PMTA deadlines delayed by three months

Dropping this here (via email):

Subject: FDA Announces Information about Outstanding Compliance Deadlines related to Deeming Final Rule


Good evening,



The U.S. Food and Drug Administration is announcing information about the outstanding compliance deadlines related to the May 2016 final rule that extended the agency’s authority to additional tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.



In lawsuits regarding the final rule, the FDA has stated that it will defer enforcement of all future compliance deadlines under the rule for electronic nicotine delivery systems (ENDS) such as e-cigarettes, cigars, and pipe tobacco for three months. In light of this, the FDA also intends to defer enforcement of all future compliance deadlines for all categories of newly regulated products for three months and plans to issue guidance describing its position in the near future.



This concerns deadlines set for May 10, 2017, or later, including those for manufacturer submission of cigar warning label plans, registration and listing, ingredient listing, health documents, substantial equivalence exemption requests, substantial equivalence applications, premarket tobacco product applications (PMTAs), and harmful and potentially harmful constituent (HPHC) reports.



This does not apply to provisions of the final rule where compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.



This extension will allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule that are now the subject of multiple lawsuits in federal court.



Please contact me with any questions.



Lindsay R. Tobias
Policy Analyst, Stakeholder Relations Office

Center for Tobacco Products

Office of the Center Director
U.S. Food and Drug Administration

 

Yes, there's quite a few PMTAs being submitted for juice and hardware.

 

Please note, they've not been submitted, but are going through the process of submission. There's quite a few steps. Some manufacturers are taking a "wait see" approach, engaging in the first part of the process but not committing to the very expensive parts until they have to.

Jury's out as to whether any of them will be approved - but if you think hard about what's likely to happen, and use this blog post to inform your thinking, I reckon you can see where this is all heading.

Short answer, we'll be able to get eliquid. Will it cost more and there be less choice? Probably. Will it gut the industry? Most likely.