Agustin Rodriguez

Agustin Rodriguez

Troutman Pepper Locke

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Takeaways from Listening Session on the Development of FDA’s Center for Tobacco Products Strategic Plan

On August 22, 2023, the Troutman Pepper Tobacco + Nicotine Team attended the Food and Drug Administration’s Center for Tobacco Products (“CTP”) virtual listening session on the development of CTP’s strategic plan.  We...more

8/28/2023  /  E-Cigarettes , Food & Drug Regulations , Food and Drug Administration (FDA) , Public Health , Public Safety , Strategic Planning , Tobacco , Tobacco Regulations , Trade Associations , Vaping

U.S. District Court Vacates FDA Deeming Rule With Respect To Premium Cigars

On August 9, 2023, Judge Amit P. Mehta of the US District Court for the District of Columbia issued his decision vacating the decision of the Food and Drug Administration (“FDA”) to “deem” premium cigars covered by FDA’s 2016...more

8/11/2023  /  Food and Drug Administration (FDA) , Labeling , Manufacturers , Product Labels , Public Health , Tobacco , Tobacco Regulations

FDA Warns 189 Retailers of Elf Bar and Esco Bar Vapes Regarding Unauthorized Sales

FDA recently announced the issuance of warnings letters to 189 retailers found to be selling unauthorized tobacco products, specifically Elf Bars and Esco Bars....more

6/29/2023  /  E-Cigarettes , Food and Drug Administration (FDA) , Public Health , Retail Sales , Tobacco , Tobacco Regulations , Vaping

Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Public Education Campaigns and Resources Task Forces

This is the fifth post in our multipart series evaluating the Food and Drug Administration’s (FDA’s) response to the Reagan-Udall Foundation report (the Report) on the operations of the Center for Tobacco Products (CTP). If...more

6/20/2023  /  Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Office of Personnel Management (OPM) , Public Health , Tobacco , Vaping

Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA's Marketing Denial Order

Recent Freedom of Information Act (FOIA) litigation raises an interesting question: When federal agency action requires analyses under a holistic, multi-factor statutory standard, may the agency withhold from disclosure as...more

5/25/2023  /  Administrative Procedure Act , FOIA , Food and Drug Administration (FDA) , Marketing , Public Health , Tobacco , Tobacco Litigation , Vaping

Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Cross-Cutting and Regulation and Guidance Task Forces

In this segment of our series evaluating FDA’s response to the Report, we review a subset of the Report’s recommendations and responses from two CTP Task Forces—Cross Cutting and Regulation and Guidance....more

4/20/2023  /  Food and Drug Administration (FDA) , Guidance Update , Joint Task Force , Public Health , Strategic Planning , Tobacco , Tobacco Regulations

Hidden FDA Report Raises Questions About Its Approach to Public Records and Premarket Tobacco Review

FDA’s approach to a premarket tobacco product application (PMTA) raises new questions about whether its marketing denial order was arbitrary and capricious and whether the deliberative-process exemption justifies its...more

3/15/2023  /  Administrative Procedure Act , FOIA , Food and Drug Administration (FDA) , Internal Memorandum , Premarket Approval Applications , Public Health , Public Records , Tobacco , Vaping

FDA Set to Propose Maximum Nicotine Level in Cigarettes

The US Food and Drug Administration (FDA) recently announced plans to publish a proposed rule that would establish a maximum nicotine level in cigarettes and certain “other combusted tobacco products.” At the moment, it is...more

6/24/2022  /  Food and Drug Administration (FDA) , Public Health , Tobacco , Tobacco Regulations

Bipartisan Coalition of 31 State AGs Urge FDA to Deny Marketing Authorization for Non-Tobacco Nicotine Products

On June 10, a bipartisan coalition of 31 state attorneys general, led by Idaho, Illinois, Nebraska, and Pennsylvania, sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, asking the agency to...more

6/16/2022  /  E-Cigarettes , Food and Drug Administration (FDA) , Public Health , State Attorneys General , Tobacco , Vaping

FDA Premarket Review Process for Premium Cigars Halted

On Wednesday, August 19, 2020, the U.S. District Court for the District of Columbia issued an order enjoining FDA from enforcing the premarket review requirement contained in the agency’s “Deeming Rule” against “premium...more

8/21/2020  /  Food and Drug Administration (FDA) , Importers , New Guidance , Premarket Approval Applications , Public Health , Public Safety , Tobacco , Tobacco Regulations
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