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FDA REGULATIONS SHOULD PREEMPT STATE LABELING WARNING REQUIREMENTS, P-A

Executive Summary

FDA REGULATIONS SHOULD PREEMPT STATE LABELING WARNING REQUIREMENTS, P-A maintained in a June 19 petition concerning a California state labeling law. The association reiterated its position that federal preemption is necessary so that "FDA's objective of ensuring uniform requirements for the content and format of OTC drug labeling will [not] be frustrated, and the effectiveness of labeling warnings deemed important by FDA will [not] be diluted by the 'cancer' and 'reproductive toxicity' warnings required by Cailifornia" under the California Safe Water and Toxic Enforcement Act of 1986. The association is asking FDA to add a new provision to its regulations that would state: "Any provision of the law of any state or any political subdivision thereof that requires a warning on the label or in the labeling for an OTC drug product that is different from or in addition to the warnings required by [chapter I of title 21] is hereby preempted." Under the statute, which was enacted as a ballot initiative in November 1986, warnings must be provided 12 months after the state's governor lists a chemical as "known to the state to cause cancer or reproductive toxicity." In February, the governor published a list of 26 "known" carcinogens and three reproductive toxicants. The governor also promulagated a "candidate" list of over 200 substances that may in the future be added to the primary list. "Many substances included in the governor's primary and candidate lists are prevalent in nature and are found in trace amounts in virtually all consumer products, including OTC drugs lawfully marketed in accordance with FDA's regulatory system," P-A said. For example, the association noted that certain mineral oils which are used in laxative products and a selenium compound used in dandruff shampoos are included on the lists although FDA has evaluated the ingredients and found them to be safe for inclusion in OTC drugs. P-A maintained that "FDA has the authority to issue a preemptive regulation [because] the warning requirement of the California act will stand as an obstacle to the full implementation of federal regulatory policies." The association noted that "on three occasions since 1982, FDA has preempted state statutes or regulations pertaining to the labeling of OTC drugs. Those occasions involved OTC drug warnings for pregnant and nursing women, tamper-resistant packaging, and Reye Syndrome." In each case, P-A said, "FDA expressly stated that its regulations were intended to preempt any state or local law that purported to establish different requirements."
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