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.

Reuters Tracks Big Tobacco’s Shift Beyond Cigarettes as Nicotine Pouches Vie for the Next Growth Curve
Reuters Tracks Big Tobacco’s Shift Beyond Cigarettes as Nicotine Pouches Vie for the Next Growth Curve
As cigarette markets face long-term pressure, major tobacco companies are increasingly turning to nicotine pouches in search of growth beyond combustible tobacco. Reuters has examined whether nicotine pouches can become the next strategic growth platform for companies including Philip Morris International, British American Tobacco and Japan Tobacco. PMI strengthened its position through the acquisition of Swedish Match and its ZYN brand, while BAT and JTI continue expanding their own nicotine pouch portfolios. The category has gained attention because of its smoke-free, device-free format, but regulation, youth-use concerns and market scale will determine whether it can become a long-term growth engine.
Regulations
Aug.18 by 2Firsts Perspectives
2Firsts Exclusive Analysis | RLX Q2 Revenue Rises 14.8%, Company Takes Control of Western European Distributor and Expands Multi-Category Strategy
2Firsts Exclusive Analysis | RLX Q2 Revenue Rises 14.8%, Company Takes Control of Western European Distributor and Expands Multi-Category Strategy
business accounting for 68.5% of sales. A new controlling investment in a Western European distributor and plans to scale modern oral nicotine pouches point to a broader international strategy spanning channels and multiple product categories.
Special Report
Aug.14
HG Innovation, linked to IMiracle and ELFBAR, wins China patent for 6-methylnicotine salts covering vaping and oral products
HG Innovation, linked to IMiracle and ELFBAR, wins China patent for 6-methylnicotine salts covering vaping and oral products
HG Innovation Limited has been granted a Chinese invention patent covering 6-methylnicotine salt formulations and their use in oral and vaping products. The technology forms salts between 6-methylnicotine and alicyclic carboxylic acids, with granted claims extending to oral products, atomization substrates and electronic atomization devices. Applicant-generated tests reported differences in oxidation stability, in-vitro cytotoxicity and aerosol heavy-metal performance compared with selected benzoate or lactate controls. HG Innovation is directly linked to the broader IMiracle and ELFBAR business network.
Sep.04
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Product | PMJ Adds Bold Ruby to IQOS ILUMA i Lineup in Japan, Convenience-Store Rollout Starts Sept. 29
Philip Morris Japan (PMJ) launched Bold Ruby as a new regular color for the IQOS ILUMA i and IQOS ILUMA i ONE in Japan on September 16, 2026, priced at JPY 6,980 and JPY 3,980, respectively. Initial sales began through IQOS online and physical channels, with convenience stores and selected tobacco retailers set to follow from September 29. Bold Ruby is a regular rather than limited-edition colorway and is available for the ILUMA i and ILUMA i ONE, but not the ILUMA i PRIME. The release does not involve changes to the devices' core hardware or functions.
Sep.22
California Lawmakers Pass Disposable Nicotine Vape Ban, With Sales Prohibition Set for 2028
California Lawmakers Pass Disposable Nicotine Vape Ban, With Sales Prohibition Set for 2028
According to CBS Los Angeles on August 27, 2026, California lawmakers have passed Assembly Bill 762, which would phase out disposable, battery-embedded nicotine vapes in the state. If signed by Governor Gavin Newsom, manufacturing and importation of the covered products would be prohibited beginning January 1, 2027, followed by a sales ban on January 1, 2028. Driven primarily by concerns over electronic waste, lithium-battery fires and environmental pollution, the legislation would further shift California’s legal vape market toward rechargeable, refillable or replaceable-pod devices.
Aug.28
NAS 2026 | Former FDA Tobacco Chief Mitch Zeller Calls for Shift From “End Game” to “End State”
NAS 2026 | Former FDA Tobacco Chief Mitch Zeller Calls for Shift From “End Game” to “End State”
At the 2026 New Approaches Summit in New York, former FDA Center for Tobacco Products Director Mitch Zeller called for the tobacco harm reduction debate to shift from the traditional “end game” toward defining a desired “end state.” He also highlighted unresolved concerns around dual use, argued that biomarkers of exposure may be more meaningful than cigarettes-per-day in assessing risk reduction, and said nicotine misperceptions remain a major barrier to public health progress.
Sep.25