Sign In About us Careers Events FDA FDA Announcements FDA Issues Marketing Denial Orders on 300,000 ENDS Products September 3, 2021 According to an announcement issued today by the U.S. Food and Drug Administration’s Center for Tobacco Products, “Marketing Denial Orders” (MDOs) were issued to manufacturers that submitted Pre-Market Tobacco Applications (PMTAs) covering approximately 300,000 different flavored electronic nicotine delivery systems/nicotine vapor products. September 3, 2021 NATO News Bulletin.pdf Perspective: FDA’s Preparations for the September 9 Submission Deadline March 4, 2021 On Sept. 9, premarket review applications for many new tobacco products, including e-cigarettes, certain cigars, and hookah products, currently on the market are due to FDA for review. FDA staff have been working tirelessly on preparations to meet this challenge in an efficient, reliable and transparent manner. FDA to Make PMTA List Public September 1, 2020 Information could hint at what tobacco products retailers may have to pull Newly Signed Legislation Raises Federal Minimum Age of Sale of Tobacco Products to 21 January 15, 2020 On Dec. 20, 2019, the President signed legislation amending the Federal Food, Drug, and Cosmetic Act, and raising the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product—including cigarettes, cigars and e-cigarettes—to anyone under 21. FDA finalizes enforcement policy on unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint January 2, 2020 Companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions FDA regulates all tobacco products, including e-cigarettes, cigars, and hookah tobacco December 26, 2019 Note: On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available. Outbreak of Lung Injury Associated with the Use of E-Cigarette, or Vaping, Products December 11, 2019 CDC, the U.S. Food and Drug Administration (FDA), state and local health departments, and other clinical and public health partners are investigating a national outbreak of e-cigarette, or vaping, product use associated lung injury (EVALI). FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns November 27, 2019 Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products September 11, 2019 FDA compliance policy would prioritize enforcement of premarket authorization requirements for non-tobacco-flavored e-cigarettes FDA warns JUUL Labs for marketing unauthorized modified risk tobacco products, including in outreach to youth September 9, 2019 Agency sends additional letter requesting more information on several issues, including outreach and marketing practices, as part of ongoing investigation Vaping Illnesses: Consumers can Help Protect Themselves by Avoiding Tetrahydrocannabinol (THC)-Containing Vaping Products September 6, 2019 The FDA is providing consumers information to help protect themselves while health officials investigate recent illnesses following the use of vaping products. Statement on federal and state collaboration to investigate respiratory illnesses reported after use of e-cigarette products August 30, 2019 Joint statement from Acting FDA Commissioner Ned Sharpless, M.D., and CDC Director Robert R. Redfield, M.D.v Statement on new results demonstrating continued success of the agency’s youth smoking prevention efforts and significant public health cost savings August 20, 2019 "The Real Cost" campaign prevents up to 587,000 youth from initiating smoking, will save more than $53 billion in smoking-related costs for youth, their families and society at large FDA launches its first youth e-cigarette prevention TV ads, plans new educational resources as agency approaches one-year anniversary of public education campaign July 22, 2019 “The Real Cost” Youth E-Cigarette Prevention Campaign aims to reach nearly 10.7 million at-risk youth through TV, digital platforms, social media, in-school ads and posters nationwide Contract Tiered Compliance for RJRV Contracted Customers April 2, 2019 Reynolds American, Inc. (RAI)1 welcomes the FDA shining a spotlight on the important issue of youth access to vapor products. RAI has always been clear that youth should not use vapor products and have had stringent measures in place to address this for some time... CC-45-19.pdf Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes November 15, 2018 As a physician who cared for hospitalized cancer patients, I saw first-hand the devastation that smoking-related diseases had wrought on the lives of patients and their families, and dedicated myself to helping ease this suffering. FDA's Comprehensive Plan for Tobacco and Nicotine Regulation November 14, 2018 FDA's comprehensive plan places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts. This plan serves as a multi-year roadmap to better protect youth and help addicted adult smokers quit, significantly reducing tobacco-related disease and death in the U.S. in the years to come. Deeming Rule August 5, 2016 FDA’s deeming rule goes into effect on August 8, 2016. The rule extends the agency’s regulatory authority to tobacco products including electronic nicotine delivery systems (ENDS) such as e-cigarettes and vape pens; all cigars; hookah (waterpipe) and pipe tobacco; nicotine gels; and certain dissolvables. Guidance for Industry and Tobacco Retailers September 15, 2015 Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent FDA News Release on RJR Brands September 15, 2015 FDA issues orders that will stop further U.S. sale and distribution of four R.J. Reynolds Tobacco Company cigarette products Home Events Careers Contact Us Investor Relations Retail Stores FDA Fall Show Sign In © 2021 AMCON Distributing Company. All Rights Reserved. Terms of Use Privacy Statement