FDA warns six 'smart e-cigarette' brands, including FUME, Craftbox, and North Vape

On October 31, 2Firsts reported that the U.S. Food and Drug Administration (FDA) issued warning letters to nine online retailers and one manufacturer, accusing them of selling unauthorized smart e-cigarettes (click to read the article). According to 2Firsts' analysis of the FDA warning letters, six e-cigarette brands were involved: FUME, Craftbox, North Vape, Posh, Halo Vapor, and Swype.

2Firsts noted that in the ten FDA warning letters, the agency described how "these products' labels or advertising may appeal to youth by imitating smartphones or other smart technologies" and "may attract teenagers by resembling gaming products," labeling these products as "highly concerning".

Below is a list compiled by 2Firsts from the FDA warning letters, detailing the brands and products mentioned:

FUME

 
The product cited in the warning letter is:

•  WeFume Vape 30K Puffs  – cited 3 times

Craftbox

The products mentioned in the warning letters are:

• Craftbox V-Touch 30k Puff Smart Disposable Vape – cited 4 times  
• Craftbox V-Play 20K Puffs Disposable Vape – cited 5 times  
• Craftbox V-Touch 30,000 Puffs Phone Call Vape Disposable– cited 1 time

North Vape

The products cited in the warning letter are:

• North South Connect 35K Puffs Phone Disposable Vape – cited 2 times
• South Connect 35K Disposable Vape Bluetooth 900mAh – cited 1 time

 Posh 

The products cited in the warning letter are:

•  Posh Xtron 30000 Disposable Vape – cited 1 time  
•  Posh Pro Max 30000 – cited 1 time

Halo Vapor

The product cited in the warning letter is:

• Halo Vapor Synix 30K – cited 2 times

Swype
 

The product cited in the warning letter is:

• Swype 30K Disposable Vape – cited 1 time

According to information disclosed by the FDA, when the agency identifies what it considers to be serious violations of federal requirements, it notifies the relevant parties.

This notification typically takes the form of a warning letter, which highlights issues such as poor manufacturing practices, problematic product efficacy claims, or incorrect usage instructions. The letter provides companies or individuals with an opportunity to address the FDA’s concerns, requiring a response within a specified timeframe. This response may include a corrective plan, after which the FDA will conduct follow-up inspections to ensure that corrective measures are sufficient.

If a company or individual disagrees with the FDA's assessment, they have the opportunity to present their reasons and supporting information to the FDA. These communications and other actions between the FDA and the letter recipient may alter the regulatory status of the issues discussed in the letter.

As of October 30, 2024, the FDA has authorized 34 e-cigarette products and devices. The agency maintains a printable one-page flyer listing all authorized e-cigarette products, which retailers can reference to verify which products may be legally marketed and sold in the United States. Entities manufacturing, importing, selling, or distributing e-cigarettes without the necessary premarket authorization will face enforcement risks.