The FDA has issued warning letters to nine online retailers and one manufacturer over the sale or distribution of unauthorized e-cigarettes that have features normally associated with smart technology. Aside from not having marketing authorization, the concern is that some of these additional features could make them particularly attractive to young people.
Several different designs and functions were highlighted in the warning letters, including devices that feature video games, connect to a smartphone, receive text or call notifications, play music, or personalize products with custom wallpaper.
“These products may resemble smart devices, but there’s nothing smart about them. They’re illegal to sell and a flagrant attempt to target kids.” – Brian King, Ph.D., M.P.H., Director of the Center for Tobacco Products.
While these features are not illegal, the devices they appear on are, as none of them have been granted marketing authorization (and are extremely unlikely ever to receive it). That means they are being sold in the United States in direct contravention of the Federal Food, Drug, and Cosmetic Act. Specific devices cited in the warning letters include:
- Craftbox V-Touch 30k Puff Smart Disposable Vape FN Fab
- CraftBox V-Play 20K Puffs Disposable Vape Blueberry Grapefruit
- CraftBox V-Play 20K Puffs Disposable Vape Strawberry Blowpop
- V-Touch 30K Disposable – Jolly Rancher
- Halo Vapor Synix 30K Bluetooth Vape – Black Cherry
- South Connect 35K Disposable – Grape Blow Pop
- WeFume Vape 30K Puffs – Lychee Soda
- WeFume Vape 30K Puffs – Apple Pineapple
The warning letters highlighted the elements of concern that some of these devices featured, for example:
“FDA finds your products particularly concerning because the product labeling and/or advertising may be attractive to youth by imitating a smartphone or other smart technology. Youth and young adults may be attracted to the product design and functionalities imitating smart phones and other smart technology, including: Bluetooth & Touch Screen, Screen Lock, Download App, Adjust Brightness, and 3 Games”
This is not the first time that retailers have been warned about selling unauthorized vapes that are either disguised as other products or have features that could make them appeal to children. It could certainly be argued that vape brands or manufacturers do themselves no favors by creating vape devices that could so easily be argued are targeted at young people.
“FDA is steadfast in our commitment to enforce the law. We will continue to take appropriate measures, working hand in hand with our federal enforcement partners, to address unauthorized tobacco products, especially those most appealing to youth.” – John Verbeten, director of CTP’s Office of Compliance and Enforcement.
The retailers receiving the warning letters are given 15 working days to respond and outline the steps they will take to correct any violations and prevent future violations. Failure to promptly correct the violations can result in the FDA initiating enforcement actions such as an injunction, seizure, and/or civil money penalties.
Add comment