Johnson & Johnson is engaged in the business of, among other things, manufacturing, selling, and marketing consumer products that include talc. One of J&J’s most popular products is Johnson’s Baby Powder, which it has sold since the 1890s. Up until 2020, one of the primary ingredients was talc.  The State, through the Attorney General, commenced an action under the Mississippi Consumer Protection Act alleging that J&J failed to warn of the risk of ovarian cancer in women who used talc, seeking an injunction, and a civil penalty of up to $10,000 for each violation.  In defense, J&J argued that the suit was preempted under the Federal Food & Drug Labelling Act.  In a unanimous decision, the Mississippi Supreme Court rejected this defense.

“The State sought to require Johnson & Johnson to establish an ovarian cancer warning on Johnson & Johnson’s talc cosmetic products. Johnson & Johnson argues that the action is expressly preempted. While an express preemption provision indeed applies to cosmetics regulation, as stated previously, in order for the provision to fully apply, the Court must determine whether the State’s sought requirement falls within the provision’s scope. The express preemption provision preempts state requirements that establish or continue in effect a requirement for labeling or packaging of a cosmetic that is different from or in addition to a requirement specifically applicable to a particular cosmetic or class of cosmetics under this chapter. However, in the case sub judice, there was no requirement by the Food and Drug Administration….

“Johnson & Johnson argues that the Food and Drug Administration’s decision in two citizen petitions establishes preemption….  Both citizen petitions requested that the Food and Drug Administration require a cancer warning on cosmetic talc products because of the risk of ovarian cancer after applying talc in the female genital area. In its letter, the Food and Drug Administration denied the citizen petitions’ request for ovarian cancer warnings because the FDA did not find that the data submitted presented conclusive evidence of a casual association between talc use in the perineal area and ovarian cancer. In order to be binding on the public, the Food and Drug Administration must follow the notice and comment rule making process. While the Food and Drug Administration letter is considered a final agency action, it does not follow the notice and comment rule making process. In a similar case, a letter written by the commissioner of the Food and Drug Administration was deemed inaction, and the United States Court of Appeals for the Third Circuit held, ‘the FDA has not acted to regulate it in a manner that could preempt the plaintiff’s claims.’ Fellner v. Tri-Union Seafoods, 539 F.3d 237, 253 (3d Cir. 2008). Additionally, the United States Supreme Court has held that courts ‘have a duty to accept the reading that disfavors pre-emption.’ Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449 (2005). Through its inaction, the Food and Drug Administration declined to make a requirement regarding cancer warnings for cosmetic products that contain talc.”

“Johnson & Johnson also argues that the State’s claim is barred by principles of implied preemption. Johnson & Johnson argues that obstacle preemption bars the State’s claim…. However, the Food and Drug Administration has declined to create a requirement, either positive or negative, regarding the cosmetic or class of cosmetics listed in the State’s claim, thus no interference could occur. There is no need to guess what Congress’ goal was when §379s(a) was enacted. The statute clearly prohibits states from having a requirement that is different from or in addition to a requirement that is already in place by the Food and Drug Administration. However, in the case sub judice, there is no existing requirement in place. Accordingly, the Food and Drug Administration chose not to exercise its regulatory authority, allowing the states the freedom to regulate cosmetics instead.”

 

Johnson & Johnson v. Fitch ex. rel. State, No.2019-0033, 2021 WL 1220579 (Miss. April 1, 2021).