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FDA Asks Court for Extension of Key Product Deadline Due to Coronavirus Outbreak

Mar 31, 2020 | By Andrew Nagy
FDA Asks Court for Extension of Key Product Deadline Due to Coronavirus Outbreak

The U.S. Food and Drug Administration performed an about-face yesterday, filing a motion in court requesting a 120-day extension of the premarket application deadline for cigars and other tobacco products that is currently set for May 12. The agency’s request, a reaction to the Coronavirus outbreak, would provide cigarmakers added time to fulfill government requirements for making and marketing many cigars.

The FDA filed the motion in the United States District Court for the District of Maryland. If granted, the new deadline will be September 9, 2020.

This deadline affects 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.

Last July, a Maryland judge ruled 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 last week the leading lobbying groups for the handmade cigar industry filed a petition asking for a stay from the deadline.

According to lawyers that represent the cigar industry, the public health groups and individual physicians who filed the original lawsuit in Maryland have indicated they do not plan to oppose the motion.

In order to grant the FDA’s motion and make the extension official, many procedural steps must be taken. A final decision is not expected for several days or possibly until next week.

FDA

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