FDA approves two Vuse e-cigarette models

May.13.2022
FDA approves PMTA review for Vuse brand e-cigarettes - Vibe and Ciro, but not for the popular Alto product.

The U.S. Food and Drug Administration (FDA) has approved PMTA applications for two Vuse brand e-cigarettes, Vibe and Ciro. However, Vuse's best-selling product, Alto, is still undergoing PMTA review.

 

Two models of electronic cigarettes, each with two corresponding battery types, as well as accompanying closed tobacco-flavored pods (Vibe with 3% nicotine, Ciro with 1.5% nicotine), have also been approved.

 

However, Vuse Vibe and Vuse Ciro flavors other than tobacco have not passed PMTA review, meaning they cannot be legally sold.

 

The Vuse Vibe and Ciro devices are outdated models with low sales in the market. In contrast, the NJOY Ace approved through PMTA in April is a more popular product in the market.

 

Earlier, two Vuse products received PMTA approval: the Vuse Solo in October 2021 and the Vuse Logic in March 2022.

 

Source: FDA

 


Disclaimer

This article is provided solely for professional research, industry discussion, and informational purposes. Any references to brands, companies, products, technologies, or policies are made for factual reporting and analytical purposes only, and do not constitute endorsement, recommendation, promotion, or advertising by 2Firsts.

Nicotine-containing products, including but not limited to cigarettes, e-cigarettes, heated tobacco products, and nicotine pouches, carry significant health risks. Readers are responsible for complying with all applicable laws and regulations in their respective jurisdictions, including age restrictions and access limitations.

The information contained in this article should not be regarded as investment, legal, medical, regulatory, or commercial advice. While 2Firsts strives to ensure the accuracy and reliability of its content, it does not assume liability for any direct or indirect loss arising from errors, omissions, inaccuracies, or reliance on the information contained herein.

This article is not intended for individuals below the legal age for accessing tobacco or nicotine-related information in their jurisdiction.

 

Copyright Notice

This article is either original content produced by 2Firsts or content reproduced, translated, summarized, or adapted from third-party sources with attribution where applicable. The intellectual property rights of the original content remain with 2Firsts or the respective original rights holders.

No individual or organization may copy, reproduce, distribute, republish, modify, translate, or otherwise use this content without prior authorization. Any unauthorized use may result in legal action.

For copyright-related inquiries, corrections, or removal requests, please contact: info@2firsts.com.

 

AI-Assisted Translation and Editing Notice

Portions of this article may have been translated, edited, or reviewed with the assistance of artificial intelligence tools to improve efficiency and readability. Due to the limitations of AI-assisted translation and editing, discrepancies, omissions, or inaccuracies may exist when compared with the original source.

Where applicable, readers are advised to refer to the original source for the most complete and accurate information. If you identify any errors or believe that any content infringes upon your rights, please contact us at info@2firsts.com, and we will review and address the matter promptly.

U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
U.S. Ninth Circuit Upholds FDA Denial of MH Global’s Flavored Vape PMTA Applications
The U.S. Court of Appeals for the Ninth Circuit upheld the FDA’s denial of MH Global LLC’s applications to market flavored electronic nicotine delivery systems (ENDS). The court ruled that FDA’s comparative-efficacy framework, which requires applicants to show that flavored products provide greater cessation or switching benefits than tobacco-flavored alternatives, is consistent with the Tobacco Control Act’s “appropriate for the protection of the public health” standard. The court also found that FDA was not required to establish the framework through notice-and-comment rulemaking.
Aug.26
Latest UK ONS Data: Vaping Rate Edges Down to 9.9% in 2025, a Year After Overtaking Cigarette Smoking
Latest UK ONS Data: Vaping Rate Edges Down to 9.9% in 2025, a Year After Overtaking Cigarette Smoking
Vaping prevalence in Great Britain edged down to 9.9% in 2025 from 10.0% in 2024, with the number of adult users holding at approximately 5.4 million for a second consecutive year, according to the Office for National Statistics (ONS). E-cigarette use had risen from 6.4% in 2020 to 10.0% in 2024, when it exceeded cigarette smoking prevalence for the first time. Cigarette smoking continued to decline to 8.7% in 2025, widening the gap to 1.2 percentage points. Daily vaping declined slightly, while usage among adults aged 25–34 increased despite falling rates in other age groups.
DATA
Oct.14
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
JUUL Purchasers Ask Ninth Circuit to Preserve Antitrust Classes in Case Over Altria’s $12.8 Billion Investment
Private antitrust litigation stemming from Altria's 2018 $12.8 billion investment for a 35% economic interest in JUUL is advancing before the U.S. Court of Appeals for the Ninth Circuit. Direct purchasers, indirect purchasers and indirect resellers of JUUL products filed answering briefs this week seeking to preserve class certifications granted by a California federal court in February. Altria and JUUL argue that individual consumers and large distributors differ too much in purchasing terms to remain in a single direct-purchaser class, while a separate dispute concerns whether California antitrust law can apply to indirect purchasers across 27 jurisdictions. A September trial has been put on hold during the appeal.
Sep.23
Major U.S.  Vape Distributor Demand Vape Pays at Least $300,000 for White House Lobbying Amid Enforcement Pressure
Major U.S. Vape Distributor Demand Vape Pays at Least $300,000 for White House Lobbying Amid Enforcement Pressure
New York vape distributor Ecto World, which operates as Demand Vape, hired political consultant Roger Stone to lobby the Executive Office of the President on regulation of vaping and related products while facing state enforcement and multiple lawsuits. Public lobbying disclosures show that Ecto World paid at least $300,000 for the work through June 30, 2026. Separately, New York State announced in March that more than 28,500 pounds of vaping products tied to the company had been seized, while New York City and the state have pursued legal or enforcement actions. Public records do not show that the lobbying directly changed any specific regulatory or enforcement outcome.
Sep.08
Special Report | From New York to Washington: How FDA’s Tobacco Center Is Reworking Product Review
Special Report | From New York to Washington: How FDA’s Tobacco Center Is Reworking Product Review
FDA’s Center for Tobacco Products is reshaping how it approaches tobacco product review. Based on 2Firsts’ on-site reporting in New York and Washington, this report traces CTP’s emerging direction: stronger links between PMTA and tobacco harm reduction, more category-specific review, greater emphasis on decision-relevant science, more predictable timelines and expanded use of sPMTA for product modifications. CTP also acknowledged major constraints, including just nine PMTA review teams, persistent backlogs and limits on hiring capacity.
Regulations
Oct.08
Australian Coalition Taskforce Calls for 80% Tobacco Tax Cut to Combat Illicit Market
Australian Coalition Taskforce Calls for 80% Tobacco Tax Cut to Combat Illicit Market
According to SGST on August 26, 2026, Australia’s Coalition Illegal Tobacco Taskforce released a report recommending an up to 80% cut in tobacco excise to reduce the appeal of the illicit tobacco market. The report claimed organised crime groups now control about 80% of Australia’s tobacco market and argued that high excise rates have widened the price gap between legal and illegal products. The recommendation remains a policy proposal and has not been adopted by the Australian government, which said its focus remains on enforcement, compliance and additional resources.
Aug.27