In the months surrounding and following the deadline, nearly 1.5 million young people – including 800,000 teens between 15 and 18 years old – used an e-cigarette for the first time. In fact, the agency has yet to complete reviews from the largest companies with the most popular products that make up over 75% of the e-cigarette market, despite the court-ordered September 2021 deadline to do so. 9, 2021, the FDA finally faced a court-ordered deadline to review millions of premarket applications (known as PMTAs) from e-cigarette manufacturers to determine whether the products are “appropriate for the protection of public health.” The agency denied the applications of nearly a million flavored products, but almost a year after the FDA’s deadline, it has yet to act on many of the most popular products with young people. Many e-cigarettes have been allowed to stay on the market for years without undergoing a review of their public health impact, sparking an epidemic of youth use. From 2020 to 2021, the disposable e-cigarette market share grew from a quarter of the total e-cigarette market to more than one-third (from 25% to 37.5%). National data from the CDC Foundation reflect these market changes as well. The most popular e-cigarette brands among 13-24-year-olds who enrolled in This is Quitting in 2022 are Puff Bar (23%), JUUL (8.4%), and Hyde (6.5%). Data from our This is Quitting text messaging program designed to help young people quit vaping showed that by the time a federal restriction on prefilled pod-based flavored e-cigarettes (excluding menthol) went into effect in February 2020, This is Quitting users had largely shifted away from JUUL to products from the brands Puff Bar and Smok. When regulation impacted the availability of many flavors in “closed pod” e-cigarettes, such as JUUL, young e-cigarette users switched to other brands still offering sweet and fruity flavors. It is well established that flavors play a significant role in enticing youth and young adults to try and use tobacco products. They come in a variety of different flavors – from pineapple ice and lemon cookies to strawkiwi and blueberry watermelon. Here are some important things to know about Elf Bar, Hyde, Breeze, and similar products. Because FDA is flouting the law, products that appeal to youth remain on the market and industry is emboldened to continue to flood the market with new flavors and products at will.īoth these product characteristics – being disposable and using synthetic nicotine – have helped allow sweet and fruity-flavored e-cigarettes to stay on the market. (Note: Some products that are considered drugs, such as Nicotine Replacement Therapies used to help people quit tobacco, are regulated under the Center for Drug Evaluation and Research and must go through CDER’s approval process for safety and effectiveness.) Despite the change in law, FDA has not followed the deadlines Congress laid out to remove these illegal synthetic nicotine e-cigarette products from the market. Puff Bar products remain on the market.Ĭongress closed the synthetic nicotine loophole in March, passing and signing into law language clarifying that synthetic nicotine products must be regulated by the FDA’s Center for Tobacco Products in the same way that tobacco-derived nicotine products are regulated. For example, the makers of Puff Bar, which the FDA ordered to stop selling their flavored, tobacco-derived e-cigarette products in July 2020, returned to the market months later claiming to use synthetic nicotine. Taking advantage of FDA’s hesitance, many e-cigarette makers that used tobacco-derived nicotine switched to synthetic nicotine to avoid regulatory oversight. While this was not accurate, the FDA was slow to determine how it would regulate these products. When products containing synthetic nicotine first came onto the market, some companies claimed that they did not have to be regulated by the Food and Drug Administration (FDA). Many disposable e-cigarette manufacturers also began using synthetic nicotine – nicotine created in a laboratory and not derived from tobacco – to exploit another regulatory loophole that has allowed sweet and fruity flavored products to proliferate.
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