Calif. Supreme Court Holds FDCA Preempts State Statute for Reproductive Risk Warnings

SAN FRANCISCO - In reversing an intermediate appellate ruling, the California Supreme Court unanimously found that the Food Drug and Cosmetic Act (FDCA) preempted a state statute that requires stronger warnings be placed on products containing chemicals that are known to cause reproductive toxicity. Dowhal v. SmithKline Beecham Consumer Healthcare, et al., No. S109306 (Calif. Sup. Ct.).

In its April 15 opinion, the state's high court held that warnings issued pursuant to California's Proposition 65 on nicotine replacement therapies (NRT), such as gums or patches, while true, could have the effect of misleading consumers because plaintiff Paul Dowhal failed to …