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FDA In Brief: FDA provides free digital calendars to retailers as part of voluntary educational program aimed at preventing illegal sales of e-cigarettes and other tobacco products to minors
… play a critical role in keeping harmful and addictive tobacco products like e-cigarettes out of the hands of … products to kids, which is especially concerning since tobacco use is almost always initiated and established during … and following the law, and we encourage them to use the free tools from the FDA like this digital calendar, as we all …
FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product
… that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA …
FDA Finalizes Rule Related to Gluten-Free Labeling for Foods Containing Fermented, Hydrolyzed Ingredients
… or hydrolyzed ingredients, and that bear the “gluten-free” claim. The rule pertains to foods such as soy sauce, … new compliance requirements for labeling a product ‘gluten-free’ will protect individuals with celiac disease, an … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA has …
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, …
FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder
… ss-announcements/fda-approves-first-treatment-increase-pain-free-light-exposure-patients-rare-disorder … The U.S. Food … approval to Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA approves …
FDA Statement on the agency’s list of known nitrosamine-free valsartan and ARB class medicines, as part of agency’s ongoing efforts to resolve ongoing safety issue
… -announcements/fda-statement-agencys-list-known-nitrosamine-free-valsartan-and-arb-class-medicines-part-agencys … Since … is alarming to patients who expect their products to be free from these types of impurities. And while we’ve … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA …
“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 …
FDA In Brief: FDA takes steps to improve efficiency, transparency of tobacco product application review process as part of comprehensive framework to reduce the disease and death related to tobacco products
… f/fda-brief-fda-takes-steps-improve-efficiency-transparency-tobacco-product-application-review-process … August 14, 2018 … the efficiency and effectiveness of our review process for tobacco product applications, as part of the commitments we … for demonstrating substantial equivalence to a predicate tobacco product. This information can help sponsors better …
FDA Insight: E-Cigarettes and the National Youth Tobacco Survey
… nts/fda-insight/fda-insight-e-cigarettes-and-national-youth-tobacco-survey … Listen (MP3, 18MB) Mitch Zeller, Director of FDA's Center for Tobacco Products, joins Dr. Shah in a discussion on … compounds in the vapor, are not safe. They are not risk free. And as you said, they contain nicotine. So, any use of …
FDA takes significant steps to protect Americans from dangers of tobacco through new regulation
… ments/fda-takes-significant-steps-protect-americans-dangers-tobacco-through-new-regulation … en español Today, the U.S. … finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah … is an important step in the fight for a tobacco-free generation – it will help us catch up with changes in …
FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information
… ws-events/press-announcements/fda-authorizes-marketing-iqos-tobacco-heating-system-reduced-exposure-information … Today, … the marketing of Philip Morris Products S.A.’s “ IQOS Tobacco Heating System” as modified risk tobacco products … presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is …
FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth
… ts/fda-warns-juul-labs-marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth … Español Today, … to JUUL Labs Inc. for marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or … exposure to a substance; and/or 3) do not contain or are free of a substance or substances. The warning letter …
FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science - 06/18/2018
… /news-events/speeches-fda-officials/fdas-nicotine-and-tobacco-regulation-and-key-role-regulatory-science-06182018 … … by Scott Gottlieb, M.D., Commissioner of Food and Drugs Tobacco Regulatory Science Program Meeting White Oak, Md. … such as “The Real Cost,” “Fresh Empire,” and “This Free Life,” designed to create awareness of tobacco products’ …
Statement from FDA Commissioner Scott Gottlieb, M.D., on forceful new actions focused on retailers, manufacturers to combat youth access to e-cigarettes as part of FDA’s Youth Tobacco Prevention Plan
… of our efforts to protect youth from the dangers of tobacco products. In recent months our vigorous enforcement efforts as part of the agency’s Youth Tobacco Prevention Plan have included a number of actions to … program called “ This is Our Watch ,” which includes free resources designed to support retailers’ efforts to …
FDA launches new, comprehensive campaign to warn kids about the dangers of e-cigarette use as part of agency’s Youth Tobacco Prevention Plan, amid evidence of sharply rising use among kids
… to protect America’s youth from the dangers of using any tobacco or nicotine-containing products. We congratulate the … announcing today seeks to snap teens out of their ‘cost-free’ mentality regarding e-cigarette use with powerful and … “Even as we consider the potential benefits of innovative tobacco products and the role that some such products may …
Remarks on New Strategies for Tobacco Policy and Therapeutic Nicotine Replacement - 12/12/2017
… /news-events/speeches-fda-officials/remarks-new-strategies-tobacco-policy-and-therapeutic-nicotine-replacement-12122017 … Duke-Margolis Center for Health Policy New Strategies for Tobacco Policy and Therapeutic Nicotine Replacement Dec. 12, … campaigns: “The Real Cost,” “Fresh Empire,” and “This Free Life.” The first campaign of this kind, “The Real Cost,” …
Protecting American Families: Comprehensive Approach to Nicotine and Tobacco - 06/28/2017
… cting-american-families-comprehensive-approach-nicotine-and-tobacco-06282017 … Remarks by Scott Gottlieb, M.D. … 28, 2017 White Oak, MD (Remarks as prepared for delivery) Tobacco use remains the leading cause of preventable disease … families to lead healthier lives, and to avoid or break free from harmful cigarette addiction. The key lies in …
FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration
… that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … The U.S. …
Evaluating the Paperwork Reduction Act Part II: Are Burdens Being Reduced?
… the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. FDA balances the need to collect the … materials, contact via email and the use of a toll-free telephone number. Other members of the Center staff are …
FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalf
… The warning letters are just one aspect of the FDA’s Youth Tobacco Prevention Plan designed to limit youth access to all tobacco products, with a particular focus on youth … e-cigarette use. “Years of progress to combat youth use of tobacco is now threatened by an epidemic of e-cigarette use …
FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response
… taking Tasigna without the leukemia returning (treatment-free remission, or TFR). In both trials, patients had to meet … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA updates …
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 …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH"
… While these scientific advances won’t be risk-free, these and equally profound clinical opportunities are … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA …
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the U.S. Senate Committee on Health, Education, Labor & Pensions Hearing, “Implementation of the 21st Century Cures Act: Progress and the Path Forward for Medical Innovation
… accelerate quickly. The advance of this field is not risk-free. Yet it’s a good example of how FDA’s embrace of the … that give off electronic radiation, and for regulating tobacco products. … Office of the Commissioner … FDA …
La FDA lanza campaña pública de educación para prevenir y reducir el consumo de tabaco entre los jóvenes LGBT
… más de 800,000 fuman de vez en cuando. La campaña “This Free Life” (Esta Vida Libre) está diseñada para llegar … consumo como una norma dentro de la comunidad LGBT. “This Free Life” está diseñada para refutar la percepción de que el … “Libertad para vivir libre del tabaco” (Freedom to Be, Tobacco-Free). La campaña también usa mensajes auténticos y …