Russ WareThe FDA has issued warning letters to 80 retailers across 15 states for the sale of e-cigarette products. Agency inspections found that all 80 of the brick-and-mortar stores were selling unauthorized disposable vapes made by brands believed to be popular with young people.
The devices mentioned in the warning letters, issued on July 25th, 2024, are predominantly Elf Bar and Lost Mary, including Elfbar Gumi and Lost Mary Lemon Mint. As the FDA is always keen to point out, the 2023 National Youth Tobacco Survey found that these brands, and Elf Bar in particular, were preferred among middle and high-school students.
Warning letters are generally only sent when the first instance of a violation is identified following an inspection. The FDA has now issued more than 690 such warning letters to retailers, brick and mortar and online, for selling unauthorized tobacco products. These include:
- June 2024 – Warning letters were issued to six online retailers for selling unauthorized e-liquid products designed to look like prescription drug bottles.
- May 2024 – Warning letters were issued to 14 online retailers for selling unauthorized e-cigarette products, including Elf Bar/EB Design and Esco Bars.
- April 2024 – Warning letters were issued to three online retailers for selling unauthorized ZYN nicotine pouches.
- March 2024 – Warning letters were sent to 61 brick-and-mortar retailers for selling unauthorized Elf Bar and Lava e-cigarette products.
- February 2024 – Warning letters were issued to five online retailers for selling unauthorized Elf Bar/EB Design/EB Create, Funky Republic, Lost Mary, Hyde, Breeze, and Cali Bars e-cigarette products.
The latest batch of 80 letters is the largest amount issued at one time for e-cigarette sales infractions in the last 12 months.
Civil Money Penalties Filed
Alongside the warning letters, the FDA has also filed complaints for civil money penalties (CMPs) against eight separate retailers. These retailers have been shown to have failed to take action after being previously warned over selling unauthorized ENDS, e-liquids, or other vape products.
To date, CTP has issued CMP complaints against 136 brick-and-mortar and 12 online retailers for selling unauthorized tobacco products for the maximum statutory amount. That means that each retailer may be liable to pay $20,678 for a single violation.
Authorized E-Cigarette Products
The amount of warning letters and penalties still being issued, sometimes for products that were denied marketing approval 2-3 years ago, perhaps highlights the ongoing confusion around the legality of vaping and vape sales in the United States. The FDA has created a database of authorized products, but retailers have to know it is there for it to be of any use.
To date, the FDA has authorized 34 e-cigarette products and devices. These are the only e-cigarette products that may be lawfully marketed and sold in the United States. The number of authorized vape products increased in July 2024 with several Vuse Alto pods being issued marketing granted orders (MGOs). These are:
- Vuse Alto Pod Golden Tobacco 5%
- Vuse Alto Pod Rich Tobacco 5%
- Vuse Alto Pod Golden Tobacco 2.4%
- Vuse Alto Pod Rich Tobacco 2.4%
- Vuse Alto Pod Golden Tobacco 1.8%
- Vuse Alto Pod Rich Tobacco 1.8%
These closed pods are designed for use with the Vuse Alto power unit, which was granted marketing approval alongside the pods. Vuse (which is part of tobacco giant R. J. Reynolds, itself a subsidiary of the world’s largest tobacco company, BAT) is now the Vape brand with the most authorized products, ahead of NJOY and Logic.
Robert Barnes
Versed Vaper Team
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