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.

TPB Q4 FY2025 Revenue Rises 29% to $121 Million; Modern Oral Business Up 266% Year Over Year
TPB Q4 FY2025 Revenue Rises 29% to $121 Million; Modern Oral Business Up 266% Year Over Year
Turning Point Brands, a U.S. nicotine and tobacco-related consumer products company, reported its fiscal 2025 fourth-quarter results: quarterly revenue was $121 million, up 29% year over year; adjusted EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) was $30 million, up 14%. Net revenue from modern oral nicotine products was $41.3 million, up 266% year over year.
Mar.03 by 2FIRSTS.ai
U.S. FDA posts TPSAC meeting materials ahead of discussion on ZYN MRTP applications
U.S. FDA posts TPSAC meeting materials ahead of discussion on ZYN MRTP applications
On January 20, 2026, the U.S. Food and Drug Administration (FDA) posted meeting materials ahead of a virtual Tobacco Products Scientific Advisory Committee (TPSAC) meeting scheduled for January 22, 2026, to discuss modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 ZYN nicotine pouch products.
Jan.21 by 2FIRSTS.ai
Reynolds Appeals ITC Defeat in Disposable Vape Section 337 Case to U.S. Federal Circuit
Reynolds Appeals ITC Defeat in Disposable Vape Section 337 Case to U.S. Federal Circuit
On March 13, 2026, R.J. Reynolds and related companies filed an appeal with the U.S. Court of Appeals for the Federal Circuit, seeking review of the U.S. International Trade Commission’s final ruling in the disposable vape Section 337 investigation.
Mar.16 by 2FIRSTS.ai
PMI says Colorado ZYN plant build advances as first pouches hit market in 2025
PMI says Colorado ZYN plant build advances as first pouches hit market in 2025
Philip Morris International (PMI) is investing $600 million to build a ZYN nicotine pouch plant in Aurora, Colorado. While the facility is still under construction, PMI said production started in September 2025 and the first pouches made at the site have already gone to market.
Feb.10 by 2FIRSTS.ai
Product | VOZOL launches new GEAR-series device in the UK and UAE, featuring a 2.1-inch colour screen and sound interaction
Product | VOZOL launches new GEAR-series device in the UK and UAE, featuring a 2.1-inch colour screen and sound interaction
Vape brand VOZOL has recently listed a disposable shisha-style product, the GEAR HOOKAH 40000, on its official website. Public information shows the device comes with a 26ml e-liquid capacity, offers 3mg/ml and 5mg/ml nicotine strengths, and is marketed at 25,000–40,000 puffs. It is currently available via selected online retail channels in the UK and the UAE.
Feb.04 by 2FIRSTS.ai
Kazakhstan’s Almaty crackdown: Telegram channels used to sell banned vapes, six face charges
Kazakhstan’s Almaty crackdown: Telegram channels used to sell banned vapes, six face charges
Authorities in Almaty have uncovered a large illegal vape distribution scheme, seizing and destroying more than 180,000 vapes. Prosecutors said potential revenue from sales could have exceeded 1 billion tenge. Suspects allegedly sold the banned products through Telegram channels and social media, storing inventory in warehouses and covert locations.
Feb.27 by 2FIRSTS.ai