Tobacco

Senate Democratic Whip Dick Durbin (IL) again took FDA Acting Commissioner Ned Sharpless to task in a letter on Wednesday (May 29), saying their May 14 meeting in which they discussed youth e-cigarette use was “one of the most disappointing and alarming meetings” in his time in public service.

The Democratic sponsors of bipartisan Tobacco to 21 legislation in the Senate are urging Majority Leader Mitch McConnell (R-KY) to sign on as a co-sponsor rather than move forward with his recently introduced bill that also would raise the minimum age to purchase tobacco from 18 to 21.

In a letter to Sen. Dick Durbin (D-IL), JUUL Labs says none of its currently marketed products required premarket authorization from FDA because the flavored pod products were introduced before and right up to the deeming rule's Aug. 8, 2016, date after which newly marketed e-cigarettes and other electronic nicotine delivery systems required agency approval.

A bipartisan group of senators introduced a bill that would raise the minimum age to purchase tobacco to 21.

FDA granted marketing authorization to Philip Morris International’s (PMI’s) smokeless tobacco product, IQOS, an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol, the agency announced Tuesday (April 30).

House Energy & Commerce Committee Chair Frank Pallone (D-NJ) and Florida Rep. Donna Shalala (D) on Tuesday (April 16) introduced a bill that would allow FDA to collect user fees for e-cigarettes, raise the minimum age to purchase tobacco to 21, prohibit online sales of tobacco products, ban all characterizing tobacco product flavors, require FDA to finalize rulemaking to implement graphic health warnings for cigarette packages, and hold all deemed tobacco products to the same advertising and sales requirements applied to combustible cigarettes.

The National Association of Accountable Care Organizations (NAACOS) recently sent a letter to CMS asking the agency to make a tobacco-use quality measure, which was changed by agency, into a pay-for-reporting measure rather than a pay-for-performance one since NAACOS said CMS didn’t adequately communicate changes and ACO performance scores have suffered.

Since his early March announcement that he would be leaving FDA, former agency commissioner Scott Gottlieb ramped up work to wrap up, or initiate, myriad goals he wanted to accomplish during his time with the agency.

Nearly two weeks after receiving the green light from the White House budget office, FDA recently proposed a rule clarifying what tobacco manufacturers should include in substantial equivalence (SE) reports.