SUPREME COURT: Justices Question FDA Case
Weighing whether the FDA has the authority to regulate cigarettes and other tobacco products, several Supreme Court Justices expressed "strong skepticism," the Wall Street Journal reports. Even though "it is impossible to predict how the high court will rule on the case, yesterday's questioning raised the prospect they could determine the FDA lacks jurisdiction over tobacco products." Arguing for the FDA, U.S. Solicitor General Seth Waxman said that the "FDA had jurisdiction to regulate tobacco because the nicotine it contains is 'highly addictive' and thus is a drug that acts as a stimulant, a sedative and an appetite suppressant." The tobacco industry's arguments hinge on two assertions. Richard Cooper, a former FDA counsel, argued that if the FDA has authority to regulate tobacco, it must ban cigarettes because the product is unsafe, thus creating the problem that 50 million smokers would be unable to legally get their fix. He also asserted that Congress never intended the FDA to have jurisdiction over tobacco products and itself has never attempted to ban tobacco products (Ritter/Greenberger, 12/2). While not one of the justices defended smoking as safe, the Richmond Times-Dispatch reports that the "debate centered on whether it properly falls to Congress or a federal agency to regulate tobacco products, and whether the FDA correctly interpreted federal law about its job." Justice Sandra Day O'Connor delivered some of the most vehement criticism of the FDA's argument, saying that cigarettes are "not marketed, are they, as products intended to treat or cure disease?" She continued, "Is it the position of the government that the use of tobacco is safe and effective? If not so, it just doesn't fit" to place cigarettes and tobacco products under FDA regulation as "drug delivery devices" (Hardin, 12/2). O'Connor cited the 1938 Food, Drug and Cosmetics Act which requires the agency to ensure that products it regulates are safe and effective (Wall Street Journal, 12/2). Justice Antonin Scalia argued that "cigarettes have been known to be harmful to health for generations, yet FDA was long understood to have no authority to control their use." Waxman countered that the FDA recently came upon documents from inside the tobacco industry that have shown that "those products are sold now with the intent to cause addiction -- and thus now qualify as drugs." Besides Justice John Paul Steven, Justice Stephen Breyer was the only other justice to question the tobacco industry's claims, saying that the "FDA should have the flexibility to decide that it would be safer health-wise to 'let some people smoke for a while' instead of shutting off everyone's access abruptly." The Baltimore Sun reports that the FDA has said it does not want to ban tobacco products use by adults, but rather seeks to create a safer cigarette. The justices are expected to cast their first vote in the case during a private conference tomorrow, but the final decision likely will not be until late spring (Denniston, 12/2).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.