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.

Uruguay Lawmaker Proposes Ban on Smoking and Vaping in Playgrounds and Bus Stops
Uruguay Lawmaker Proposes Ban on Smoking and Vaping in Playgrounds and Bus Stops
A bill introduced by Uruguayan lawmaker Álvaro Dastugue proposes banning smoking and vaping in public spaces that include children’s play areas, as well as at bus stops and nearby waiting zones. The draft legislation aims to reduce involuntary exposure to smoke and aerosols from tobacco, marijuana and electronic vaping devices.
Dec.24 by 2FIRSTS.ai
Special Report|With Charlie’s US Line Online, the US-Filled Vape Supply Chain Model Enters a New Phase
Special Report|With Charlie’s US Line Online, the US-Filled Vape Supply Chain Model Enters a New Phase
Charlie’s Holdings has activated its first US-based manufacturing and filling line, enabling the company’s Pachamama 25K vape series to meet Texas’ new domestic manufacturing requirements. As state-level rules tighten, the move signals a broader industry shift toward US-filled supply chains and marks an inflection point for brands historically reliant on China-based prefilled production.
Industry Insight
Dec.02
Russia’s Perm Region Finalises Law Banning E-Cigarettes from March Next Year
Russia’s Perm Region Finalises Law Banning E-Cigarettes from March Next Year
The Governor of Russia’s Perm Region has confirmed that the newly adopted regional law banning vapes will take effect on March 1, 2026, despite lobbying from manufacturers and pressure from the federal level. The law prohibits the sale of all vaping products within the region, with penalties for violators, including fines for kiosks operating in residential areas.
Nov.26 by 2FIRSTS.ai
Lancet Study Finds Rising Use of Nicotine Pouches in Britain
Lancet Study Finds Rising Use of Nicotine Pouches in Britain
A study published in The Lancet has found that nicotine pouch use is increasing in Britain, particularly among young men. Usage among people aged 16 to 24 has risen sharply since early 2022.
Dec.17 by 2FIRSTS.ai
Russia’s Federation Council Approves Law Allowing Extrajudicial Blocking of Online Tobacco Sales
Russia’s Federation Council Approves Law Allowing Extrajudicial Blocking of Online Tobacco Sales
Russia’s Federation Council has approved legislation allowing authorities to block websites offering online sales of tobacco, nicotine-containing products, heated tobacco devices and hookahs without a court order.
Dec.26 by 2FIRSTS.ai
Philippine police seize illegal cigarettes and e-cigarettes worth USD 206,400, arrest four suspects
Philippine police seize illegal cigarettes and e-cigarettes worth USD 206,400, arrest four suspects
CIDG-Laguna Provincial Field Unit seizes $200k worth of illegal cigarettes and e-cigarettes, arrests four suspects. PNP vows to continue crackdown.
Nov.28 by 2FIRSTS.ai