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Court Strikes Down Prop 65 Warning for OTC Drug

Date: May 04, 2004


In a unanimous decision and as a major victory for industry, the California Supreme Court reversed a lower court of appeals and ruled that the Proposition 65 warning requirement for over-the-counter smoking cessation products that contain nicotine directly conflicts with the federal labeling requirement. And, in the face of such conflicts, the federal requirement must prevail.

Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, requires, among other things, "clear and reasonable" warnings on consumer products that, when used, would result in exposure to any of more than 750 substances recognized by the State of California as causing cancer or reproductive toxicity. The law, however, exempts from the requirements "an exposure for which federal law governs warning in a manner that preempts state authority." This is as it should be: Per the Supremacy clause of the U.S. Constitution, federal laws override state laws that conflict with or are inconsistent with federal laws.

FDA's Stance Prevails

In this case, the plaintiff sued several manufacturers, distributors and retailers of products, such as gum and patches that contain nicotine and that are designed to help people quit smoking. The plaintiff maintained that the defendants had failed to comply with Proposition 65 because the labeling did not include the Prop 65 warning identifying the product as containing a reproductive toxicant (nicotine).

The case has a long and convoluted history. With great consistency, FDA has time and again considered the nature of the warning needed for these products and has rejected the Prop 65 language as being inconsistent with sound public health policy.

Specifically, FDA sought to balance the warning so that women would consult with their doctors and properly balance the risks of using a nicotine replacement product versus continuing to smoke. The agency determined that the Prop 65 warning language, "This product contains a chemical known to the State of California to be a reproductive toxin," would run counter to this goal.

FDA was so adamant on the point that, when approached by several manufacturers with alternative warning language that they hoped would satisfy both the federal and state requirements, the agency said no.

FDA also rejected a citizen's petition filed by the plaintiff that requested a change in the warning that would have made it consistent with Prop 65.

Finding itself between the proverbial rock and a hard place, the producers of these products had no other choice but to fight the matter in court and hope that the California court would see reason.

Thankfully, it did.

In response to the plaintiff's argument that the FDA cannot prohibit truthful labeling, the court responded that although the Prop 65 warning may be literally true, FDA could still find its use to be misleading because it fails to properly inform and guide a consumer concerning risks from using the product or going with the alternatives.

It's important to keep in mind the ruling's limitations, though. The court did not find that any labeling different than a federally approved label is ipso facto preempted. Instead, it made clear that just because a state requirement is different than the federal is no reason for FDA to reject it out of hand; the agency can only reject it if the state requirement stands in opposition to achieving the legitimate objectives of the federal agency.

This case stands not as a panacea for industry complaints about Prop 65, but it certainly is a help.

Used with permission. Copyright FOOD & DRUG PACKAGING, May, 2004.

For further information about this article, please conyact George G. Misko at 202-434-4170 or by email at misko@khlaw.com