Premarket Tobacco Product Marketing Granted Orders

Industry Insight
May.15.2022
2022 Premarket Tobacco Product Marketing Granted Orders

2022 Premarket Tobacco Product Marketing Granted Orders 

Premarket Tobacco Product Marketing Granted Orders
Premarket Tobacco Product Marketing Granted Orders

Before making documents available to the public, FDA must redact trade secret and confidential commercial information (CCI) and ensure documents posted to the FDA website are accessible to everyone. For these reasons, the full decision summary for marketing authorizations may not be posted to the website until after the order issuance date. In the interim, to provide as much information as possible at the time of order issuance, we are making redacted versions of the order letter and the “Executive Summary” section of the decision summary available to broadly explain the public health rationale for authorization of these products.

 

Source:FDA

Malaysia joint operation seized $19,000 worth of vape liquid in Likas
Malaysia joint operation seized $19,000 worth of vape liquid in Likas
More than 2,300 units of vape liquid worth over RM75,000 were seized during an integrated operation at premises in Likas near Kota Kinabalu. During Ops Taring Landai E-Cigarette Mega on Feb 10 night, the Marine Police, Sabah Health Department officials and district police detected a shop displaying 92 types of vape pods and, after further searches, found 2,353 units of vape liquid stored on the premises.
Feb.11 by 2FIRSTS.ai
Vape Club: Over 1.3 Million Illegal E-Cigarettes Seized in UK by 2025, Worth £10 Million on Streets
Vape Club: Over 1.3 Million Illegal E-Cigarettes Seized in UK by 2025, Worth £10 Million on Streets
Vape Club report reveals 1.3 million illegal e-cigarettes seized in UK by 2025, worth £10 million on the streets.
Mar.12 by 2FIRSTS.ai
European survey: current e-cigarette use among 15–19-year-olds rises from 14% (2019) to 22% (2024)
European survey: current e-cigarette use among 15–19-year-olds rises from 14% (2019) to 22% (2024)
A European study cited in the report says the share of young people aged 15 to 19 who are current e-cigarette users increased from 14% in 2019 to 22% in 2024, with Italy reflecting the broader European pattern. Over the same period, conventional cigarette smoking among young people is described as declining, with the proportion of students who have smoked at least once in their lifetime falling sharply from 1995 to 2024, and the largest drop occurring between 2019 and 2024.
Feb.12 by 2FIRSTS.ai
Bonnie Herzog:U.S. nicotine market seen at about $67B in revenue by 2035 as smoke-free expands
Bonnie Herzog:U.S. nicotine market seen at about $67B in revenue by 2035 as smoke-free expands
Goldman Sachs Managing Director Bonnie Herzog said the U.S. nicotine market is attractive and growing, with total revenue projected to reach about $67 billion by 2035. She expects cigarettes to account for a smaller share of revenue (47%) as smoke-free revenue expands and becomes a key driver of industry profit growth. Herzog said smoke-free products represent about 48% of U.S. nicotine volumes today and could rise to roughly 75% by 2035.
Mar.04 by 2FIRSTS.ai
Exclusive: Glas says FDA-authorized G2 vape includes age-gating technology
Exclusive: Glas says FDA-authorized G2 vape includes age-gating technology
Glas has confirmed to 2Firsts that its G2 device, which received a FDA Marketing Granted Order (MGO), incorporates age-gating technology. Based on currently public information, this means the FDA has granted an MGO to the first ENDS product confirmed to incorporate age-gating technology, validating 2Firsts’ earlier inference.
Mar.17
Special Report | Breeze and Glas Seek White House Review as FDA Advances Flavored ENDS Guidance
Special Report | Breeze and Glas Seek White House Review as FDA Advances Flavored ENDS Guidance
Breeze Smoke and Glas, Inc. have separately requested White House review under Executive Order 12866 as the FDA advances draft guidance on flavored ENDS (RIN 0910-ZC78). The guidance aims to clarify evidentiary standards under the statutory “appropriate for the protection of public health” (APPH) framework. The parallel filings highlight industry concern over regulatory predictability, particularly as Glas’s PMTA review status has recently drawn market attention.
Special Report
Mar.03