In Eckler v. Neutrogena (certified for publication 7/1/15, Case No. B2536910), the California Court of Appeal, Second Appellate District, upheld the trial court’s determination that plaintiffs’ claims of mislabeling sunscreen products by Neutrogena under California law were preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”) and FDA regulations.
The appeal was based on two separate yet similar lawsuits filed by plaintiffs Engel and Eckler. Engel’s lawsuit alleged Neutrogena had misused labeling terms on its sunscreen packaging, including “sunblock,” “waterproof,” and “sweatproof,” in violation of California’s Unfair Competition Law (Bus. & Prof. Code §17200), False Advertising Law (Bus. & Prof. Code §17500), and Consumer Legal Remedies Act (Civil Code §1750, et seq.). In June 2011, the FDA had issued a rule specifically prohibiting the use of such labeling terms and that such regulation would take effect in 18 months. Accordingly, Engel alleged Neutrogena was liable for continuing to market such products within the 18-month period between the publication of the FDA’s 2011 rule and the date upon which the rule was to take effect. Neutrogena successfully moved for judgment on the pleadings based upon federal preemption.
Similarly, Eckler’s action claimed Neutrogena violated California’s Unfair Competition Law and Consumer Legal Remedies Act because Neutrogena’s sunscreen product labels were misleading to customers in that, among other things, the SPF 50+ rating inferred added clinical benefits of the product that did not actually exist. Thus, Eckler contended Neutrogena omitted a material disclaimer by failing to state that the sunscreen did not provide added clinical sun protection. Neutrogena successfully demurred to Eckler’s complaint.
Both Engel and Eckler appealed the dismissal of their respective lawsuits. On review, the Court of Appeal conducted a lengthy analysis of the federal statutory and regulatory scheme for sunscreen products as well as the case law interpreting the preemptive effect of FDA regulations. This discussion lead the Court to conclude that the FDA’s express preemption under 21 U.S.C. §379r requires federal preemption of state law claims (other than product liability actions) in light of the congressional intent exhibited by the FDA’s 2011 rule regarding sunscreen labeling. Specifically, under 21 U.S.C. §379r, any lawsuits premised upon state laws that imposed labeling or advertising requirements in addition or not identical to those contained in the FDA rules, are preempted by federal law.
Turning to the actions at issue, the Court first determined that Engel’s case was precisely the type of action Congress intended to avoid because Engel’s lawsuit would in effect allow states to require compliance with a federal regulation before the actual federal agency requires such compliance. Accordingly, Engel’s action was expressly preempted by federal law under 21 U.S.C. §379r. The Court then went one step further holding Engel’s claims were also impliedly preempted because they posed obstacles to the accomplishment and objective of Congress and the FDA, which is to enact a uniform national labeling for nonprescription drugs.
Next, the Court addressed Eckler’s claims finding they too were expressly and impliedly preempted by federal law. Specifically, because Eckler’s suit sought to impose additional labeling requirements not identical to federal law on Neutrogena, the claims were expressly preempted by 21 U.S.C. §379r. Moreover, while Eckler’s suit was based on products with an SPF value above 50 (which the FDA had not yet addressed in its regulations) to allow such actions would impose an obstacle on the FDA’s goal of offering choices to consumers with different needs. The FDA had previously acknowledged the value of sunscreen products with SPF ratings 50 or above, and thus, left open the possibility for enacting a labeling program to address the use of such products. To allow Eckler’s suit would undermine the FDA’s ability to do its job and therefore the lawsuit was impliedly preempted.
This case is significant because it highlights the importance of both express and implied federal preemption for state law actions raising labeling or advertising issues covered by the FDCA and FDA. Specifically, where a consumer’s claim alleges a product distributor/manufacturer failed to comply with state law labeling/advertising requirements, but the state law adds additional requirements or requirements not identical to FDA regulations, or the claims conflicts with the congressional intent of the FDA’s regulatory scheme, federal preemption most likely bars such actions.
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