On June 23, 2022, the U.S. Food and Drug Administration (FDA) issued marketing denial orders (MDOs)[1] to Juul Labs Inc. for all of the company’s JUUL electronic nicotine delivery system (ENDS) products currently marketed in the United States. After review, FDA determined that Juul’s Premarket Tobacco Product Applications (PMTAs), submitted more than two years
FDA Enforcement Blitz Combats Underage Use of Cartridge-Based E-Cigarettes and Threatens to Sack Premarket Review Compliance Policy and Flavors
On September 12, 2018, in a self-described “blitz”, FDA announced a deluge of enforcement actions, including more than 1,300 warning letters and fines to retailers aimed at addressing youth use of e-cigarettes, which FDA asserts has reached “epidemic” proportions, based on new, not-yet-released survey data.[1] FDA also requested manufacturers of five “national brands,” whose…
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…
Cyclops Vapor Posts Q&A with Azim Chowdhury about Keller and Heckman’s Upcoming E-Vapor and Tobacco Law Symposium
This interview originally appeared here: https://www.cyclopsvapor.com/blog/qa-with-azim-chowdhury-pRight to be Smoke-Free artnerfda-group-tobacco-evapor-food-packaging-at-keller-and-heckman-llp/
Azim Chowdhury is nationally recognized as an expert on FDA issues as they relate to the tobacco and e-vapor industries. He represents tobacco, e-cigarette and e-liquid manufacturers, suppliers and trade associations in matters of FDA regulatory and corporate compliance, and spearheaded Keller and Heckman’s FDA…
Azim Chowdhury and Adam Susser to Participate in the FDLI Tobacco Products and Regulation and Policy Conference
Azim Chowdhury and Adam Susser will participate in the FDLI Tobacco Products and Regulation and Policy Conference, which will take place October 26-27, 2017 in Washington, DC.
This KH sponsored event will bring together public health advocates, researchers, manufacturers, lawyers, consumer interests, entrepreneurs, governmental agencies and others to effectively regulate the broad spectrum of tobacco…