Court Tells FDA to Make a Decision Regarding Substantial Equivalence Extension This Week or Risk Trial

The U.S. Food & Drug Administration (FDA) will have until this Friday to grant an extension for the upcoming substantial equivalence deadline, set for May 12, or the agency will likely have to defend its decision in court.

Substantial equivalence is amongst the most pressing issues for the cigar industry as it’s the most stringent part of the current set of regulations from FDA. If manufacturers have not filed for either substantial equivalence or grandfather status for their products by May 12, 2020, those products would no longer be allowed to be sold.

Last week, two cigar trade groups—Cigar Rights of America and the Premium Cigar Association—sent a letter to FDA asking the agency to use its authority to extend the upcoming deadline due to the coronavirus COVID-19 pandemic. In that letter, the groups told the agency that if it didn’t extend the deadline by Friday, it would ask a Washington D.C.-based federal court to do so for it.

This morning, attorneys for those two groups and the Cigar Association of America (CAA), the three cigar trade groups suing FDA, sent a letter to the court notifying it of the planned actions. The letter asks the agency to use its powers under Section 319 of the Public Health Service Act, which would allow the secretary of the Department of Health & Human Services—the agency over FDA—to delay the deadline.

Judge Amit P. Mehta responded fairly quickly. He informed both sides that if FDA has not extended the deadline by April 3, this Friday, that a hearing would be set for April 23 with filings due by April 7.

Substantial equivalence is expected to be the main approval process for cigars once FDA’s regulations are fully in 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.

Cigar manufacturers are required to either file for substantial equivalence or grandfather status by May 12, 2020 in order for their cigars to stay on the market. If they fail to do so, that product must be removed from sale in the U.S. and will not be able to be sold until FDA approves the report.

Complicating matters is that FDA has still not issued an update on its planned new procedures for substantial equivalence and also never issued guidelines from HPHC testing for cigars and other tobacco products. In January, FDA indicated that premium cigars were its lowest priority and that it would handle enforcement in a corresponding manner, though its unclear what that means.

Substantial equivalence was not scheduled to be due until next August, but last year FDA lost a court case in Maryland and the judge forced the agency to move up the deadline to this May due to concerns over vaping and e-cigarette use by minors.

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.