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.

2Firsts Hosts U.S. Compliance Briefing on Building PMTA Support Capabilities Across the Nicotine Supply Chain
2Firsts Hosts U.S. Compliance Briefing on Building PMTA Support Capabilities Across the Nicotine Supply Chain
2Firsts held a U.S. compliance briefing in Shenzhen to help vaping, heated tobacco and nicotine pouch supply chain companies strengthen PMTA support capabilities. The event focused on supplier documentation, quality systems, traceability, TPMF/TPMP pathways, age verification and customer audit readiness as U.S. compliance expectations increasingly extend deeper into the nicotine supply chain.
Events
Jun.12
Product | JTI Expands Ploom Ecosystem as LYO Tobacco-Free Nicotine Sticks Roll Out Across Europe
Product | JTI Expands Ploom Ecosystem as LYO Tobacco-Free Nicotine Sticks Roll Out Across Europe
Japan Tobacco International (JTI) is expanding its Ploom heated product ecosystem with LYO tobacco-free nicotine sticks. Designed specifically for Ploom devices, LYO contains nicotine but no tobacco. Public information shows that the product has gradually entered several European markets, including Spain, Portugal and Germany, and was officially introduced in Romania in July 2026. The launch highlights JTI’s efforts to explore broader nicotine consumable formats beyond traditional tobacco-based sticks.
JTI
Jul.21 by 2Firsts Perspectives
UK Disposable Vape Ban Marks One Year as Adult Use Falls to 8% and Youth Use to 13%
UK Disposable Vape Ban Marks One Year as Adult Use Falls to 8% and Youth Use to 13%
One year after the UK ban on single-use disposable vapes took effect, YouGov data commissioned by Action on Smoking and Health shows that 13% of 11-17-year-old vapers and 8% of adult vapers now mainly use disposable products.
Jun.18
Vapesourcing Lists RELX Creator Pro 15K as “Coming Soon,” Shows U.S. Warehouse Shipping Options
Vapesourcing Lists RELX Creator Pro 15K as “Coming Soon,” Shows U.S. Warehouse Shipping Options
2Firsts found that U.S.-facing and cross-border vape retailer Vapesourcing has created a product page for the “RELX Creator Pro 15K Disposable Vape Kit 3%,” marked as “Coming Soon.” The page lists U.S. warehouse shipping options, but does not show that the product is currently available for purchase.
Market
Jun.08
U.S. Military Nicotine Policy Sparks Debate as Nicotine Pouches Enter Discussion
U.S. Military Nicotine Policy Sparks Debate as Nicotine Pouches Enter Discussion
An opinion article published by Stars and Stripes argued that the Pentagon’s January nicotine clinical guidelines overemphasize abstinence, fail to reflect the reality that about 30% of active-duty personnel use nicotine, and do not address nicotine pouches as potential harm-reduction products.
Industry Insight
Jun.08
Malaysia Police Plan Saliva Tests at Roadblocks to Detect Synthetic Drugs Mixed Into Vape Liquids
Malaysia Police Plan Saliva Tests at Roadblocks to Detect Synthetic Drugs Mixed Into Vape Liquids
Malaysian police plan to use saliva test kits at roadblocks to detect drivers using synthetic liquid drugs marketed as “Piu Piu” and “Magic Mushroom,” substances that authorities say are mixed into vape liquids and inhaled through e-cigarette devices, raising road-safety concerns and adding pressure on vape regulation.
Jun.29