Seven health groups and five Maryland-based doctors filed a lawsuit today against the U.S. Food & Drug Administration (FDA) and its delay of the deeming regulations.
The lawsuit argues that FDA’s decision to delay substantial equivalence requirements until 2021 does not adhere to the agency’s mandate given by Congress. FDA opted to delay the specific rule from taking effect in May 2018 to August 2021, largely because the agency still has not finalized the requirements for substantial equivalence.
That lack of clarity is also part of the lawsuit.
The groups argue that the Administrative Procedures Act (APA) requires FDA to make these decisions before a new rule is introduced, not after. It argues that FDA’s reliance on guidance documents—which are non-binding—specifically in delaying the implementation of the final rule is illegal.
FDA’s regulations were introduced in 2016 and went into effect that August. Since then, nearly every part of the rule has been delayed for one reason or another, though many are now in effect. In August, warning label requirements are scheduled to go into effect, which would mark the most resource-intensive compliance mandate to date.
Last year, six of the seven health groups sought to become co-defendants in a lawsuit filed by three cigar trade groups. Their motion, which was ultimately rejected by the court, argued that by adding themselves as co-defendants they would force FDA to keep its public health mission.
Those groups are:
- American Academy of Pediatrics
- American Cancer Society Cancer Action Network
- American Heart Association
- American Lung Association
- Campaign for Tobacco-Free Kids
- Truth Initiative
They are now joined by the Maryland Chapter of the American Academy of Pediatrics as well as Dr. Leah Brasch, Dr. Cynthia Fishman, Dr. Linda Goldstein, Dr. Steven Hirsch and Dr. David Myles.
Over the last two weeks, FDA has issued three Advanced Notice of Proposed Rulemaking (ANPRM), including one that seeks input on whether the agency should modify its regulations of cigars.