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.

China’s Nov. Vape Exports to U.S. Hold at $549 Million, Sustaining High After October’s $591 Million Peak
China’s Nov. Vape Exports to U.S. Hold at $549 Million, Sustaining High After October’s $591 Million Peak
China’s Nov. vape exports to the U.S. held at $549 million, following October’s $591 million record. 2025 YTD exports reached $3.72 billion, officially eclipsing 2024’s full-year total. This $1.14 billion 60-day surge signals a critical inventory overhang, heightening financial and regulatory risks for manufacturers.
Dec.22
Brazil’s federal prosecutors sue for strict e-cigarette rules, urging regulation over a “paper ban”
Brazil’s federal prosecutors sue for strict e-cigarette rules, urging regulation over a “paper ban”
Brazil’s Federal Public Prosecutor’s Office (MPF) has filed a public civil action seeking to compel the federal government and Anvisa to establish a strict, enforceable regulatory framework for electronic smoking devices, replacing the current blanket ban. The lawsuit calls for mandatory product registration, nicotine caps, bans on youth-targeted advertising, and clear health warnings on packaging, and demands a national consumption report and an implementation timetable within 90 days.
Jan.30 by 2FIRSTS.ai
Finland’s Ostrobothnia Police Seize Over 6,000 E-Cigarettes in Vaasa Raid, Probe Cross-Border Supply
Finland’s Ostrobothnia Police Seize Over 6,000 E-Cigarettes in Vaasa Raid, Probe Cross-Border Supply
According to a statement from Finland’s Ostrobothnia Police, officers seized more than 6,000 e-cigarettes during a home search in the Haapaniemi area of Vaasa in early January, after the case surfaced in connection with drug enforcement work.Police suspect the products were ordered from abroad for resale in Finland and were marketed and sold via Telegram.
Jan.29 by 2FIRSTS.ai
2Firsts Observation | Element Vape Launches “Made in USA” Section as Product Pages Show “Assembled in USA” and “Made in USA” Labels
2Firsts Observation | Element Vape Launches “Made in USA” Section as Product Pages Show “Assembled in USA” and “Made in USA” Labels
Element Vape, a U.S. online vaping retailer, uses origin labels such as “Made in USA” and “Assembled in USA” across disposable vape product pages and a dedicated collection page, grouping items under “Made in USA Disposable Vapes,” but the platform does not disclose on its public pages the applicable standards or evidentiary basis for these different claims.
Jan.20 by 2FIRSTS.ai
Alabama SB9 advances: Senate committee clears bill to treat vaping like smoking in enclosed public places
Alabama SB9 advances: Senate committee clears bill to treat vaping like smoking in enclosed public places
Alabama’s Senate Bill 9 advanced after clearing the Senate Committee on Healthcare, moving to the full Alabama Senate for consideration. The proposal would update the state’s 2003 Clean Indoor Air Act by including e-cigarettes and other vaping devices under the same restrictions that apply to smoking in most enclosed public places.
Jan.22 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