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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.

February 28, 2019 | Daily News

FDA Commissioner Scott Gottlieb on Wednesday (Feb. 27) told House appropriators he would support increasing the federal minimum age for purchasing tobacco to 21, as doing so could help FDA with the immediate problem of addressing youth use of e-cigarettes.

February 20, 2019 | Daily News

FDA has rewritten a 2015 draft guidance to clarify the tobacco industry can conduct nonclinical lab studies of novel tobacco products without facing agency review or scrutiny.

February 07, 2019 | Daily News

FDA on Thursday (Feb. 7) announced it is barring a Walgreens store in Miami and a Circle K store in Charleston, SC, from selling tobacco products for 30 days due to repeated violations of sales and distribution restrictions, including selling cigars and menthol cigarettes to minors.

February 05, 2019 | Daily News

A group of leading public health organizations and advocates pushed back on one coalition’s attempt to convince President Donald Trump to stop FDA from regulating e-cigarettes, saying the coalition’s efforts are an “orchestrated effort by the tobacco industry and its political allies” to protect industry’s profits.

January 28, 2019 | Daily News

In comments to the agency, two health advocacy organizations urge FDA to partner with other federal agencies to address youth e-cigarette and tobacco product use and addiction.

January 24, 2019 | Daily News

As FDA and Congress take steps toward enhancing reliance on over-the-counter and nonprescription medicine, the OTC drug lobby group, Consumer Healthcare Products Association, continues to advocate for passage of OTC monograph reform legislation, incentivizing OTC drug makers to help spur prescription-to-OTC switches, and oversight of dietary supplements, CHPA President and CEO Scott Melville told Inside Health Policy.