Already in effect:
The following restrictions are already in effect as of Aug. 8, 2016:
In May 2017, as part of an ongoing lawsuit, FDA agreed to extend the deadline for all future deadlines regarding the deeming rule.
Certain deadlines have been pushed back more than once, which is why some deadlines are nine months after their original proposed deadline.
|Rule||Original Deadline||Updated Deadline|
|Warning Plans Due for Cigar Makers||05/10/17||08/10/17|
|Domestic Manufacturers Submit Product Listing||12/31/16||09/30/17|
|Substantial Equivalence Exemption Request Due||08/08/16||11/08/17|
|Ingredient Listing Due||03/15/17||11/08/17|
|Substantial Equivalence Reports Due||02/08/18||05/08/18|
|Substantial Equivalence Due||03/10/18||06/10/18|
|Warning Labels on Ads||05/10/18||08/10/18|
|All Product in Production Must Be Compliant With Warning Labels||05/10/18||08/10/18|
|All Product at Retailers Must Have Warning Labels||05/10/18||08/10/18|
|POS Warning Labels Required at Retailers||05/10/18||08/10/18|
|All Products Sent from Manufacturers Must Be Compliant With Warning Labels||06/11/18||09/11/18|
|All Products Not Removed/Not Applied for Removed from Marketing||08/08/18||11/08/18|
|Ad Plans Required||08/08/18||11/08/18|
|Warning Labels Required for Packaging||08/08/18||11/08/18|
|HPHC Reports Due||08/08/19||11/08/19|
An earlier version of this list incorrectly stated an ingredient list by a foreign manufacturer. There is no such requirement at this time.
*The warning label restrictions for products at retailers are subject to "safe harbor" exemptions. Something FDA has not specifically defined.
More information about all dates can be found here.
- When can a manufacturer begin applying for substantial equivalence?
While the website for FDA submissions is already active, it will likely need to wait until after FDA publishes guidances for HPHC testing.
- When can a manufacturer begin applying for grandfather status?
- How did the FDA come up with this Feb. 15, 2007 date?
- Will FDA change the Feb. 15, 2007 date?