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Achievements in Tobacco Regulation Over the Past Decade and Beyond
… /news-events/fda-voices/achievements-tobacco-regulation-over-past-decade-and-beyond … By: Ned … Commissioner, and Mitch Zeller, J.D., Director, Center for Tobacco Products Ned Sharpless, M.D. When Congress passed the … and young adult campaigns — “ Fresh Empire ” and “ This Free Life ” — as well as an adult-focused cessation campaign, …
“This is Our Watch”: FDA Supports Retailers in Keeping Tobacco Out of Youth’s Hands
… -events/fda-voices/our-watch-fda-supports-retailers-keeping-tobacco-out-youths-hands … November 7, 2017 By: Mitch Zeller, … the first time than light up a cigarette (about 1,100). Tobacco retailers – including store owners, managers, and … 18 years old. FDA’s “This is Our Watch” program provides free resources to help retail store owners and their …
Understanding the Health Impact and Dangers of Smoke and 'Vapor'
… illnesses, and numerous other serious health problems. Tobacco smoke harbors more than 7,000 chemicals, at least 70 … from those posed by the addictive chemical nicotine that tobacco products contain. Nicotine is especially problematic … contains formaldehyde, acetaldehyde, and unstable atoms (free radicals) that can damage cells and cause illness and …
How FDA is Regulating E-Cigarettes
… at night?” I always answered this question the same way: “tobacco control in the era of e-cigarettes.” Ned Sharpless, … health: The 480,000 deaths per year in the U.S. from tobacco-associated cancers, emphysema, heart disease, stroke … the deeming rule, including a ban on the distribution of free tobacco product samples and the prohibition of sales in …
FDA In Brief: FDA notifies Eonsmoke LLC to remove nearly 100 flavored electronic nicotine delivery system products from the market for not having required marketing authorization, among other violations
… proliferation of illegally marketed e-cigarettes or other tobacco products, to come at the expense of our children,” … M.D. “Preliminary data from the 2019 National Youth Tobacco Survey demonstrate a continued rise in the disturbing … marketed tobacco products and/or do not contain or are free of a substance. For example, the company’s website …
The Federal Response to the Epidemic of E-Cigarette Use, Especially Among Children, And the Food and Drug Administration’s Compliance Policy - 12/04/2019
… of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP). I also want to recognize the … Background Let me start with some background on our tobacco regulatory authorities and the regulatory history of … as efforts to prevent youth sales and the availability of free educational resources for retailers to assist them in …
FDA Roundup: May 10, 2024
… safe and effective. On Wednesday, the FDA’s Center for Tobacco Products (CTP) announced a webinar to be held on June … anniversary of the award-winning “The Real Cost” youth tobacco prevention campaign . CTP will provide information … comprehensive tobacco regulation efforts. The webinar is free of charge, but prior registration is required. On …
FDA Chief Counsel's Remarks to the 2019 FDLI Policy Conference - 05/02/2019
… entire staff at CPB for their commitment to public health. Tobacco The agency’s tobacco work has been such a significant part of FDA’s work … court cases in FDA’s recent history have been in the tobacco space, starting with the Supreme Court’s decision in …
FDA Roundup: May 19, 2023
… the firm Mothers Milk WTA for more than 250 flavored and tobacco-flavored e-liquids. After completing initial … a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), the FDA determined that … people have some difficulty in differentiating progression-free survival and overall response rate from overall survival …
Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
… that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … Coronavirus …
Reflections on Travel to Europe – Part One
… and freedom from the death and disability caused by tobacco products, and we are all increasingly dependent on … … Biologics … Drugs … Food & Beverages … Medical Devices … Tobacco … Reflections on Travel to Europe – Part One …
Speech by Commissioner Robert M. Califf to the House of Medicine - 06/16/2023
… health issues related to medical products, food, and tobacco – outbreaks, diseases, treatments that are safe and … We see it across the spectrum -- from continuing use of tobacco products and vaping, to failure to use effective … on strategy. One thing we are NOT doing is to suppress free speech. The First Amendment is fundamental to the …
Remarks by Dr. Woodcock to the FDA Science Forum and introduction of Dr. Fauci - 05/26/2021
… that will dramatically change the landscape of combusted tobacco products -- one proposed product standard banning … … Biologics … Drugs … Food & Beverages … Medical Devices … Tobacco … Janet Woodcock … Remarks by Dr. Woodcock to the FDA …
Remarks by FDA Commissioner Robert Califf to Health Connect South - 09/22/2022
… harm, such as the opioid crisis and continued use of tobacco products, both of which continue to evolve and lead … therapies? We need renewed focus on reducing harm from tobacco products. The FDA has the primary responsibility at the federal level to regulate tobacco and vaping, but this is a national problem, like most …
FDA Roundup: October 27, 2023
… of news from around the agency: Today, the FDA Center for Tobacco Products (CTP) Director Brian King published a …
Harnessing the Potential of Artificial Intelligence
… or digital health technologies, for example. We can free up staff by automating repetitive administrative … … Medical Devices … Radiation-Emitting Products … Tobacco … Harnessing the Potential of Artificial Intelligence …
Remarks by Dr. Woodcock to the RAPS (Regulatory Affairs Professionals Society) 2021 Convergence Conference - 09/12/2021
… Also, as many of you know, we have been engaged in user free negotiations across a number of programs. Fortunately … … Biologics … Drugs … Food & Beverages … Medical Devices … Tobacco … Janet Woodcock … Remarks by Dr. Woodcock to the …
Remarks by Commissioner Robert Califf to the National Consumer League Health Advisory Council Winter Meeting - 11/29/2023
… Supplements … Drugs … Food & Beverages … Medical Devices … Tobacco … Robert Califf … Remarks by Commissioner Robert …
FDA's “All-in” Approach to Enterprise Transformation
… … Medical Devices … Radiation-Emitting Products … Tobacco … FDA's “All-in” Approach to Enterprise Transformation …
FDA Commissioned Corps Officers on the Front Line of COVID-19 Response
… officers who are answering the phone 24/7 at our toll-free phoneline, 1-888-INFO-FDA (1-888-463-6332), and thanked … … Medical Devices … Radiation-Emitting Products … Tobacco … FDA Commissioned Corps Officers on the Front Line …
Remarks by Commissioner Califf at the Reagan Udall Foundation's Public Meeting on Strategies for Improving Public Understanding of FDA-Regulated Products - 10/05/2023
… more voices or increased opportunities for information. Free speech is a foundation of our society. My concern … … Medical Devices … Radiation-Emitting Products … Tobacco … Robert Califf … Remarks by Commissioner Califf at …
Remarks by Dr. Califf and Dr. Bumpus at the FDA Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees - 06/13/2024
… and ensuring that the FDA hears from external voices, free to agree or disagree with FDA reviewers and leaders, as … … Medical Devices … Radiation-Emitting Products … Tobacco … Robert Califf … Namandjé Bumpus … Remarks by Dr. …