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

Events by THE EPOCH TIMES
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.

PMI Q3 2025 Earnings: Net Revenues Reach $10.85 Billion, Smoke-Free Products Account for 41% of Sales
PMI Q3 2025 Earnings: Net Revenues Reach $10.85 Billion, Smoke-Free Products Account for 41% of Sales
PMI reported strong third-quarter 2025 results, underscoring the continued success of its smoke-free transformation. Net revenues rose 9.4% year-over-year to $10.85 billion, driven by robust growth in the smoke-free segment, which now accounts for 41% of total net revenues and over 42% of gross profit.Despite a 3.2% decline in cigarette shipments, combustible revenues climbed 4.3% thanks to strong pricing.
Oct.21
84% of Britons Back Regulation of Nicotine Pouches, Survey Finds
84% of Britons Back Regulation of Nicotine Pouches, Survey Finds
A Northerner survey finds 84% of Britons support regulating nicotine pouches and 82% back a licensing scheme for vape sales, aligning with the Tobacco and Vapes Bill to improve consumer safety and youth protection.
Nov.06 by 2FIRSTS.ai
South Korea Plans Unified Regulation for Synthetic and Look-Alike Nicotine Products
South Korea Plans Unified Regulation for Synthetic and Look-Alike Nicotine Products
South Korea Parliament discusses including "nicotine" in Tobacco Business Act; synthetic nicotine testing method established, awaiting legislation approval.
Oct.22 by 2FIRSTS.ai
Australia Leads COP11 Seminars as Exploding Illicit Tobacco Market Raises Questions
Australia Leads COP11 Seminars as Exploding Illicit Tobacco Market Raises Questions
Australia sent a delegation to COP11 in Switzerland and is leading three major seminars to showcase its vape and tobacco control policies. But at home, illicit cigarette sales are skyrocketing amid record-high taxes, drawing criticism from the tobacco industry and prompting doubts over policy effectiveness.
Nov.20 by 2FIRSTS.ai
Australian Border Force Blocks Massive Vape Shipment Following China Intelligence
Australian Border Force Blocks Massive Vape Shipment Following China Intelligence
Australia has seized more than 600,000 illicit vapes in two months, following coordinated intelligence with overseas partners. The Australian Border Force (ABF) warns that illegal vaping products now form a multibillion-dollar black market dominated by organised crime syndicates.
Nov.21 by 2FIRSTS.ai
Singapore Police Dismantle Cross-Border E-Cigarette Smuggling Ring, Arrest 12 and Seize Over 64,000 Devices
Singapore Police Dismantle Cross-Border E-Cigarette Smuggling Ring, Arrest 12 and Seize Over 64,000 Devices
Singapore authorities crack down on cross-border e-cigarette smuggling syndicate, arresting 12 individuals and seizing over $43,000 worth of contraband.
Oct.20 by 2FIRSTS.ai