FDA's Tough Stance on Popular Disposable Vape Brands

The FDA sent warning letters to 14 internet merchants on May 1st for selling illicit vaping goods that are well-liked by young people. These goods, which include disposable e-cigarettes sold under a variety of brands, such as Hyde, Esco Bar, and Elf Bar, have been shown to be extensively utilized by young people; more than 50% of young vapers have reported using Elf Bar items alone.

The Federal Food, Drug, and Cosmetic Act was broken by the aforementioned merchants when they sold items without FDA approval . They have 15 days to reply to the warning letters with a plan for making amends and averting such infractions in the future. Further FDA measures, including as injunctions, seizures, or civil fines, may result from noncompliance.

Just one day before, the U.S. Department of Justice (DOJ) and the FDA jointly reported the significant seizure of illicit vapes valued at over $700,000 at a warehouse in Alhambra, California. Once again, the majority of the items seized were flavor-infused disposable vape pens from Puff Bar, Elf Bar , and Esco Bar. It is thought that these pens are distributed by a number of wholesalers in California.

This is the first time that the FDA, DOJ, and US Marshals Service have together seized tobacco goods. Products owned by MDM Group, doing business as Eliquidstop.com, were the subject of the seizure after the company persisted in marketing illegal goods in spite of being issued a warning notice in May 2023.

The FDA has only allowed 23 tobacco-flavored e-cigarettes for sale in the United States.

Elf Bar was the most widely used vape brand among middle and high school kids, according to the 2023 National Youth Tobacco Survey. This information led to the issuing of CMPs against merchants that sold the brand.

Meanwhile, the FDA said earlier in April that it was filing complaints for civil money penalties (CMPs) against two online merchants and twenty physical stores for selling vape pens without authorization. Elf Bar was the most widely used vape brand among middle and high school kids, according to the 2023 National Youth Tobacco Survey . This information led to the issuing of CMPs against merchants that sold the brand. Follow-up inspections found ongoing infractions despite prior warning letters, leading the FDA to demand a CMP of almost $20,000 from each business.

These steps are a part of the FDA's larger campaign to get illegal e-cigarettes off the market, especially the ones that appeal to young people. The government has so far filed charges, requested injunctions against offenders, and sent hundreds of warning letters to distributors, retailers, importers, and manufacturers. In addition, the government has prosecuted producers and distributors of illicit tobacco products in addition to issuing many CMPs to merchants. As of right now, the FDA has only authorized 23 tobacco-flavored e-cigarette brands and devices for sale in the US.

Is the FDA adopting a successful strategy?

Experts in tobacco harm reduction, meantime, have differing opinions on the US FDA's warnings, civil money penalties (CMPs), and product seizures related to illicit vaping. Given the ubiquity of underage vaping and the possible hazards involved with using unapproved goods, several experts believe that these efforts are important to control the industry and safeguard the public's health. They contend that these kinds of enforcement measures guarantee that laws are followed and help limit young people's access to dangerous drugs.

Others, on the other hand, disagree with the FDA's strategy, arguing that it may unintentionally restrict adult smokers looking for safer substitutes for regular cigarettes in their harm reduction efforts. They contend that too stringent laws and regulations might make it more difficult for adult smokers to get vaping goods, which could drive them to switch back to combustible tobacco, which is associated with more health concerns. Additionally, it forces the goods into the illicit market, where anybody may get them and their safety could be jeopardized.

More significantly, research conducted by these specialists casts doubt on the efficacy of sanctions like CMPs and seizures, arguing that they may not fully address the underlying issues that lead to underage vaping or the sale of illicit products. Generally, attitudes on the best ways to balance public health concerns with harm reduction aims are divided, despite agreement on the need for regulation.