Get 1 Year of Cigar Aficionado for Just $24.95 + 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
D.C. Court Rules Against Cigar Industry, Rejects Appeal In FDA Lawsuit

D.C. Court Rules Against Cigar Industry, Rejects Appeal In FDA Lawsuit

A Washington D.C. Court of Appeals has delivered a blow to the cigar industry.

Jul 21, 2021
Bill To Exempt Premium Cigars from FDA Regulation Returns to House

Bill To Exempt Premium Cigars from FDA Regulation Returns to House

The cigar bill is back—again.

Jun 22, 2021
J.C. Newman Hoping To Import Cuban Tobacco

J.C. Newman Hoping To Import Cuban Tobacco

Newman is asking the U.S. to rethink its position on importing Cuban tobacco leaf.

Jun 3, 2021
Michigan Tax Cap Bill Passes in House of Representatives

Michigan Tax Cap Bill Passes in House of Representatives

The Great Lake State is one step closer to making its tobacco tax cap permanent.

May 19, 2021
California Cigar Tax to Increase in July

California Cigar Tax to Increase in July

California’s state tobacco tax will increase by 11.5 percent on the first of July.

May 18, 2021
FDA Aims to Ban Flavored Cigars

FDA Aims to Ban Flavored Cigars

If you’re one to smoke a flavored cigar, your days of enjoying a smoke like this might be numbered.

Apr 29, 2021
z