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

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.

FDA Launches Elsa 4.0 and Completes HALO Data Platform Consolidation
FDA Launches Elsa 4.0 and Completes HALO Data Platform Consolidation
The U.S. Food and Drug Administration announced on May 6 that it has advanced its modernization initiative by launching Elsa 4.0, an upgraded internal AI tool, and consolidating more than 40 application and submission data sources, systems and portals into a new platform called HALO. FDA said the integration of HALO and Elsa will allow staff to query data and build workflows without manually uploading documents in each chat.
May.07 by 2FIRSTS.ai
One Year After UK Disposable Vape Ban: Youth Use Falls to 13%, Adult Use to 8%
One Year After UK Disposable Vape Ban: Youth Use Falls to 13%, Adult Use to 8%
among both youth and adults. However, industry groups and regulators warn that the illicit vape market remains a growing concern.
Jun.09
Product | Geek Bar BURJ 80K Extends High-Puff Competition Into Hookah-Style DTL Use
Product | Geek Bar BURJ 80K Extends High-Puff Competition Into Hookah-Style DTL Use
2Firsts has noted that Geek Bar has added BURJ to its official product portfolio under the E-HOOKAH category. Public information shows that BURJ 80K is a hookah-style disposable vape featuring a 25ml e-liquid capacity, a 1500mAh battery, 0.4Ω dual coils and three operating modes: ECO, Regular and Pulse. According to publicly available product information, the device is rated for up to 80,000 puffs in ECO mode and uses a nicotine strength of 0.5% (5mg/ml).
Market
May.29
Product | VEEV One Plus Goes Official as PMI Strengthens Its Closed-Pod Vaping Portfolio
Product | VEEV One Plus Goes Official as PMI Strengthens Its Closed-Pod Vaping Portfolio
Philip Morris International (PMI) has officially introduced the VEEV One Plus, the next-generation device in its closed-pod vaping lineup. The product is now featured on the official VEEV website in Portugal, bringing hardware upgrades including a new dual-pod storage system, a larger battery, and an updated device design while maintaining compatibility with existing VEEV One pods.
Jul.02
Turning Point Brands Reports Q1 2026 Net Sales of $124.3 Million as Modern Oral Net Sales Rise 133%
Turning Point Brands Reports Q1 2026 Net Sales of $124.3 Million as Modern Oral Net Sales Rise 133%
Turning Point Brands reported first-quarter 2026 results on May 7, covering the period ended March 31, 2026. Total consolidated net sales were $124.3 million, up 16.8% year on year. Gross profit was $68.3 million, up 14.6%, while net income fell 19.0% to $11.7 million. Adjusted EBITDA declined 6.5% to $25.9 million.
May.08 by 2FIRSTS.ai
Reuters: Shopify May Ban All Vape Sales This Week Amid Illegal Market Crackdown
Reuters: Shopify May Ban All Vape Sales This Week Amid Illegal Market Crackdown
Reuters reported that Shopify may ban all vape products from its platform as soon as this week, signaling that U.S. enforcement against the illegal vape market is expanding from retailers and importers to e-commerce platforms and payment networks.
MarketBAT
Jun.23 by 2Firsts Perspectives