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.

EU Tobacco Tax Reform Targets November Push as Sweden Holds Nicotine-Pouch Minimum at €20 per Kilogram
EU Tobacco Tax Reform Targets November Push as Sweden Holds Nicotine-Pouch Minimum at €20 per Kilogram
The Irish presidency of the Council of the European Union is using bilateral talks to push the bloc’s Tobacco Taxation Directive toward a political agreement in November. According to Law360, citing an EU official, Sweden is unwilling to accept a minimum excise threshold above €20 per kilogram for nicotine pouches. Council negotiations have already lowered the European Commission’s original proposal, but a May 2026 presidency compromise still set the minimum at 10% of the tax-inclusive retail price or €30 per kilogram in 2028-29, with higher levels later.
Market
Sep.17 by 2Firsts Perspectives
NAS 2026 | Cliff Douglas: Risk Continuum Should Play a Central Role in Tobacco Policy
NAS 2026 | Cliff Douglas: Risk Continuum Should Play a Central Role in Tobacco Policy
Cliff Douglas, a veteran U.S. tobacco-control and public health policy figure, told NAS 2026 that the “continuum of risk” should play a central role in tobacco policy. He called for clearer market pathways, stronger risk communication, differentiated regulation and enforcement, and said possible FDA reforms to PMTA reviews could be a “welcome correction” if they create a more efficient, predictable route for scientifically substantiated lower-risk products. Read 2Firsts’ on-site coverage.
Sep.26
PMI CEO Attends Opening of IQOS Global Flagship in Tokyo’s Ginza as 1,814 Limited ILUMA i PRIME Sets Launch
PMI CEO Attends Opening of IQOS Global Flagship in Tokyo’s Ginza as 1,814 Limited ILUMA i PRIME Sets Launch
IQOS opened its first global flagship, IQOS Flagship Ginza, in Tokyo on September 4, 2026, replacing the former IQOS Store Ginza after nearly a decade of operation. The new location expands conventional product retail into member lounges, digital experiences, art installations and brand programming. IQOS also launched a Ginza-exclusive IQOS ILUMA i PRIME set limited to 1,814 individually numbered units, priced at JPY11,980, or about US$77. PMI Sales Strategy Consultant Yuji M. later said on LinkedIn that more than 500 people had lined up from the night before the opening.
Sep.07
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Elf Bar Vape Explosion and Amputation Claim Spurs Coverage Suit, U.S. Insurer MUSIC Seeks Ruling It Owes No Duty to Defend or Indemnify Distributor i5
Mesa Underwriters Specialty Insurance Company has asked a federal court in Washington to declare that it has no duty to defend or indemnify vape distributor i5 Distribution in a product liability case involving an Elf Bar BC5000. The plaintiff alleges that the disposable vape caught fire and exploded in his pocket, causing severe burns and ultimately requiring an above-the-knee amputation of his left leg. MUSIC is relying on a tobacco, nicotine or nicotine replacement products exclusion and a premises limitation endorsement. The court has not ruled on the coverage dispute.
News
Sep.10
Product | RELX Partners With UK E-Liquid Brand T-Juice for Prime Pro × Red Astaire Bundle in France
Product | RELX Partners With UK E-Liquid Brand T-Juice for Prime Pro × Red Astaire Bundle in France
RELX and UK e-liquid brand T-Juice have launched the Prime Pro × Red Astaire bundle in France, combining the RELX Prime Pro open-system pod device with T-Juice’s signature Red Astaire nicotine salt e-liquid. The collaboration retains the existing Prime Pro hardware platform while using an established flavor brand to create a complete open-system offering. The product appeared in French retail and distribution channels in August 2026 and represents a co-branded retail bundle rather than a new device launch.
Aug.27
Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
Reynolds Showcases Vuse Pro Flavors and VELO Nicotine Pouches at NACS Show 2026
Reynolds American, a BAT subsidiary, showcased four Vuse Pro flavored e-cigarette pods and its VELO nicotine pouch portfolio at NACS Show 2026. Booth staff confirmed to 2Firsts that the Vuse Pro flavors are sold in the U.S., although they have not received FDA marketing authorization. BAT outlined plans to expand Vuse retail distribution and reported that VELO held a 30.5% year-to-date volume share of the U.S. modern oral nicotine category through August 2026. The booth also featured the newly launched VELO MAX range and merchandising displays combining cigarettes, vaping products and oral nicotine brands.
EXPO
Oct.09