FDA Issues Guidance on Three-Month Extension for Deeming Regulations

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The U.S. Food & Drug Administration (FDA) has issued a guidance document clarifying the the three-month extension to future deadlines as part of the deeming regulations. That delay was due to an agreement it made in exchange for delaying legal proceedings in a lawsuit brought about regarding the lawsuit.

In short, the three-month delay is exactly that. Any deadline that falls on or after May 10, 2017 will be delayed by three months. To calculate the change, you just need to change the original month to the month that comes three months after it.

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For example, FDA cites a delay of May 10, 2017 now being Aug. 10, 2017. While it might be a three-month delay, it’s actually 92 days.

The following dates are the new compliance deadlines.

RuleOriginal DeadlineUpdated Deadline
Deeming Regulations Begin08/08/1608/08/16
Warning Plans Due for Cigar Makers05/10/1708/10/17
Domestic Manufacturers Submit Product Listing12/31/1609/30/17
Ingredient Listing Due03/15/1705/08/18
Substantial Equivalence Reports Due02/08/1808/08/21
Substantial Equivalence Exemption Request Due08/08/1608/08/21
PMTA Due08/08/1808/08/21
All Products Not Removed/Not Applied for Removed from Market08/08/1811/08/21
Ad Plans Required08/08/18Delayed Indefinitely
POS Warning Labels Required at Retailers05/10/18Delayed Indefinitely
Warning Labels Required for Packaging08/08/18Delayed Indefinitely
Warning Labels on Ads05/10/18Delayed Indefinitely
HPHC Reports Due08/08/19Delayed Indefinitely
All Products Sent from Manufacturers Must Be Compliant With Warning Labels06/11/18Delayed Indefinitely
All Product in Production Must Be Compliant With Warning Labels05/10/18Delayed Indefinitely
All Product at Retailers Must Have Warning Labels05/10/18Delayed Indefinitely
Last Updated: May 31, 2019.

Some dates listed above are beyond the original three months, that’s because a few deadlines were pushed back before the latest delay.

The delay was brought because FDA asked for a delay in a lawsuit 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.

Last week, it was announced FDA would agree to a three-month extension for both the court case and deadlines.

While the lawsuit brought on by the three groups specifically deals with cigars, the delay affects all parts of the deeming regulations, which created regulations for cigars, pipe tobacco, hookah and shisha tobacco and e-cigarettes and vaping products.

FDA requested the delay saying its new officials, brought on by the Trump White House, needed time to review the regulations and the lawsuit. Yesterday, Dr. Scott Gottlieb was confirmed as the new FDA commissioner.

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Charlie Minato
About the author

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 handle the editing of our written content, the majority of the technical aspects of the site and work with the rest of our staff on content management, business development and more. I’ve lived in most corners of the country and now entering my second stint in Dallas, Texas. I enjoy boxing, headphones, the Le Mans 24-hour, wearing sweatshirts year-round and gyros. echte liebe.

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