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.

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
Multi-State Coalition Urges F1 to End Nicotine Sponsorships, Citing Zyn and Velo
Multi-State Coalition Urges F1 to End Nicotine Sponsorships, Citing Zyn and Velo
Hawaii Attorney General Anne Lopez is co-leading a coalition of 19 states and jurisdictions urging the Fédération Internationale de l’Automobile (FIA) and Formula 1 to end sponsorships involving tobacco and nicotine products, including nicotine pouch brands such as Zyn and Velo.
News
Jun.09
AHA Journal Study: WS-23 Triples Premature Heartbeats, Raising Concerns Over Vape Cooling Agents
AHA Journal Study: WS-23 Triples Premature Heartbeats, Raising Concerns Over Vape Cooling Agents
A University of Louisville research team published a study in an American Heart Association journal suggesting that synthetic cooling agents used in e-cigarettes, including WS-3 and WS-23, may disrupt cardiac electrical activity and increase arrhythmia risk. In animal experiments, WS-23 tripled premature heartbeats.
Jun.16
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
Canada Recalls Siberia and ZYN Nicotine Pouches Over Unauthorized Sales
Canada Recalls Siberia and ZYN Nicotine Pouches Over Unauthorized Sales
Health Canada has issued a nationwide recall for nicotine pouch products sold under the Siberia and ZYN brands, citing a lack of market authorization. All affected lots are subject to the recall.
Jun.15
India Seizes $14 Million Worth of Illegal Vaping Products Imported From China
India Seizes $14 Million Worth of Illegal Vaping Products Imported From China
India’s Directorate of Revenue Intelligence (DRI) seized approximately 300,000 illegal e-cigarettes and vaping devices worth more than ₹120 crore (approximately $14 million) during coordinated multi-state enforcement operations.
Regulations
May.22