FDA Issues Two Warning Letters to E-cigarette Businesses for Unauthorized Sales

Events by THE EPOCH TIMES
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 | OXVA launches Artio 2 liquid-tobacco pod device, positioned as distinct from HNB and traditional flavored e-cigarettes
Product | OXVA launches Artio 2 liquid-tobacco pod device, positioned as distinct from HNB and traditional flavored e-cigarettes
OXVA has released its Artio 2 pod device featuring the Liquid Tobacco Intelligent (LTI) platform. It offers around 400 puffs per charge, pods equivalent to about 35 cigarettes, five tobacco and shisha flavors, and a 900mAh battery with 30-minute fast charging. The company positions the device as distinct from HNB and traditional flavored e-cigarettes.
Nov.27 by 2FIRSTS.ai
Belgian Drug Commissioner Warns of Hidden Opioids in Illegal Vapes
Belgian Drug Commissioner Warns of Hidden Opioids in Illegal Vapes
Belgium’s drug commissioner Ine Van Wymersch has warned that more than 80% of illegal refillable vape capsules seized in Belgium contain synthetic opioids, posing serious risks of early addiction among children. She told Euronews that these substances, which have no distinctive smell or color, could lead to opioid dependence from a young age.
Dec.08 by 2FIRSTS.ai
Luxembourg Passes Bill 8333: Heated Tobacco and Nicotine Pouches Regulated
Luxembourg Passes Bill 8333: Heated Tobacco and Nicotine Pouches Regulated
Luxembourg’s Chamber of Deputies adopted Bill No. 8333, transposing EU Directive 2022/2100 and extending tobacco controls to heated tobacco, e-cigarettes and nicotine pouches. The law bans flavourings, restricts sales to minors, and caps nicotine content at 0.048 mg per pouch. CBD and caffeine additives are prohibited.
Nov.03 by 2FIRSTS.ai
PMI Japan Upgrades IQOS ILUMA i One with New Button Layout, Aluminum Base
PMI Japan Upgrades IQOS ILUMA i One with New Button Layout, Aluminum Base
PMI Japan has refreshed its all-in-one heated tobacco device, IQOS ILUMA i One, with upgraded materials and exterior design. Sales begin October 29 via IQOS stores and the official website. The new model retains core features such as auto-start and continuous use, but is not compatible with accessories from the previous version.
Oct.30 by 2FIRSTS.ai
Thailand Seizes Over 42,000 Illegal Vapes Worth USD 340,000
Thailand Seizes Over 42,000 Illegal Vapes Worth USD 340,000
Thai authorities announced the seizure of more than 42,000 smuggled vapes worth approximately THB 10.87 million (USD 340,000).
Dec.12 by 2FIRSTS.ai
Illegal tobacco syndicate dominates Australia’s vape market through threats and extortion
Illegal tobacco syndicate dominates Australia’s vape market through threats and extortion
Australia’s The Age has revealed that a local tobacco cartel is working with a crime syndicate to dominate the illicit vape trade. The Australian Border Force (ABF) intercepted 115,200 vapes worth A$4.5 million disguised as “furniture” at Sydney port. Authorities say over 12 million illegal vapes have been seized since 2024.
Nov.03