Maryland Lawsuit

  • Name:American Academy of Pediatrics et al. v. United States Food and Drug Administration et al.
  • Filed: March 2018
  • Location: U.S. District Court for the District of Maryland

One strategy of anti-tobacco groups has been to sue the government for not regulating in the manner they want. It's proven to be a successful strategy and it is no surprise that a lawsuit was filed by those groups against the FDA for delaying parts of the deeming regulations.

A year of the main cigar-related lawsuit was filed against FDA in Washington, D.C., six health/anti-tobacco groups request to be named co-defendants alongside FDA in Cigar Association, et al. v. FDA.

Those groups were:

  • American Academy of Pediatrics
  • American Cancer Society Cancer Action Network
  • American Heart Association
  • American Lung Association
  • Campaign for Tobacco-Free Kids
  • Truth Initiative

Their argument was that they believed FDA was no longer fully committed to defending the legality of the rule and by being named co-defendants, they could ensure that the regulations received the most vigorous defense possible.

Motion Denied

October 2017

The three cigar trade groups opposed the attempt by the anti-tobacco groups to enter the lawsuit, arguing that it was not their right to decide whether FDA might decide to modify parts of the deeming regulations. For its part, FDA said it was indifferent the motion.

Ultimately, the motion was rejected as U.S. District Court Judge Amit P. Mehta ruled that the groups could not prove that the reversal of new FDA cigar regulations would cause “concrete and demonstrable injury” and that the groups could not prove FDA would not defend the rule.

The anti-tobacco groups were not done and less than six months later, they opted to file a lawsuit, now joined by the Maryland Chapter of the American Academy and five Maryland pediatricians against FDA.

It seems like the lawsuit was in large part due to FDA's decision to delay substantial equivalence deadlines by three years. The groups argued that FDA had no authority to decide to delay these rules because the Administrative Procedures Act (APA) required FDA to finalize these rules before announcing them, not after.

They also argued that because FDA was delaying the implementation of some parts of the rules, it was abandoning the agency's public health mission, forcing the groups themselves to take up research and public health campaigns, specifically in regards to e-cigarettes and vaping products.

FDA responded by arguing that the groups didn't have the right to file the lawsuit as they were suing over a guidance document, not over a final rule. It also argued that the groups could not prove the harms done to them by choosing to delay.

Most of the time, the cigar industry would be happy about FDA losing a court battle over the deeming regulations.

This was not one of those times.

District Court Paul W. Grimm ruled in favor of the anti-tobacco groups and doctors, soundly rejecting FDA's arguments. More importantly, he threw out FDA's substantial equivalence delay and asked both the anti-tobacco groups and the agency to submit plans for a more advanced timeline.

It is unclear whether FDA plans to appeal this ruling, though it is highly likely that both the cigar industry and e-cigarette/vaping industry will file appeals.

Grimm asked both FDA and the plaintiffs to submit a new date for substantial equivalence to be due. The plaintiffs asked for it to be due in four months, until October 2019, while FDA asked for a 10-month delay. Ultimately, Grimm sided with FDA and created a new deadline for substantial equivalence for May 12, 2020.

A variety of appeals were filed against the deadline including by FDA, the cigar industry and the e-cigarette/vaping industry. Those appeals remain active.

As the May 2020 deadline neared, the coronavirus COVID-19 pandemic ravaged the world.

Many—including FDA—were substantially affected by the event and as such, FDA asked Grimm for a four-month delay of the May 2020 deadline. After a series of procedural legal events, FDA formally changed the deadline to Sept. 9, 2020.

Last Updated: April 29, 2020.