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Executive Summary

ASPIRIN/REYE'S SYNDROME LABEL WARNING LEGISLATION IN ILLINOIS is now pending action by a Senate cmte. of the state legislature. Introduced March 27 by Sen. Jeremiah Joyce, the bill would amend the Illinois FD&C Act to prohibit the offering for sale of "any aspirin the label of which does not warn against giving aspirin to any person under 18 years of age recently suffering from chicken pox to the danger of contracting Reye's Syndrome." The bill is being considered by the Illinois Senate's Public Health Cmte. The bill is the first attempt by a state to require a label warning of an association between Reye's Syndrome and aspirin. The agency began developing a proposal on an aspirin label warning rule in June 1982 at the request of former HHS Secty. Schweiker. The proposal was subsequently stayed by Schweiker in November 1982 in the face of opposition by the American Academy of Pediatrics, which said a warning should be delayed pending more conclusive evidence, and the Office of Management & Budget. In lieu of a label warning, FDA initiated public service advertisements to inform the public of a possible link between salicylates and Reye's Syndrome. The Illinois initiative is similar to action taken by California on the issue of an OTC pregnancy/nursing warning. California's law requiring a label warning for systemic OTCs forced FDA to propose a uniform warning to avoid conflicting state-by-state label requirements. The regulation was subsequently adopted by FDA. The Illinois bill if passed could raise the issue of federal preemption again.

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