Amicus Brief Argues Constitution Bars Talcum Powder “Consumer Protection” Suit

By Lawrence S. EbnerSeptember 24, 2021

FDA has determined that a talcum powder cancer warning is scientifically unwarranted.

Thousands of product liability suits have been filed against Johnson & Johnson alleging that the company failed to warn consumers that women’s use of talcum powder can cause ovarian cancer. Based on the same failure-to-warn theory, Mississippi’s Attorney General has filed a state consumer protection action against Johnson & Johnson seeking millions of dollars in civil penalties.  The federal Food and Drug Administration (FDA), however, after extensive review of scientific data, and exercising its comprehensive regulatory authority under the Food, Drug, and Cosmetic Act (FDCA), has determined that providing an ovarian cancer warning on cosmetic talcum powder products is scientifically unwarranted and should not be required.

The FDCA contains an express preemption provision that prohibits a State from establishing “any requirement for labeling or packaging of a cosmetic that is different from or in addition to, or that is not otherwise identical with, a requirement specifically applicable to a particular cosmetic or class of cosmetics” under the Act.  21 U.S.C. § 379s(a). The purpose of this provision is to maintain national labeling uniformity by vesting the FDA with exclusive authority over the content of cosmetic product labeling, including determining what warnings should be provided to prevent a product from being “misbranded.”  Although product liability suits are exempt from this particular preemption provision, consumer protection actions brought by a state attorney general are not. 

The Mississippi Supreme Court rejected Johnson & Johnson’s preemption arguments, and now Johnson & Johnson has filed a certiorari petition seeking U.S. Supreme Court review.  Johnson & Johnson v. Mississippi, ex rel. Lynn Fitch, Attorney General of Mississippi, No. 21-348.

I today filed an amicus brief on behalf of the the Atlantic Legal Foundation and DRI urging the Court to grant certiorari. The brief argues that in addition to being expressly preempted, the Mississippi AG’s suit is impliedly preempted by direct operation of the Constitution’s Supremacy Clause, Art. VI, cl. 2. This is because the suit is predicated on a state-law duty that logically contradicts federal law since the ovarian cancer warning that the State claims is required under state law is the same warning that  FDA has determined is not required under federal law.

In addition, the amicus brief contends that no “presumption against preemption” is applicable to logical contradiction preemption, which is derived directly from the Supremacy Clause. If state law logically contradicts federal law, the Supremacy Clause automatically preempts the state law.

Read more about the case on ALF’s website.


Capital Appellate Advocacy founder Larry Ebner serves as Executive Vice President & General Counsel of the Atlantic Legal Foundation. He also volunteers as Vice Chair of DRI’s Center for Law & Public Policy and is Immediate Past Chair of DRI’s Amicus Committee.