FDA Delays Upcoming Deeming Compliance Deadlines by Three Months; Sign Up for our FDA Compliance Webinar on May 9, 2017

Although we are still waiting for an official announcement, FDA's Stakeholder Relations Office recently indicated that the Agency will be delaying enforcement of all future Deeming Regulation compliance 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. We understand that this does not apply to provisions of the Deeming Regulation where compliance deadlines have already passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors.

The Stakeholder Relations Office further indicated that "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".