Our team has previously written about the Food and Drug Administration’s (FDA) response to the Reagan-Udall Foundation report on the Center for Tobacco Product’s operations. If you missed our prior posts, check them out at the links below:Continue Reading FDA Touts “Significant Strides” in Addressing Reagan-Udall Report but Acknowledges More Work Remains
Agustin Rodriguez and Nicholas Ramos of the Troutman Pepper Tobacco Team will be attending the 2023 Federation of Tax Administration (FTA) Tobacco Section Annual Conference. This in-person event will be held in Tucson, Arizona from August 20-23, 2023, and presents a great opportunity for government and industry members to collaborate on issues related to regulatory compliance.
Agustin and Nicholas will present at the conference on the status of pending flavor ban litigation.
We look forward to seeing you at the conference.
Virginia’s new hemp-derived products statutes (Va. Code § 3.2-5145.1 et seq.) went into effect as of July 1, standing to drastically alter the availability of hemp-derived products in Virginia.Continue Reading Virginia’s New Hemp Regulations – How It Affects Businesses
FDA recently announced the issuance of warnings letters to 189 retailers found to be selling unauthorized tobacco products, specifically Elf Bars and Esco Bars.
As a result of the passage of the Family Smoking Prevention and Tobacco Control Act (TCA), new tobacco products may only be sold in the U.S. if they have received marketing authorization from FDA. Products with pending premarket applications are currently subject to FDA’s enforcement discretion. According to FDA, Elf Bars and Esco Bars have neither received marketing authorization, nor have applications pending with the agency, and therefore cannot be lawfully sold.Continue Reading FDA Warns 189 Retailers of Elf Bar and Esco Bar Vapes Regarding Unauthorized Sales
Published in Law360 on June 27, 2023. © Copyright 2023, Portfolio Media, Inc., publisher of Law360. Reprinted here with permission.
On May 11, R.J. Reynolds Tobacco Co. Inc. went on the offensive to keep its new line of nonmenthol cigarettes marketed with language like “crisp,” “smooth” and “mellow” on store shelves in California.
This suit, R.J. Reynolds Tobacco Co. v. Bonta, seeks declaratory relief in the Superior Court of California, County of Fresno, that California’s attorney general misinterpreted and misapplied the state’s ban on flavored tobacco products, and incorrectly concluded that R.J. Reynolds’ new products violate this ban.Continue Reading What RJ Reynolds’ Calif. Suit Means for Tobacco Regulation
On June 8, more than 50 members of Congress signed a letter addressed to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, expressing concerns over FDA’s delays in reviewing pending Premarket Tobacco Product Applications (PMTAs) and its failure to remove unauthorized products from the market. The letter strongly urges “FDA to (1) expeditiously complete review of remaining e-cigarette PMTAs; (2) follow the science on the risks flavored [e-cigarettes] pose to youth and deny PMTAs for all non-tobacco flavored e-cigarettes, including menthol flavored products; and (3) increase enforcement actions against companies that make, distribute, and sell flavored products without a marketing order, especially products with a significant market share, or products that are most popular with youth.” The letter also requests that FDA respond to several questions by June 23, as summarized below (as of the date of this blog post, we are not aware of any FDA response).
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 you missed our prior posts on the Report and FDA’s response, check them out at the links below:
- Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products
- FDA Responds to Reagan-Udall Foundation Report
- Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force
- 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 — “Public Education Campaigns” and “Resources.”Continue Reading Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Public Education Campaigns and Resources Task Forces
The Troutman Pepper Tobacco + Nicotine Team will attend a TMA workshop on FDA’s proposed rule on tobacco product manufacturing practices. Bryan Haynes will participate in a panel discussion of the legal implications of the proposed rule. The workshop is on Tuesday, June 13 at the Hyatt Regency at Reagan National Airport. We hope you will join us!
Published in Update on May 25, 2023. © Copyright 2023, Food and Drug Law Institute, publisher of Update. Reprinted here with permission.
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 “deliberative” records related to analyses that purportedly were not factored into the agency’s final decision? A federal court will address this question of public disclosure in litigation between Juul Labs, Inc. (JLI) and the U.S. Food and Drug Administration (FDA).Continue Reading <em>Juul Labs, Inc. v. FDA</em>: A FOIA Twist on the Challenge to FDA’s Marketing Denial Order
The Virginia ABC will assess a regulatory scheme for liquid nicotine, with the consultation of stakeholders, and issue a report and recommendations.
On April 12, the Virginia General Assembly enacted House Bill 2296 and Senate Bill 1350, incorporating recommendations of Governor Glenn Youngkin to have the Virginia Alcoholic Beverage Control Authority (ABC) “assess” a potential licensing scheme for liquid nicotine manufacturers, distributors, and retail dealers, as well as administrative and enforcement matters relating to liquid nicotine licensing, age verification, product verification, and advertising restrictions. These bills effectively instruct the ABC to tell the Virginia General Assembly whether and how the Commonwealth should regulate liquid nicotine. The ABC’s report and recommendations are due by November 1, and will be informed by stakeholder input. The enactments specify that the ABC will conduct its assessment “in consultation with stakeholders, including public and community health organizations, retailers, tobacco and vaporized nicotine companies, and wholesalers.”Continue Reading Stakeholders’ Input Welcome: Virginia ABC to Assess Options for Regulating Liquid Nicotine in the Commonwealth