific computer searches.  Sometimes it seems as if the lawyers punch a search term into Lexis or Westlaw that would capture only cases that are precisely on point.  The problem with that approach is the possibility of missing cases that support general principles, or offer other oblique ammunition for one’s position.  Today’s case, Canale v. Colgate-Palmolive Co., 2017 U.S. Dist. LEXIS 97506 (S.D.N.Y. June 23, 2017), is an example of that kind of helpful, albeit indirect, authority.  The plaintiffs in Canale filed a class action attacking the defendant for allegedly overstating the whitening power of its toothpaste.  The toothpaste contained hydrogen peroxide, and its advertising bragged of deep whitening – more than three shades.  The plaintiffs asserted that the hydrogen peroxide was not strong enough and was not in contact with tooth enamel long enough to achieve the promised results.  The causes of action were based on breach of warranty and violations of New York’s General Business Law sections 349 and 350, which outlaw deceptive practices and false advertising.

What can this case possibly have to say for drug litigation?  To begin with, the toothpaste’s peroxide content meant that it was both a cosmetic and an over-the-counter (OTC) drug.  A product qualifying as both a cosmetic and drug is subject to the stricter requirements applicable to drugs.  Either way, such a product enjoys the preemption protections in the Food, Drug and Cosmetics Act,  21 U.S.C. sections 379r and 379s.  The FDCA forbids state law (including jury verdicts) or regulations that would impose a requirement on cosmetics or OTC drugs that are “different from or in addition to, or that is otherwise not identical with, a requirement specifically applicable” via the FDCA.  Thus, the defendant filed a motion to dismiss the case in its entirety, and preemption was one of the grounds. The plaintiffs ultimately evaded preemption because the court found no FDA requirement regarding the tooth whitening claim, so there was nothing federal that the state laws against deceptive advertising  contradicted.

Okay, you’re still probably wondering why a drug defense hack would care about this case.  If an associate failed to find this case in her research, who cares?

There are two preemption points in Canale that are valuable:

1. The plaintiffs’ opposition to the defendant’s motion rested solely on implied preemption cases.  That is, the plaintiffs argued that there was no impossibility preemption.  That is, the plaintiffs had completely missed the point.  The defendant was not arguing impossibility preemption.  Rather, the defendant argued that Congress had expressly manifested an intent to preempt state law.  The plaintiffs had confused express preemption with implied preemption, but the Canale court kept the distinction straight.  So should you.

2.  The plaintiffs, predictably, argued that there was a presumption against preemption.  But, consistent with point 1 above, the Canale court held that “where, as here, Congress has expressly manifested its intent to preempt state law, no presumption against preemption arises.”  It is nice to have in your pocket such a clear statement on this issue from SDNY.

Still, as we mentioned, the preemption argument did not carry the day for the defendant.  So was this a win for the plaintiffs?  Not at all.  The issue of whether or not the advertising for the whitening toothpaste was deceptive had already been addressed to the Federal Trade Commission.  The issue was pending. The FTC had at least as much expertise as the court in deciding whether the hydrogen peroxide in the toothpaste had sufficient whitening power (let’s face it, the FTC has more expertise), the FTC is specifically tasked with discretion to police allegedly deceptive labeling, there was a risk of inconsistent rulings, and the FTC had gotten the issue first.  Consequently, the Canale court – after observing that “primary jurisdiction” is something of a misnomer because it isn’t , strictly speaking, jurisdictional – decided to stay the litigation to allow the FTC to do its job and determine whether the toothpaste advertising really was deceptive.

Staying a class action is definitely a good result for the defendant.  Despite the setback on the preemption front, we bet the Canale result put smiles on the faces of the defendant and its lawyers – nice, big, shiny smiles.