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.

KT&G Launches Two New lil AIBLE Dedicated Sticks as Aim Portfolio Expands to 13
KT&G Launches Two New lil AIBLE Dedicated Sticks as Aim Portfolio Expands to 13
KT&G said on April 20 that it has launched two new “AIIM” sticks for its lil AIBLE heated tobacco device at convenience stores nationwide in South Korea. The new products are “AIIM CHANGE UP” and “AIIM COOL SHOT.” The company said the products were developed based on the existing lil SOLID dedicated sticks “Fiit Change Up” and “Fiit Cool Shot.” With the launch, the Aim lineup for lil AIBLE has expanded to 13 products.
Apr.20 by 2FIRSTS.ai
Canada’s Federal Vape Flavor Restrictions Remain Unclear Five Years After Announcement
Canada’s Federal Vape Flavor Restrictions Remain Unclear Five Years After Announcement
Five years after Canada’s federal government announced plans to restrict vaping flavors nationwide, Health Minister Marjorie Michel has not said when or whether the measure will still proceed. In 2021, Health Canada said it planned to limit vaping flavors nationwide to mint, menthol and tobacco, citing evidence that fruity and sweet flavors appeal to youth.
May.11 by 2FIRSTS.ai
FDA Tobacco Center Pushes Review-Efficiency Statement After Commissioner’s Exit
FDA Tobacco Center Pushes Review-Efficiency Statement After Commissioner’s Exit
FDA CTP issued a May 7 statement on accelerating product review and improving PMTA efficiency, but did not push it via official X and newsletter until May 13, one day after FDA Commissioner Marty Makary’s resignation was confirmed. FDA has not explained the delay, and no public evidence links it directly to the leadership change. The timing is notable given CTP’s usual 24-hour distribution practice.
Special Report
May.14
EU Launches Online Feedback as TPD Revision Enters New Milestone
EU Launches Online Feedback as TPD Revision Enters New Milestone
The European Commission has opened an online call for evidence on revising EU tobacco products and advertising rules, marking a new phase in the TPD/TAD review. Policy options may cover novel products, flavours, packaging, digital marketing and advertising. A 2Firsts review of 855 early submissions shows rapid engagement and recurring debate over differentiated regulation, harm reduction, youth protection, illicit trade and economic impact.
Special Report
May.21
Australian State Targets Illegal Tobacco Retailers With Tougher Closure Powers
Australian State Targets Illegal Tobacco Retailers With Tougher Closure Powers
According to Reuters, Australia’s state of Victoria introduced legislation to give police and the state tobacco licensing regulator stronger powers to shut businesses selling illegal tobacco, with non-compliant operators facing fines of more than A$2.4 million and up to 20 years in prison.
Jun.05
FDA Adds 18 Tobacco Harmful Constituents and Seeks Comment on 3 More
FDA Adds 18 Tobacco Harmful Constituents and Seeks Comment on 3 More
U.S. Food and Drug Administration published a Federal Register notice finalizing the addition of 18 constituents to the established list of Harmful and Potentially Harmful Constituents in tobacco products. With the update, the list now contains 111 constituents. FDA also proposed adding three more constituents to the list and opened a public comment period ending at 11:59 p.m. ET on May 26, 2026.
Apr.24 by 2FIRSTS.ai