United States: Protein Shake Preemption

Of all the products regulated by the FDA, drugs and medical devices receive the most erratic preemption protection. Thank you, Levine, Lohr, and gibberings about CBEs, clear evidence, and parallel claims. Perhaps it is bad form to accuse SCOTUS of incoherence, but we wouldn't be the first. (Try reading the SCOTUS doctrinal wanderings through obscenity law or jury unanimity requirements and then try to convince yourself that the "least dangerous branch" is not really the least consistent branch.) Anyway, for drugs preemption is least robust for the products that probably most need it, and for medical devices it is often hard to set out the rule for preemption, except that it can be really, really complicated.

By contrast, preemption for ready-to-drink protein shakes is pretty, pretty clear, and pretty, pretty strong. In Rubio v. Orgain, Inc., 2019 U.S. Dist. LEXIS 65214 (C.D. Cal. March 5, 2019), the plaintiffs sued a manufacturer of protein shakes because the advertising said the drinks contained 16 grams of protein while the plaintiffs' own testing showed only 13.33-14.98 grams of protein. It is not a huge drop in the amount of protein, and it did not deprive the plaintiffs – classes of California and New York purchasers – of the strength to file a muscular complaint alleging violations of California's False Advertising, Consumer Remedies, and Unfair Competition Laws, violations of various New York Business Laws, violation of the Magnuson-Moss Warranty Act, as well as unjust enrichment, negligent misrepresentation, and fraud. The defendant argued that all these claims were preempted by the Food, Drug and Cosmetic Act ("FDCA") because the testing the plaintiffs used to determine the amount of protein in the shakes did not comply with the testing methods established by the FDA, and therefore the plaintiffs sought to impose obligations at odds with those set forth by the FDA. The Central District of California court agreed with the defendant and poured all the claims out of court.

Under the FDCA, states are prohibited from imposing "any requirement for the labeling of food that is not identical to the federal requirements." Right away we see a standard much more defense-friendly than what we see with drugs. Further, there are specific federal regulations not only requiring that the "declaration of nutrition information on the label" include "the number of grams of protein in a serving, expressed to the nearest gram," but also setting forth the specific testing methodology to count the protein content. And we do mean specific: the "sample for nutrient analysis shall consist of a composite of 12 subsamples (consumer units), taken 1 from each of 12 different randomly chosen shipping cases, to be representative of a lot," etc.

The plaintiffs in Rubio helpfully attached several certificates of analyses to their complaint in an effort to support their allegation of false labeling. The plaintiffs did not dispute that the testing method they utilized was not compliant with the FDA's methodology. Instead, the plaintiffs argued that the FDA's sampling method regulations applied only to FDA enforcement actions, not actions brought by consumers. That is a clever argument. It is also completely at odds with Ninth Circuit precedent that the sampling regulation "is not just an internal guidance, it is an interpretation of the statutory provision requiring that manufacturers disclose a product's protein content, a concept that requires federal agent clarification if there is to be national uniformity in labeling." Durnford v. MusclePharm Corp., 907 F.3d 595, 602 (9th Cir. 2018). Did that inconvenient controlling appellate authority dissuade the plaintiffs? It did not. Rather, the plaintiffs urged the district court to disregard the Durnford case as "wrongly decided" and to follow contrary holdings by other California federal courts. Now, we have occasionally believed that the Ninth Circuit has gotten things wrong and said so. SCOTUS has occasionally believed that the Ninth Circuit has gotten things wrong, and has reversed it. But good luck trying to get a district court within the Ninth Circuit to depart from Ninth Circuit authority.

Remember how we said the plaintiffs "helpfully" attached certificates of analysis of shakes' protein content? Well, they helped themselves straight into preemption and dismissal. Nothing in the certificates suggested that the 12-sample method required by FDA regulations was employed. The Rubio court dismissed the complaint, and it was not really, really complicated — it was pretty, pretty easy.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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