Last summer, we wrote about the Iowa Attorney General’s $133 million suit against the tobacco manufacturers that are signatories to the Master Settlement Agreement (MSA). Brought in Iowa state court, this suit alleged that those manufacturers (commonly referred to as “Participating Manufacturers”) acted in bad faith by disputing (and delaying the ultimate payment of) the amounts they owe to the state under the MSA. On August 22, 2023, Iowa compromised its past and future claims under the lawsuit and joined 37 other states that have settled similar disputes. Iowa Attorney General Brenna Bird announced that the state reached a settlement with the Participating Manufacturers that will result in the state receiving payments of more than $171 million over the next six years. Continue Reading Iowa Reaches MSA Settlement with Tobacco Manufacturers, Ending 18-Year Legal Dispute
FDA’s Center for Tobacco Products to Hold Public Meeting on PMTA Process
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) will hold a two-day public meeting on the agency’s premarket tobacco product application (“PMTA”) process. The meeting will be held October 23-24 and can be attended in person in Silver Spring, Maryland, or online.
CTP’s press release indicates that staff from the Office of Science
Virginia’s New Hemp Regulations – How It Affects Businesses
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 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.
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
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 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
Federal Government Ramping Up Vapor Enforcement
Over the last several months, FDA and DOJ enforcement efforts have increasingly focused on manufacturers and distributors of vapor products covered by the Food, Drug, & Cosmetic Act and the PACT Act.
The Food & Drug Administration (FDA) and Department of Justice (DOJ) are increasingly focusing enforcement efforts on electronic nicotine delivery systems (ENDS). Such enforcement priorities have been reflected in six DOJ complaints for injunctions and four FDA complaints for civil monetary penalties (CMP) against businesses dealing in ENDS without marketing authorization under the Food, Drug, and Cosmetic Act (FD&C Act). In addition, ENDS businesses have been receiving communications from DOJ’s Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) alleging violations of the PACT Act, and FDA has issued a substantial number of warning letters alleging ENDS businesses’ FD&C Act violations. Federal prioritization of ENDS enforcement has also been reflected in FDA statements in connection with its CMP complaints and the Reagan-Udall Foundation’s operational evaluation of FDA’s Center for Tobacco Products (CTP), which we have discussed here, here, and here.Continue Reading Federal Government Ramping Up Vapor Enforcement
FDA Responds to Reagan-Udall Foundation Report
On February 24, 2023, the Food and Drug Administration (“FDA”) issued a response to the report prepared by the Reagan-Udall Foundation in December 2022. The Foundation’s report was originally commissioned by FDA Commissioner Robert Califf, highlighted a number of issues with the operations of the agency’s Center for Tobacco Products, which has been tasked with regulating tobacco and nicotine products in the U.S., and proposed 15 recommendations for consideration by the agency. You can read our summary of the report’s findings here.Continue Reading FDA Responds to Reagan-Udall Foundation Report
Connecticut AG Sues Retailers for Illegal Delta-8 THC Product Sales
On February 9, Attorney General William Tong sued five Connecticut retailers for violating the state’s Unfair Trade Practices Act (UTPA) by selling allegedly illegal delta-8 tetrahydrocannabinol (THC) products, many of which mimicked snack foods and candies popular among youth.Continue Reading Connecticut AG Sues Retailers for Illegal Delta-8 THC Product Sales
Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products
The Reagan-Udall Foundation, an independent nonprofit created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety” recently released its report Operational Evaluation of Certain Components of FDA’s Tobacco Program. The report was commissioned by FDA Commissioner Robert Califf in July, 2022 amid ongoing controversy over the agency’s handling of premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) and a lack of enforcement against unlawful ENDS.Continue Reading Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products
Bipartisan Marijuana Research Bill Heads to Biden’s Desk
The Senate recently passed the Medical Marijuana and Cannabidiol Research Expansion Act (the Act) by a voice vote after the House of Representatives passed the bill with strong bipartisan support (325-95) last July. The Act is the first stand-alone marijuana legislation passed in decades and, according to some news sources, President Biden will likely sign it within the next two weeks. Historically, conducting research with Schedule I controlled substances has been subject to numerous administrative hurdles and onerous security requirements that have deterred many potential researchers. The Act amends key sections of the Controlled Substances Act (CSA) to ease some of those restrictions and to facilitate research on marijuana and its potential therapeutic benefits, without changing marijuana’s designation as a Schedule I controlled substance. Some of the key provisions are summarized below.Continue Reading Bipartisan Marijuana Research Bill Heads to Biden’s Desk