Cigar Trade Groups Appeal Court Decision to Throw Out FDA Substantial Equivalence Delay

Earlier today, attorneys for three cigar trade groups and three Texas-based cigar businesses filed a motion to throw out a May court decision that would have serious implications on the FDA cigar approval process.

Michael Edney—the lead attorney for the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipe Retailers’ Association (IPCPR) in the groups’ legal fight against the U.S. Food & Drug Administration (FDA)—filed a motion in support of the FDA.

Yes, in support.

Edney also filed a similar motion on behalf of the plaintiffs in the Texas-based cigar lawsuit: El Cubano Cigars, En Fuego Tobacco Shop and Texas Cigar Merchants Association.

THE BACKGROUND

In May, a federal court in Maryland ruled against FDA in a lawsuit brought against the agency by health groups and pediatricians. The plaintiffs in that case argued that FDA’s 2017 decision to delay its substantial equivalence was unconstitutional and hurt the groups because it meant the health groups would now be burdened by having to do marketing campaigns to raise awareness of the youth use of e-cigarettes.

The judge ultimately agreed and threw out a 2017 decision to delay the requirement for substantial equivalence to be filed by deemed products—including cigars and e-cigarettes—from 2018 to 2021.

WHAT IS SUBSTANTIAL EQUIVALENCE?

Substantial equivalence is expected to be the main approval process for tobacco products once FDA’s regulations are fully into effect. In short, a manufacturer would argue that its product is substantially equivalent to an already approved or grandfathered product, and as such poses no additional health risks and does not market towards children.

Products marketed prior to Feb. 15, 2007 will be grandfathered, but any cigar introduced after that date will likely need to go through the substantial equivalence process.

What that process looks like isn’t entirely clear. In March, FDA issued separate guidance announcing that it would be redoing its substantial equivalence process in an effort to make it easier for manufacturers to understand what the agency was looking for in a substantial equivalence report. At this time, the agency is still seeking comments on how this new substantial equivalence process should go, the comment period ends June 14.

Further complicating matters is that FDA has not announced its testing protocols for measuring harmful and potentially harmful constituents (HPHCs). In a separate announcement, the agency announced in March that it would delay HPHC testing requirements until the agency issued guidelines for the testing.

THE APPEAL

The judge asked each side to present an alternative plan. Those doctors and health groups suggested a plan that would see substantial equivalence due in four months and then give the agency a year to review the applications. FDA suggested at least 10 months and then an additional year to review the applications.

ENTER THE CIGAR INDUSTRY

The cigar industry asked Judge Amit P. Mehta, the Washington, D.C.-based federal judge that is currently deciding both the main cigar/FDA lawsuit and the Texas-based lawsuit, to throw out the Maryland decision.

In its motion before the court, the cigar industry argues that the health groups shouldn’t have the ability to influence the FDA process, particularly after they were removed as defendants in the original cigar/FDA lawsuit because they couldn’t prove their standing.

Furthermore, those groups argue that the D.C.-based court is uniquely equipped to decide the cigar-related FDA questions given its the venue for the other two cases.

It also argues that the Maryland decision violates an understanding between the cigar industry and FDA in which the cigar industry agreed to delays in the lawsuit process so long as it got delays in the substantial equivalence process.

Judge Amit P. Mehta is scheduled to hear oral arguments on July 31 involving the two cigar industry/FDA lawsuits.

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.