Search
FDA’s Proposed New Requirements for Tobacco Product Manufacturing Practices - 04/12/2023
… … On this page: Session Recording Public Oral Hearing Objective Session Recording Transcript: Oral Hearing on FDA’s Proposed New Requirements for Tobacco Product Manufacturers Public Oral Hearing Objective FDA held a public oral hearing on April 12, …
JUUL Labs, Inc. - 590950 - 09/09/2019
… (FDA) reviewed testimony from the July 24-25, 2019 hearing on “Examining JUUL’s Role in the Youth Nicotine … of testimony from the July 24-25, 2019 House Subcommittee hearing, documents from FDA’s inspection of JUUL’s … products. The July 24-25, 2019 House Subcommittee hearing included the following evidence: A JUUL …
Section 908 of the Federal Food, Drug, and Cosmetic Act - Notification and Other Remedies
… subject to the order with an opportunity for an informal hearing, to be held not later than 10 days after the date of … product. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds … If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that …
May 18, 2023: Tobacco Products Scientific Advisory Committee Meeting - 05/18/2023
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
Section 906 of the Federal Food, Drug, and Cosmetic Act - General Provisions Respecting Control of Tobacco Products
… under subparagraph (A), afford opportunity for an oral hearing; provide the Tobacco Products Scientific Advisory … tobacco product will be in compliance with this chapter. Hearing. After the issuance of an order under subparagraph … the petitioner shall have an opportunity for an informal hearing on such order. Compliance . Compliance with …
February 6-7, 2019: Tobacco Products Scientific Advisory Committee Meeting Announcement
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
Section 103 of the Tobacco Control Act - Conforming and Other Amendments to General Provisions
… under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through … civil money penalties, including at a retailer's request a hearing by telephone, or at the nearest regional or field … Administration prior to the violation; providing for a hearing pursuant to the procedures established through …
Reports to Congress
… tobacco use." On December 17, 2012, FDA held a public hearing, under 21 CFR Part 15, to gather input from all … issues raised by Section 918. The input received at that hearing (including comments submitted to the associated …
FDA's Comprehensive Plan for Tobacco and Nicotine Regulation
… quit. The Nicotine Steering Committee held a public hearing in early 2018, which focused on Evaluating Safety and …
Quitting Smoking and Other Tobacco Public Health Resources
… counselor Call 1-800-QUIT-NOW (1-800-784-8669); for the hearing impaired: TTY 1-800-332-8615 Get instant messaging …
2023 TPSAC Meeting Materials and Information
… Product Manufacturing Practice (Proposed Rule) Part 15 Hearing … Center for Tobacco Products … 2023 TPSAC Meeting …
Section 910 of the Federal Food, Drug, and Cosmetic Act - Application for Review of Certain Tobacco Products
… and after due notice and opportunity for informal hearing for a tobacco product for which an order was issued … If, after providing an opportunity for an informal hearing, the Secretary determines there is reasonable …
FDA Files Another Round of Actions Seeking Fines Against Retailers for Selling Illegal E-Cigarette Products
… answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days …
FDA Seeks Approximately $20,000 Each from 22 Retailers Selling Elf Bar and Other Unauthorized E-Cigarettes
… agreement, request an extension to respond, or request a hearing. Retailers that do not take action within 30 days …
Section 912 of the Federal Food, Drug, and Cosmetic Act - Judicial Review
… committee with respect to such regulation or order; any hearing held with respect to such regulation or order; and …
Listening Sessions: FDA’s Recently Proposed Tobacco Product Standards - 06/13/2022
… during the sessions, FDA was especially interested in hearing from those with relevant lived experience and those …
FDA Seeks $20K+ Fines Against Retailers Selling Unauthorized Youth-Appealing E-Cigarettes
… answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days …
Q&A: Modified Risk Tobacco Products
… MRTP order, it will provide an opportunity for an informal hearing as required under the law. … Center for Tobacco …
FDA Files Complaints Seeking Maximum Fines Against 20 More Retailers for Selling Unauthorized Elf Bar E-Cigarettes
… answer to the complaint, or file an answer and request a hearing. Retailers that do not take action within 30 days …
FDA Tobacco Compliance Webinars
https://www.fda.gov/tobacco-products/compliance-enforcement-training/fda-tobacco-compliance-webinars
… Sale Order Complaint English 10/16/2018 Part 5 – The Hearing Process for a Civil Money Penalty or a …
Safety Reporting Portal for Tobacco Products
… change in the user’s behavior, alertness, vision or hearing Details about the pattern of product use or exposure …
January 22, 2016: Counterfeit Cigarette Smuggler Receives Jail Sentence
… factual statement and statements made at the sentencing hearing, the investigation began in January 28, 2013, when a …
Section 903 of the Federal Food, Drug, and Cosmetic Act - Misbranded Tobacco Products
… be issued by the Secretary after an opportunity for a hearing; if it is a tobacco product subject to a tobacco …
2023 News and Events
… Product Manufacturing Practices Event – Public Oral Hearing: FDA’s Proposed New Requirements for Tobacco Product …
Implementing the Tobacco Control Act through Policy, Rulemaking, and Guidance
… of proposed rules that we have not thought about. Hearing from you gives us a chance to make the rules …