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June 20, 2019 | Daily News

After two months as FDA Acting Commissioner, Ned Sharpless said he would like to be nominated for the position permanently, though he acknowledged the decision ultimately lies with The White House.

June 14, 2019 | Daily News

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.

June 13, 2019 | Daily News

Sen. Dick Durbin (D-IL) once again took a jab at FDA for “sitting on the sidelines” as the United States grapples with an epidemic of youth use of e-cigarettes, and he laid out the three steps he believes FDA can take right now to stem youth use of the products.

June 12, 2019 | Daily News

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.

June 11, 2019 | Daily News

FDA finalized guidance on Tuesday (June 11) that details the type of information sponsors of electronic nicotine delivery systems should include in their premarket approval applications.

June 04, 2019 | Daily News

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.

May 29, 2019 | Daily News

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.

May 24, 2019 | Daily News

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.

May 23, 2019 | Daily News

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.

May 22, 2019 | Daily News

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.

May 16, 2019 | Daily News

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.

May 15, 2019 | Daily News

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).

May 08, 2019 | Daily News

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

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).