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We have often characterized preemption as one of the most powerful tools in product liability defense lawyers’ toolboxes.  It also gets utilized effectively by lawyers defending against a variety of consumer fraud cases about FDA-regulated products.  We have, for instance, covered a number of decisions where plaintiffs complained about a range of food labeling issues that are often quite trivial, like how much air is in a bag of chips or whether a food labeled “organic” meets the plaintiff’s personal standards.  We also have talked about nutritional supplements, which occupy part of the regulatory space between food and drugs.  In 1994, the FDCA was amended by the Dietary Supplement Health and Education Act and carved out requirements for, you guessed it, dietary supplements.  What is a dietary supplement is defined pretty broadly, but it does not include any substance regulated as a drug.

Vitamins are an obvious example of dietary supplements and the case discussed here involved Vitamin E.  Enzymes are also supplements.  If you have insufficient resources of the enzyme lactase to help you digest the dairy you ingest, then you will probably know it, as may those around you.  Well, there is a supplement for that.  Some people with lactose intolerance—that is, people who do not make enough lactase to handle lactose, the sugar found in dairy—consume goodly amounts of the supplement rather than eschew a gooey slice of real cheese pizza.  We can pause to appreciate why complete avoidance of lactose-rich cheese may not be a realistic option for everyone.  And there is an ice cream cone on a hot day, with melt floes that require lingual dexterity, social mores be damned.  If we are done with that bit of dairy decadence, we can turn to DiCroce v. McNeil Nutritionals, LLC, No. 22-1910, — F.4th –, 2023 WL 6056144 (1st Cir. Sept. 18, 2023).  The plaintiff brought a consumer protection suit on behalf of a putative class of Massachusetts purchasers of a well-known enzymatic supplement who were allegedly deceived by its labeling.  Well, it was about the labeling only in a roundabout way.  It was more of a stop selling theory, but not tied to purported risks or lack of efficacy.  We can explain.

Fundamentally, the plaintiff claimed that lactose intolerance is a disease, the enzymatic product treats this disease, and it should really be regulated as a drug instead of a supplement.  Id. at *1.  The labeling claims flow from that.  We suppose a citizen’s petition to FDA would be a way to challenge its regulatory approach, but a consumer protection surely was not.  The district court dismissed the case because the plaintiff had failed to plead the elements of the state law with sufficient facts to state a claim.  Id. at *2.  On appeal, the First Circuit affirmed on a more fundamental issue:  implied preemption of a state law claim predicated entirely on a purported violation of the FDCA.  As we have said many times over the years, only the FDA can enforce violations of the FDCA, which provided no private right of action.  Id. at *3.  As such, “§337(a) [of the FDCA] preempts any state-law claim that exists ‘solely by virtue’ of an FDCA infraction.”  Id. at *4 (citation omitted).  By contrast, conduct that would violate the FDCA and the Massachusetts consumer protection law “if the FDCA did not exist” is not preempted.  Id. (citation omitted).

Plaintiff complained that the supplement’s labeling mislead consumers by “disclaiming [FDA] approval, thereby implying that FDA approval is not required,” which it would have been had the product been regulated as a drug.  Id. at *1.  While simultaneously circular and tenuous, this theory of liability clearly hinges on the hinges on the exist of the FDCA’s regulatory schemes for drugs and supplements.  Without the FDCA, there could be no misleading statement about the lack of FDA approval.  Of course, the supplement label’s statement about the lack of FDA approval was “literally true,” using the redundant language of plaintiff’s complaint.  Id.  Plaintiff “does not contend that [the supplement] did not perform as promised, nor does she provide any basis, independent of federal labeling laws, from which we could conclude that a consumer would be misled by [the supplement’s] label.”  Id.  So, the dismissal was affirmed on the alternate ground that any claim, even if pleaded with sufficient factual support, would be preempted.

Is this decision a victory for the stomachs of lactose intolerant individuals?  Yes.  Will this help deter plaintiff lawyers from bringing lawsuits predicated on the labeling of FDA-regulated products allegedly needing to say things that FDA would not have allowed or on an alternate reality where the FDCA requires different things?  Probably not.  There will still be plenty of lawyers willing to bring such cases, particularly where consumer protection remedies and class action procedures provide the lure of big dollars.