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.

Exclusive | Shenzhen Tobacco Authorities Ask Licensed Chinese Vape Manufacturers to Submit STN Details for U.S.-Bound Products
Exclusive | Shenzhen Tobacco Authorities Ask Licensed Chinese Vape Manufacturers to Submit STN Details for U.S.-Bound Products
Shenzhen tobacco authorities have asked licensed Chinese vape manufacturers to submit STN details for U.S.-bound products, including CTP Portal or STN email screenshots, highlighting a new compliance signal in cross-border oversight.
Apr.02
Product | Dual-Chamber 20ml E-liquid and 35,000 Puffs: JNR ShishaSip 35K Goes on Sale Online in the Spanish and French Markets
Product | Dual-Chamber 20ml E-liquid and 35,000 Puffs: JNR ShishaSip 35K Goes on Sale Online in the Spanish and French Markets
E-cigarette brand JNR has recently launched its new pod-based device, the JNR ShishaSip 35K, on its official website. The product adopts a dual-chamber structure with two built-in 10ml prefilled pods, bringing total e-liquid capacity to 20ml. It is officially claimed to provide about 35,000 puffs and features a 1050mAh battery, a 0.6Ω mesh coil, a display screen, and adjustable airflow. The product is already on sale through online channels in France and Spain at a price of EUR 15.90.
Apr.10 by 2FIRSTS.ai
Bulgaria’s Disposable Vape Ban Receives Formal Approval From the European Commission
Bulgaria’s Disposable Vape Ban Receives Formal Approval From the European Commission
The European Commission has formally published its decision approving Bulgarian legislation banning the placing on the market, offering and sale of disposable e-cigarettes.
Mar.17 by 2FIRSTS.ai
Alberta Seeks to Add New Vape Restrictions on Top of Existing Tobacco Framework
Alberta Seeks to Add New Vape Restrictions on Top of Existing Tobacco Framework
A new Alberta bill aimed at reducing vaping rates, especially among young people, is moving into the legislative process. Bill 208, the Vaping Reduction Act, was introduced by United Conservative Party MLA Chelsae Petrovic and appears to build on the province’s existing Tobacco, Smoking and Vaping Reduction Act. Early reporting suggests the bill could focus on disposable vapes and impose further limits on youth access to vaping products.
Apr.15 by 2FIRSTS.ai
Serbian Parliament Passes Trade Laws Banning Sales of E-Cigarettes and Nicotine Products to Minors
Serbian Parliament Passes Trade Laws Banning Sales of E-Cigarettes and Nicotine Products to Minors
Serbia’s parliament has adopted a package of trade laws aimed at increasing consumer protection while introducing a range of changes for merchants and online platforms. One of the most important new measures is a ban on the sale of e-cigarettes and other nicotine products to minors, tightening youth protection rules.
Apr.24 by 2FIRSTS.ai
Illinois HB 4652 Targets Discarded Vapes, Would Require Manufacturer-Funded Disposal Programs
Illinois HB 4652 Targets Discarded Vapes, Would Require Manufacturer-Funded Disposal Programs
Illinois House Bill 4652 proposes e-cigarette companies establish and fund safe disposal programs to combat environmental risks.
Mar.09 by 2FIRSTS.ai