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
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…
Azim Chowdhury Quoted in Law360 Article on Legislation to Watch at Midyear
Keller and Heckman Partner Azim Chowdhury was quoted in the Law360 article, “Product Liability Regulation & Legislation To Watch At Midyear.” The article discusses e-cigarette company Juul’s decision to file an application with the U.S. Food and Drug Administration (FDA) for a new device that has been on the market in the U.K. for several…
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 and FTC Issue Six Warning Letters for Delta-8 THC Copycat Snacks
Reposted from Keller and Heckman’s Blog, The Daily Intake
- Delta-8 Tetrahydrocannabinol (Delta-8 THC) is an isomer of Delta-9 THC, the intoxicating component of certain cannabis plants. It is naturally occurring at very low levels in hemp and can be synthetically manufactured by chemical conversion of cannabidiol (CBD) extracted from hemp. We have discussed a September
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…
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…