A California plaintiff survived a challenge to her consumer fraud complaint against Playtex Products and other makers of Banana Boat sunscreens with SPF [sun protection factor] of 85 to 110. The critical allegation is the claim that that scientific studies show that sunscreen with SPF over 50 provides no clinically-significant benefit over the use of SPF 50 products. Plaintiff claims the marketing of the Banana Boat products is misleading because the advertising campaign combined extreme SPF values with unproven claims of greater sun protection than typical SPF 50 products. A copy of the opinion can be found here.
The federal court analyzed defendants’ three central arguments for dismissal:
1) federal preemption, and
2) whether the FDA had primary jurisdiction over the claims, and
3) whether plaintiff had standing to challenge all nine versions of the high SPF product line or only the specific product she bought.
As to preemption, the first question was whether Congress intended to displace state law through its regulations governing the labeling of sunscreens. Defendants argued the regulations requiring prominent display of SPF values, but not prohibiting values greater than 50, demonstrated the intent to entirely preempt state law. The argument was rejected because plaintiff’s challenge was not that the SPF 85-110 itself was misleading, but whether the linking of the high SPF with claims of greater protection and a higher pricing was misleading. As the court explained, “if Plaintiff were to prevail under the [California consumer fraud law], Defendants’ [federal] SPF labeling duties would remain unchanged.”
The court rejected a claim that it would be impossible to comply with both FDA regulations and California law (implied preemption), because the challenge required an assessment of allegedly misleading advertising, not an interpretation of the federal sunscreen regulations themselves.
The court rejected the argument that it should defer to the FDA under the primary jurisdiction doctrine because there was neither a complicated administrative issue outside the competence of the court, nor an issue of first impression for FDA.
Finally, the court held that plaintiff had standing to challenge all nine of defendants’ high SPF products, including the eight that she did not buy, because the products were substantially similar.
The lesson here is that health product manufacturers, even in areas regulated by FDA, would be wise to ensure that their legal and business units work closely together to carefully analyze proposed advertising that may stretch existing scientific support in order to avoid high-stakes class action challenges.