A new study published this month in The Lancet’s eClinical Medicine – the largest electronic cigarette (e-cigarette) clinical trial in the U.S. to date – confirms the role of e-cigarettes in smoking cessation. Specifically, the new research supports that e-cigarettes can be a viable means of quitting or reducing more harmful combustible cigarette use for
China Update: STMA Publishes Guidelines on Quality Assurance for E-Cigarettes for Export
Although e-cigarettes manufactured in China for export to overseas markets are not subject to pre-market approval in China, and are only required to comply with the regulations of the destination country, China’s State Tobacco Monopoly Administration (STMA) still attaches great importance to the quality management of e-cigarettes for export.
On July 18, 2023, STMA released
Federal Court Vacates FDA Deeming of Premium Cigars Subject to the Tobacco Control Act
On August 9, 2023, Judge Amit P. Mehta of the U.S. District Court of the District of Columbia issued a final Memorandum Opinion in Cigar Association of America et al. v. United States Food and Drug Administration et al., vacating the decision of the Food and Drug Administration (FDA) to deem premium cigars subject
Keller and Heckman Files Supreme Court Amicus Brief on Behalf of ENDS Industry in Support of Request to Overturn or Limit the Chevron Doctrine
On July 24, 2023, Keller and Heckman Partners Eric Gotting and Azim Chowdhury, along with co-counsel, on behalf of members of the Electronic Nicotine Delivery Systems (ENDS) industry[i], filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of petitioners in Loper Bright Enterprises v. Raimondo[ii]
FDA Inspection Blitz Leads to Over 180 Warning Letters to Retailers for the Sale of Unauthorized E-Cigarettes
On June 22, 2023, FDA announced it had issued warning letters to 189 retailers for selling unauthorized flavored tobacco products manufactured by Elf Bar and Esco Bar brands. This enforcement action comes on the heels of earlier aggressive action by FDA in its issuance of more than 570 warning letters to firms for the manufacture
Experts Recommend FDA Adopt an Enhanced Regulatory Strategy for Nicotine and Tobacco Products to Help Reach Cancer Moonshot Goals
As we previously reported, the Reagan-Udall Report evaluated FDA’s Center for Tobacco Products (CTP) and reported that stakeholders were concerned over, among other things, a lack of clear guidance and transparency regarding regulations, the premarket review process, and enforcement priorities. On February 24, 2023, CTP responded to the report and committed to addressing all
Keller and Heckman Files Supreme Court Amicus Brief on Behalf of Public Health Experts in Support of Avail Vapor’s Cert Petition Challenging FDA’s Marketing Denial Order
On June 14, 2023, Keller and Heckman Partners Eric Gotting and Azim Chowdhury, on behalf of a group of public health experts, filed an amicus brief with the Supreme Court of the United States (SCOTUS) in support of Avail Vapor’s writ of certiorari petitioning SCOTUS to review the Fourth Circuit’s decision to uphold the Food
The Reagan Udall Foundation – A Critical Evaluation of FDA’s Center for Tobacco Products
I. Reagan-Udall Report
In July 2022, the Food and Drug Administration (FDA) Commissioner, Dr. Robert Califf, released a public statement saying the agency “has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations.” As such, Commissioner Califf was “prompt[ed] . . . to take a closer look at
News Alert: Public Consultation on the EU’s Tobacco Products Legislation: Comment Period Open Until May 16, 2023
On February 21, 2023, the European Commission opened a public consultation[1] seeking feedback on the performance of the current legislative framework for tobacco products, and ways that the legislation could be improved. All interested stakeholders can submit comments until May 16, 2023.
I. Background
In May 2008, the European Commission issued a report[2]
FDA Publishes Proposed Rule on Tobacco Product Manufacturing Practices
On March 10, 2023, the U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule on Requirements for Tobacco Product Manufacturing Practice (TPMP),[1] which sets forth proposed requirements for the manufacture, design, packing, and storage of tobacco products[2]. The proposed requirements are essentially “good manufacturing practices” for tobacco products and are intended to minimize