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.

Italy Proposes Earlier Vape and HTP Tax Hikes, New Rules for E-Liquid Pricing, Exclusive Deals and Distribution
Italy Proposes Earlier Vape and HTP Tax Hikes, New Rules for E-Liquid Pricing, Exclusive Deals and Distribution
Italy's proposed 2027–2029 budget would bring forward scheduled tax increases for e-cigarette liquids and heated tobacco products from January 1, 2028, to July 1, 2027. The consumption tax coefficient for nicotine-containing e-liquids would rise from 20% to 22%, that for nicotine-free liquids and applicable flavorings from 15% to 17%, and the heated-tobacco coefficient from 41% to 42%. The bill would also introduce official retail price schedules for e-liquids, restrict exclusive agreements between retailers and suppliers, and limit single-brand-dominated displays, sales incentives and bundled offers. Importing, authorized warehousing and retailer sourcing arrangements would also change. The proposals remain subject to parliamentary approval and subsequent implementing regulations.
Regulations
Nov.04
PMI Showcases ZYN, IQOS and U.S. Investments at NACS Show 2026
PMI Showcases ZYN, IQOS and U.S. Investments at NACS Show 2026
At the 2026 NACS Show in Las Vegas, Philip Morris International (PMI) showcased its ZYN nicotine pouches, IQOS heated tobacco products and U.S. investments. A 2Firsts review of FDA records found that several ZYN products displayed at the booth were not on the agency's marketing authorization list, including certain nicotine strengths and flavors. A PMI booth representative also confirmed that IQOS is currently sold in three U.S. states, while the newer IQOS ILUMA system remains under FDA review.
EXPO
Oct.10
Japanese Addiction Psychiatrist Says Complete Abstinence Is Not Always the Goal of Harm Reduction | 2Firsts Interview
Japanese Addiction Psychiatrist Says Complete Abstinence Is Not Always the Goal of Harm Reduction | 2Firsts Interview
Complete abstinence is not always the goal of addiction treatment under a harm-reduction approach, Japanese psychiatrist Tomohiro Shirasaka told 2Firsts in Manila. In the interview, he discussed patients' quality of life, Japan's shift towards heated tobacco products, and the challenges of quitting smoking for people with mental illness. Drawing on addiction treatment work in the Philippines, he advocated support rather than punishment and questioned whether fear-based health warnings effectively address the reasons people continue smoking.
Nov.10
Russia's Vape Ban Decisions Reach 17 Regions With 39 More Considering Laws, Putting Over 3,000 St. Petersburg Retail Outlets in Focus
Russia's Vape Ban Decisions Reach 17 Regions With 39 More Considering Laws, Putting Over 3,000 St. Petersburg Retail Outlets in Focus
Russia's regional vape retail restrictions are expanding. State Duma Speaker Vyacheslav Volodin said on November 7 that 17 regions had adopted decisions to ban vape sales, while another 39 were preparing or considering similar legislation. On November 12, lawmakers in Leningrad Oblast and the Republic of Karelia adopted bans scheduled to begin on March 1, 2027. A day earlier, St. Petersburg unanimously approved a five-year ban proposal in its first reading. The city has 615 specialist vape shops and more than 2,400 other retail outlets selling vaping products alongside other goods. Under Federal Law No. 186-FZ, enacted in June 2026, Russian regions may prohibit retail sales of electronic nicotine delivery systems and related liquids between March 2027 and March 2032. The legislation also restricts licensed suppliers from delivering covered products to retail premises in regions where bans apply.
Regulations
Nov.13
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
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
JTI Proposes 25-Cent Irish Cigarette Tax Increase, Says It Could Raise €45 Million
Japan Tobacco International's Irish business has proposed a €0.25 tax increase on a pack of 20 cigarettes in its pre-Budget 2027 submission, below the €0.50-or-more increases typically imposed in recent Irish budgets. JTI says the proposal could generate around €45 million in additional Exchequer revenue while limiting further movement toward illicit and non-Irish-tax-paid tobacco. Revenue's existing estimate for a comparable €0.25 increase, including pro-rata rises on other tobacco products, is about €18 million for a full year.
JTI
Sep.18 by 2Firsts Perspectives