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

Philippine Lawmakers Push Bill to Close Vape Tax Loopholes
Philippine Lawmakers Push Bill to Close Vape Tax Loopholes
Lawmakers in the Philippines are pushing House Bill 5207 (HB 5207), which seeks to harmonize excise tax rates on vapor products and address disparities between nicotine salt and freebase nicotine taxation. The bill, supported by more than 40 lawmakers including Deputy Speaker Kristine Singson-Meehan, would raise taxes on freebase nicotine products to align them with nicotine salt rates.
Regulations
Feb.22
Six Years of Data Show FDA Clearing PMTA Backlog
Six Years of Data Show FDA Clearing PMTA Backlog
FDA data from FY2020 to FY2025 show how the PMTA system for e-cigarette products evolved after an early surge of submissions created prolonged front-end delays. Millions of applications accumulated at the Acceptance stage before entering substantive review. Since 2023, the number of applications pending acceptance has declined sharply, and industry participants report shorter initial decision timelines in late 2025.
Feb.06
2Firsts “Decisive 2026” Concludes: Reviewing the 2025 U.S. Market and Mapping Compliance Pathways Ahead
2Firsts “Decisive 2026” Concludes: Reviewing the 2025 U.S. Market and Mapping Compliance Pathways Ahead
2Firsts hosted “Decisive 2026” in Shenzhen, bringing together industry perspectives to examine major shifts in the U.S. new tobacco market in 2025 and their global implications. Sessions covered U.S. market dynamics, technical insights from recently PMTA-authorized products, an investor lens on tobacco capital markets, and 2025 news/product highlights. The event underscored a structural shift from “gray business” toward compliance and sustainable growth, expected to become clearer by 2026.
Jan.09
Guam names retailers fined for selling tobacco to under-21 customers; penalties range from $2,000 to $4,000
Guam names retailers fined for selling tobacco to under-21 customers; penalties range from $2,000 to $4,000
Guam disclosed enforcement details for its 2025 tobacco retail compliance program, showing a 97.1% compliance rate among 277 inspected retailers. Nine violations were recorded, including eight underage sales cases and one signage violation, with fines ranging from $500 to $4,000.
Feb.10 by 2FIRSTS.ai
Russian consumer group urges Kremlin administration to reject regional vape sales bans
Russian consumer group urges Kremlin administration to reject regional vape sales bans
A Russian consumer organization has urged the Presidential Administration to block proposals that would let regions ban ENDS and e-liquid sales, warning it would create fragmented regulation and turbocharge the illicit market. The group cites WHO statistics and overseas experiences to argue for a more targeted regulatory model.
Feb.06 by 2FIRSTS.ai
Malaysian police raids across five states: 51 held and over RM1 million in vapes seized
Malaysian police raids across five states: 51 held and over RM1 million in vapes seized
Police in Malaysia detained 51 individuals and seized over RM1 million worth of electronic cigarettes and liquid refills in a five-state operation dubbed “Op E-CIG,” conducted by the GOF Central Brigade on February 10. The report said the operation involved 30 raids across Kuala Lumpur, Johor, Melaka, Selangor and Negeri Sembilan. Authorities seized 2,263 vape units and 165.463 litres of liquid.
Feb.12 by 2FIRSTS.ai