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.

Product | JT Launches Ploom AURA Glacier White in Japan, Expanding the Device Ecosystem Through Color and Accessories
Product | JT Launches Ploom AURA Glacier White in Japan, Expanding the Device Ecosystem Through Color and Accessories
Japan Tobacco Inc. (JT) has introduced the Ploom AURA Glacier White heated tobacco device in Japan, adding a new color option to the existing Ploom AURA lineup. The device maintains the existing SMART HEATFLOW technology and HEAT SELECT SYSTEM with four heating modes, while expanding the ecosystem through new accessories including front panels, back covers, a car holder and wireless charging covers. The product entered pre-sale in Japan on June 30, 2026, followed by broader retail availability from July 7.
Aug.03
PMI Oral Products Chief Says Lack of Rules May Push Nicotine Pouch Market Into Illicit Trade
PMI Oral Products Chief Says Lack of Rules May Push Nicotine Pouch Market Into Illicit Trade
Nick Ricketts, President of Oral Products at Philip Morris International (PMI), told Logos Press that nicotine pouches should be brought under clear regulatory frameworks covering nicotine limits, flavor rules, age verification, sales controls and marketing standards, arguing that the absence of clear rules or blanket bans may push consumer demand into illegal or semi-legal channels.
Jul.06
VEEV Arrives in South Korea, Completing PMI’s IQOS-ZYN-VEEV Portfolio
VEEV Arrives in South Korea, Completing PMI’s IQOS-ZYN-VEEV Portfolio
Philip Morris Korea has officially launched its VEEV e-vapor brand in South Korea, introducing both the VEEV inPRIME device and VEEBI inPRIME pods. The launch further expands PMI’s smoke-free portfolio in Korea, alongside its IQOS heated tobacco products and ZYN nicotine pouches.
Jun.16
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
Product | YOOZ Launches Waker Electronic Shisha Device, Expanding Vape Applications Beyond Portable Devices
Product | YOOZ Launches Waker Electronic Shisha Device, Expanding Vape Applications Beyond Portable Devices
YOOZ has introduced the Waker Electronic Shisha device, expanding its vaping portfolio into the electronic shisha category. The device combines a rechargeable hardware platform with dedicated cartridges, featuring a 4,000mAh battery, up to 60W output power, and LED lighting effects. The product has appeared across multiple French retail channels, reflecting the continued expansion of vaping products into new consumption scenarios.
Jul.13
Korean component maker ITM Semiconductor says Indonesia unit starts e-cigarette device output as related Q1 revenue rises 55.4%
Korean component maker ITM Semiconductor says Indonesia unit starts e-cigarette device output as related Q1 revenue rises 55.4%
South Korea’s KOSDAQ-listed electronics-component maker ITM Semiconductor said its Indonesia subsidiary has begun full-scale mass production of e-cigarette devices, with first-quarter revenue from the business rising 55.4% year on year to 42.1 billion won, Maeil Business Newspaper reported.
Jul.08