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.

Russian Vape GOST Revision Would Limit Capacity, Packaging Design and Warning Labels
Russian Vape GOST Revision Would Limit Capacity, Packaging Design and Warning Labels
Russia is preparing changes to its e-cigarette state standard GOST R 58109–2018. Under a draft order submitted to Rosstandart, the shelf life of vape devices and liquids would be limited to no more than two years, and capacity would be strictly capped at 2 mL for replaceable capsules, 10 mL for disposable systems and 30 mL for refill containers.
Apr.27 by 2FIRSTS.ai
Malaysian Court Rules Liquid Nicotine Exemption Irrational, Renewing Vape Regulation Debate
Malaysian Court Rules Liquid Nicotine Exemption Irrational, Renewing Vape Regulation Debate
Malaysia’s High Court ruled that the government’s earlier decision to remove liquid nicotine from the country’s Poisons List was “irrational,” reigniting debate over vape regulation, illicit trade, and youth protection.
Regulations
May.18
Nearly 35.00% of Surveyed Retailers Shifted to Online Sales After Tighter Controls in Vietnam
Nearly 35.00% of Surveyed Retailers Shifted to Online Sales After Tighter Controls in Vietnam
A study of nearly 2,500 university students in Hanoi, Da Nang, Hue, and Ho Chi Minh City found that the average age of first use of e-cigarettes and heated tobacco products was 16.90. The findings were presented on April 9 in Hanoi. The study also found that 14.00% of students had tried e-cigarettes and 3.00% were current users, while the figures for heated tobacco were 6.00% and 0.80%. % of surveyed retail outlets moving to online sales.
Apr.10 by 2FIRSTS.ai
Smoore International Q1 Results: Enterprise-Focused Business Up 48.6% Year-on-Year, Proprietary E-Vapor Brand Business Up 14.3%
Smoore International Q1 Results: Enterprise-Focused Business Up 48.6% Year-on-Year, Proprietary E-Vapor Brand Business Up 14.3%
Smoore International reported its Q1 financial results, with revenue for the period reaching RMB3.856 billion, up 41.7% year-on-year, and net profit (profit for the period) totaling RMB262.5 million, up 36.6% year-on-year. Revenue from its enterprise-focused business was RMB3.2674 billion, representing a 48.6% increase from RMB2.1989 billion in the same period last year. Revenue from its proprietary brand business was RMB588.6 million, up 12.6% from RMB522.6 million a year earlier.
Apr.10 by 2FIRSTS.ai
FDA Wins Default Entry in Case Against E-Cigarette Distributor, to Seek Permanent Injunction
FDA Wins Default Entry in Case Against E-Cigarette Distributor, to Seek Permanent Injunction
The U.S. Food and Drug Administration (FDA) has made procedural progress in its lawsuit against North Carolina-based e-cigarette distributor Dream Distro LLC and its owner. A federal district judge granted the government’s request for entry of default after the defendants failed to respond to the complaint within 21 days of service. The government will next seek a default judgment, including a permanent injunction.
Apr.09 by 2FIRSTS.ai
Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Moscow Police Seize About 65,000 E-Cigarettes Worth More Than RUB 30 Million
Russian Interior Ministry spokesperson Irina Volk said on May 6 that police in Moscow seized about 65,000 nicotine-containing products from a man during searches of residential and warehouse premises. The products were valued at about RUB 30 million, or about USD 395,727 based on an exchange rate of USD 1 = RUB 75.81.
May.11 by 2FIRSTS.ai