The Dangers of Flavored Disposable E-Cigarettes with Synthetic Nicotine

Disposable e-cigarettes with flavors like cheesecake, bubblegum, and strawberry ice cream, such as top brands Puff Bar and similar products Elf Bar, Hyde, and Breeze, are popular among young people. The lack of significant regulation has encouraged the growth of these similar products.

These products remain on the market due to a gap in federal policy, and they come in a variety of e-cigarette flavors. In early 2020, the federal government only restricted JUUL's flavored e-cigarettes (excluding mint) and exempted other types of flavors, including disposable and open system refillable devices. Between 2019 and 2020, the popularity of disposable e-cigarettes skyrocketed after obtaining exemptions, with high school e-cigarette use increasing by approximately 1,000% (from 2.4% to 26.5%) and middle school e-cigarette use increasing over 400% (from 3% to 15.2%).

Many manufacturers of disposable electronic cigarettes have started using synthetic nicotine - nicotine produced in a laboratory rather than extracted from tobacco - to exploit another regulatory loophole and boost sweet and fruity flavored products. When products containing synthetic nicotine were first introduced to the market, some companies claimed they did not have to be regulated by the US Food and Drug Administration (FDA). Although this is not accurate, the FDA has been slow to determine how to regulate these products. Taking advantage of the FDA's hesitation, many e-cigarette manufacturers using tobacco-derived nicotine have turned to synthetic nicotine to avoid regulatory oversight. For example, the manufacturer of Puff Bar was ordered by the FDA in July 2020 to stop selling its flavored tobacco-derived e-cigarette products, but a few months later they were reintroduced to the market claiming to use synthetic nicotine. Puff Bar products are still being sold on the market.

In March, the Congress closed the loophole on synthetic nicotine by passing and signing into law language that clarifies synthetic nicotine products must be regulated by the FDA's Center for Tobacco Products, just like tobacco-derived nicotine products.

Note: Some products that are considered drugs, such as nicotine replacement therapy for smoking cessation, are regulated by the Center for Drug Evaluation and Research and must go through the safety and efficacy approval process by CDER. Despite changes in the law, FDA has not complied with the deadline set by Congress to remove these illegally synthesized nicotine e-cigarette products from the market. Due to FDA's disregard for the law, products that appeal to young people are still on the market, allowing the industry to continue flooding the market with new flavors and products.

The two product features – disposable and use of synthetic nicotine – both contribute to the continued presence of sweet and fruity flavored e-cigarettes in the market. Here are some important details about Elf Bar, Hyde, Breeze, and similar products.

How much nicotine does a disposable electronic cigarette contain?

These types of disposable e-cigarettes can contain up to 5% by weight of nicotine (50mg/mL) - similar to Puff Bar. Some, including Hyde and Breeze, use a synthetic nicotine formula. Synthetic nicotine products are often marketed as "smoke-free," "healthier," and "better" than products containing tobacco-derived nicotine, which could mislead consumers because the products still contain addictive chemical nicotine.

Any form of nicotine is harmful to brain development. Teenage use can disrupt the formation of brain circuits that control attention and learning, and may make them more susceptible to addiction later in life. Studies have shown a link between early smoking and pleasurable initial experiences with daily use and lifelong nicotine dependence. Nicotine can also exacerbate symptoms of anxiety and amplify feelings of depression and stress.

What flavors do Elf Bar, Hyde, and Breeze offer?

They come in a variety of flavors, ranging from pineapple ice and lemon cookies to strawberry and blueberry watermelon. It is well-known that flavors play a significant role in attracting young people to try and use tobacco products.

As regulation has impacted the supply of various flavored "closed system" e-cigarettes like JUUL, young e-cigarette users have turned to other brands still offering sweet and fruity flavors. Data from our "This is Quitting" text message program aimed at helping young people quit e-cigarettes shows that by the time federal restrictions on pre-filled pod-style flavored e-cigarettes (excluding menthol) went into effect in February 2020, "This is Quitting" users had largely shifted from JUUL to products by Puff Bar and Smok. Among 13-24 year olds participating in This is Quitting in 2022, the most popular e-cigarette brands were Puff Bar (23%), JUUL (8.4%), and Hyde (6.5%).

National data from the CDC Foundation also reflects these market changes. From 2020 to 2021, the market share of disposable e-cigarettes increased from a quarter of the entire e-cigarette market to over a third (from 25% to 37.5%).

What actions need to be taken to handle these seasoning products?

Many e-cigarettes were allowed to be sold on the market for years without undergoing public health impact reviews, which sparked a youth usage epidemic.

On September 9th, 2021, the FDA faced a court-ordered deadline to review millions of pre-market applications, known as PMTAs, from electronic cigarette manufacturers to determine whether these products are "appropriate for protecting public health." The agency rejected applications for nearly a million flavored products, but nearly a year after the FDA's deadline, it has yet to take action on many of the most popular products among young people. In fact, even though the court ordered a deadline in September 2021, the agency has not completed its review of the largest companies of the most popular products that make up over 75% of the e-cigarette market. In the months before and after the deadline, nearly 1.5 million young people, including 800,000 adolescents aged 15 to 18, started using electronic cigarettes for the first time.

The agency must prioritize the review of the top brands that dominate the majority of the e-cigarette market and are most popular among young people. As part of this process, the FDA must also use its congressional authorization to address the issue of synthetic nicotine, so that leading single-use brands cannot continue to slip through this loophole.

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