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Tobacco

November 15, 2018 | Daily News

In a highly anticipated move, FDA Commissioner Scott Gottlieb on Thursday (Nov. 15) announced a number of new tobacco-related initiatives the agency is undertaking, including revisiting the deeming rule compliance policy to restrict access to flavored electronic nicotine delivery systems (ENDS).

November 15, 2018 | Daily News

In a slate of tobacco-related policy proposals issued Thursday (Nov. 15), FDA Commissioner Scott Gottlieb said the agency will move forward with a proposed ban on menthol in combustible tobacco products, including cigars and cigarettes, as well as a ban on all flavored cigars.

November 02, 2018 | Daily News

FDA on Dec. 5 will hold a public hearing to discuss its efforts to curb youth use of e-cigarettes and other tobacco products and explore the potential for development of drug therapies that could help support youth cessation, the agency announced Friday (Nov. 2).

October 31, 2018 | Daily News

FDA by mid-November will announce a new comprehensive tobacco and nicotine action plan focused on curbing youth use of and addiction to e-cigarettes, FDA Commissioner Scott Gottlieb said Wednesday (Oct. 31).

October 31, 2018 | Daily News

FDA tobacco center director Mitch Zeller urged the tobacco industry, public health advocates, researchers and policymakers to stop posturing and find some common ground around how to curb youth use of tobacco products.

October 22, 2018 | Daily News

FDA plans to issue regulations that outline what information should be included in various tobacco product applications, and it will update currently existing guidance on electronic nicotine delivery systems (ENDS) products and e-cigarettes, agency chief Scott Gottlieb says in a press statement Monday (Oct. 22), the same day as FDA's two-day public meeting discussing the tobacco product application review process.

October 17, 2018 | Daily News

FDA is planning to move forward on a series of regulatory actions in the tobacco space, including proposing a ban on characterizing flavors in all cigars, according to the agency’s fall 2018 regulatory agenda, released Tuesday (Oct. 16).

October 12, 2018 | Daily News

FDA sent letters to 21 e-cigarette companies to find out whether more than 40 products, including some flavored e-cigarette products, are being marketed illegally and outside the agency's current premarket compliance policy, the agency announced Friday (Oct. 12).

September 21, 2018 | Daily News

Sen. Chuck Grassley (R-IA) is pressing FDA to provide more information about its recent spate of warning letters and civil monetary penalties to more than 1,300 e-cigarette companies.

September 14, 2018 | Daily News

E-cigarette manufacturer JUUL Labs says it will work with FDA to devise a plan for how the company can address the widespread youth use of e-cigarettes, coming in response to FDA Commissioner Scott Gottlieb's announcement that the agency will take enforcement action if JUUL and four other major e-cigarette manufacturers do not respond to the agency's request that they develop plans to reduce youth access and use within 60 days.

September 12, 2018 | Daily News

FDA is evaluating the role that e-cigarette flavors play in driving youth use of the products and will factor that into a decision on whether to bump up the compliance deadlines for premarket review, FDA Commissioner Scott Gottlieb announced Wednesday (Sept. 12).

September 12, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Wednesday (Sept. 12) put five major e-cigarette manufacturers on notice that FDA will investigate their sales and marketing practices, including with boots-on-the-ground inspections, to figure out why youth are using and abusing their products.

September 12, 2018 | Daily News

FDA is contemplating moving up the enforcement deadlines for premarket review of e-cigarettes in light of what Commissioner Scott Gottlieb declared is an epidemic of e-cigarette use among teenagers.

August 15, 2018 | Daily News

FDA now will make it easier for companies to obtain the review documents the agency uses when it decides not to approve certain tobacco products based on a lack of evidence of substantial equivalence to a predicate tobacco product, the agency announced Tuesday (Aug. 14).

August 03, 2018 | Daily News

FDA released the first of what will be two draft guidances aimed at facilitating the development of orally inhaled nicotine-cessation products, like e-cigarettes and other electronic nicotine delivery systems (ENDS), that would go through FDA's approval process for nonprescription drug products sold over-the-counter, instead of being approved by the tobacco center.

August 02, 2018 | Daily News

The vaping industry is speaking out in opposition to a proposed 25 percent tariff on e-cigarettes imported from China, arguing the tariffs would have a negative effect on public health and would exacerbate the regulatory uncertainty created by FDA's tobacco deeming rule.

July 31, 2018 | Daily News

Tobacco industry groups argue that FDA's efforts to set a maximum nicotine standard for combustible tobacco products may violate the Food, Drug and Cosmetic Act (FDCA) and Administrative Procedure Act (APA) because there is a lack of scientific evidence showing a reduction would be appropriate for protection of public health and because reducing nicotine levels to a proposed range of .3 to .5 milligrams per gram of tobacco filler is technically impossible to achieve due to the currently available manufacturing and processing methods.

July 23, 2018 | Daily News

Sen. Dick Durbin (D-IL) soon will introduce legislation that would ban kid-friendly e-cigarette flavors unless the makers can prove the products do not appeal to kids and that they help current smokers quit combustible cigarettes, the senator said during a recent briefing.

June 21, 2018 | Daily News

The California Department of Public Health (CDPH) is calling on FDA to eliminate the sale of flavored tobacco products -- a request made just two months before San Francisco voted to uphold a ban on the sale of flavored tobacco products and before FDA granted requests to extend the comment deadline for its advance notice of proposed rulemaking that seeks information about the role flavored tobacco products play in initiation, use and cessation of tobacco products.

May 16, 2018 | Daily News

The House Appropriations Committee approved Wednesday (May 16) a fiscal 2019 FDA spending bill, and in the process tacked on a controversial tobacco amendment that several Democrats and one Republican argued would essentially rewrite the Tobacco Control Act and weaken FDA’s ability to regulate tobacco products, especially e-cigarettes and cigars that appeal to youth.

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