Get 1 Year of Cigar Aficionado Including 'The Rock' Issue for Just $10 + A Free Gift!

Legislation

Cigar Industry Fights to Delay FDA Product Approval Deadline

Jul 3, 2019 | By Andrew Nagy
Cigar Industry Fights to Delay FDA Product Approval Deadline

The fight between the cigar industry and the FDA continued yesterday when the three major cigar industry associations filed a motion asking a Washington D.C. court to maintain the compliance deadlines that had been previously been set for handmade cigars.

Filed in front of Judge Amit P. Mehta of United States District Court for the District of Columbia, the motion seeks to keep the August 2021 deadline, arguing that any Substantial Equivalence reports for handmade cigars that were on the market as of August 2016 should be allowed to submit applications at that point, two years from now.

Substantial Equivalence is one of the three pathways to product approval that the FDA established when it published its Final Deeming Rule in May 2016. According to the FDA, a cigar manufacturer files an SE report to show that a new tobacco product has similar characteristics to a grandfathered (predicate) tobacco product, or has different characteristics, but doesn't raise any new questions of public health. A predicate tobacco product is one that was on the market on February 15, 2007.

Back in July 2017, then-FDA commissioner Dr. Scott Gottlieb extended the SE report deadline to August 2021, and this deadline was recognized by Judge Mehta.

Earlier this year, in May, a Maryland judge ruled in favor of a coalition of public health groups that had sued the FDA and ordered the agency to speed up its approval process for deemed tobacco products.

The motion was filed on behalf of the Cigar Rights of America, Cigar Association of America and Premium Cigar Association, formerly known as IPCPR.

FDA

More in Legislation

See all
Cigars in the Senate: Rubio Brings Back Cigar Bill

Cigars in the Senate: Rubio Brings Back Cigar Bill

Senator Marco Rubio is reintroducing a bill to protect premium cigars.

Feb 24, 2021
Cigar Trade Associations File for Injunction Against FDA Regulation

Cigar Trade Associations File for Injunction Against FDA Regulation

The cigar industry’s three major trade organizations file injunction against the FDA.

Feb 22, 2021
FDA Finalizes Rules For Premarket Review—Premium Sector Still Exempt

FDA Finalizes Rules For Premarket Review—Premium Sector Still Exempt

The FDA attempts to clarify the application process for new tobacco products.

Jan 20, 2021
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