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.

Special Report|Haypp’s Nicotine Pouch Volumes Rise 40%: Who Controls the Digital Shelf for Modern Oral?
Special Report|Haypp’s Nicotine Pouch Volumes Rise 40%: Who Controls the Digital Shelf for Modern Oral?
Haypp Group reported a 40% year-on-year increase in nicotine pouch volumes in the first quarter of 2026, with U.S. and U.K. volumes rising 123% and 102%, respectively. Haypp says around 97% of its consumer traffic is organic and that its Media & Insights business provides brand owners with on-site visibility, trial activation and consumer intelligence. For international tobacco companies, Haypp may be both a growth partner for modern oral products and a new source of channel leverage.
Special Report
May.22
Adani’s Mumbai Airport Duty-Free Shops Face Scrutiny Over Nicotine Pouch Sales in India
Adani’s Mumbai Airport Duty-Free Shops Face Scrutiny Over Nicotine Pouch Sales in India
An Indian investigation found that duty-free shops at Mumbai international airport operated by billionaire Gautam Adani’s business group sold nicotine pouches in breach of the law, Reuters reported, in a case that could shape how India regulates sales of new nicotine products at airport retail outlets.
Jul.08
Bloomberg: Zyn’s Dry-Mouth Problem Threatens Its Hold on Nicotine Pouch Market
Bloomberg: Zyn’s Dry-Mouth Problem Threatens Its Hold on Nicotine Pouch Market
According to Bloomberg, Philip Morris International’s Zyn is facing growing competition in the U.S. nicotine pouch market as consumers shift toward moister alternatives such as British American Tobacco’s Velo Plus.
BATPMI
May.22
Innovation, Insights and Networking: NUBIZ Brings the Global NGP Industry Together in Dortmund
Innovation, Insights and Networking: NUBIZ Brings the Global NGP Industry Together in Dortmund
The market for next-generation products is expanding rapidly, with vapes, e-cigarettes, pouches, snus and heat-not-burn products among the industry’s most innovative segments. As part of InterTabac, NUBIZ provides a central platform for reduced-risk tobacco and nicotine products, bringing together global leaders and newcomers from 15 to 17 September. The show combines market insights, product comparisons, networking, a high-level conference programme and exclusive side events.
Jun.03
One Year After UK Disposable Vape Ban: Youth Use Falls to 13%, Adult Use to 8%
One Year After UK Disposable Vape Ban: Youth Use Falls to 13%, Adult Use to 8%
among both youth and adults. However, industry groups and regulators warn that the illicit vape market remains a growing concern.
Jun.09
Illegal Vape Retailers in UK Could Face 12-Month Shutdowns
Illegal Vape Retailers in UK Could Face 12-Month Shutdowns
The UK government plans to expand police and trading standards powers by extending closure orders for shops selling illegal vapes and cigarettes from a maximum of six months to 12 months, in a crackdown on organised crime on high streets.
Jun.12