Maryland Judge Strikes Down FDA’s Tobacco Product Approval Guidance

Maryland Judge Strikes Down FDA’s Tobacco Product Approval Guidance
Decision could force cigar manufacturers to immediately file Substantial Equivalence applications

A judge in Maryland yesterday ruled in favor of a coalition of public health groups suing the U.S. Food and Drug Administration and has ordered the agency to speed up its approval process for deemed tobacco products, which includes handmade cigars.

Judge Paul Grimm, of U.S. District Court for the District of Maryland, agreed with the health group’s claim that the FDA shirked its legal duties when the agency decided to extend the review period for e-cigarettes, handmade cigars and other deemed tobacco products back in 2017. In his ruling, Judge Grimm tasked the health groups and FDA to submit new procedures and plans for moving forward with deemed tobacco reviews within 30 days.

Last year, the health groups, led by the American Academy of Pediatrics, filed a federal lawsuit challenging the FDA’s decision to delay the review of e-cigarettes. While Judge Grimm’s decision focused on e-cigarettes, his order also affects premium, handmade cigars because both types of products are considered deemed tobacco by the FDA.

It was May 2016 when the FDA issued its so-called Final Deeming Rule, which extended the agency’s authority to all tobacco products, including e-cigarettes, pipe tobacco and all types of cigars. One of many strict regulations included in the FDA’s final rule was product approval.

In the rule, three pathways to product approval were outlined: Substantial Equivalence, Exemption from Substantial Equivalence (SE) and a Premarket Tobacco Application (PMTA). According to the FDA, a cigar manufacturer files an SE report to show that a new tobacco product has similar characteristics to a grandfathered (predicate) tobacco product, or has different characteristics, but doesn't raise any new questions of public health. A predicate tobacco product is one that was on the market on February 15, 2007.

When the FDA’s Final Deeming Rule was published in May 2016, the original deadline to file SE reports was May 2018. That deadline was extended to August 8, 2021 just two years ago. However, Judge Grimm’s decision means the original deadline is now back in effect.

The matter, however, is much more complicated. Earlier this year the FDA announced it was adjusting the procedures for how cigar manufacturers should submit their SE reports. In that announcement, the agency said it was opening up a public commenting period to gain feedback. That comment period is still open and doesn’t end until June 17.

In other words, even if a cigar manufacturer wanted to submit a SE report, they wouldn’t know how.

The FDA is able to appeal Judge Grimm’s ruling and will likely do so, as the agency has stated before that it needs more time, along with manufacturers, to prepare for regulation.