title: FDA regulation of tobacco: blessing or curse for FDA professionals?
abstract: Upwards of 400,000 Americans will die that year from the effects of cigarettes, which FDA will now "regulate" very gently, with its hands tied by a slick statutory protection for the largest existing tobacco marketers. Career FDA professionals will be criticized as enablers of mega-marketers' continued sales, working at the margins, arranging the paperwork for protection of megafirms' market share, and sitting by as the deaths and addictive behaviors continue. "Join the Public Health Service, inspired by a public health mission," they were told, and yet they will be unable to do much regulating of the addictive and fatal products for which they now have titular responsibility. This essay observes that these fine FDA professionals are handed the sticky remains of a messy bargain, negotiated in a distracted Congress by expensive lawyers with clients who were potent contributors to political action committees. The only formula that is not secret about the 2009 law is the way in which industry purchased sufficient allegiance to gather the votes for its adoption. The remaining mystery is how FDA could be expected to do these tasks without losing its best and brightest professionals to other fields.
authors.affiliation: College of Law, University of Cincinnati, Cincinnati, OH, USA.
authors.forename: James T
authors.initials: JT
authors.lastname: O'Reilly
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence; D033161:Government Regulation; D006801:Humans; D016365:Liability, Legal; D040541:Marketing / Q000331:legislation & jurisprudence*; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D057051:Product Recalls and Withdrawals / Q000331:legislation & jurisprudence; D016540:Smoking Cessation / Q000331:legislation & jurisprudence*; D019460:Tobacco Industry / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*