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.

Chinese Disposable Brands OXBAR, LYCO Challenge Vuse and JUUL: Pennsylvania’s Pending List Offers a Glimpse of the Future Legal Vape Market
Chinese Disposable Brands OXBAR, LYCO Challenge Vuse and JUUL: Pennsylvania’s Pending List Offers a Glimpse of the Future Legal Vape Market
Pennsylvania’s June 26 ENDS Pending Certifications list previews the state’s future legal vape market, placing Vuse, JUUL and Logic alongside Chinese-linked disposable brands OXBAR and LYCO. Shaped by PMTA eligibility and state rules, the list shows competition shifting from market share to market access.
Special Report
Jul.06
PMI Highlights 43 Million Smoke-Free Users at Stockholm Summit
PMI Highlights 43 Million Smoke-Free Users at Stockholm Summit
Philip Morris International says about 43 million adults worldwide now use its smoke-free products, with nearly 70% having stopped using cigarettes and smoke-free products accounting for about 43% of its net revenues.
Jun.18
FDA Grants MRTP Orders for 20 ZYN Nicotine Pouches
FDA Grants MRTP Orders for 20 ZYN Nicotine Pouches
The U.S. Food and Drug Administration (FDA) has issued modified risk granted orders to Swedish Match USA for 20 ZYN nicotine pouch products, allowing the already-authorized products to be marketed with a specific claim that using ZYN instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.
Jul.01
Special Report | Russia, Ukraine and Belarus Launch Fresh Push to Rein in Vaping
Special Report | Russia, Ukraine and Belarus Launch Fresh Push to Rein in Vaping
Russia, Ukraine and Belarus are tightening vape regulation through different tools, from Ukraine’s stronger enforcement push and Belarus’s proposed advertising restrictions to Russia’s new GOST standard and regional sales-ban mechanism. As black-market concerns persist, some Russian experts argue that China’s tightly controlled but legalised model — built around licensing, traceability and taxation — may offer a more effective alternative to blanket prohibition.
Jul.15
Product | YOOZ Launches Waker Electronic Shisha Device, Expanding Vape Applications Beyond Portable Devices
Product | YOOZ Launches Waker Electronic Shisha Device, Expanding Vape Applications Beyond Portable Devices
YOOZ has introduced the Waker Electronic Shisha device, expanding its vaping portfolio into the electronic shisha category. The device combines a rechargeable hardware platform with dedicated cartridges, featuring a 4,000mAh battery, up to 60W output power, and LED lighting effects. The product has appeared across multiple French retail channels, reflecting the continued expansion of vaping products into new consumption scenarios.
Jul.13
Canada Recalls Siberia and ZYN Nicotine Pouches Over Unauthorized Sales
Canada Recalls Siberia and ZYN Nicotine Pouches Over Unauthorized Sales
Health Canada has issued a nationwide recall for nicotine pouch products sold under the Siberia and ZYN brands, citing a lack of market authorization. All affected lots are subject to the recall.
Jun.15