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Judge Extends Deadline for FDA Product Approval Reports

Apr 28, 2020 | By Andrew Nagy
Judge Extends Deadline for FDA Product Approval Reports

Cigar manufacturers received a bit of good news last week as the FDA’s premarket application deadline for cigars and other tobacco products was officially extended by a Maryland judge.

The deadline, originally slated for May 12 of this year, will now be September 9. The Coronavirus outbreak was the main reason for the shift.

This deadline concerns only cigars that need to be filed with the FDA using either Substantial Equivalent reports or Premarket Tobacco Applications (PMTAs). Cigars that were commercially marketed before February 15, 2007, are considered “grandfathered” and therefore do not require FDA review.

The same Maryland judge who issued last week’s order actually ruled last July against the FDA’s decision to extend the Substantial Equivalence deadline to 2021, shortening it instead to May 12, 2020. Recently, the cigar industry argued in court for relief from the approval deadline, and the leading lobbying groups for the handmade cigar industry also filed a petition asking for a stay from the deadline.

“While we are pleased with this extension by the court, it should be noted that this action could have been granted by the Secretary of Health and Human Services and the FDA Commissioner without using the courts," said Glynn Loope, executive director of CRA. "We will use this time to continue our efforts to seek a more streamlined approach to this issue with the Trump administration.”

FDA

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