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.

Cross-Party Romanian Lawmakers Propose Ban on E-Cigarettes and Heated Tobacco Use in All Enclosed Public Spaces
Cross-Party Romanian Lawmakers Propose Ban on E-Cigarettes and Heated Tobacco Use in All Enclosed Public Spaces
Lawmakers from Romania’s USR, PSD and PNL have submitted a bill that would ban e-cigarettes, vapes and heated tobacco devices in all enclosed public spaces. The proposal would redefine “smoking” so that inhaling aerosols produced by heating or vaporizing products containing tobacco, nicotine or other substances intended for inhalation would also be considered smoking, except for medical-use products.
Apr.17 by 2FIRSTS.ai
New Movement Emerges on EU Tobacco Excise Directive as Cyprus Tables Compromise Draft
New Movement Emerges on EU Tobacco Excise Directive as Cyprus Tables Compromise Draft
The long-stalled debate over the European Union’s Tobacco Excise Directive may be moving forward, with Cyprus, as holder of the EU Council presidency, putting forward a compromise draft. The reported proposal includes lowering the minimum excise duty requirement and granting a transitional period, with the aim of reaching political agreement by June 2026. The revision also covers e-cigarettes, heated tobacco, nicotine pouches and stronger controls on raw tobacco.
Apr.21 by 2FIRSTS.ai
Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Russian Interior Ministry spokesperson Irina Volk said on May 6 that police in Moscow seized about 65,000 nicotine-containing products from a man during searches of residential and warehouse premises. The products were valued at about RUB 30 million, or about USD 395,727 based on an exchange rate of USD 1 = RUB 75.81.
May.11 by 2FIRSTS.ai
Philip Morris Says Its Smoke-Free Transition in Spain Now Has Economic Impact Above EUR 3.3 Billion
Philip Morris Says Its Smoke-Free Transition in Spain Now Has Economic Impact Above EUR 3.3 Billion
Philip Morris said it is accelerating its transition toward smoke-free products in Spain and claimed that the related economic impact now exceeds EUR 3.3 billion. Philip Morris also said that more than 90% of nicotine consumption in Spain still comes from conventional cigarettes, leaving room for growth in smoke-free categories, while regulation and taxation remain major obstacles in its view.
Apr.21 by 2FIRSTS.ai
KT&G Moves Ahead With Oral Nicotine Product Development and Pilot Line Preparation
KT&G Moves Ahead With Oral Nicotine Product Development and Pilot Line Preparation
According to a Korean media report, KT&G is developing a smokeless nicotine product that delivers nicotine through oral absorption and is preparing a pilot production line for research and development.
Apr.08 by 2FIRSTS.ai
Imperial Tobacco Canada Responds to Anti-Smoking Groups on Youth Vaping
Imperial Tobacco Canada Responds to Anti-Smoking Groups on Youth Vaping
Imperial Tobacco Canada responded to the April 17 press conference by anti-smoking groups by calling for a more focused, fact-based discussion on youth vaping that targets the illicit market. The company said youth should not be using nicotine products and that it supports strong measures to prevent youth access, but argued that the discussion failed to clearly distinguish between the regulated market and the illicit market that is driving youth access.
Apr.22 by 2FIRSTS.ai