A Massachusetts federal district court judge issued a ruling last week in an action brought by the American Academy of Pediatrics, among others, which claimed that the Food and Drug Administration (FDA) had “unreasonably delayed” actions required as a part of the 2009 The Family Smoking Prevention and Tobacco Control Act (the “Act”). Among other things, the Act requires the FDA to, “issue a final rule mandating color graphic warnings on cigarette packs and in cigarette advertisements by June 22, 2011.” The images must show a warning about the hazards of tobacco and must be at least half the size of a cigarette pack or cover 20 percent of any advertisement. In the ruling, the court found:
“ . . .that the FDA has both “unlawfully withheld” and “unreasonably delayed” agency action, and that pursuant to the Administrative Procedure Act (“APA”), the court must compel agency action.”
The judge’s order gives the FDA until no later than September 26,2018 to provide an expedited schedule for the publication of proposed graphics warning rules.
Mass. judge rules that FDA ‘unlawfully withheld’ action to require graphic cigarette warnings, Boston Globe, September 5, 2018.
Memorandum and Order, American Academy of Pediatrics, et al. v. United States Food and Drug Administration, September 5, 2018.
The The 2009 The Family Smoking Prevention and Tobacco Control Act, Public Law No: 111-31