Sale of Flavored Disposable E-Cigarettes Continues Despite FDA Regulations

On June 23, 2022, flavored electronic cigarette products were seen on store shelves in Raleigh, North Carolina, USA. Image source: REUTERS/Arrana Mclymore/File Photo.

Since 2016, the US Food and Drug Administration (FDA) has been actively working to combat the use of flavored electronic cigarettes that contribute to nicotine addiction among youths.

According to a Reuters investigation, at least 20 brands are still selling disposable devices manufactured in China with flavors targeting children, such as "peach blueberry candy" and "pineapple strawberry," in liquor and convenience stores across the United States.

According to a review of retail sales data by Reuters, flavored disposable e-cigarette devices account for one-third of US e-cigarette sales, up from nearly 2% three years ago. Some critics say that their surge has raised questions about public health agencies' ability to control the booming flavored e-cigarette market and enforce regulations.

The investigation by Reuters is based on a dataset produced by Chicago market research firm IRI, which uses scanner data and other information to track retail purchases. The IRI dataset measured purchasing behavior between January 12, 2014 and June 12, 2022, and observed the rise of disposable flavored e-cigarettes following the FDA crackdown on Juul Labs Inc.

New data has revealed that consumers spent over $2 billion on next-generation disposable electronic cigarettes in the past year, surpassing Juul's previously dominant market share by about 3 percentage points since March.

The data was shared with Reuters by an anonymous individual outside of IRI. A spokesperson for IRI stated that the company "cannot confirm any information received from external sources," and that this data should not be attributed to IRI. According to a 2019 press release from IRI, the company measures purchasing activity of retailers, including over 30,000 convenience stores.

In its written response to the issue, the FDA stated that it is "firmly committed to addressing the ongoing public health concerns surrounding youth e-cigarette use," and "continuously monitoring the evolving market.

According to data obtained by Reuters, in June 2022, the FDA attempted to ban the sale of all Juul e-cigarettes. However, the agency later suspended its order, stating that "there are some unique scientific issues with the Juul application that require additional review.

According to a statement made by Juul to Reuters, the company has expressed that it does not want underage consumers to use their products and looks forward to "re-engaging with the FDA" during the suspension of the ban.

A sweet-flavored disposable electronic cigarette hit the market in 2020, attempting to capitalize on the popularity of Juul and its pod-based device. Both varieties vaporize a liquid that contains nicotine, an addictive chemical that keeps smokers hooked. The nicotine concentration in both is roughly equivalent.

According to interviews conducted by Reuters with nine retail sellers of these products, disposable devices are pre-filled with liquid and cost between $15 and $25, containing 5 to 20 times the amount of liquid found in a Juul pod. Some promotions of these products claim that users can take thousands of puffs from one device. In contrast, Juul devices which cost about $10 require users to add a separate pod of liquid nicotine, priced at $20 to $25 for every four packs.

Representatives of Esco Bars and Breeze Smoke have stated that their products contain synthetic nicotine, an addictive substance that does not come from tobacco plants and was not under the FDA's jurisdiction until earlier this year when Congress took action. Both companies have told Reuters that they applied for FDA authorization in 2022.

The FDA refuses to disclose the name of the applied synthetic nicotine product.

Darrell Suriff, CEO of Texas-based Pastel Cartel, the producer of Esco Bars, revealed that the company has spent nearly $3 million in preparation for its application submission to the FDA. Suriff, who is committed to adhering to regulations, believes that companies like his should not be penalized, stating that "the industry has a lot of bad players... we are not one of them.

Jon Glauser, the Chief Strategic Officer of Hyde in Buffalo City, New York, is representing another disposable brand of synthetic nicotine that grosses nearly $3 million in weekly sales. He acknowledges the concerns of critics who worry that flavored e-cigarettes may lure in young people and get them addicted. However, he adds that adults "really enjoy the taste.

Representatives of privately held Shenzhen Kangweipei Technology Co., Ltd. did not respond to requests for comment.

Filling the Gap of "Sweetness

Juul began promoting electronic cigarettes among teenagers in 2017. After facing regulatory pressure in 2019, Juul gradually lost popularity among young people with the introduction of mango, mint, and fruit flavors, leaving space for dozens of other brands. As sales of flavored disposable electronic cigarettes soared, data shows that Juul's market share in the US dropped from over 70% in 2018 and 2019 to around 30%.

At Luxury Tobacco & Vape in Raleigh, North Carolina, a recent display of disposable Elf Bars showcased over a dozen flavors such as sour apple and rainbow candy. Juul products only occupied a small portion of the shelf space. Juul declined to comment on the exhibit, while Elf Bar did not respond to comment requests.

According to FDA regulations, e-cigarettes cannot be sold in the United States unless manufacturers submit scientific applications by September 2020, proving the products are beneficial to public health. E-cigarettes containing synthetic nicotine must apply by May 14, 2022.

Reuters has provided the FDA with a list of over two dozen seasoning devices that were found in stores and online, despite not being included on the product list submitted to the FDA by 2020.

According to data seen by Reuters from IRI, the FDA refused to answer questions about whether the product identified by Reuters has obtained the necessary authorization.

A spokesperson for the FDA has stated that the agency's website indicates that their compliance and enforcement efforts are a multi-step process that cannot be accomplished all at once.

Mitch Zeller, the retired head of the tobacco department at the Food and Drug Administration (FDA), told Reuters that his list may have gaps because the FDA requires the cooperation of applicants to publicly list them.

Will the FDA catch every regulatory violation? No," said Zeiler, although he stated that targeting manufacturers who have not yet applied is the "top priority" for the FDA.

On August 3rd, the organization stated on its website that the sale of any electronic cigarettes using synthetic nicotine without its authorization is considered "illegal". As of August 15th, the FDA has not granted any authorization to any of them.

Epileptic seizure.

Nineteen-year-old Alex Morrin began using Juul back in 2017 when he was a high school freshman in Tampa, Florida, attracted to its flavors such as "fruit," "cream," and "mint." However, when Juul eliminated these flavors, Morrin started purchasing fruity and sweet disposable e-cigarettes such as Cali Plus and HQD Cuvie Plus, manufactured by Cali Pods and HQD Tech USA based in Florida. "They simply taste better and have more variety," he said. "They're still around and easy to buy.

Cali Pods and HQD did not respond to requests for comment.

After beginning to use e-cigarettes, he experienced headaches and nausea, and then suffered from six seizures between January 2020 and November of last year, resulting in hospitalization. Morlin and his mother, Winna Morlin, say he had never experienced seizures before becoming addicted to e-cigarettes. Winna Morlin provided hospital records confirming the seizures. Researchers have not yet determined a clear link between e-cigarette use and seizures.

The FDA has informed Reuters that it is seeking to understand whether the nicotine content or formula of these devices may cause seizures. According to the FDA, most reports about e-cigarette seizures come from teenage or young adult users.

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