The U.S. Food & Drug Administration (FDA) has issued a guidance document clarifying 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.
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.
|Rule||Original Deadline||Updated Deadline|
|Deeming Regulations Begin||08/08/16||08/08/16|
|Warning Plans Due for Cigar Makers||05/10/17||08/10/17|
|Domestic Manufacturers Submit Product Listing||12/31/16||09/30/17|
|Ingredient Listing Due||03/15/17||05/08/18|
|Substantial Equivalence Reports Due||02/08/18||09/09/20|
|Substantial Equivalence Exemption Request Due||08/08/16||09/09/20|
|All Products Not Removed/Not Applied for Removed from Market||08/08/18||12/09/20|
|Ad Plans Required||08/08/18||No Longer Required|
|POS Warning Labels Required at Retailers||05/10/18||Delayed Indefinitely|
|Warning Labels Required for Packaging||08/08/18||No Longer Required|
|Warning Labels on Ads||05/10/18||No Longer Required|
|HPHC Reports Due||08/08/19||Delayed Indefinitely|
|All Products Sent from Manufacturers Must Be Compliant With Warning Labels||06/11/18||No Longer Required|
|All Product in Production Must Be Compliant With Warning Labels||05/10/18||No Longer Required|
|All Product at Retailers Must Have Warning Labels||05/10/18||No Longer Required|
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.