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 Continuum of Risk
A Law Blog for Vapor, Tobacco and Reduced-Harm Product Companies
Latest from The Continuum of Risk - Page 2
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…
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…
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
…
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…
Azim Chowdhury Quoted in a CSP Magazine Article on 2023 Tobacco Regulations
Keller and Heckman Partner Azim Chowdhury was interviewed for the CSP Magazine article, “Regulations 2023: One Thing After Another.” The article discusses the many regulatory updates coming for tobacco products in 2023, including a likely ban on menthol cigarettes, an…
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…
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…
Keller and Heckman Tobacco and E-Vapor Attorneys to Speak at Upcoming Industry Events
On June 7, Partner Kathryn (Katie) Skaggs will present at the Food and Drug Law Institute’s (FDLI) Legal and Practical Issues in Cannabis Regulation virtual event, to be held June 7 – 8, 2023. Katie will participate on the panel,…
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…