FDA Issues Two Warning Letters to E-cigarette Businesses for Unauthorized Sales

2Firsts 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.

Product | RELX Partners With UK E-Liquid Brand T-Juice for Prime Pro × Red Astaire Bundle in France
Product | RELX Partners With UK E-Liquid Brand T-Juice for Prime Pro × Red Astaire Bundle in France
RELX and UK e-liquid brand T-Juice have launched the Prime Pro × Red Astaire bundle in France, combining the RELX Prime Pro open-system pod device with T-Juice’s signature Red Astaire nicotine salt e-liquid. The collaboration retains the existing Prime Pro hardware platform while using an established flavor brand to create a complete open-system offering. The product appeared in French retail and distribution channels in August 2026 and represents a co-branded retail bundle rather than a new device launch.
Aug.27
China Tobacco Zhejiang files patent for pressure-triggered, on-demand oral nicotine release
China Tobacco Zhejiang files patent for pressure-triggered, on-demand oral nicotine release
China Tobacco Zhejiang Industrial Co., Ltd. has filed a patent application for an oral nicotine delivery product designed to let users actively adjust nicotine release. The product embeds two types of nicotine reservoirs with different wall thicknesses and positions inside a deformable matrix. Pressure applied with the tongue or lips can rupture the reservoirs and accelerate nicotine release. In simulated oral tests, several patent examples showed sharply higher peak nicotine release rates as applied force increased from 0 N to 1 N and 3 N. The filing explores a shift from preset release profiles toward user-triggered nicotine delivery.
Sep.01
New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
New York’s 75% Wholesale Tax on Nicotine Pouches Takes Effect Sept. 1, With Aug. 31 Inventory Subject to Floor Tax
New York State will extend its tobacco products tax to “alternative nicotine products,” including tobacco-free nicotine pouches, from September 1, 2026, at a rate of 75% of the wholesale price. Distributors, wholesalers and retailers must also inventory products held as of 11:59 p.m. on August 31 and pay a floor tax. Vapor products are excluded from the new category and remain subject to New York's separate 20% supplemental sales tax on the retail price.
Aug.26
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s Victoria Steps Up Illegal Tobacco Enforcement With Store Closures and Penalties of Up to A$2.5 Million
Australia’s state of Victoria has activated new powers allowing Tobacco Licensing Victoria and police to shut premises suspected of selling, supplying or possessing illicit tobacco for up to 90 days. Longer closures can be ordered by a magistrates’ court. Businesses subject to closure orders must generally cease all trading and will be placed on a public list. Breaching a closure order can carry penalties of up to A$2.5 million and 20 years in prison.
Sep.10
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
PMI Expands U.S. ZYN Portfolio With New 1.5 mg and 8 mg Strengths, Moves Toward a Unified 20-Pouch-Per-Can Format
Philip Morris International is expanding its U.S. ZYN nicotine pouch portfolio with new 1.5 mg and 8 mg strengths and plans to move its core 3 mg and 6 mg dry-pouch products from 15 to 20 pouches per can in the fourth quarter of 2026. ZYN ULTRA is also commercially available, with FDA authorization covering 10 products at 9 mg and one 11 mg Smooth product. PMI U.S. lists the new 1.5 mg and 8 mg strengths as commercially available, but as of September 10 they do not appear on the FDA’s public authorization list. Public materials do not identify which PMTA submissions cover the two new strengths or their current review status.
Sep.11
JTI Makes Third Bet on South Korea as Ploom AURA Enters a Market Dominated by lil and IQOS
JTI Makes Third Bet on South Korea as Ploom AURA Enters a Market Dominated by lil and IQOS
Japan Tobacco International is stepping up its heated tobacco push in South Korea with Ploom AURA. Since its official launch in April 2026, the device's limited First Edition and Glacier White version have sold out, while distribution has expanded across Seoul, Incheon, Gyeonggi Province and airport duty-free channels. The rollout marks JTI's third major attempt to build a stronger heated tobacco position in South Korea, following Ploom TECH in 2019 and Ploom X Advanced in 2024. At the group level, JT plans to invest about ¥800 billion, approximately $5 billion, in reduced-risk products from 2026 through 2028, with heated products and Ploom identified as its primary investment priority.
Aug.14