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Tobacco

May 02, 2019 | Daily News

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.

April 30, 2019 | Daily News

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).

April 19, 2019 | Daily News

Senate Majority Leader Mitch McConnell (R-KY) plans to introduce legislation in May that would raise the national minimum age to purchase tobacco products, including vaping devices, from 18 to 21, the senator announced Thursday (April 18).

April 18, 2019 | Daily News

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.

April 16, 2019 | Daily News

Newly minted FDA Acting Commissioner Ned Sharpless said he will not stray far from FDA’s current goals, especially those that were laid out under former commissioner Scott Gottlieb’s leadership.

April 11, 2019 | Daily News

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.

April 09, 2019 | Daily News

FDA is extending by 15 days the comment period for its proposal that would effectively remove flavored e-cigarettes from the market and move up the deadline by which manufacturers of flavored electronic nicotine delivery systems (ENDS) products must submit premarket applications, the agency announced Monday (April 8).

April 08, 2019 | Daily News

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.

April 04, 2019 | Daily News

During a House Appropriations subcommittee hearing on Wednesday (April 3), Rep. Robert Aderholt (R-AL) previewed a bill he plans to release this week that will raise the minimum age to purchase tobacco to 21 and put in place certain requirements and restrictions for online tobacco product purchases.

April 04, 2019 | Daily News

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.

April 01, 2019 | Daily News

The Campaign for Tobacco-Free Kids welcomed an announcement by outgoing FDA Commissioner Scott Gottlieb that the agency will expand its youth e-cigarette prevention campaign beyond social media and high school bathrooms and onto television screens.

March 25, 2019 | Daily News

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.

March 20, 2019 | Daily News

FDA Commissioner Scott Gottlieb said he will testify before Congress in support of FDA’s 2020 budget on April 3, before leaving the agency two days later.

March 19, 2019 | Daily News

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.

March 13, 2019 | Daily News

FDA Commissioner Scott Gottlieb announced new policy proposals that he expects will effectively ban some flavored e-cigarettes and cigars and restrict others from being used by minors.

March 12, 2019 | Daily News

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).

March 11, 2019 | Daily News

FDA experts applauded President Donald Trump’s fiscal 2020 budget request, which includes large increases for FDA, including a net $362 million boost for the agency’s taxpayer-paid budget authority, a $120 million increase for its user fee programs and $161 for new user fee programs.

March 06, 2019 | Daily News

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.

March 05, 2019 | Daily News

FDA Commissioner Scott Gottlieb’s unexpected resignation leaves myriad agency policy and regulatory plans, many of which Gottlieb identified as key priorities, hanging in the balance.

March 04, 2019 | Daily News

FDA on Monday (March 4) sent a letter to Walgreens corporate management requesting a meeting to discuss corporate-wide issues that might be contributing to its stores’ track record of illegally selling tobacco products to kids.

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