FDA Pushing Back All Regulation Deadlines By Three Months

It’s been almost a year since the U.S. Food & Drug Administration (FDA) unveiled its plans to regulate premium cigars, pipe tobacco, e-cigarettes and other tobacco products. Today came some of the best news on that front in quite some time: the agency will delay all future deadlines regarding the deeming regulations by at least three months.

The delays are actually due to the trial brought on by the Cigar Association of America (CAA), Cigar Rights of America (CRA) and the International Premium Cigar & Pipes Retailers Association (IPCPR). In March, a request was granted to delay the trail by a month, something the three groups agreed to. However, the groups argued that any further delay in the trial should also mean an equal delay in any deadlines regarding the deeming regulations.

That’s exactly what’s happening now.

Earlier today, Judge Amit P. Mehta ordered new deadlines for the trial, pushing it back three months. In his order, he noted that FDA agreed to delay all future deadlines by three months. This will apply to any and all dates regarding the deeming regulations, including those scheduled later than three months for now.

For example, the date to apply for substantial equivalence is now pushed back from March 10, 2018 to sometime around June 10, 2018. FDA has issued a compliance document clarifying the delays.

It affects the following key dates:

• Product Listings Due — Originally June 3, 2017
• Substantial Equivalence Exemptions Due — Originally Aug. 8, 2017
• Substantial Equivalence Due — Originally March 10, 2018
• PMTA Due/All Products Not Applied for Approval Removed From Market — Originally Aug. 8, 2018
• Ad Plans Required — Originally Aug. 8, 2018
• Warning Labels Required — Originally Aug. 8, 2018

The extension will not be retroactive, meaning cigarmakers cannot change the Aug. 8, 2016 date for when products must have been on the market to avoid pre-approval and it will not change the Feb. 15, 2007 date that established grandfathered products.

The new dates for the court case are now:

• Aug. 1, 2017 — Defendants’ opposition to Plaintiffs’ motion for summary judgment and cross-motion for summary judgment.
• Aug. 8, 2017 — Briefs of any amici granted leave to file in support of Defendants.
• Sept. 14, 2017 — Plaintiffs’ reply in support of their motion for summary judgment and opposition to Defendants’ cross-motion for summary judgment.
• Oct. 16, 2017 — Defendants’ reply in support of their cross-motion for summary judgment.
• Oct. 30, 2017 — Plaintiffs shall file the appendix of excerpts of the administrative record.

A new date for the start of oral arguments has not been set. The most recent scheduled date was Aug. 30. Given that Nov. 30 is Thanksgiving, it seems unlikely the trial will begin before December.

Update (May 10, 2017) — FDA has issued a guidance document regarding the new deadlines.

Charlie Minato

I am an editor and co-founder of halfwheel.com/Rueda Media, LLC. I previously co-founded and published TheCigarFeed, one of the two predecessors of halfwheel. I have written about the cigar industry for more than a decade, covering everything from product launches to regulation to M&A. In addition, I handle a lot of the behind-the-scenes stuff here at halfwheel. I enjoy playing tennis, watching boxing, falling asleep to the Le Mans 24, wearing sweatshirts year-round and eating gyros. echte liebe.