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

Product | JTI Philippines Expands Nordic Spirit Nicotine Pouch Portfolio With Dark Pop and Red Frost
Product | JTI Philippines Expands Nordic Spirit Nicotine Pouch Portfolio With Dark Pop and Red Frost
JTI Philippines has expanded the Nordic Spirit nicotine pouch portfolio in the Philippines with two new variants, Dark Pop and Red Frost. Both products maintain the brand’s tobacco-free nicotine pouch positioning, with Dark Pop featuring a fizzy cola profile with citrus and sweet notes, while Red Frost combines cool mint with sweet red berry flavors. The two variants are now available through Philippine online retail channels.
Aug.18
Australia Brings in Deloitte to Support Illicit Tobacco and Vape Enforcement Across Data, Processes and Project Delivery
Australia Brings in Deloitte to Support Illicit Tobacco and Vape Enforcement Across Data, Processes and Project Delivery
Australia’s Department of Home Affairs has hired Deloitte to provide data analytics, business-process, communications and project-delivery support to the Office of the Illicit Tobacco and E-Cigarette Commissioner. The government says Deloitte personnel do not provide policy advice to the Commissioner or the Australian government, with policy development and decision-making remaining with public officials. The arrangement has nevertheless drawn scrutiny because Deloitte has previously provided professional services to several tobacco and vaping companies.
Sep.03
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
South Korea Constitutional Court Upholds Volume-Based E-Liquid Tax, With Challenged Rates at KRW 370 and KRW 628 per Milliliter
South Korea's Constitutional Court has upheld fixed taxes on nicotine-containing e-cigarette liquids based on solution volume, ruling that challenged provisions imposing KRW 370 per milliliter in individual consumption tax and KRW 628 per milliliter in tobacco consumption tax do not violate the Constitution. The cases stemmed from historical disputes involving importers that reported nicotine as being extracted from tobacco stems rather than leaves. South Korea has since broadened its tobacco definition to include synthetic nicotine, while current tax laws provide reduced rates for certain products not derived from tobacco.
Sep.18
Germany's Four-Year Tobacco Tax Plan Heads to Parliament as BAT, JTI and PMI Push for Changes
Germany's Four-Year Tobacco Tax Plan Heads to Parliament as BAT, JTI and PMI Push for Changes
Germany's parliament is scheduled to hold a first reading of amendments to the Tobacco Tax Act on September 24. The government plans annual tax increases from 2027 through 2030 covering cigarettes, heated tobacco, vaping liquids and other categories. It expects the reform to generate €756 million in additional revenue in 2027, rising to €3.589 billion in additional annual revenue by 2030. Ahead of the parliamentary debate, the German Association of the Tobacco Industry and Novel Products, or BVTE, launched the "Tabaksteuer mit Augenmaß" campaign backed by BAT, JTI, Philip Morris, Reemtsma and wholesale and retail groups.
Sep.23
From Nicotine Salts to Cocrystals: China’s Shenzhen Huabao institute explores a more stable form for sustained nicotine release
From Nicotine Salts to Cocrystals: China’s Shenzhen Huabao institute explores a more stable form for sustained nicotine release
China-based Shenzhen Huabao Collaborative Innovation Technology Research Institute Co., Ltd. has filed a patent application for a nicotine-ascorbic acid cocrystal, exploring a new solid-state form of nicotine. The patent proposes applications across e-liquids, heated tobacco sticks, oral tobacco, chewing tobacco and snuff. In nicotine pouch tests disclosed in the filing, cocrystal formulations showed less than a 6% decline in nicotine content after three months of accelerated storage and a release profile combining early-stage release with sustained delivery over 60 minutes. The filing reflects exploration of nicotine forms beyond conventional nicotine base and nicotine salts.
Aug.13
How Large Is France’s Off-Channel Tobacco Market? Logista Says It Has Become Structural, While the Official Estimate Is 17.7% and Some Industry Studies Put It Above 50%
How Large Is France’s Off-Channel Tobacco Market? Logista Says It Has Become Structural, While the Official Estimate Is 17.7% and Some Industry Studies Put It Above 50%
Logista France says tobacco consumption outside France’s official tobacconist network has become a large and structural market phenomenon, but official and industry estimates differ sharply. France’s TAFE study estimates that 17.7% of tobacco consumption escaped domestic taxation in 2023, with most of that volume attributed to cross-border purchasing rather than street sales. Some industry studies use broader off-channel definitions and put the figure above 50%. Meanwhile, French Customs seized 547.94 tonnes of tobacco in 2025, up 12%, showing continued pressure from illicit trade.
Sep.04