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 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]
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
California Votes “Yes” on Proposition 31 Banning the Retail Sale Non-Tobacco Flavored Tobacco Products; Keller and Heckman Files Supreme Court Amicus Brief in Case Challenging Los Angeles County Flavor Ban
On November 8, 2022, California voters approved[1] the Referendum on 2020 Law That Would Prohibit the Retail Sale of Certain Flavored Tobacco Products (Proposition 31). The referendum, submitted in accordance with the provisions of Section 9 of Article II of the California Constitution, asked California citizens to vote on whether to uphold a 2020
FDA’s Marketing Denial Order Issued to Bidi Vapor’s Non-Tobacco Flavored ENDS Products are Set Aside and Remanded by the 11th Circuit Court of Appeals for being Arbitrary and Capricious
Last year, Bidi Vapor LLC (Bidi or the Company), represented by Keller and Heckman LLP Partners Eric Gotting and Azim Chowdhury, petitioned the 11th Circuit Court of Appeals to review the Food and Drug Administration’s (FDA) order denying the Premarket Tobacco Product Applications (PMTA) for its non-tobacco flavored BIDI® Sticks, a disposable electronic nicotine
Keller and Heckman LLP Files Citizen Petition Requesting 180-day Extension of PMTA Deadline for Small Open-System Vape Companies Due to COVID-19
On August 24, 2020, Keller and Heckman LLP filed a citizen petition (here) with the U.S. Food and Drug Administration (FDA) on behalf of a group of small vapor product manufacturers, retailers, and trade associations requesting that the agency seek a 180-day extension of the September 9, 2020 deadline (until March 8, 2021)
Maryland District Court Extends Premarket Application Submission Deadline to September 9, 2020 In Light of Coronavirus Outbreak; Appeal of the Merits Continues with the Fourth Circuit
On April 22, 2020, the U.S. District Court for the District of Maryland modified its July 12, 2019 Remedies Order (the “Remedies Order”) in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.) to extend the May 12, 2020 premarket application deadline to September 9, 2020 for all deemed
Debrief TODAY! American Academy of Pediatrics et al. vs. FDA: How Will the Decision Impact the Vapor Industry?
Azim Chowdhury and Eric Gotting, partners at Keller and Heckman, will discuss the recent decision in the case American Academy of Pediatrics et al. vs. FDA, which struck down the extended premarket review compliance policy for deemed tobacco products. Find out what the decision will mean to your business, both short and long term.
All
Oral Argument Held in Deeming Rule Appeal by Nicopure Labs and Right to be Smoke-Free Coalition
On September 11, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the “Appellants”) appeared for oral argument before a three-judge panel in the United States Court of Appeals for the District of Columbia Circuit to appeal a decision issued last year by the U.S. District Court for the District of Columbia, which ruled in favor of the U.S. Food and Drug Administration (“FDA”) in the first lawsuit challenging various provisions of the Family Smoking Prevention and Tobacco Control Act (“TCA” or “Act”) and the FDA’s Deeming Rule as they are being applied to the vapor industry. During oral argument, the Appellants argued that the Modified Risk Tobacco Product (“MRTP”) preclearance requirement imposed by Section 911 of the TCA violates the First Amendment as applied to e-cigarettes and other vapor products. In addition, the Appellants argued that application of the Act’s free sample ban to vapor products violates the First Amendment, and that FDA failed to tailor the premarket tobacco application (“PMTA”) requirements to ensure the continued availability of vapor products. Below, we provide a brief overview of the issues discussed at the oral argument. The recording of the hearing is available here. For background on the appeal, see our previous blog posts, including copies of the legal briefs, available here and here.
Continue Reading Oral Argument Held in Deeming Rule Appeal by Nicopure Labs and Right to be Smoke-Free Coalition
FDA and Right to Be Smoke-Free Coalition File Briefs Opposing Summary Judgment Motion in Public Health NGOs’ Lawsuit Seeking to Nullify FDA’s PMTA Filing Deadline Extension
Defendant U.S. Food and Drug Administration (FDA) and the Right to Be Smoke-Free Coalition (RSF) recently submitted briefs to the federal district court of Maryland opposing a motion for summary judgment filed by various public health NGOs in American Academy of Pediatrics v. FDA.[1] The NGOs are challenging various extensions to premarket application