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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.

April 17, 2018 | Daily News

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.

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).