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.

Canada Faces Growing Debate as Youth Nicotine Pouch Use Reaches 34.8%
Canada Faces Growing Debate as Youth Nicotine Pouch Use Reaches 34.8%
New Canadian research shows that 34.8% of people aged 17 to 27 have tried nicotine pouches, up more than fourfold from 7.6% in 2022. The findings come as Conservative politicians, Alberta’s government and the tobacco industry push Ottawa to relax current restrictions on pouch sales.
Jun.12
South Korea Expands Tobacco Harmful Components Testing System to Cover Synthetic Nicotine Liquid Vapes
South Korea Expands Tobacco Harmful Components Testing System to Cover Synthetic Nicotine Liquid Vapes
South Korea’s Ministry of Food and Drug Safety said on April 17 that it has additionally designated the International Characterization Research Institute as a tobacco harmful components testing body under the Act on the Management of Tobacco Harmfulness. The institute has research experience in analyzing harmful components in liquid e-cigarettes and has obtained recognition for tobacco-sector ISO 17025 requirements.
Apr.17 by 2FIRSTS.ai
Special Report|U.S.-Facing Retailer Lists RELX Creator Pro 15K: A Chinese Brand Signal Under FDA’s Lower-Priority Enforcement Window
Special Report|U.S.-Facing Retailer Lists RELX Creator Pro 15K: A Chinese Brand Signal Under FDA’s Lower-Priority Enforcement Window
Vapesourcing has listed RELX Creator Pro 15K as “Coming Soon” with U.S. warehouse shipping options; while the page does not show that RELX has entered the U.S. market through official channels or that the product has received FDA authorization, the listing suggests that Chinese brand-led ENDS products are becoming a new point of observation as the U.S. market reassesses regulatory risk following the FDA’s updated enforcement-priority policy.
Industry Insight
Jun.11
Spanish parties PP and PSOE reach agreement on sales restrictions for e-cigarettes and nicotine pouches
Spanish parties PP and PSOE reach agreement on sales restrictions for e-cigarettes and nicotine pouches
Spain’s Popular Party and Socialist Party reached an agreement in the Joint Congress-Senate Commission for the Study of Addiction Problems and approved a non-binding motion calling for the sale of e-cigarettes, nicotine pouches and related products to be limited to authorized and controlled channels, such as tobacco shops and specialized stores, while excluding internet sales and general retail outlets.
Apr.27 by 2FIRSTS.ai
 BAT London Shares Gain 13.99% as FDA Vape Decision Draws Market Attention
BAT London Shares Gain 13.99% as FDA Vape Decision Draws Market Attention
British American Tobacco’s London-listed shares rose 13.99% last week, as investors focused on the U.S. Food and Drug Administration’s recent authorization of flavored Glas e-cigarette products, the dismissal of a U.S. sanctions-related criminal case against BAT, and the company’s previously announced share buyback plan and newer nicotine business performance.
BAT
May.18
Turning Point Brands Reports Q1 2026 Net Sales of $124.3 Million as Modern Oral Net Sales Rise 133%
Turning Point Brands Reports Q1 2026 Net Sales of $124.3 Million as Modern Oral Net Sales Rise 133%
Turning Point Brands reported first-quarter 2026 results on May 7, covering the period ended March 31, 2026. Total consolidated net sales were $124.3 million, up 16.8% year on year. Gross profit was $68.3 million, up 14.6%, while net income fell 19.0% to $11.7 million. Adjusted EBITDA declined 6.5% to $25.9 million.
May.08 by 2FIRSTS.ai