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.

Kyrgyzstan Extends Import Ban on E-Cigarettes and Nicotine Liquids by Six Months
Kyrgyzstan Extends Import Ban on E-Cigarettes and Nicotine Liquids by Six Months
The Kyrgyz government has extended its ban on the import of electronic cigarettes and nicotine-containing liquids for another six months. The decision, signed by the chairman of the Cabinet of Ministers, covers e-cigarettes, integrated nicotine delivery systems, and nicotine liquids used in such devices. The original ban was introduced in July and was due to expire soon.
Dec.24 by 2FIRSTS.ai
California DOJ publishes first-ever Unflavored Tobacco List; products not on the list are ineligible for sale
California DOJ publishes first-ever Unflavored Tobacco List; products not on the list are ineligible for sale
California Attorney General Rob Bonta announced the publication of the first-ever Unflavored Tobacco List (UTL), listing unflavored tobacco products lawful for sale under California’s flavored tobacco restrictions. Any covered tobacco product not appearing on the UTL is deemed a flavored tobacco product and ineligible for sale.
Jan.04 by 2FIRSTS.ai
Russia to Start Extrajudicial Blocking of Sites Selling Tobacco and Nicotine Products Online From March 1
Russia to Start Extrajudicial Blocking of Sites Selling Tobacco and Nicotine Products Online From March 1
Russia will introduce an extrajudicial (non-court) blocking mechanism starting March 1, 2026, allowing authorities to block websites selling tobacco and nicotine-containing products online without a court order. State Duma member Anton Nemkin said the change will place offending sites directly onto the prohibited information registry, speeding up enforcement, reducing the court burden, and increasing platform obligations to proactively monitor content.
Jan.29 by 2FIRSTS.ai
 Breaking News | FDA Adds on! Plus Nicotine Pouches to PMTA-Authorized List
Breaking News | FDA Adds on! Plus Nicotine Pouches to PMTA-Authorized List
The U.S. Food and Drug Administration (FDA) has added ON! Plus nicotine pouch products to its list of authorized products, disclosing that the brand has received Marketing Granted Orders (MGO) through the Premarket Tobacco Product Application (PMTA) pathway. The update makes on! Plus the second nicotine pouch brand authorized via PMTA, following ZYN. As of publication, the FDA had not issued a separate press release on the decision.
News
Dec.20
Alan Zhao: What Altria’s on! PLUS Authorization Really Signals About FDA PMTA Enforcement
Alan Zhao: What Altria’s on! PLUS Authorization Really Signals About FDA PMTA Enforcement
In this in-depth commentary for 2Firsts, Alan Zhao examines what Altria’s on! PLUS authorization really signals about FDA PMTA enforcement. Beyond the headline approval, FDA’s language, process design and product choices offer rare insight into how nicotine pouch regulation is taking shape—and what it means for industry compliance, in one of the earliest expert reads of the decision.
Regulations
Dec.20 by 2Firsts Perspectives
Japan Tobacco International Malaysia Appoints Didier Ellena as Managing Director; Predecessor Reassigned to North Asia Role
Japan Tobacco International Malaysia Appoints Didier Ellena as Managing Director; Predecessor Reassigned to North Asia Role
Japan Tobacco International (JTI) Malaysia has appointed Didier Ellena as managing director, effective Jan 5. Ellena has spent more than 30 years with JTI and has held leadership roles across multiple countries and regions. His predecessor, Juliana Mohd Yahaya, will become vice president of sales and marketing for JTI North Asia.
Jan.15 by 2FIRSTS.ai