1 Year of Cigar Aficionado for $10 PLUS a Free Gift!

Legislation

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

More in Legislation

See all
Court Strikes Down Key Premarket Review Process for Premium Cigars

Court Strikes Down Key Premarket Review Process for Premium Cigars

Premium cigar manufacturers no longer have to worry about the upcoming September 9 deadline for some …

Aug 19, 2020
FDA Asks Court to Consider Premium Cigar Deferral Proposal

FDA Asks Court to Consider Premium Cigar Deferral Proposal

As the September 9 deadline for cigar manufacturers to submit their premarket applications to the FDA …

Aug 6, 2020
Pennsylvania Reps Prod President to Eliminate Premium Cigar Regulations

Pennsylvania Reps Prod President to Eliminate Premium Cigar Regulations

Half of Pennsylvania’s 18 representatives earlier this week signed and sent a letter to President …

Jul 15, 2020
Court Strikes Down FDA’s Cigar Warning Label Plan

Court Strikes Down FDA’s Cigar Warning Label Plan

A trio of judges on the U.S. Court of Appeals for the Washington D.C. Circuit ruled unanimously this …

Jul 7, 2020
Florida Representatives Urge President to Drop Cigar Industry Regulations

Florida Representatives Urge President to Drop Cigar Industry Regulations

In response to the economic downturn, a dozen representatives from Florida have signed and sent a …

Jun 8, 2020
Court Ruling Ends Chances of 2021 Deadline for FDA Product Reports

Court Ruling Ends Chances of 2021 Deadline for FDA Product Reports

The FDA’s pre-market application deadline for cigars will remain September 9 after a trio of judges …

May 5, 2020