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Tobacco

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.

May 14, 2018 | Daily News

FDA and producers of so-called abuse-deterrent formulations of opioids -- dubbed ADFs -- are expected to discuss at an upcoming meeting whether the words “abuse-deterrent” should be changed or better described when associated with such products, coming as the agency also faces pressure from Congress to broach the issue.

May 10, 2018 | Daily News

FDA on Thursday (May 10) issued four warning letters to tobacco retailers for marketing and selling flavored tobacco products sold in packages and flavors that mimic kid-friendly foods, including cereal, soda and pancakes -- all of which, FDA notes, could kill a young child if less than a teaspoon was ingested.

May 09, 2018 | Daily News

In the next 12 months FDA plans to write safety standards for e-liquids and establish regulations for detaining tobacco products believed to be misbranded during inspections, according to the agency's spring 2018 regulatory agenda.

May 07, 2018 | Daily News

FDA Commissioner Scott Gottlieb’s recent remark that the agency's review of tobacco product applications was never the agency’s best way to deal with youth-use of tobacco has reignited debate over the agency's strategy for stemming youth tobacco use.

May 03, 2018 | Daily News

FDA Commissioner Scott Gottlieb, in a wide-ranging speech at the annual Food and Drug Law Institute conference Thursday (May 3), announced a slate of new agency projects, including: making e-cigarettes over-the-counter drug products; reorganizing the FDA drug center; rethinking the regulatory approach toward gene therapy; and developing a framework for regulating genetically modified animals.

May 01, 2018 | Daily News

FDA and the Federal Trade Commission (FTC) on Tuesday (May 1) issued 13 warning letters to e-cigarette sellers and distributors for selling e-cigarette e-liquids that are packaged and labeled similarly to kid-friendly food products, such as juice boxes, lollipops and cookies.

April 25, 2018 | Daily News

E-cigarette maker JUUL Labs announced Wednesday (April 25) that it will support federal and state initiatives to raise the minimum age to purchase tobacco products to 21.

April 25, 2018 | Daily News

FDA on Tuesday (April 24) demanded retailers stop selling e-cigarettes to youth and provide information requested by the agency or face regulatory action, following a nationwide blitz that revealed numerous violations related to illegal sales of JUUL Labs’ products.

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