May 2017

This week, the Administration took two administrative actions that cast serious doubt about President Trump's commitment to the FDA's deeming rule which extended its regulatory authority of all tobacco products to include e-cigarettes and cigars.  The first involved the Department of Justice seeking a 90-day delay in court action on industry challenges to the FDA's authority to regulate tobacco products.  The DOJ motions sought the additional time to "more fully consider" issues raised by the industry challenges.

In separate, but related action, the Food and Drug Administration this week announced a 90-day delay in enforcement of all future compliance deadlines associated with the deeming rule, including: 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. The FDA announcement 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.

"While the request for additional time could just be signs of a new Administration trying to catch up to speed, I am very concerned that it forebodes a significant policy shift at FDA on regulation of tobacco products," commented ATS Tobacco Action Committee member Enid Neptune, MD.  "The medical and public health community may need to engage in a very public fight to preserve the FDA's authority to appropriately regulate all tobacco products, including e-cigarettes and cigars."