A National Legal-Action Antismoking Organization
Entirely Supported by Tax-Deductible Contributions
| Home | Search | About ASH | Why Join | Comment | Email page |
|
Action on Smoking and Health
A National Legal-Action Antismoking Organization Entirely Supported by Tax-Deductible Contributions
|
CA Supreme Court Rules in Favor of FDA's Nicotine Patch Warning Labels [04/16-2]
Excerpts from: Calif Supreme Court OK's FDA warning label on nicotine patches
By Kim Curtis The Mercury News [04/16/04]
The California Supreme Court ruled Thursday that a Food and Drug Administration label warning pregnant women of the dangers of nicotine patches trumps a stricter state-mandated label required by a 1986 voter-approved proposition.
In 1999, consumer advocate Paul Dowhal sued GlaxoSmithKline Consumer Healthcare and other makers of nicotine gum and patches - products designed to help people quit smoking - for failing to warn pregnant consumers about the risks of nicotine.
At the time, the only warning on the labels mentioned a risk of increased fetal heart rates, according to Mark Todzo, who argued Dowhal's case before the state Supreme Court. It did not warn users that nicotine can harm a fetus.
It also did not conform with the requirements of Proposition 65, which was passed by two-thirds of California voters. That measure requires companies to warn consumers about the presence of any one of hundreds of toxic chemicals, including nicotine and cigarette smoke. In many cases, that warning reads: "This product contains a chemical known to the state of California to cause birth defects or other reproductive harm."
The high court's unanimous decision, which reversed an earlier appeals court decision, said a federal warning label should be used in place of the state warning label only when the federal warning is more balanced.
"The risk of harm may be so remote that it is outweighed by the greater risk that a warning will scare consumers into foregoing use of a product that in most cases will be to their benefit," the court said, adding that the stricter wording of the state warning may lead some women "overly concerned about those risks, to continue smoking."
| Home Web Page | Search This Site | Learn About ASH | Why Join ASH | Comment on This | Email This Page |