Photo of Steven Boranian

The recent Thanksgiving weekend and the hearty meals that exemplify that great American holiday give us a segue to a post on food. Specifically we write today on another interesting and useful case from a federal court in California on the FDA’s primary jurisdiction over product labeling.

The food product at issue in Watkins v. Vital Pharmaceuticals, Inc., No. CV 12-09374, 2013 U.S. Dist. LEXIS 162495 (C.D. Cal. Nov. 7, 2013), was a “high protein meal replacement bar.” We admit that we did a double take after reading that moniker. We are familiar with granola bars, energy bars, fruit bars, protein bars, fiber bars, nut bars, and candy bars. But we had never seen a bar held out as a “meal replacement.” Maybe a meal replacement bar resembles the three-course meal gum famously consumed by the precocious Violet Beauregard in Willy Wonka & the Chocolate Factory (the 1971 Gene Wilder version).

As entertaining as that would be, a meal replacement bar more likely resembles the many other kinds of bars that consumers embrace as portable nutrition, including the chocolate oat bars that we sometimes place in our coat pockets as leave for work in the morning, i.e., to “replace” breakfast.  The high protein meal replacement bar at issue in Watkins was part of a line of sports nutrition products called “ZERO IMPACT,” and the plaintiff claimed on behalf of himself and a proposed class of bar purchasers that the “ZERO IMPACT” label was misleading.  According to the plaintiff, the bars “certainly have an impact on consumers’ carbohydrate, sugar and overall caloric intake,” and to claim otherwise is misleading.  Id. at *3.  How did the plaintiff know that eating the bars “certainly” had an impact on his carbohydrate, sugar, and caloric intake?  Well, the product was food, with the intended purpose of placing it in his mouth, chewing it, and swallowing it for the purpose of sustaining his life.

But even if we grant that consumers sometimes make counterintuitive assumptions, the plaintiff knew that the bar contained carbohydrates, sugar, and calories also because the label said so.  All the labels included the FDA-required Nutrition Facts (Id. at *2), and to provide an example, the Pumpkin Supreme Zero Impact Bar has 35 grams of total carbohydrates, 11 grams of sugar, and 415 calories.  The labeling also included a “marketing statement” that “the low Dextrose Equivalent sugars contained in the Bars ‘have significantly less impact on blood sugar and glycemic index than most whole grain carbohydrates.’”  Id. at **2-3.  So there you have it:  The label expressly disclosed an “impact.”  An impact “less” than others, but an impact nonetheless.

On these facts, the district court dismissed the plaintiff’s class action claims under California’s Unfair Competition Law and Consumer Legal Remedies Act because Congress has granted regulatory authority over false and misleading food labeling to the FDA.  Id. at **5-14.  The FDA connection is why we write on these food cases, as it seems that the FDA’s primary jurisdiction ought to extend to drug labeling as well. As the district court put it in Watkins,

“Primary jurisdiction ‘is a doctrine specifically applicable to claims properly cognizable in court that contain some issue within the special competence of an administrative agency.’”

Id. at **5-6.

The special competence of the FDA in its regulation of drug and medical device labeling calls to mind the conundrum created when drug and medical device labeling is regulated through civil litigation:  When the FDA determines what drug labeling should and should not say, it applies its expertise to a balanced view of the product’s risks and benefits. When regulating that same labeling through civil litigation, the jury sees only the one plaintiff who has experienced an alleged injury.  It is a skewed and incomplete depiction of the product’s true risk profile and, by extension, the adequacy of the labeling that accompanies it.

We therefore see it as a positive trend that the FDA’s primary jurisdiction has taken hold in litigation involving allegedly misleading food labeling. Citing the Ninth Circuit’s opinion in Pom Wonderful LLC v. Coca-Cola Co., 679 F.3d 1170 (9th Cir. 2012) (on which we have written here, here, and here), the district court in Watkins observed that the Ninth Circuit had declined to rule on whether food labeling was misleading because the “it was within the FDA’s authority to regulate food labels for misleading information” and taking jurisdiction over the case “would risk undercutting the FDA’s expert judgments and authority.”  Id. at *9.  A key part of the Ninth Circuit’s reasoning in Pom Wonderful was that the FDA had not addressed the precise labeling issue presented.  As a result, the Ninth Circuit was deferring not to an agency decision already made, but rather to an agency’s prerogative to take have the first say over issues within its regulatory bailiwick.  Id.

That made the difference in Watkins, where the district court ruled that:
Following the Ninth Circuit’s deference to the FDA in Pom Wonderful, courts have found it inappropriate to “decide an issue committed to the FDA’s expertise without a clear indication of how the FDA would view the issue.”  A recurring example of such a situation is “where the FDA has yet to speak on whether a particular label of claim on a consumer product is unlawful or misleading.”

Id. at **9-10 (citations omitted).

As it turns out, the FDA had yet to consider whether the claim “ZERO IMPACT” could be misleading about a product’s nutritional content.
There is no FDA rule on how “ZERO IMPACT,” or even the word “impact” alone, can or should be used.

Id. at **11-12.

There are rules on “zero calorie,” “zero sodium,” and “zero fat,” but the district court found no useful analogy from those rules to the treatment of “ZERO IMPACT.” The court thus held that

“[w]ithout guidance about the context in which the FDA would find the claim ‘ZERO IMPACT’ to be permissible, any determination on whether the term is misleading risks ‘undermining through private litigation, the FDA’s considered judgments.

Id. at **11-12.

We will repeat part of the last sentence because we believe
it encapsulates an important point:

“[A]ny determination on whether the term is misleading risks ‘undermining through private litigation, the FDA’s considered judgment.”


We have that thought when we are defending against prescription drug cases alleging inadequate warnings, which uniformly second guess prescribing information with the FDA’s stamp of approval, often after considerable and lengthy consideration.

We understand that the doctrine of primary jurisdiction rarely applies in drug and medical device cases, but we think the doctrine’s application in food cases highlights the incongruence of regulating drug warnings simultaneously through FDA regulation on the one hand and through civil litigation on the other.  As we have written before (and here we are referring mainly to Bexis), there must be a better way.

Having found that the FDA had primary jurisdiction, the district court in Watkins could have either stayed the action or dismissed it outright.

The district court chose the latter, without prejudice, reasoning that the plaintiff had abundant time to re-file his case if the FDA were to provide guidance on the use of the “ZERO IMPACT” claim. It could be that the facts of the case made it easier for the district court to enter a dismissal rather than a stay, as it seems to us that this is an action that should not have been filed in the first place.