Dowhal

Plaintiff filed this action to challenge the failure of defendants to place health warnings mandated by California’s Proposition 65 on products containing nicotine sold over the counter as aids to stop smoking. The trial court granted summary judgment to defendants, ruling that in this setting the requirements of Proposition 65 were impliedly preempted by the federal Food, Drug, and Cosmetic Act (FDCA) ( 21 U.S.C. § 301 et seq.). The Court of Appeal reversed; we granted review.

We conclude: (1) Notwithstanding language in the FDCA exempting Proposition 65 from the preemptive effect of the federal act, when the warning mandated by California law directly conflicts with the one that the federal Food and Drug Administration (FDA) requires, the federal requirement prevails; (2) this is a case of direct conflict; and (3) the FDA has authority to prohibit use of the Proposition 65 warning, even though that warning is literally truthful, if the FDA concludes that it would have the effect of misleading consumers. We therefore reverse the judgment of the Court of Appeal.

I. FACTUAL AND PROCEDURAL BACKGROUND

On November 4, 1986, the voters of this state enacted Proposition 65 as…