Notice & Comment

Public Health Groups Ask Court to Make FDA Do Its Job

Eight public health groups, joined by three individual physicians, filed a lawsuit today asking a federal court to order the FDA to implement graphic health warnings for cigarettes.

Quick background: The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) instructed to the FDA to promulgate a rule within two years that required graphic health warnings (GHWs) on the top 50% of cigarette packages and the top 20% of cigarette advertisements. Exactly two years to the day—June 22, 2011—the FDA issued a final rule as required by the TCA. Although implementing the rule was not discretionary, it should be noted that GHWs have been adopted by more than 90 other countries around the world, they have been strongly endorsed by the WHO’s Framework Convention on Tobacco Control, and there is voluminous evidence that they reduce smoking initiation and also support smoking cessation.

Although the GHW requirement survived a facial challenge in the Sixth Circuit, the FDA’s rule was struck down by a 2-1 decision in the D.C. Circuit on First Amendment grounds. I have written about that decision here and here, so I won’t go over it again, except to note two points:

  • One key legal pillar of the court’s reasoning—that the more relaxed Zauderer standard only applies when the government is seeking to counter consumer deception—has since been overturned by an en banc panel of the D.C. Circuit.
  • A key factual pillar of the court’s reasoning—that the FDA had not provided sufficient evidence of the rule’s likely public health effects—has been undercut by subsequent research demonstrating that the FDA dramatically underestimated the rule’s likely impact (here and here).

The government chose not to appeal the case to Supreme Court, instead writing that because the ruling against the FDA was on an as-applied challenge, the FDA would be able to issue a new rule that complied with both the TCA’s requirements and the D.C. Circuit’s ruling. That letter was written on March 13, 2013, and did not include any timeline for a the FDA to issue a revised rule. More than three and a half years later (and more than four years since the D.C. Circuit’s opinion), the FDA has not given any indication of when a new rule might be proposed, much less finalized.

Today’s lawsuit, filed in the District of Massachusetts with the American Academy of Pediatrics as the lead plaintiff, argues quite simply that the FDA has ignored a nondiscretionary duty and therefore should be ordered—pursuant to the APA or the Mandamus Statue (28 U.S.C. § 1361)—to issue a new GHW rule.

I’ll leave it to other to analyze the lawsuit’s viability—and I’d be very interested in hearing from administrative law experts on this issue. But more than seven years since the TCA has been enacted, this lawsuit is an important milestone. Until today, as far as the FDA’s tobacco regulatory activities are concerned, the FDA has only had to worry about lawsuits from the tobacco industry—of which it has already faced quite a few. Today’s lawsuit is an important reminder that the public health community—which has been extremely frustrated by the FDA’s slow regulatory pace (see, e.g., here and here)—is also keeping a close eye on the FDA and is also willing to take legal action if need be.

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