FDA Issues Two Warning Letters to E-cigarette Businesses for Unauthorized Sales

2Firsts Events
Jun.30.2022

The Food and Drug Administration (FDA) posted warning letters on June 28 to two e-cigarette businesses, VAPORIZIT LLC and Elk River Vapor Shop, for selling e-cigarette products not previously on the market.

 

According to the Federal Food, Drug, and Cosmetic Act, new tobacco products, including vapes, need a pre-market authorization order to be sold in the United States.

 

However, the FDA found Elk River’s Crack the Whip 6mg 60 ml and Peach Wht. Grape 3mg 60ml were new products not previously commercially marketed in the United States. Therefore, the products need FDA marketing authorization orders to allow the stores to sell them legally.

 

The company has over 1,100 products listed with FDA and has opened four stores across Alabama and Tennessee.

 

VAPORIZIT, with over 12,800 of its products listed with the FDA, was warned for selling Vaporizit Cosmic Cow e-liquid products without FDA approval, as the vape has not been marketed commercially before.

 

However, Victory Liquid, a business founded before VAPORIZIT in 2013, sells the same product on its website, though it is not known which company sold it first.

 

VAPORIZIT and Elk River Vapor Shop have 15 working days from June 28 to “address any violations” and bring their “products into compliance,” announce the date they will discontinue sales, or provide reasoning if they believe their sales were not a violation of the food and drug policies.

South Korea Vape Strategies Diverge as BAT Reconsiders Exit and PMI Takes VEEV to About 14,000 Stores
South Korea Vape Strategies Diverge as BAT Reconsiders Exit and PMI Takes VEEV to About 14,000 Stores
BAT Rothmans says it previously considered exiting South Korea's vaping market because of competitive pressure from unregulated products, but is now reassessing conditions following changes to the country's nicotine regulatory framework. Vuse and other BAT vaping products remain available through existing distribution channels. The statement followed a South Korean media report that interpreted BAT's broader withdrawal from selected Vapour markets as a full exit from South Korea. Meanwhile, Philip Morris International launched VEEV inPRIME in the country in June and began expanding distribution to around 14,000 convenience stores and other retail channels in July. The contrasting moves highlight differing investment strategies as South Korea's regulated vaping market evolves.
Aug.14
NAS 2026 | FDA CTP Director Says PMTA Pathway Is “Predicated on Tobacco Harm Reduction”
NAS 2026 | FDA CTP Director Says PMTA Pathway Is “Predicated on Tobacco Harm Reduction”
At the 2026 New Approaches Summit in New York, FDA Center for Tobacco Products Director Bret Koplow said the PMTA pathway is “predicated on tobacco harm reduction.” He outlined four CTP priorities: youth prevention, helping adults quit or switch to lower-risk products, improving relative-risk communication, and reducing unauthorized products. Koplow also addressed flavored e-cigarettes, public risk perceptions, industry credibility and efforts to make PMTA reviews more efficient and predictable.
Sep.26
Kumulus Vape2026 H1 Revenue Falls 8.3% but Profit Rises 24% as B2B Weakens and Consumer Channels Grow
Kumulus Vape2026 H1 Revenue Falls 8.3% but Profit Rises 24% as B2B Weakens and Consumer Channels Grow
French vaping company Kumulus Vape reported first-half 2026 revenue of €25.5 million, down 8.3% year over year, as its core B2B distribution business fell 11% to €21.6 million. B2C and store-network revenue rose 5.6% and 17.8%, respectively. Commercial margin increased to 26.3% from 21.7%, while net profit rose 24.1% to €0.8 million. The company attributed the profitability improvement to catalog optimization, logistics restructuring and the ramp-up of Labster, its in-house production unit for proprietary brands.
Market
Sep.17 by 2Firsts Perspectives
China Tobacco Regulator Deputy Head Visits Laos as Both Sides Strengthen Cooperation on Illegal Tobacco Trade
China Tobacco Regulator Deputy Head Visits Laos as Both Sides Strengthen Cooperation on Illegal Tobacco Trade
China’s official Xinhua News Agency reported that Liu Sanjiang, deputy head and Party group member of China’s tobacco regulator, led a delegation to Laos from July 31 to Aug. 2, 2026, for discussions with Lao authorities on combating cross-border illegal tobacco trade. The two sides discussed areas including law enforcement cooperation, information sharing and efforts to address tobacco-related illegal activities such as counterfeiting and smuggling. The visit highlights cooperation between Chinese and Lao authorities on illicit tobacco control.
News
Aug.05
Product | JT Refreshes Ploom CUBE Design and Expands Japan Retail Distribution, Targeting Younger Men and Female Users
Product | JT Refreshes Ploom CUBE Design and Expands Japan Retail Distribution, Targeting Younger Men and Female Users
Japan Tobacco (JT) launched a refreshed Ploom CUBE design in Japan on September 8, 2026, with broader convenience-store and tobacco-retail distribution planned from October 13. The updated device retains the existing Rounded Cube form and heating platform while replacing four previous body colors with Pebble White and Cobalt Black. JT is also introducing new Front Panels and Fabric Back Covers, although the new accessories are not compatible with the previous Ploom CUBE design. The company says the update is intended to broaden appeal among younger male and female users.
Sep.09
 $20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
$20 Million, a Permanent Injunction and Distributor Controls: Posh Deal Tightens Illinois Vape Compliance
An Illinois court ordered three companies tied to Posh vapes to pay $20 million and permanently restricted the sale, marketing and distribution in Illinois of products lacking required FDA authorization. The consent order also imposes downstream distributor controls, age-verification measures and social-media marketing limits, creating a new state-level compliance benchmark for disposable vape businesses.
Regulations
Aug.05