Photo of Rachel B. Weil

We start with the usual poodle report – actually with a comment that these may be drawing to a close, as Luca is only a few points from finishing his championship and coming home.  We suspect this will cause little grief for readers of this blog (the Drug and Device Law Rock Climber and other family members and close friends long ago reached their “Luca talk” saturation point), but we have appreciated this outlet for our excitement about this unexpected adventure and our pride in our beautiful baby boy. 

We will celebrate Luca’s final victories as we did his last, with an order from the new takeout cookie bakery that has appeared in our neighborhood shopping center.  And this bakery provides our typical rickety bridge to today’s case.  We read the nutritional information for the warm peanut butter cookie (roughly the size of a hubcap) studded with chunks of peanut butter cups – 180 calories per serving!  Not bad, right?  But readers of this Blog, and the author of this post, are smart enough to know that the line below the calorie count is the most important:  four servings per cookie.  Today’s case is about a butter substitute spray, not about cookies.  But the plaintiffs/appellants disclaimed the intelligence to understand the relationship between serving size and calorie count and asked the court to require the spray’s manufacturer to slather on far more label information than the FDA required.  The claims were preempted, of course.  But we get ahead of ourselves.

Pardini v. Unilever United States, Inc., — F.4th —, 2023 WL 2980312 (9th Cir. Apr. 18, 2023), is a to-be-published appeal of the Northern District of California’s grant of the defendant/appellee’s Rule 12(b)(6) motion to dismiss.  The plaintiffs were consumers of the defendant’s product, a “butter-flavored vegetable oil” dispensed with “pump action squirt bottles” with a “spray mechanism.”  Pardini, — F.4th —, 2023 WL 2980312 at *2.  As the court explained, the nutrition panel on the back of the spray bottle lists one serving size for use of the product as a “cooking spray” (1 spray = 0.20 g.) and a second for use of the product as a “topping” (5 sprays = 1 g.).  Both serving sizes are listed as having no calories and zero grams of fat.  The plaintiffs alleged that the entire bottle of the butter substitute spray contains 1160 calories and 124 grams of fat and claimed that, “because the [listed] serving sizes [were] “artificially small,” the product did not really have “0 calories” or “zero grams of fat” per serving.  They alleged that the product’s nutrient content claims were “misleading because they [were] based on unrepresentative serving sizes.”  Id. at *2-3.  They argued that, for purposes of identifying the appropriate serving sizes for the nutritional information, the product should be classified in the “same product category as butter itself with a required serving size of one tablespoon, rather than as a ‘spray type’ fat or oil.”  Id. at *3 (internal punctuation omitted).  Obviously, in that case, neither the calorie count nor the fat gram total for a tablespoon of the vegetable oil product would be “zero.” 

In the trial court, the plaintiffs “allege[d] that consumers [had] expressed confusion and frustration upon learning that larger servings of the product contain[ed] non-negligible amounts of calories and fat,” and that they would not have purchased the product, or would have paid less for it (one can only wonder how any consumer would have “paid less,” since the store price is what it is), if they had “known the true nature” of the product.” Id.  They sought to certify a nationwide class of consumers.  The court dismissed the claims as preempted by the FDCA, and the plaintiffs appealed.

The Ninth Circuit began its decision by commenting:

Over 125 years ago, the Supreme Court decided whether a tomato is a fruit or a vegetable (the answer:  a vegetable).  In a more modern iteration of this legal genre, we today decide, in effect, whether the [appellee’s product] is a butter or a spray.  The question turns out to matter because the plaintiff consumers contend that the product’s label makes misrepresentations about the fat and calorie content based on artificially low serving sizes.

Id. at *1.  The court went on to explain that a “vast regulatory scheme” governs food labeling, and that the FDCA expressly preempts “causes of action [that] would directly or indirectly impose nutrition label requirements different than those prescribed by federal law.”  Id. at *3 (citation to Riegel omitted).  Under the relevant regulations, if a product has less than five calories per serving, the calorie content may be expressed as zero calories per serving.  Likewise fat content of less than five grams per serving.  Because, obviously, “the larger the serving of a food product, the more calories and fat are ingested,” id. at *4, determination of the appropriate “serving size” is the tipping point of the analysis. 

