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In a long-anticipated decision, the U.S. Court of Appeals for the Fifth Circuit ruled against FDA on January 3, 2024, criticizing the Agency for its handling of Wages and White Lion Investments, LLC, d/b/a Triton Distribution and Vapetasia LLC (“Vapetasia”) (collectively, “Triton”) premarket tobacco product applications (“PMTAs”) for its non-tobacco flavored, open-system e-liquid products.

Keller and Heckman is pleased to announce the addition of a distinguished keynote speaker for the 2024 E-Vapor and Tobacco Law Symposium. Dr. Brian King, Director of FDA’s Center for Tobacco Products (CTP), will provide expert insight into current issues facing the industry. More information regarding this valuable keynote presentation will be available soon.

We are excited to announce the agenda for Keller and Heckman’s 2024 E-Vapor and Tobacco Law Symposium. Click here to view the program agenda, and don’t forget to register by this Friday for your last chance to save $200!

Register now to join us Monday, January 29 – Tuesday, January 30, 2024, in Las Vegas

We’re back! Keller and Heckman’s E-Vapor and Tobacco Law Symposium is returning in 2024 for our 8th annual conference. The symposium will be held Monday, January 29 – Tuesday, January 30, 2024, in Las Vegas, NV (right before TPE). Register today to join us for a two-day comprehensive seminar focused on legal and regulatory issues

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

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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]

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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

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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

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Seal of the Supreme Court of the United States

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

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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