Effective Aug. 8, 2016
Once the deeming regulations went into effect there were three main changes:
- No "New" Product Without FDA Approval — Officially speaking, no new product could be introduced after Aug. 8, 2016 without FDA approval. Because FDA has not finalized how to get approval, this effectively serves as an indefinite ban on new product. Many manufacturers have determined ways around this and a lawsuit in late 2016 opened another door for newly-branded products of existing cigars.
- Free Samples Are Banned — In order for a manufacturer or retailer to provide a consumer with a cigar, there must be a transaction. This could be a buy five get one free promotion, a ticketed event or other, but a cigar can longer truly be "free." In addition, this prevents manufacturers from directly donating cigars to charities like Operation Cigars for Warriors.
- 18 & Over, I.D. Until 27 — The deeming regulations also require all customers of tobacco in the U.S. to be 18 and that retailers check the identification of anyone buying tobacco who is under the age of 27.*
*In December 2019, President Donald Trump signed into a law H.R. 1865, a $1.4 trillion spending bill that also included a provision that increased the minimum age to purchase tobacco from 18- to 21-years-old on the federal level.
Other Deadlines
FDA has delayed many of the deadlines for the more complex parts of the regulations including product approval and HPHC testing.
A D.C. Court delayed the requirements for warning labels for cigar and pipe tobacco products until 60 days after the resolution of the D.C. lawsuit.
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 |
PMTA Due | 08/08/18 | 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 |
More information about all dates can be found here.
Last Updated: April 29, 2020