“Under FDA regulations,” as the Ninth Circuit explained, “the term serving or serving size means an amount of food customarily consumed per eating occasion by persons 4 years of age or older which is expressed in a common household measure that is appropriate to the food.”  Id. (internal punctuation and citations omitted).  Serving size is identified using national consumption data with reference to “the major intended use of the food; for example, milk as a beverage and not as an addition to cereal.”  Id. (internal punctuation and citations omitted). 

Within the category “fats and oils,” there are two pertinent categories:  “butter, margarine, oil, shortening” (serving size one tablespoon) and “spray types” (serving size expressed in fractions of a gram and duration of spray, in seconds).  So the key to deciding whether the labeling for the defendant’s product correctly identified reference serving size is the determination of whether the product is in the former or the latter category (as the Ninth Circuit said at the beginning of the opinion); in other words, whether the “should be classified as a butter/oil or a spray.”  Id. at *5. 

The court held, “As a matter of legal classification, it is a spray.”  Id.  The court explained that federal regulations are interpreted based on their plain language.   It emphasized,

There is no well-pleaded allegation in the complaint that, in form and function, [the product] is anything other than a spray.  Images in the complaint and record indicate that the product comes in a spray bottle, with a finger-activated pump at the top.   Plaintiffs at one point in their operative complaint themselves reference the product’s ‘spray mechanism.’  They similarly describe the product as on that is ‘dispensed in pump-action squirt bottles.  These allegation support [the manufacturer’s] characterization of [the product] as a spray, based on the properties of the product and the liquefied form in which it is indisputably applied.

Id. at *6.  In other words, if it looks like a spray, it comes in a spray bottle, and you spray it to dispense it, it is a “spray” for purposes of the regulation.  Moreover, the court commented, it would be implausible to conclude that the product could be classified as “butter, margarine, oil [or] shortening,” for which the reference serving size is one tablespoon – it would take 40 sprays to equal a tablespoon, and that is “not how such a product is typically used.”  Id.  So the label complied with federal law because the manufacturer properly categorized the product as a “spray type” of fat and used the reference serving size for that category.  Moreover, the regulations did not prohibit the manufacturer from including the “five sprays” alternative serving size, for which the calories and fat grams were also zero. 

The plaintiffs next argued that the label was misleading because people do not typically use only one spray of the product, and “serving sizes must reflect customary usage.”  Id. at *7.  According to the plaintiffs, this created an issue of fact because the manufacturer was required to “determine how their customers consume food products” in creating their labels.  Id.  The court didn’t bite, dismissing this argument as “backwards,” stating, “In a lawsuit such as this, whether the serving size listed on the nutritional label is lawful is not a factual question about consumer behavior, but rather a legal question that turns on whether the manufacturer identified the proper product category and complied with the applicable product category regulations.”  Id. 

The court concluded,

Because plaintiffs’ challenge to the [product’s] serving sizes would “directly or indirectly establish a requirement for food labeling that is not identical to federal requirements, the FDCA preempts their serving size claims.  It follows that plaintiffs’ claims about fat and calorie content are preempted as well. . . .  [I]f plaintiffs . . . believe that the FDA should not allow products to be labeled as containing zero fat or calories when a given serving size may contain some of each, they may raise the issue with the agency.  This argument cannot overcome the FDCA’s express preemption provision.

Id. at *8.  Dismissal affirmed. 

We had a lot of fun reading and reporting this case (we rolled our eyes a lot), and we agree wholeheartedly with the Ninth Circuit’s decision.  On to the weekend and its dog shows.  In your leisure, raise a fourth of a cookie to our almost-champion puppy, and stay safe out there.