Metropolitan News-Enterprise


Friday, April 16, 2004


Page 1


Nicotine Products Do Not Need Proposition 65 Warnings—S.C.


By KENNETH OFGANG, Staff Writer/Appellate Courts


Nicotine replacement products, which are used by cigarette smokers hoping to quit the habit, are exempt from the cancer warning requirements of Proposition 65, the California Supreme Court ruled yesterday.

“We conclude that the [Food and Drug Administration]  established a federal policy prohibiting defendants from giving consumers any warning other than the one approved by the FDA...and that the use of a Proposition 65 warning would conflict with that policy,” Justice Joyce L. Kennard wrote for a unanimous court.

The ruling rejects a private citizen’s action against companies that market, manufacture, package, and sell Nicorette, Nicoderm CQ, and Nicotrol. The companies argued that the FDA-approved warning on reproductive toxicity is the only one they can legally use in connection with those  products, while the plaintiff contended that a 1997 congressional amendment exempting Proposition 65 from FDA preemption was controlling.

The FDA warning reads:

“If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.  Smoking can seriously harm your child.  Try to stop smoking without using any nicotine replacement medicine.  This medicine is believed to be safer than smoking.  However, the risks to your child from this medicine are not fully known.” 

Proposition 65, by contrast, allows affected businesses to craft their own warnings, in which case they would be subject to liability if a warning were later determined to be inadequate, or to use “safe harbor” warnings approved by the state.

  The approved warning for nicotine reads:

“This product contains nicotine, a chemical known to the State of California to cause birth defects or other reproductive harm.” 

Reveiw Granted

The Supreme Court granted review after the First District Court of Appeal overturned a summary judgment and held the defendants might be liable for violating Proposition 65. The 1986 initiative requires businesses that use or market products that may cause cancer or reproductive toxicity to warn consumers of that fact.

State health officials determined in 1990 that nicotine causes reproductive toxicity. The FDA determined that same year that nicotine delivery products should not be used by pregnant women under any circumstances, but later altered that stance and concluded that such products could be used by pregnant women with a doctor’s prescription.

Paul Dowhal, who brought the suit, and others had urged the FDA to adopt a more direct warning. The FDA did so in 1999 when it approved a warning for a new nicotine replacement product, Habitrol.

The warning for Habitrol, a product of Novartis Consumer Health Care, In.c, which is not a party to the Dowhal suit, reads:

“Nictoine, whether from smoking or medication, can harm your baby.”

Warnings Kept

The FDA, however, instructed the makers of the older products to continue to use the old warnings pending review. The agency ultimately determined that the longstanding  warning should be maintained because the alternative might be to mislead pregnant women into smoking, in the belief that doing so was no more dangerous than using nicotine replacement products.

Kennard, writing for the high court, said this was a policy judgment the FDA was entitled to make and took precedence over Proposition 65.

The plaintiff had argued that even if there was a conflict, Proposition 65 warnings are still required under the savings clause of the Food and Drug Administration Modernization Act of 1997. The clause provides that a state requirement “that is different from or in addition to, or that is otherwise not identical with” FDA regulations is not preempted if it was “adopted by a State public initiative or referendum enacted prior to September 1, 1997.”

Proposition 65 is apparently the only law in the country preserved by the savings clause. Kennard, however, said the savings clause only preserves the Proposition 65 requirements in situations where there is no direct conflict with the FDA.

Thus, she explained, if the FDA had agreed to allow the defendants to use the warning approved for Habitrol, the federal and state warnings would be different, but not conflicting, so both would be required.

“In this case, however, any warning that conformed in substance to the FDA’s warning would not comply with [Proposition 65] because it would not provide clear and reasonable warning to the consumer that the product contained a chemical ‘known .†.†. to cause .†.†. reproductive toxicity,’” the justice wrote. “Thus, the FDA determination has effectively barred all warnings on labels that comply with Proposition 65.”

The case drew a number of amicus briefs. The Consumer Healthcare Products Association, other trade groups for FDA-regulated products, the California Medical Association, and the U.S. government support the defendants, while Attorney General Bill Lockyer, the Environmental Law Foundation, and Public Citizen argued against preemption.

The case is Dowhal v. SmithklineBeecham Consumer Healthcare, 04 S.O.S. 1931.


Copyright 2004, Metropolitan News Company