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.

U.S. Court Rules Zyn Marketing Dispute Can Proceed, Rejects Philip Morris International’s Bid to Dismiss
U.S. Court Rules Zyn Marketing Dispute Can Proceed, Rejects Philip Morris International’s Bid to Dismiss
A U.S. federal court in Florida denied Philip Morris International and its subsidiaries’ motion to dismiss, allowing consumers to proceed with claims under the Florida Deceptive and Unfair Trade Practices Act alleging that Zyn nicotine pouches’ “tobacco-free” marketing is misleading. The court held that the allegations do not amount to a fraud claim and may move forward to the merits stage.
Dec.15 by 2FIRSTS.ai
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
The Spark of Reason| 2Firsts 2026 New Year Message
The Spark of Reason| 2Firsts 2026 New Year Message
Looking ahead to 2026, we do so with genuine anticipation. This will be a milestone year—the dawn of a new era.
Jan.01
KT&G Revises Partnership Terms with PMI, Secures Overseas Commercialization Rights for Multiple Heated Tobacco Platforms
KT&G Revises Partnership Terms with PMI, Secures Overseas Commercialization Rights for Multiple Heated Tobacco Platforms
KT&G has revised the terms of its 15-year partnership agreement with Philip Morris International (PMI), securing overseas commercialization rights for multiple heated tobacco platforms and adjusting the minimum guaranteed sales volume for lil-exclusive heated tobacco sticks from 16 billion units to 11 billion units.
Dec.12 by 2FIRSTS.ai
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
San Francisco reaches $1 million settlement with nicotine pouch retailer Lucy Goods
San Francisco reaches $1 million settlement with nicotine pouch retailer Lucy Goods
In the United States, California, San Francisco City Attorney David Chiu announced a $1 million settlement requiring online tobacco retailer Lucy Goods, Inc. to stop shipping illegal tobacco products into San Francisco.
Jan.09 by 2FIRSTS.ai