Amado v. The Procter & Gamble Co.

Background

The Procter & Gamble Co. sold several Metamucil products, including unflavored and orange-flavored psyllium-fiber powders containing added sugar. The product labels stated that fiber helped support appetite control, heart health by lowering cholesterol, healthy blood sugar levels, and digestive health. The plaintiffs did not base their claims on the heart-health representation.

Tara Amado and Regina Pellegrino alleged that they purchased the products seeking benefits related to healthy blood sugar levels, appetite control, and digestive health. They claimed that the products’ statements were false or misleading because the added sugar allegedly decreased appetite control, harmed blood sugar levels, and damaged digestive health. They also alleged that the labels omitted material information about sugar’s effects and failed to warn about the risks of sugar consumption.

The plaintiffs asserted ten causes of action under California and New York consumer-protection and advertising statutes, warranty theories, unjust enrichment, and negligent and intentional misrepresentation. They sought relief on their own behalf and for a proposed nationwide class and California and New York subclasses.

Rule 12(b)(6) standard

The court applied Rule 12(b)(6), which allows dismissal when a complaint lacks a legally recognized theory or does not allege enough facts to make relief plausible. The court generally must accept material factual allegations as true and view them favorably to the nonmoving party, but it need not accept legal conclusions presented as facts.

Federal preemption

The Procter & Gamble Co. argued that the federal Food, Drug, and Cosmetic Act, as amended by the Nutrition Labeling and Education Act and the Dietary Supplement Health and Education Act, expressly preempted the plaintiffs’ state-law claims. Federal preemption means that federal law overrides certain state-law requirements.

The court explained that federal law recognizes disease claims and structure/function claims for dietary supplements. Structure/function claims describe the general role of a nutrient or ingredient in maintaining the body’s structure or function. They must be truthful and substantiated, include the required disclaimer, and not claim to diagnose, mitigate, treat, cure, or prevent disease.

The court held that the front-label and back-label statements were sufficiently narrow to qualify as structure/function claims about fiber, rather than promises about the products as a whole. The statements used language such as “helps support” and were presented in a context referring to fiber or psyllium husk fiber. The court was not persuaded that the separate “Made with Real Sugar” statement changed that interpretation.

The court also rejected the plaintiffs’ argument that the products were marketed as laxatives or contained implied disease claims. It relied on the Food and Drug Administration’s treatment of “regularity” and occasional-constipation statements as acceptable structure/function claims and deferred to that interpretation.

The court found that the labels contained the required disclaimer and concluded that the claimed fiber benefits were substantiated, noting that they were essentially the same benefits listed on a Centers for Disease Control and Prevention webpage. It therefore held that the plaintiffs’ causes of action, to the extent based on the front-label and back-label statements, were subject to dismissal as preempted.

The court likewise held that the omission and failure-to-warn theories were preempted. The plaintiffs sought to impose labeling requirements concerning the negative effects of sugar that federal law did not impose. The court noted that the labels disclosed the amount of sugar and concluded that federal law did not require the additional warnings the plaintiffs sought.

Failure to plead falsity or deception

The court separately considered whether the plaintiffs adequately alleged that the statements were false or misleading. It found that the scientific studies cited by the plaintiffs generally concerned sugar-sweetened beverages, high-sugar diets, or populations and circumstances different from those alleged in this case. The studies did not sufficiently address the effect of the amount of added sugar in the challenged fiber supplements.

The court found a mismatch between the challenged representations and the evidence offered to disprove them. It therefore concluded that the plaintiffs had not adequately pleaded that the front-label and back-label statements were false or misleading.

The court also rejected the plaintiffs’ alternative theory under the “unfair” prong of California’s Unfair Competition Law. One theory overlapped with the plaintiffs’ unsuccessful fraudulent and unlawful theories. The other alleged that the sugar-containing products were marketed identically to sugar-free Metamucil products, but the court found no label representation comparing the products and no facts plausibly establishing falsity.

The court dismissed theories based on the side-label statement, “#1 Doctor Recommended,” because the plaintiffs had not adequately pleaded the falsity of the statements that it allegedly reinforced. To the extent the statement was challenged independently, the plaintiffs also alleged no facts plausibly establishing that it was false.

The court further explained that the unjust-enrichment claim was based on the same conduct as the other claims and could not stand independently if those underlying claims failed.

Disposition

Judge Maxine Chesney granted the defendant’s motion to dismiss. The court afforded the plaintiffs leave to amend and required any Third Amended Complaint to be filed by June 30, 2023. The plaintiffs could not add new defendants or new claims without first obtaining leave of court.