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.

Product | JNR Launches Crown Shisha 100K for International Wholesale, Pairing 58ml Capacity With Triple-Mesh DTL Design
Product | JNR Launches Crown Shisha 100K for International Wholesale, Pairing 58ml Capacity With Triple-Mesh DTL Design
JNR released the Crown Shisha 100K on August 14, 2026, positioning the ultra-high-capacity disposable around a direct-to-lung (DTL) e-shisha experience. The device combines a 58ml e-liquid capacity, triple 1.0Ω mesh coils and a 1,300mAh rechargeable battery, with JNR claiming up to 100,000 puffs. Adjustable airflow, battery and e-liquid status displays, a leather-style exterior and a shisha-inspired sound effect further differentiate the product. JNR is currently promoting the device through international wholesale and distribution channels, while a specific first retail market has not been disclosed.
Aug.31
Imperial Brands Sees Double-Digit NGP Growth as Sixth Year of Tobacco Revenue Gains Backs £1.5 Billion Buyback
Imperial Brands Sees Double-Digit NGP Growth as Sixth Year of Tobacco Revenue Gains Backs £1.5 Billion Buyback
Imperial Brands reaffirmed its FY26 guidance in its October 8 pre-close trading update, forecasting double-digit net revenue growth in next-generation products and share gains across heated tobacco, vape and modern oral. Tobacco net revenue is expected to grow at a low-single-digit rate, marking a sixth consecutive year of growth. The company has completed its £1.45 billion FY26 share repurchase and announced a £1.5 billion buyback for FY27. Group adjusted operating profit is expected to increase 3% to 5%, while free cash flow is forecast to exceed £2.2 billion.
Oct.09
Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Special Report | Can Nicotine Be Replaced? 6-MN Is Already on the Market While Key Human Evidence Is Still Missing
Nicotine analogues such as 6-methylnicotine are already appearing in e-cigarettes and oral pouches, even as key human evidence remains limited. A new Nixodine-S study adds nonclinical data showing differences from nicotine in cytotoxicity and receptor activity, while independent studies point to a more complex toxicological picture. With supply-chain activity growing and FDA seeking clearer authority over nicotine analogues, the industry now faces a larger question: what evidence is needed before these substances can credibly replace nicotine?
SCIENCE
Sep.23
IKE Tech Launches IKE 2.0 Compliance Platform for Nicotine Products
IKE Tech Launches IKE 2.0 Compliance Platform for Nicotine Products
IKE Tech launched IKE 2.0 on September 28, initially targeting nicotine products with a platform that combines user identity verification, product authentication, configurable policy controls and data analytics. Products can be authenticated through direct device integration or NFC smart tags. IKE Tech was formed with participation from Ispire's Aspire North America, Berify and Chemular, with Ispire currently holding a 40% interest. Its age-verification component PMTA was accepted by the FDA in 2025 and remains under review. The company did not disclose customer names, commercial deployment volumes, pricing or revenue tied to IKE 2.0.
News
Sep.29 by 2Firsts Perspectives
Smoore Seeks to Toss CCELL Price-Fixing Claim as Court Weighs Vertical Distribution Versus Horizontal Conspiracy
Smoore Seeks to Toss CCELL Price-Fixing Claim as Court Weighs Vertical Distribution Versus Horizontal Conspiracy
Smoore and four authorized U.S. CCELL distributors are asking a California federal court to permanently dismiss a core antitrust claim brought by direct purchasers. Plaintiffs allege that Smoore coordinated minimum wholesale prices, customer allocation and limits on price competition among distributors, amounting to a per se unlawful horizontal conspiracy. The defendants say the alleged conduct reflects ordinary vertical relationships between a manufacturer and its distributors. The court previously dismissed a similar claim, and the latest dispute centers on whether the second amended complaint adds sufficient facts to establish a horizontal agreement.
Sep.14
Juul Displays FDA-Authorized JUUL2, Highlights Age Verification at NACS Show 2026
Juul Displays FDA-Authorized JUUL2, Highlights Age Verification at NACS Show 2026
At the 2026 NACS Show in Las Vegas, Juul Labs displayed its JUUL2 e-cigarette system alongside existing products, age-verification messaging and mobile coupons, 2Firsts observed. The JUUL2 device and Virginia Tobacco and Polar Menthol pods received FDA marketing authorization in August 2026. Booth materials highlighted longer battery life, greater e-liquid capacity and connected-device features. A TruAge sign and a mobile coupon presentation also featured at the booth, with weekly offers available to age-verified adult nicotine consumers at participating retailers.
EXPO
Oct.09