House appropriators used a Tuesday (March 17) hearing on FDA’s fiscal 2019 budget request to delve into the agency's approach toward tobacco -- leading FDA Commissioner Scott Gottlieb to promise “very vigorous enforcement action” on youth use of vapor products in coming weeks.
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Tobacco
April 16, 2018 |
Daily News
The Campaign for Tobacco-Free Kids is countering arguments that it doesn't have standing to sue FDA for the agency's delay of the tobacco deeming rule compliance dates.
April 16, 2018 |
Daily News
FDA on Monday (April 16) issued a revised guidance that pushes back tobacco ingredient listing compliance dates for small-scale manufacturers to Nov. 8, sets a compliance date of May 8 for all other manufacturers and clarifies that the agency will not enforce tobacco ingredient listing submission requirements for certain tobacco product components or parts, including software, digital displays and electrical components.
April 12, 2018 |
Daily News
FDA on April 5 announced it will not review 1,500 substantial equivalence applications for cigarettes, as the products, which under the Tobacco Control Act must be shown to be substantially equivalent to their predicate products that were on the market in 2007, have not made changes significant enough to raise different public health questions.
April 02, 2018 |
Daily News
The nation's leading patient advocates sued FDA last Tuesday (March 27) for delaying the date by which tobacco products must comply with the tobacco deeming rule, asking the federal district court in Maryland to vacate the agency's recently published guidance that sets out new compliance deadlines for certain tobacco products.
March 23, 2018 |
Daily News
FDA issued an advance notice of proposed rulemaking on Friday (March 23) seeking input on whether and how it should regulate premium cigars, despite the agency's apparent skepticism over the quality of data it received the last time it made a similar request to stakeholders.
March 20, 2018 |
Daily News
FDA is seeking information about the role that flavors play in initiation, use and cessation of tobacco products, and is considering whether it can restrict advertising, promotion or access to these products, the agency announced in its advance notice of proposed rulemaking published on Tuesday (March 20).
March 07, 2018 |
Daily News
Three preliminary regulations crafted to help FDA set its approach toward reducing nicotine levels in cigarettes and regulating premium cigars and flavored tobacco cleared the White House Office of Management and Budget Tuesday (March 6).
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