Proposition 65 Covers OTC Medications, Exempt from Federal ‘Uniform Labeling’ Rule, State Appeals Court Rules
A three-judge panel of the state Court of Appeal in San Francisco last Friday ruled that Proposition 65, a state law that requires warning labels on products that contain toxic chemicals, covers over-the-counter medications, the San Francisco Chronicle reports. In 1986, California voters approved Proposition 65, which requires companies to place warning labels on products, such as nicotine, that contain toxic chemicals known to cause "birth defects or other reproductive harm." The FDA, however, has allowed manufacturers of nicotine products to place "milder labels" on their products. The labels state, for example, "This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known." The labels also advise pregnant women or women who are breastfeeding to consult a physician before they use the products. The FDA said that "it did not want to discourage use of the products" and told companies "not to use any other warning labels," the Chronicle reports. A South Lake Tahoe man had filed a lawsuit to force the companies to place new or additional warning labels on nicotine patches and other products that contain nicotine, but San Francisco Superior Court Judge David Garcia dismissed the lawsuit. In the decision, Garcia said that Proposition 65 "conflicted with federal regulation of the same products." However, the Court of Appeal decision last Friday reinstated the lawsuit. The court ruled that a 1997 federal law "expressly exempted" Proposition 65 from a "requirement of uniform labeling of OTC drugs and cosmetics" (Egelko, San Francisco Chronicle, 7/13).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.