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FDA Issues 189 New Warning Letters to Retailers

The U.S. Food and Drug Administration (FDA) has sent warning letters to 189 retailers identified as selling unauthorized e-cigarette products. 

The FDA’s initiative primarily targets the Elf Bar and Esco Bars brands, both known for their disposable e-cigarettes. These brands offer diverse flavors, such as bubblegum and cotton candy, which have been found to captivate the youth market.

Interestingly, these retailers were not warned for selling vaping products to underage people. Instead, they’ve been issued warning letters for selling “unauthorized” vaping products to adults of legal-age.

These products are “unauthorized” because they have not yet been approved by the FDA through a Premarket Tobacco Product Application (PMTA).

This recent wave of warning letters is the result of an intense nationwide retailer inspection carried out over the past few weeks.

Both Elf Bar and Esco Bars have been highlighted in the agency’s surveillance for their increasing popularity and appeal to young people, however these enforcement actions are set to hurt legal-age, adult vapers, the most. 

Insights into E-cigarette Trends and FDA’s Regulatory Measures

On June 22, two significant studies were published, providing valuable insights into the e-cigarette market trends and the enforcement of regulations. These studies, featured in the Morbidity & Mortality Weekly Report by the Centers for Disease Control and Prevention, examine the popularity of Elf Bar products, especially among young consumers.

One study delved into retail sales of e-cigarettes. This investigation found Elf Bar to be the top-selling disposable e-cigarette brand in the U.S. as of December 2022. 

Moreover, this supports information from the International Tobacco Control Survey, which previously showed that Elf Bar is the most popular disposable e-cigarette brand among 16 to 19-year-olds in the United States as of August 2022.

Another study highlighted a notable increase in the number of cases where minors were exposed to e-cigarettes and reported it to poison centers in the United States over the past year. Among the cases that specified the brand involved, Elf Bar was frequently mentioned between April 2022 and March 2023. Most of these incidents affected children under five years old.

Dr. Brian King, who is in charge of the Center for Tobacco Products (CTP) at the FDA, emphasized that everyone involved in the e-cigarette supply chain, including retailers, has a crucial role to play in making sure that e-cigarette sales follow the current regulations. It is a shared responsibility.

King further pointed out that the latest round of warnings should serve as a clear signal to retailers nationwide dealing with Elf Bar and Esco Bars products. He highlighted the readiness of the FDA to enforce compliance using every tool at its disposal, including issuing warning letters. 

Additionally, King underscored the commitment of the FDA to uphold the law and ensure that every entity in the e-cigarette market complies with established regulations to safeguard young consumers.

Again, these retailers were not warned for selling vaping products to underage people but rather for selling “unauthorized” vaping products to adults of legal-age.

FDA Intensifies Measures Against Unlawful E-cigarette Products

The FDA’s recent warning letters represent the latest in a series of actions targeting specifically flavored disposables, such as Elf Bar and Esco Bars. 

The FDA placed import alerts on all items under these two brands just last month. An import alert effectively puts these products on the ‘red list,’ facilitating the FDA to detain the items without needing a physical examination upon entry.

Neither Elf Bar nor Esco Bars products possess the necessary FDA marketing authorization. Currently, the FDA has given the green light to only 23 tobacco-flavored e-cigarette products and devices for lawful sale within the United States. All of these products are manufactured by companies affiliated with “big tobacco”. No products in flavors other than tobacco have been authorized by the FDA.

FDA’s Steady Progress in E-cigarette Market Regulation

As of June 16, the FDA’s regulatory actions have been marked by more than 570 warning letters sent to firms concerning the manufacturing, sale, and/or distribution of unauthorized tobacco products, including e-cigarettes. 

This approach also involved filing civil money penalty complaints against several e-cigarette manufacturers. By October 2022, the first lawsuits for permanent injunctions were initiated against six e-cigarette manufacturers.

May 2023 saw the FDA’s attention focused on two companies producing unauthorized flavored disposable e-cigarette products. Shenzhen Innokin Technology Co. Ltd., the manufacturer of Esco Bars, and Breeze Smoke, LLC, the producer of Breeze products, both received warning letters. 

Furthermore, the FDA also launched a nationwide initiative to monitor the sale of unauthorized e-cigarettes favored by young consumers, such as Puff and Hyde products. This resulted in issuing additional warning letters to over 30 retailers and a distributor.

Once issued a warning letter, most companies will need to make prompt corrections to the stated violations. However, if these are not quickly rectified, the FDA is ready to escalate its enforcement measures, which could include injunction, seizure, or civil money penalties.

Additionally, to broaden its oversight of the evolving tobacco landscape, the FDA, in conjunction with the National Institutes of Health, announced funding for a new Center for Rapid Surveillance of Tobacco (CRST). 

The specialized center will enhance the FDA’s existing surveillance efforts by providing prompt updates on shifts in tobacco product markets and usage trends.

Final Thoughts

While the FDA’s vigorous approach to regulating the e-cigarette industry is admirable for its intent to protect consumers, especially young ones, it’s worth considering the challenges that such strict control measures pose for adult vapers who want to vape on flavors other than tobacco. The FDA’s actions have, so far, only made it more difficult for adult vapers to get the flavored products that they need. 

Robert Barnes Author Picture

Robert Barnes

Robert is the Senior Editor for News and Reviews here at Versed Vaper. Robert previously worked in tech journalism and even wrote commercials. Initially, he joined our team to cover important vaping industry news. Now, he oversees and produces news, reviews, and deals content across a wide variety of topics ranging from law and policy changes, ENDS (Electronic Nicotine Delivery Systems) products and Cannabis and CBD vaping products. When he’s not keeping track of all the latest vaping trends, he can most likely be found marathoning television series or playing with his awesome dog, Lupa.

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