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Court Signals FDA Substantial Equivalence Deadline Will be Delayed Until Sept. 9

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While not yet official, the deadline for cigar companies to submit substantial equivalence reports to the U.S. Food & Drug Administration (FDA) will almost certainly be delayed from May 12, 2020 to Sept. 9, 2020 due to the coronavirus COVID-19 pandemic.

Judge Paul W. Grimm of the U.S. District Court for the District of Maryland, the same judge who moved the deadline up more than a year, issued an “indicative ruling” granting FDA’s request to delay the deadline by 120 days.

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However, his ruling isn’t final—hence the indicative status—due to procedural issues that are expected to be resolved quickly.

Because of appeals filed by a variety of organizations, including FDA itself, Judge Grimm no longer has the authority to modify his original ruling which moved the deadline to May 2020. That power now lies with the U.S. Court of Appeals for the Fourth Circuit.

What needs to happen next is the Fourth Circuit will modify Grimm’s order to allow FDA to delay the change. FDA will then need to update its regulations to move the date to Sept. 9, 2020.

The process for the delay has been swift. On Monday, FDA filed a motion to request the deadline to be moved, the plaintiffs in the Maryland lawsuit—anti-tobacco groups and doctors—said they had no objection to a 120-day delay and Grimm made his decision on Friday.

Any roadblocks to the postponement are now effectively removed: industry supports moving the deadline, so does FDA, so do the plaintiffs in the Maryland lawsuit and so does Judge Grimm.

Of note, the 120-day delay is not the length of time that was requested by most of the cigar and vaping industries. FDA has said those groups largely asked for 180-day delays, but FDA thought 120 days is sufficient at this time.

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 the deadline—still legally 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 Judge Grimm forced the agency to move up the deadline to this May due to concerns over vaping and e-cigarette use by minors.

While this particular legal matter is likely to reach its conclusion shortly, it won’t stop the appeals by various parties against Grimm’s initial ruling. The cigar industry, the vaping industry and FDA itself have all filed appeals against the ruling for a variety of reasons. Those lawsuits seek to move the date back to the August 2021 deadline.

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Charlie Minato
About the author

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 handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.

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