Health Law Daily Wrap Up, LABELING AND PACKAGING (FOOD, DRUGS & MEDICAL DEVICES)—N.D. Ill: Court dismisses false advertising action involving allegedly ineffective wellness shots, (Sep 10, 2026)

By Sara Cracau, J.D.

The court dismissed the proposed class action for failure to state a claim for consumer deception involving the dietary supplements.

A federal district court in Illinois has granted the motion to dismiss of a dietary supplement manufacturer in a deceptive advertising class action involving immunity boosters, finding that the complaint failed to state a claim. The court found that because the complaint did not show that the “Immunity Boost” claim on the product’s label met the requirement to trigger preemption, the manufacturer did not show that the immunity assertion was protected by the federal Nutrition Labeling and Education Act of 1990 (Labeling Act) and, that, therefore, the consumer’s state law claims were not preempted. However, the court found that the consumer failed to plausibly allege the first element of a claim under the Illinois Consumer Fraud and Deceptive Business Practices Act (Fraud Act) and, that, therefore, he failed to state a falsity claim. Because the court dismissed the consumer deception claims and the claims for breach of express warranty and for unjust enrichment are based on the consumer deception claims, the court dismissed those also. The court granted the consumer leave to amend (Freifeld v. Vive Organic, Inc., No. 1:25-CV-09541 (N.D. Ill. Sept. 4, 2026)).

Background. A consumer filed a putative class action against Vive Organic, Inc., a dietary supplement maker, alleging that the wellness shots he purchased did not provide an immunity boost as advertised. He alleged that he relied on the “Immunity Boost” claim on the label when he purchased the wellness shots and that he paid a higher price than he would have otherwise paid if the shots were not advertised as providing an “Immunity Boost.” He claimed that, in fact, he would not have purchased them at all. He also alleged that the wellness shots cannot actually boost a person’s immunity based on the conclusion of a Harvard Health Publishing report that described the unproven nature of immunity-boosting claims. In the action, he asserted claims of false and deceptive advertising in violation of the Fraud Act and similar consumer-fraud statutes in other states, and claims for breach of express warranty and unjust enrichment in violation of each state’s laws. The manufacturer moved to dismiss, arguing that the claims were preempted by federal law and that the complaint failed to adequately allege the claims.

Preemption. The court found that because the complaint did not show that the “Immunity Boost” claim met the requirement to trigger preemption, the manufacturer did not show that the immunity assertion was protected by the Labeling Act and, that, therefore, the consumer’s state law claims were not preempted. The parties agreed that the wellness shots were dietary supplements and, as such, they were covered by the Labeling Act. The court focused on the question of whether the “Immunity Boost” claim met three statutory elements and was, therefore, permitted under the Labeling Act. If it was, then any state law that prohibited the claim would impose a nonidentical requirement from the federal law and would be preempted. For the manufacturer to prevail, it would have to show the “Immunity Boost” claim complies with the three elements of Section 343(r)(6) of the Labeling Act.

The analysis centered on the first element, the so-called “structure/function” claims which described the role of a nutrient or dietary ingredient as intended to affect the structure or function in humans or characterized the documented mechanism by which such an ingredient acts to maintain the structure or function. The Labeling Act prohibits disease claims which purport to diagnose, mitigate, treat, or prevent a special disease or a class of diseases. The manufacturer argued that “Immunity Boost” was a structure/function claim as it was akin to claiming that the wellness shots strengthen or support the immune system and the FDA endorsed this provided that the label does not refer to any disease. Regardless, the court found, even if the complaint did not support the first requirement for preemption, the consumer did not plead himself out of court because no allegation addressed the second requirement for preemption. Specifically, the consumer did not allege that the manufacturer has substantiation that the “Immunity Boost” claim was “truthful and not misleading.” Because the complaint did not show that the “Immunity Boost” claim met this requirement to trigger preemption, Vive Organic had not shown that the immunity assertion is protected by the Labeling Act. The state law claims were thus not preempted.

Failure to state a claim. Next, however, the court found that the consumer failed to plausibly allege the first element of a claim under the Fraud Act and, that, therefore, he failed to state a falsity claim. Illinois law distinguishes between actual falsity and lack of substantiation. A lack of substantiation is deceptive only when the underlying claim implies that there is substantiation for the claim made. In this case, the complaint did not allege that there was substantiation for the “Immunity Boost” claim. The complaint alleged that the “Immunity Boost” claim was false because products such as the wellness shots could not boost immunity. Yet, this allegation was a mere conclusion, and conclusory allegations must be supported by factual claims. The two sources that were cited in the complaint to support these conclusory allegations did not actually provide support. One report did not state that boosting immunity was impossible but, rather, noted that there was no evidence that boosting immunity was possible. Furthermore, there were other problems with the report which caused it to have questionable value including that it was more than 15 years old. Furthermore, reliance on settlements with the Federal Trade Commission which were the second source of support in the complaint was not a firm foundation on which to adequately plead a claim. Importantly, the court added, settlements do not vindicate a plaintiff’s liability theory.

Other claims. Because the court dismissed the consumer deception claims and the claims for breach of express warranty and for unjust enrichment are based on the consumer deception claims, the court dismissed those also. There was no breach of an affirmation of fact or promise that was part of the basis of the bargain and, therefore, the complaint failed to plausibly allege that the shots did not possess immunity-boosting qualities. Similarly, because the consumer failed to plead adequate factual allegations to support his claim that the wellness shots did not have immunity-boosting qualities, he also failed to adequately state an unjust enrichment claim.

The case is No. 1:25-CV-09541.

Judge: Chang, E.

Attorneys: Sue Jung Nam (Reese LLP) for David Freifeld. Gregory Edward Ostfeld (Greenberg Traurig, LLP) for Vive Organic, Inc.

Companies: Vive Organic, Inc.

Cases: CaseDecisions AdvertisingNews SupplementNews FoodNews LabelingNews PreemptionNews IllinoisNews