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

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.

Altria and Juul Ask Court to Pause Antitrust Case Pending Ninth Circuit Review
Altria and Juul Ask Court to Pause Antitrust Case Pending Ninth Circuit Review
Altria and Juul are asking a California federal court to pause an antitrust case while they appeal a class certification ruling to the Ninth Circuit. The case alleges that Altria’s 2018 investment in Juul, a $12.8 billion deal for a 35% stake.
May.07 by 2FIRSTS.ai
FEELM Releases Four Transparent Pod-Related Solutions for the TPD Market
FEELM Releases Four Transparent Pod-Related Solutions for the TPD Market
FEELM, a technology brand under Smoore, released four product solutions at an industry expo held in France, including OMNI POD MINI, OMNI POD MAX, TWINBREEZE, and CRYSBERG. The solutions are designed around TPD market needs and involve transparent pod design, leak-resistant structures, flavor performance, smart recognition, and different capacity configurations.
Apr.09 by 2FIRSTS.ai
Imperial Brands Launches 2ml+10ml blu MAX 6000 Vape System
Imperial Brands Launches 2ml+10ml blu MAX 6000 Vape System
mperial Brands has launched blu MAX 6000 in the UK, positioning the product as a higher-puff vape kit with longer-lasting use and replaceable pod+refill options. The device uses a 2ml+10ml click-on box format, with starter kits priced at £10.99 (approximately $14) and replacement pod+refill packs priced at £7.99 (approximately $10).
Market
May.19
Capital Group Takes 5.61% Stake in KT&G, Joining Major Foreign Shareholders
Capital Group Takes 5.61% Stake in KT&G, Joining Major Foreign Shareholders
KT&G disclosed in a regulatory filing on Friday that Capital Research and Management Company, the investment management arm of Capital Group, had acquired a 5.61% stake through purchases made on April 22 and May 4. The move places Capital Group among KT&G’s prominent foreign shareholders, alongside BlackRock, First Eagle Investment Management and Singapore’s sovereign wealth fund GIC.
May.08 by 2FIRSTS.ai
Product | Vaporless Mode + Transparent Display Screen: Kanger Launches Subox Mix 50K in the U.S.
Product | Vaporless Mode + Transparent Display Screen: Kanger Launches Subox Mix 50K in the U.S.
E-cigarette brand Kanger has recently launched its new e-cigarette, the Subox Mix 50K, across multiple online channels in the United States. The product features a “vaporless mode” and a transparent digital display design, supporting switching between approximately 25K vapor puffs and 25K vaporless puffs, for a total of 50,000 puffs, while displaying battery level and mode status in the transparent pod section.
Apr.13 by 2FIRSTS.ai
 NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
NYT: Reynolds American Donated $5 Million Before FDA Vape Policy Shift
According to The New York Times, Reynolds American donated $5 million to a Trump-backed super PAC shortly before the FDA introduced a new policy that could benefit major tobacco companies seeking to sell flavored vaping products.
News
May.21