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Tobacco Premarket Approval Applications E-Cigarettes

Troutman Pepper Locke

FDA Sued Over Years-Long Internal Review of Flavored ENDS MDO

Troutman Pepper Locke on

On August 21, 2025, NJOY, LLC (NJOY), a subsidiary of Altria Group, Inc., sued the U.S. Food and Drug Administration (FDA), alleging that the agency has unlawfully delayed rendering a decision on supervisory review of its...more

Knobbe Martens

Flavored E-cigarette Manufacturers Face Regulatory Challenges

Knobbe Martens on

Manufacturers of e-cigarettes find themselves in a challenging regulatory environment to obtain U.S. Food and Drug Administration (FDA) marketing approval of flavored products.  On October 12, 2023, the FDA denied premarket...more

Troutman Pepper Locke

Congress Urges FDA to Complete Its Review of E-Cigarette Applications

Troutman Pepper Locke on

On June 8, more than 50 members of Congress signed a letter addressed to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, expressing concerns over FDA’s delays in reviewing pending Premarket Tobacco Product...more

Akerman LLP

FDA Orders JUUL E-Cigarettes Off The Market Over Safety Concerns

Akerman LLP on

The U.S. Food and Drug Administration (the FDA) issued marketing denial orders (MDOs) to JUUL Labs for all of its products currently marketed in the United States. As a result of this MDO, JUUL must stop selling and...more

Morgan Lewis

FDA Grants First E‑Cigarette PMTA Authorization

Morgan Lewis on

The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These authorizations mark the first...more

Nilan Johnson Lewis PA

Vaping Deaths: What Manufacturers and Retailers Need to Know about Current Laws and Regulations

Nilan Johnson Lewis PA on

In recent weeks, the news has been full of stories of vaping-related illnesses and deaths. An eighth person has now died from a vaping-related illness, and reports state that hundreds more have been sickened with severe...more

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