Date: Aug 01, 2006
The food industry in general and the tuna industry specifically have won a major victory. A California judge has ruled that the Proposition 65 warning requirements for canned tuna conflict with the Food and Drug Administration's (FDA) broad regulatory authority over food safety and nutrition, and is therefore preempted.
The ruling came as a result of a lawsuit brought by the state of California against three major tuna canners, alleging violation of the Prop 65 warning requirements with respect to the presence of methyl mercury in canned tuna products.
In issuing the ruling, the judge sided with the tuna canners on most of their other claims, including that a warning should not be required because "virtually all the methyl mercury is naturally occurring" and because the level of exposure is lower than the limit originally established by the state for requiring a warning.
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 "an exposure for which federal law governs warning in a manner that preempts state authority." The Supremacy clause of the U.S. Constitution has long been understood to preempt state laws that conflict with or are inconsistent with a federal requirement.
The presence of methyl mercury in fish has long been a source of concern for women who are pregnant or may become pregnant and young children because of developmental hazards related to it. Since the mid '90s, the FDA has issued a number of advisories to ensure that the at-risk population limits its intake of fish to safe levels. But, at the same time, the FDA does not want to discourage anyone from consuming fish, which is an important part of a balanced diet.
Last summer, the then Commissioner of the FDA, Lester Crawford, advised the California attorney general of the studied and balanced approach taken by the federal government on the matter, and suggested that California "should not interfere."
The judge agreed fully that the FDA has provided balanced nutritional information to consumers on the consumption of fish and that an additional California-mandated warning would conflict with that strategy.
Although just a trial court decision, the ruling is important because it demonstrates a further recognition on the part of California courts that these types of health and safety issues are complex matters that require careful consideration. They should not be subject to knee-jerk issuance of warnings that the State and others contend are required by Prop 65.
This case follows on a 2004 decision by the California Supreme Court in which it found Prop 65 warning requirements to be preempted for an overthe-counter nicotine replacement product. There, as here, the court found that the FDA had a well-reasoned approach to the use of nicotine gums by pregnant women and others, and that the Prop 65 warning would interfere with this legitimate objective.
The state is likely to appeal this latest decision on tuna; we'll see whether the appellate courts will continue to follow the reasoning of this earlier precedent.
Used with permission. Copyright FOOD & DRUG PACKAGING, August, 2006.
For further information about this article, please contact George G. Misko at 202-434-4170 or by email at firstname.lastname@example.org.