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.

Tajikistan Signals Plan to Ban Use, Production and Circulation of E-Cigarettes
Tajikistan Signals Plan to Ban Use, Production and Circulation of E-Cigarettes
According to Kazinform, Tajikistan addressed the issue of electronic cigarettes during the fourth session of the Majlisi Milli, stating a position to prohibit the use, production, and circulation of e-cigarettes. Chairman Rustam Emomali emphasized that the position aims to protect public health and prevent negative impacts on youth and adolescents.
Dec.16 by 2FIRSTS.ai
Walgreens Brings Vapes Back to Some U.S. Stores; Juul Says It’s in or Near 6,000 Locations
Walgreens Brings Vapes Back to Some U.S. Stores; Juul Says It’s in or Near 6,000 Locations
Walgreens has begun selling vape products again in some U.S. stores, marking a notable reversal after the chain pulled vapes from shelves in 2019 amid concerns over youth use and health risks. Juul says it is expanding across thousands of Walgreens locations, and NJOY also lists Walgreens stores as retailers.
Jan.26 by 2FIRSTS.ai
Fourth Circuit weighs federal preemption challenge to North Carolina’s vape sales restrictions
Fourth Circuit weighs federal preemption challenge to North Carolina’s vape sales restrictions
Vape manufacturers and sellers urged the U.S. Court of Appeals for the Fourth Circuit to find that the federal Food, Drug, and Cosmetic Act (FDCA) preempts North Carolina’s new law restricting the sale of certain e-cigarette/ENDS products.
Feb.03 by 2FIRSTS.ai
Florida AG announces largest illegal vape seizure in state history, 2,183 contraband devices seized
Florida AG announces largest illegal vape seizure in state history, 2,183 contraband devices seized
Florida’s attorney general announced a record-breaking statewide enforcement push against illegal vaping products, with four joint operations seizing 2,183 contraband vapes and additional nitrous oxide-related items. Regulators also reported removing thousands of noncompliant products from store shelves, while investigations remain ongoing.
Feb.09 by 2FIRSTS.ai
California: Stiiizy hit with another lawsuit alleging high-THC vapes marketed to teens
California: Stiiizy hit with another lawsuit alleging high-THC vapes marketed to teens
A new lawsuit in California state court accuses Stiiizy Inc. of steering high-THC vape products toward teens through youth-appealing branding and weak age verification, alleging the plaintiff’s underage use was followed by cannabis-induced psychosis-related symptoms and significant personal harm.
Feb.06 by 2FIRSTS.ai
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