Thursday, October 15, 2020

9th Cir.: formal structure/function supplement claims can falsely imply disease claims

Kroessler v. CVS Health Corp., 2020 WL 5987498, --- F.3d ----, No. 19-55671 (9th Cir. Oct. 9, 2020)

Kroessler alleged that CVS glucosamine-based supplements didn’t provide the advertised benefits; the district court dismissed his California claims on preemption grounds. The court of appeals reversed and remanded.

The express marketing message—which CVS concedes—states that CVS’s glucosamine-based supplements maintain or support joint health. Kroessler alleges that the implied marketing message—which CVS contests—states that the supplements ameliorate the cardinal symptoms of arthritis, namely joint pain, discomfort, stiffness, and lack of mobility or flexibility. Kroessler alleges that the supplements do not provide the advertised benefits.

Label claims included “[s]upports flexibility & range of motion,” “help[s] support and maintain the structure of joints,” and “work[s] to support joint comfort while helping to promote joint mobility.” The label also states that the supplement “is not intended to diagnose, treat, cure, or prevent any disease” and that “[i]ndividual results may vary.” Another label stated that the supplement “[n]ourishes cartilage and promotes comfortable joint movement” and “[s]upports cartilage health & joint comfort.”

Kroessler alleged that glucosamine neither supports healthy joint function nor ameliorates joint pain, discomfort, stiffness, or other symptoms of joint disease, and alleged that good studies supported his claims.

The FDCA expressly preempts “state-law requirements for claims about dietary supplements that differ from the FDCA’s requirements.” Private plaintiffs may bring only actions to enforce violations of “state laws imposing requirements identical to those contained in the FDCA.” But: The FDCA requires manufacturers of dietary supplements to ensure that the labels on their products are not “false or misleading in any particular.”

The FDA specifies that a supplement’s label is misleading if, among other things, it “fails to reveal facts that are: (1) Material in light of other representations made or suggested by statement, word, design, device or any combination thereof; or (2) Material with respect to consequences which may result from use of the article under: (i) The conditions prescribed in such labeling or (ii) such conditions of use as are customary or usual.” The FDCA distinguishes between “disease claims” and “structure/function claims”; the latter requires (1) substantiation of truth/nonmisleadingness; (2) prominent disclaimers of FDA evaluation and of lack of disease claims; and (3) avoidance of a disease claim. Appropriate structure/function claims don’t require FDA preapproval.

FDA guidance recognizes that structure/function claims may use general terms such as “strengthen,” “improve,” and “protect,” as long as the claims “do not suggest disease prevention or treatment.” For example, the FDA states that “ ‘joint pain’ is characteristic of arthritis ... [but] [t]he claim ‘helps support cartilage and joint function,’ on the other hand, would be a permissible structure/function claim, because it relates to maintaining normal function rather than treating joint pain.” Supplement makers “can substantiate structure/function claims with evidence of an effect on a small aspect of the related structure/function, rather than with evidence of an effect on the main disease that consumers might associate with a given bodily structure or function.”

Previous case law has found preemption when plaintiffs challenged structure/function claims without sufficient evidence of misleadingness. Moreover, even though the FDCA requires substantiation, California private plaintiffs can’t bring pure lack of substantiation claims. “But just because California law prohibits private plaintiffs from forcing defendants to substantiate their advertising claims, that does not mean California law prohibits those plaintiffs from attacking defendants’ substantiation.” There isn’t preemption “when a plaintiff attempts to hold a defendant to the same substantiation standard required by the FDCA.”

In a footnote, the court pointed out that the FDA said structure/function claims have to be truthful and not misleading, which counsels in favor of adequate substantiation “for each reasonable interpretation of the claims,” consistent with the FTC’s view. The FDA also considers whether, if multiple studies exist, the most reliable of them point in a particular direction, and it considers the totality of the evidence; the court commented that “[t]his implies that a defendant’s substantiation may be evaluated and challenged.”

The district court interpreted past precedent to preempt any state law claim “seeking to challenge the substantiation of a structure/function claim … so long as the manufacturer’s claims are proper structure/function claims.” It thus rejected citations to studies alleging that glucosamine is “ineffective at supporting or benefiting joint health.” This was error. Kroessler alleged that the structure/function claims themselves were false “because scientific studies directly refute them.” To be sure, many of the studies didn’t match the exact terms of the labels, and many of the titles suggested that they narrowly address glucosamine’s effects on osteoarthritis, rather than its wider efficacy in supporting or maintaining joint health. But he alleged that the contents of the studies support the conclusion that glucosamine is “ineffective” at “supporting, maintaining, or benefiting the health of human joints.” If true, CVS’s explicit claims would be false.

“The FDCA does not preempt California false advertising causes of action simply because the challenged label contains a proper structure/function claim; instead, preemption applies only if the plaintiff’s legal claims and factual allegations would hold a defendant to a different ‘substantiation’ standard than the FDCA.”

Ultimately, “the district court erred by greatly expanding the present state of federal preemption jurisprudence under the FDCA, contrary to public policy.” It isn’t enough for a supplement maker to make “proper structure/function claims.” Rather (quoting a treatise), “it is well established that ‘supplement makers can be sued for false claims, and no federal preemption exists under the FDCA either by statute or by implication, since the FDA does not occupy the field and its controls are unaffected by private false advertising suits against supplement makers.’” The FDCA explicitly leaves open a path for non-FDA enforcers against false or misleading statements.

In addition, Kroessler should have been allowed leave to amend to add an “implied disease” claim.  “The FDA recognizes that products marketed as supplements may nevertheless implicitly claim to impact a disease or the signs of symptoms of a disease.” Its definition says that structure/function claims aren’t disease claims “unless the statement implies disease prevention or treatment,” which can depend on context. Implication can come from words or images, and there can be implied disease claims even without anything specific on the label. “We need not delineate what types of evidence courts may consider when evaluating implied disease claims. It is sufficient to state that many other courts have considered extra-label material when identifying implied disease claims and that those considerations are best made by district courts on a case-by-case basis.” In a footnote, the court mentions “factors such as the product’s advertisements, the consumer’s experience with the product, and market research showing consumer’s typical uses of the product.”

The district court erred when it “considered only the objective representations on the label of the glucosamine-based supplement that Kroessler purchased,” and found that no implied disease claim could be stated because the label had only proper structure/function claims.  Kroessler should have been allowed to amend his complaint, even though the district court was correct to hold that the label on its face didn’t present implied disease claims. E.g., “the images on the labels show an elderly couple leisurely walking along a beach, far from suffering with the symptoms of arthritis,” and there weren’t before and after comparisons. But Kroessler might be able to allege extra-label evidence showing that CVS’s glucosamine-based supplements present implied disease claims.

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