A recent published opinion from the Ninth Circuit covers two issues near and dear to our hearts—federal preemption and claims based on outside laboratory testing. We care about federal preemption because . . . well, because we are the Drug and Device Law Blog, where there are some weeks when we write on preemption every day. Litigation-driven testing by “independent” laboratories has come into its own more recently, although it is by no means new. Our most recent posts (here and here) on the topic lament how “independent” labs purport to detect contaminants in products, sometimes by subjecting the products to totally unrealistic conditions and otherwise non-validated methods.
In Hollins v. Walmart Inc., 67 F.4th 1011 (9th Cir. 2023), the plaintiffs relied on an outside lab to claim that the defendant’s product was not what it purported to be. The Ninth Circuit, however, dismantled the plaintiffs’ testing (which was by no means “independent”) and held that federal law preempted their claims. The plaintiffs in Hollins alleged that the defendant’s Glucosamine Sulfate (which some use for osteoarthritis) violated California’s consumer protection laws because the product was mislabeled. To be more specific, the plaintiffs claimed that their lab’s testing showed that the defendant’s product contained glucosamine hydrochloride, not glucosamine sulfate or glucosamine sulfate potassium chloride. Id. at 1013. These chemical names are difficult to keep straight, but don’t worry. The gist is that the plaintiffs alleged a blended version of the product (like the defendant’s product) cannot be labeled “glucosamine sulfate.”
The plaintiffs were wrong, and the district court and the Ninth Circuit both ruled that federal regulation of dietary supplements preempted their state-law claims. How did the courts get there? The starting point is the federal Food Drug & Cosmetics Act, which expressly preempts any state-law requirement for the labeling of food that is not identical to federal requirements. Id. at 1016. A private plaintiff therefore can bring state-law claims only if the state law imposes requirements that are identical to those contained in the FDCA. Id.
That was the plaintiffs’ hook in Hollins. They argued that they were seeking to enforce state-law requirements that were identical to federal requirements—namely, that a food is misbranded (1) if it is offered for sale under the name of another food or (2) if its label does not bear the FDA-required nutritional information. Id. at 1014 (citing 21 U.S.C. §§ 343(b), 343(q)). We understand those rules. Rockfish should not be held out as red snapper, and maple-flavored corn syrup should not be called maple syrup.
The problem with the plaintiffs’ glucosamine claims was that FDA regulations clearly allowed the defendant to label its product “glucosamine sulfate.” The FDA has promulgated regulations governing the labeling for dietary supplements; and for many ingredients, the FDA has established specific reference values. However, where the FDA has not established reference values, such dietary ingredients “shall be declared by their common or usual name.” Id. at 1014-15.
This next part is really important. An ingredient’s “common or usual name” is determined by specified testing protocols: “Official Methods of Analysis” of the AOAC International or, if no AOAC method is available, “by other reliable and appropriate analytical procedures.” Id. at 1015. Finally, alternate testing methods must be validated—often known as “compendial test methods.” Id.
Why is this so important? Because the plaintiffs’ outside lab followed none of these rules. The lab analyzed the defendant’s product and reported that it was a blend of glucosamine hydrochloride and potassium sulfate, which the plaintiffs (wrongly) claimed could not be labeled “glucosamine sulfate.” The lab, however, did not use a validated scientific method. The plaintiffs’ expert admitted that he did not publish his testing methods, that he did not submit them for peer review, and that he did not document them in a standard operating procedure. Id. at 1018. He therefore agreed, as he evidently had to, that his methods were neither validated nor accepted by the FDA for glucosamine-related dietary supplements. Id.
And, to put a final nail in the coffin, the expert agreed that a blended product (like the defendant’s product) would satisfy accepted compendial testing methods for glucosamine sulfate potassium chloride—which was the ultimate issue in the case. Id. at 1019. “Glucosamine sulfate” is therefore the “common or usual name” for the defendant’s blended product, and the defendant complied with federal law when it labeled its product as it did.
The Ninth Circuit therefore found the plaintiff’s claims preempted. Federal law allowed the defendant to call its product glucosamine sulfate. Thus, the plaintiffs’ claim that the product was mislabeled sought to impose a different state-law labeling requirement, and federal law preempts any requirement that is not identical to federal requirements. Id. at 1022. This is a good example of a dietary supplement manufacturer doing what it was supposed to do, and no amount of rogue science could undo it.