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.

Mexican Congress Postpones Debate on Vape and E-Cigarette Ban
Mexican Congress Postpones Debate on Vape and E-Cigarette Ban
Mexico’s Chamber of Deputies has postponed the debate on a reform to the General Health Law that seeks to completely ban the sale and distribution of electronic cigarettes and vapes. Lawmaker Amancay González Franco (MC) criticized the draft for excluding tobacco heating devices, such as Philip Morris’s IQOS, arguing that these products are even more harmful according to the World Health Organization.
Dec.05 by 2FIRSTS.ai
Virginia appeals to the Fourth Circuit over partial block on flavored vape ban enforcement
Virginia appeals to the Fourth Circuit over partial block on flavored vape ban enforcement
Virginia has asked the Fourth Circuit to overturn a district court order that partially blocked enforcement of the commonwealth’s flavored vape ban. In a notice, the state told U.S. District Judge David J. Novak it seeks to upend his December ruling that Virginia’s Chapter 23.2 statute is preempted by the Food, Drug and Cosmetic Act and the Family Smoking Prevention and Tobacco Control Act.
Jan.12 by 2FIRSTS.ai
Vape Company Takes FDA to Court for Stalling Premarket Decision for Half a Decade
Vape Company Takes FDA to Court for Stalling Premarket Decision for Half a Decade
California-based vape manufacturer Schwartz E-Liquid (USA Vape Lab) has sued the U.S. Food and Drug Administration (FDA) in federal court, alleging the agency unlawfully failed to issue a decision on its premarket application for flavored e-cigarette products for more than five years. The company is seeking a court order compelling the FDA to act within 90 days.
Nov.26 by 2FIRSTS.ai
Nicoventures Granted Rehearing After Philip Morris Challenge Rejected
Nicoventures Granted Rehearing After Philip Morris Challenge Rejected
Nicoventures Trading Ltd., a subsidiary of British American Tobacco (BAT), has won an appeal at the European Patent Office (EPO), convincing the appellate board that examiners had violated its right to be heard by failing to review all of its submissions.
Dec.09 by 2FIRSTS.ai
Comedian Shuib fined  US$2,460 after pleading guilty to promoting an e-cigarette on a podcast
Comedian Shuib fined US$2,460 after pleading guilty to promoting an e-cigarette on a podcast
Bernama reported that comedian Shahmira Muhamad, better known as Shuib Sepahtu, was fined RM10,000 (about US$2,460.93) after pleading guilty to promoting an electronic cigarette product on a YouTube podcast in 2024. The magistrate ordered one month’s jail in default of payment, and he paid the fine. He was charged over a promotion at 4.26pm on Oct 22, 2024, under Section 9(1) of the Control of Smoking Products for Public Health Act 2024 (Act 852).
Jan.08 by 2FIRSTS.ai
Russia’s Federation Council Approves Law Allowing Extrajudicial Blocking of Online Tobacco Sales
Russia’s Federation Council Approves Law Allowing Extrajudicial Blocking of Online Tobacco Sales
Russia’s Federation Council has approved legislation allowing authorities to block websites offering online sales of tobacco, nicotine-containing products, heated tobacco devices and hookahs without a court order.
Dec.26 by 2FIRSTS.ai