Tobacco

A Maryland court has ordered all e-cigarette makers to submit premarket applications for their products to FDA within 10 months, by May 2020, or be subject to FDA enforcement actions.

Senate Majority Leader Mitch McConnell’s (R-KY) bipartisan tobacco-to-21 bill has made its way into the Senate health committee’s health care costs legislation that will be marked up Wednesday (June 26).

FDA asks a Maryland court to give makers of all e-cigarettes and electronic nicotine delivery system (ENDS) products at least 10 months to submit premarket applications.

Sen. Tim Kaine (D-VA) defended his and Senate Majority Leader Mitch McConnell’s (KY) tobacco-to-21 bill against criticism from health advocacy groups and some senators that the bill would put states at risk of losing funding for substance abuse treatment programs and would allow the tobacco industry to undermine anti-tobacco proposals at the state level.

An FDA regulatory proposal to establish requirements for premarket tobacco product applications is being reviewed by the White House budget office, according to the office’s online regulatory review dashboard.

The Campaign for Tobacco-Free Kids on Thursday (May 23) urged Senate Majority Leader Mitch McConnell (R-KY) to remove from his bill, which raises the minimum purchase age of tobacco from 18 to 21, a provision that would require each state to individually pass laws raising the minimum age.

FDA expects to propose a number of significant new rules over the next year that will address tobacco product applications, warnings for cigarette packages and advertisements, annual reporting requirements for investigational new drugs, and requirements for drug products that are deemed difficult to compound.

Much to the chagrin of Sen. Dick Durbin (D-IL), FDA Acting Commissioner Ned Sharpless plans to stick with FDA’s plan to not enforce premarket compliance dates for e-cigarettes until 2021, according to the senator, who met with Sharpless Tuesday (May 14).

A group of seven state attorneys general is urging FDA to expand its proposed market removal of flavored electronic nicotine delivery systems (ENDS) to include mint- and menthol-flavored products; move premarket approval requirement deadlines for ENDS products up to 2020; and ban online sales of ENDS.