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CALIFORNIA's PROPOSITION 65 WARNING REQUIREMENTS: OFF-PACKAGE NOTICES

Executive Summary

CALIFORNIA's PROPOSITION 65 WARNING REQUIREMENTS: OFF-PACKAGE NOTICES or in-store placards are examples of what FDA considers acceptable alternatives to on-package consumer product label warnings, according to an agency spokesperson. The alternatives were indicated in an Aug. 28 letter from FDA Commissioner Young to California Governor George Deukmejian. Suggesting ways to ease the burden of the law's public warning requirement, Young urged Deukmejian to "consider implementing the warning requirement through means appropriate to sale only within California, rather than requiring warnings on the products themselves, which would directly affect interstate commerce as well." The law requires that products containing suspected carcinogens or reproductive toxins carry a clear toxicity warning about exposure unless they pose no significant lifetime risk or will have no observable effect. Under the law, pharmaceuticals could be required to carry warning labels. While suggesting the off-package warning as an alternative, the commissioner's first priority was to urge the governor to preempt from the law those products found by FDA to present no significant risk under the provisions of the Food, Drug & Cosmetic Act. Young noted that "even with regard to substances not affirmatively approved by FDA . . . the agency has adequate procedures for determining their safety and taking necessary regulatory action if problems arise." These compromises might, according to Young, prevent confusion of consumers who, "when confronted by warnings labels on large numbers of products . . . may be less likely to heed those warnings that have been carefully designed by FDA, Congress and your state to protect against more significant and possibly more immediate harm." These steps would also eliminate the extra expense that companies doing business both inside and outside the state would incur by having to change packaging for products sold in California. FDA must be "especially sensitive" regarding Proposition 65's potential impact nationally, particularly in the "efficient interstate distribution of products regulated by FDA," Young said. He told Deukmejian, however, that if FDA and the state worked together, "we can avoid unnecessary inconsistency and duplication of regulatory efforts in the implementation" of the law. Trade groups, including the Proprietary Association, organized under the new Council for Labeling Uniformity coalition are looking at the possibility of filing a lawsuit seeking federal preemption. The Proprietary Association, the Pharmaceutical Manufacturers Association and the Health Industry Manufacturers Association have petitioned FDA and the state for exemptions from the label warning requirements on the grounds that OTCs, prescription drugs and medical devices, respectively, are deemed safe by FDA, and federal law preempts state law. A draft of proposed regulations implementing the statute was submitted to the California Health & Welfare Agency by the Environment Working Group Aug. 31. The draft contains proposals for risk assessment models, labeling alternatives and product category exemptions. However, it is unlikely that any regs will be promulgated before the February deadline. Proposition 65 and the still uncertain nature of its impact continues to be a high visibility issue outside California. The law's label warning requirement was the subject of three recent letters to Health and Human Services Secretary Otis Bowen, MD, from Sens. Hatch (R-UT) and Lent (R-NY) and Rep. Madigan (R-IL). The letters urged federal preemption from the California law, and any similar laws pending in other states, for cosmetics, drugs, foods and medical devices on the grounds that the law could undermine the authority of FDA.
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