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.

BAT FY2025 Results Review Series by 2Firsts
BAT FY2025 Results Review Series by 2Firsts
Feb.12
UK’s North Yorkshire Council plans up to £477,000 spend on e-cigarettes to support quitting smoking
UK’s North Yorkshire Council plans up to £477,000 spend on e-cigarettes to support quitting smoking
North Yorkshire Council in the UK is set to spend up to £477,000 on e-cigarettes to support residents quitting smoking. Since e-cigarettes were added to the council’s Living Well Smokefree service in July 2023, 487 people have used them to quit, with about a third remaining smoke-free after a year.
Mar.03 by 2FIRSTS.ai
Glasgow bin lorry fires spark calls to broaden vape and battery disposal messaging
Glasgow bin lorry fires spark calls to broaden vape and battery disposal messaging
Glasgow residents have been warned that throwing batteries and vapes away at home can endanger refuse workers, amid bin lorries catching fire. The city council said it will launch a communications campaign next month to tell people to place batteries in special bins at supermarkets or household waste recycling centres, supported by a dedicated web page listing other disposal sites.
Feb.11 by 2FIRSTS.ai
UK vape firm Plxsur sold for £76,500 after touting $1 billion revenue target
UK vape firm Plxsur sold for £76,500 after touting $1 billion revenue target
London-based vaping company Plxsur, which had claimed in fundraising materials it could reach $1 billion in annual revenue and capture about 10% of the global vaping market, has been sold out of administration for £76,500. Administrators said the figures were aspirational and depended on acquisitions that were never completed, as the company later ran out of cash and entered insolvency, with a shareholder ultimately buying the business.
Jan.22 by 2FIRSTS.ai
Make Your Brand Understood by the People Who Matter
Make Your Brand Understood by the People Who Matter
Feb.02
China’s tobacco regulator names Yao Laiying as top leader
China’s tobacco regulator names Yao Laiying as top leader
China’s tobacco regulator has undergone a top leadership change, according to an official announcement on March 20.
Mar.20