Conspicuous Disclaimers on Dietary Supplement's Label Lead to Dismissal of Lawsuit

In Dicroce v. McNeil Nutritionals, LLC, No. 21-11660, 2022 WL 16847696 (D. Mass. Nov. 10, 2022), a consumer brought a putative class action lawsuit under the Massachusetts laws prohibiting deceptive trade practices and false advertising against a manufacturer of a product called LACTAID®, marketed as a dietary supplement to assist with digestion of dairy products. The consumer alleged that despite advertising the product as a dietary supplement and not a drug, the manufacturer claimed on the product's labels that it was effective to treat a disease in violation of the Food, Drug and Cosmetic Act and U.S. Food & Drug Administration (FDA) regulations.

Specifically, the plaintiff took issue with the following statements for LACTAID®'s Fast Act Chewables, Fast Act Caplets and Original Strength Caplets:

• "For the Prevention of Gas • Bloating • Diarrhea associated with digesting dairy."
• "Enjoy Dairy Again!"
• By taking LACTAID®, "nothing can stop you from eating the foods you love. Our delicious vanilla chewables should be taken with your first bite of dairy, so that milk doesn't mess with you."
• "Don't let that annoying lactose get in the way of eating. LACTAID® Fast Act Caplets make dairy easier to digest so you can enjoy your favorite foods anytime, anywhere."
• "Experience the Total Joy of Dairy."
• "It's easier than ever to manage your lactose intolerance. Take up to three caplets with your first sip or bite of dairy to ensure that milk doesn't mess with you. LACTAID® Original Strength Caplets lets you enjoy dairy anytime, anywhere."

The consumer alleged that this labeling claims "to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases," 21 U.S.C. Section 343(r)(6), and is misleading because it "omits facts that are material either 'in light of other representations made or suggested' or 'with respect to consequences which may result from use of the article under (i) [t]he conditions prescribed in such labelling or (ii) such conditions of use as are customary or usual.'" 21 C.F.R. Section 1.21(a). Consequently, the plaintiff claimed to have paid at least 11 cents per dietary supplement pill more than she would have paid for alternative products because of the supplement's claim that it was effective to treat a disease.

Not Deceptive

The court was not impressed. It ruled that no reasonable consumer could find deceptive the product labels for the dietary supplement, nor did the consumer identify any misrepresentation of fact. Each label plainly stated that the supplement was not a drug and was not intended to treat any disease, with disclaimers conspicuously located on the front and back of each box. After describing LACTAID® as preventing gas, bloating and diarrhea associated with digesting dairy, the labels add, "THIS STATEMENT HAS NOT BEEN EVALUATED BY THE FOOD & DRUG ADMINISTRATION." In addition, the labels caution that "THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE." The packages also proclaim that LACTAID® "is a dietary supplement, NOT A DRUG…."

The plaintiff alternatively argued that the labels misled her because they falsely imply that LACTAID®'s packaging does not require FDA evaluation, but the court ruled that the allegation does not accord with the language of the disclaimers, which says only that statements about LACTAID® have not been evaluated by the FDA. The court added that whether LACTAID®'s label statements require FDA evaluation would not influence a reasonable consumer's purchasing decision where the product's label discloses that they are not FDA-approved. The court dismissed the complaint with prejudice.

Courts routinely conclude that the presence of a disclaimer, considered in context, precludes the finding that a reasonable consumer would be deceived by the defendant's conduct. Especially when conspicuously located on both sides of a box and bolded, disclaimers prevent liability. Please let us know if we can be helpful as you consider product labeling, promotion or menu design in the interest of minimizing potential liability.