The letter, from an FDA policy analyst, says 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.”
As we report in a separate story today, it may be possible for new leadership at the Department of Health and Human Services (DHHS) to change the agency’s course on regulating vapor products. This delay may have been initiated by the Trump administration, which recently appointed Dr. Tom Price to run the DHHS.
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
Two of the previous compliance deadlines for manufacturers of the newly deemed products had already been extended, so this delay may not indicate anything unusual. But the timing is interesting, since DHHS Secretary Price just received a letter signed by over 2,000 vaping manufacturers and vape shop owners last week, asking for a review of the rule’s enforcement.