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.

2Firsts On-Site | PMI Brings IQOS, ZYN, VEEV and Marlboro Together at Its “Boulevard” at InterTabac 2026
2Firsts On-Site | PMI Brings IQOS, ZYN, VEEV and Marlboro Together at Its “Boulevard” at InterTabac 2026
At InterTabac 2026 in Dortmund, PMI is presenting multiple brands and products along “The PMI Boulevard,” including IQOS, ZYN, VEEV and Marlboro. On-site images captured by 2Firsts show dedicated spaces including the IQOS Boutique, ZYN Café, PMI Gallery and Marlboro Office
Market
Sep.16 by 2Firsts Perspectives
India Duty-Free Nicotine Pouch Sales Face Regulatory Test as ZYN, FOX Classification Remains Open
India Duty-Free Nicotine Pouch Sales Face Regulatory Test as ZYN, FOX Classification Remains Open
The Bombay High Court has ruled that airport duty-free shops are not exempt from India's domestic regulatory laws merely because they operate beyond the customs barrier, leaving in place a sales halt covering ZYN and FOX nicotine pouches at Mumbai's international airport. The court, however, did not determine that the products necessarily qualify as "drugs" under India's Drugs and Cosmetics Act. The retailers have four weeks to submit product information to the appropriate authorities, including CDSCO, which must complete its review within 30 days of receiving the submissions.
Sep.24
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
Ispire Q4 Revenue Rebounds 33% but Full-Year Sales Still Fall 25% as FY2027 Focus Shifts to Malaysia Manufacturing, ODM, Nicotine Pouches and Age Verification
Ispire Technology reported FY2026 revenue of about $96 million, down 24.7% year over year, as U.S. cannabis-vapor hardware and European e-cigarette sales declined by $17.4 million and $12.7 million, respectively. Fourth-quarter revenue rose 32.5% to $26.7 million, while quarterly gross margin fell to 6.3%. For FY2027, the company is prioritizing Malaysia manufacturing and vapor ODM while continuing to develop nicotine pouches, IKE Tech age-verification technology and G-Mesh licensing. Ispire has not separately disclosed the revenue or profit contribution of those newer businesses.
Regulations
Sep.17 by 2Firsts Perspectives
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
Germany Probes 7.6 Million Illegal Vape Case With Estimated €33.3 Million Tax Loss; Four Chinese Manufacturer Employees Under Investigation, Some Packaging in Enforcement Images Resembles FUMOT Products
German prosecutors and customs authorities are conducting a criminal investigation into an alleged cross-border organised vape network. Authorities say that between January 2024 and March 2025, four employees of an unnamed Chinese e-cigarette manufacturer allegedly built a network of sales agents and wholesalers that brought more than 7.6 million nicotine disposable vapes into Germany, causing an estimated €33.3 million in excise-tax losses. The manufacturer has not been named. Some products visible in enforcement images have packaging resembling products from FUMOT’s portfolio. European regulatory records from 2024, FUMOT’s public overseas-sales materials and records involving German vape importer and distribution company Zamu-Pro GmbH also show FUMOT/RandM products and German distribution activity during the period covered by the investigation.
Sep.21
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA Issues First U.S. Clinical Guidance on Vaping for Smoking Cessation, Urging Complete Switch From Cigarettes
JAMA has published a Special Communication offering systematic recommendations for U.S.-based clinicians on the use of nicotine e-cigarettes in adult smoking cessation. Developed by the Harm Reduction Workgroup of the Society for Research on Nicotine and Tobacco’s Treatment Research Network, the paper recommends including e-cigarettes alongside FDA-approved cessation medications in risk-benefit discussions. It cites high-certainty evidence that nicotine e-cigarettes achieve higher quit rates than nicotine replacement therapy and evidence suggesting efficacy comparable to highly effective medications such as varenicline and cytisine. For adults who choose vaping to quit, the authors recommend FDA-authorized products, sufficient nicotine delivery and a rapid, complete transition away from cigarettes rather than prolonged dual use.
Aug.13
Product | PMI Japan Expands ZYN by IQOS Strength Portfolio With Strong Series, Increasing Lineup to 12 Products
Product | PMI Japan Expands ZYN by IQOS Strength Portfolio With Strong Series, Increasing Lineup to 12 Products
Philip Morris Japan (PMJ) has expanded the ZYN by IQOS oral tobacco pouch portfolio in Japan with four new ZYN Strong products, adding a third intensity level alongside the existing Low and Medium ranges. The Strong series first entered selected duty-free channels in Japan on July 1, 2026, before expanding to IQOS stores, the ZYN Online Store and selected tobacco retailers from August 18. The expansion increases the Japanese ZYN by IQOS lineup from eight to 12 products.
Aug.20