## Facts

- California listed nicotine as a chemical known to cause reproductive toxicity.
- Manufacturers and distributors sold over-the-counter nicotine replacement therapy (NRT) products (gum and patches) in California without a Proposition 65 reproductive-toxicity warning.
- A private enforcer sued on behalf of the public, alleging that selling NRT without a Proposition 65 warning unlawfully exposed pregnant women to nicotine without a “clear and reasonable” warning.
- The NRT products already carried FDA-approved pregnancy-related warnings that cautioned about risks, advised consultation with a health professional, and conveyed that NRT was believed safer than smoking though fetal risks were not fully known.
- Defendants argued that adding a categorical Proposition 65 warning would conflict with FDA’s risk-communication choices by discouraging pregnant smokers from using NRT and thereby increasing continued smoking.

## Issues

1. Whether federal law conflict-preempted a state-law requirement to place a Proposition 65 reproductive-toxicity warning on FDA-regulated NRT products, despite a federal statutory provision referencing Proposition 65.
2. Whether FDA may bar a Proposition 65 warning if the agency reasonably concludes the warning, though literally true, would render the overall labeling misleading under federal misbranding standards.

## Decision

- The California Supreme Court reversed the Court of Appeal and reinstated summary judgment for defendants.
- The court held that the Proposition 65 warning requirement directly conflicted with FDA’s labeling scheme for NRT pregnancy warnings and was therefore preempted.
- The court concluded that the federal provision referencing Proposition 65 did not eliminate conflict preemption where an FDA labeling determination would be obstructed.
- The court held FDA could prohibit inclusion of a Proposition 65 warning on NRT products if FDA reasonably determined the warning would mislead consumers in context and undermine FDA’s labeling objectives.
- The matter was remanded with directions consistent with the opinion, leaving defendants not required to add the Proposition 65 warning.

## Legal Principles

- Conflict preemption applies when a state-law warning requirement directly conflicts with an FDA-required labeling scheme or stands as an obstacle to federal objectives, even absent broad express preemption.
- A federal statutory reference preserving room for state warnings does not authorize a state warning that contradicts a specific FDA labeling judgment for a regulated drug.
- Under federal misbranding authority, FDA may treat labeling as “misleading” based on the overall impression created, even if particular statements are literally true.
- Where federal law governs warnings in a way that preempts state authority, Proposition 65 does not require the warning for that exposure.

## Conclusion

The court held that California could not compel a categorical Proposition 65 reproductive-toxicity warning on FDA-regulated NRT products because it would conflict with FDA’s pregnancy-warning scheme and could be barred as misleading under federal misbranding standards.


Dowhal v. SmithKline Beecham Consumer Healthcare, 32 Cal. 4th 910, 88 P.3d 1 (Cal. 2004)