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June 14, 2021 | Daily News

FDA will move forward with finalizing a controversial rule that aims to clarify what kind of evidence the agency will consider when determining a product’s intended use, the agency reveals in its Spring 2021 regulatory agenda published Friday (June 11).

May 28, 2021 | Daily News

The Biden administration’s fiscal 2022 budget released Friday (May 28) proposes giving FDA $3.6 billion in budget authority, which FDA says would provide an 8% increase over fiscal 2021 enacted levels, though FDA watchers assert it would actually add up to an 11% increase.

April 29, 2021 | Daily News

FDA on Thursday (April 29) announced plans to issue two proposed rules that would ban menthol in cigarettes and ban all characterizing flavors, including menthol, in cigars.

April 06, 2021 | Daily News

The White House Office of Management and Budget is again reviewing two FDA tobacco rules that were pushed out in the last days of the Trump administration but then promptly withdrawn under President Joe Biden’s regulatory freeze.

March 09, 2021 | Daily News

A coalition of health and consumer advocacy organizations on Tuesday (March 9) filed suit against HHS over a Trump-era rule that requires health agency regulations be assessed every 10 years or be automatically scrapped.

January 22, 2021 | Daily News

The White House Office of Management and Budget pulled six FDA guidances and rules from its review, a move prompted by President Joe Biden’s freeze on all regulations issued by the Trump administration that have not yet gone into effect.

January 19, 2021 | Daily News

FDA on Tuesday (Jan. 19) finalized two tobacco rules -- one that establishes application and recordkeeping requirements for premarket tobacco products and another that sets out format and content requirements for substantial equivalence reports.

October 22, 2020 | Daily News

In a meeting with the White House budget office earlier this month, Juul urged the Trump administration and FDA to make it clear to states and tobacco retailers that the new national law setting 21 as the minimum age to purchase tobacco products preempts state laws that still have 18 as the minimum age.

September 21, 2020 | Daily News

HHS on Sunday evening (Sept. 20) defended a new internal policy that requires HHS Secretary Alex Azar to formally sign off on any health agency rules, including those from FDA, saying that it’s intended to minimize litigation risks.

September 03, 2020 | Daily News

Rep. Raja Krishnamoorthi (D-IL), chair of the House oversight committee’s consumer policy subcommittee, and Sen. Dick Durbin (D-IL) are urging the Centers for Disease Control and Prevention to encourage college campuses to go tobacco-free after a recent study showed that 13- to 24-year-olds who smoke both cigarettes and e-cigarettes are seven times more likely than non-smokers to be diagnosed with COVID-19.

August 18, 2020 | Daily News

In addition to hoping to reduce opioid deaths and emergency room visits, the Healthy People 2030 plan HHS released Tuesday (Aug. 18) sets goals around how to respond to public health threats like COVID-19 and, for the first time, addresses outside factors that affect health, like housing and food insecurity.

July 02, 2020 | Daily News

FDA plans to issue a handful of new regulations this year that will clarify new minimum age requirements for purchasing tobacco, amend the agency’s good guidance practices, and set agricultural water standards, according to the agency’s newly issued Spring 2020 Unified Agenda, which was published Tuesday (June 30).

June 19, 2020 | Daily News

Tobacco control groups on Wednesday (June 17) sued FDA for not banning menthol-flavored cigarettes and providing no justification for its inaction, which they say violates the Administrative Procedure Act.

May 28, 2020 | Daily News

Per a U.S. district court order, FDA has pushed back the date by which all cigarette packages and advertisements must bear new textual warning label statements and color graphics that depict the negative health consequences of smoking.

May 28, 2020 | Daily News

A group of Democratic senators, led by health committee ranking Democrat Patty Murray (WA), say FDA should make public a list of marketed e-cigarettes and other deemed tobacco products for which the agency receives premarket applications by Sept. 9, the deadline by which all deemed products must submit premarket tobacco applications and substantial equivalence reports.

April 24, 2020 | Daily News

A federal district court on Thursday (April 23) granted FDA’s request to give tobacco companies until Sept. 9 to file premarket tobacco applications for e-cigarettes, cigars and other new tobacco products.

April 01, 2020 | Daily News

FDA on Monday (March 30) asked a federal district court to give tobacco companies an additional 120 days -- until Sept. 9 -- to submit premarket tobacco applications to the agency because the coronavirus pandemic makes it difficult for industry to meet the deadline and FDA’s tobacco center is short staffed.

February 28, 2020 | Daily News

Despite objections from the Trump administration, the House on Friday (Feb. 28) passed Rep. Frank Pallone’s (D-NJ) vaping bill that would ban all characterizing e-cigarette flavors, allow FDA to collect user fees from all classes of tobacco products and increase the total amount of user fees collected by $100 million.

February 21, 2020 | Daily News

Eleven Senate Democrats, including 2020 presidential candidates Elizabeth Warren (MA) and Amy Klobuchar (MN), wrote to HHS Secretary Alex Azar on Thursday (Feb. 20) expressing concern that FDA plans to exclude certain tobacco products from the May 12 court-ordered deadline by which all electronic nicotine delivery system (ENDS) manufacturers must submit their premarket submissions to FDA for review.

February 14, 2020 | Daily News

FDA has put out a call for more data and information about the outbreak of vaping-related lung illnesses that started last summer.