Tobacco

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.

FDA finalized guidance on Friday (March 22) that pinpoints when vape shops engage in modifications to electronic nicotine delivery system (ENDS) products and are subject to the same requirements as tobacco product manufacturers.

The White House budget office on Tuesday (March 19) finished its review of an FDA proposed rule that lays out the format and content of reports that can be used in premarket submissions to demonstrate substantial equivalence of new tobacco products.

National Cancer Institute Director Ned Sharples will become acting commissioner of FDA when current Commissioner Scott Gottlieb resigns in early April, HHS Secretary Alex Azar announced at a House hearing Tuesday (March 12).

FDA Commissioner Scott Gottlieb said he’s “extremely confident” FDA’s policy to ban the sale of flavored e-cigarettes in convenience stores will be released before he leaves his position in a month.