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.

ZYN ULTRA Expands Haypp’s U.S. E-Commerce Lineup With 9 mg Pouches
ZYN ULTRA Expands Haypp’s U.S. E-Commerce Lineup With 9 mg Pouches
Haypp Group said ZYN ULTRA became available nationwide in the United States on June 15 through its e-commerce platforms Nicokick.com and Northerner.com for verified adult nicotine consumers.
Jun.17
Germany Seizes 56 Pallets of Illegal Vapes, Probe Estimates €1.8 Million Tax Loss
Germany Seizes 56 Pallets of Illegal Vapes, Probe Estimates €1.8 Million Tax Loss
German authorities have seized dozens of pallets of illegal disposable vapes in a criminal investigation, with the products estimated to have caused at least €1.8 million in tax losses. The case has also raised concerns over cross-border supply chains linked to unauthorized nicotine products entering the European market.
Jul.14
Opinion | As EU Reviews Tobacco Rules, Experts Warn Against Overlooking Smokers’ Alternatives
Opinion | As EU Reviews Tobacco Rules, Experts Warn Against Overlooking Smokers’ Alternatives
As the European Commission reviews its tobacco and advertising rules, two experts who provided written comments to 2Firsts argue that future EU policy should not overlook adult smokers’ alternatives. Dr Garrett McGovern and Dr Carmen Escrig say regulators should weigh relative risk, adult switching, flavours, consumer behaviour and scientific uncertainty alongside youth protection.
Industry Insight
Jun.01
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
South Korea Brings Synthetic-Nicotine E-Cigarettes Under Tobacco Rules From June 24, Targeting Online Sales and Evasion
South Korea Brings Synthetic-Nicotine E-Cigarettes Under Tobacco Rules From June 24, Targeting Online Sales and Evasion
South Korea began full enforcement of tobacco-style rules for synthetic-nicotine e-cigarettes on June 24, 2026, with fines of up to 100,000 won for use in non-smoking areas and enforcement focus on online sales, raw nicotine liquids and products falsely marketed as nicotine-free.
MarketNews
Jun.25 by 2Firsts Perspectives
PMI’s ZYN Launches Loyalty Platform in Mexico, Tapping World Cup Viewing Scenes for Nicotine Pouch Marketing
PMI’s ZYN Launches Loyalty Platform in Mexico, Tapping World Cup Viewing Scenes for Nicotine Pouch Marketing
PMI’s nicotine pouch brand ZYN has launched the ZYN Club loyalty platform in Mexico and introduced ZYN Live Stadium viewing experiences around football matches, showing how nicotine pouch brands are using rewards, limited benefits and offline consumption settings to reach adult consumers.
Jun.29