More than 100 years ago, during the discussion regarding what was finally passed as the original Food and Drug Act of 1906, JAMA stated that “ . . . the poisoning of the population for profit by mercenary manufacturers is in its way a much more vital question. . . . ”2 In 2000, by a 5 to 4 decision, the Supreme Court, in FDA v Brown & Williamson Tobacco Corp, denied the US Food and Drug Administration (FDA) jurisdiction over cigarettes.3 Justice Stephen Breyer, who wrote the dissenting opinion, observed at the time of oral argument: “Is the statute [Federal Food, Drug, & Cosmetic Act of 1938] supposed to stop the FDA from looking at the real world?”4 However, Justice Sandra Day O’Connor, who wrote the majority opinion, unrealistically stated that “ . . . we must be guided to a degree by common sense as to the manner in which Congress is likely to delegate a policy decision of such economic and political magnitude to an administrative agency.”3 During oral argument, Justice Antonin Scalia asked, “Why wasn't the Surgeon General's report fully enough?”4