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.

Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
Trump Reportedly Signs Off on Plan to Fire FDA Commissioner Marty Makary
According to The Wall Street Journal, people familiar with the matter said President Trump has signed off on a plan to fire FDA Commissioner Marty Makary, though the plan is not yet final and could change. The report said Makary’s tenure has included clashes over vaping, abortion and drug policy, and that some senior administration officials view him as struggling to manage the agency.
May.09 by 2FIRSTS.ai
Putin Signs Russia’s Tobacco and Nicotine Product Licensing Law, Banning Unlicensed Sales From 2027
Putin Signs Russia’s Tobacco and Nicotine Product Licensing Law, Banning Unlicensed Sales From 2027
Russian President Vladimir Putin has signed a law introducing mandatory licensing for wholesale and retail trade in tobacco and nicotine-containing products, with the system taking effect on October 1, 2026, and unlicensed operations banned from March 1, 2027, while vape and e-liquid retail may also face uncertainty from temporary regional sales-ban powers.
Jul.01
 NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
According to The New York Times, Reynolds American donated $5 million to a Trump-backed super PAC shortly before the FDA introduced a new policy that could benefit major tobacco companies seeking to sell flavored vaping products.
News
May.21
Special Report|Haypp’s Nicotine Pouch Volumes Rise 40%: Who Controls the Digital Shelf for Modern Oral?
Special Report|Haypp’s Nicotine Pouch Volumes Rise 40%: Who Controls the Digital Shelf for Modern Oral?
Haypp Group reported a 40% year-on-year increase in nicotine pouch volumes in the first quarter of 2026, with U.S. and U.K. volumes rising 123% and 102%, respectively. Haypp says around 97% of its consumer traffic is organic and that its Media & Insights business provides brand owners with on-site visibility, trial activation and consumer intelligence. For international tobacco companies, Haypp may be both a growth partner for modern oral products and a new source of channel leverage.
Special Report
May.22
Scotland Plans to Remove Business Rates Relief From Vape Shops From 2027
Scotland Plans to Remove Business Rates Relief From Vape Shops From 2027
The Scottish Government plans to remove business rates relief from vape shops from April 1, 2027, saying the measure is intended to ensure vape retailers contribute to the high street and align rates relief with public health commitments, while the impact on convenience stores that sell vaping products remains unclear.
News
Jun.26 by 2Firsts Perspectives
Ispire and Jincheng Pharma Form Joint Venture to Enter Global High-Growth Nicotine Pouch Market
Ispire and Jincheng Pharma Form Joint Venture to Enter Global High-Growth Nicotine Pouch Market
Summary Ispire Technology announced a strategic joint venture with Chinese pharmaceutical company Jincheng Pharma to manufacture and commercialize nicotine pouch products. The partnership combines pharmaceutical-grade production capabilities with Ispire’s global regulatory infrastructure and distribution network as the company expands beyond vaping hardware into oral nicotine products.
Business
May.13