Recently, the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) coordinated to release the 2022 National Youth Tobacco Survey (NYTS), which provides federal data on the use of e-cigarettes by American youth. The survey results, published in the Morbidity and Mortality Weekly Report, revealed that the usage of e-cigarettes among young people remains high, with 2.5 million (9.4%) middle and high school students nationwide reporting current use of e-cigarettes.
The FDA remains deeply concerned about the use of electronic cigarettes among our nation's youth. Clearly, we still have a serious public health problem that threatens the progress we have made over the years in combatting youth tobacco product use," said FDA Commissioner Robert M. "We cannot and will not let our guard down on this issue. The FDA remains steadfast in its commitment to using all its authority to address the issue of youth electronic cigarette use head-on.
According to a study conducted through online surveys from January to May 2022, approximately one in ten middle school (3.3%) and high school (14.1%) students in the United States reported current (within the past 30 days) use of electronic cigarettes. Among these young e-cigarette users, nearly 85% reported using flavored e-cigarettes and over a quarter (27.6%) reported daily use of e-cigarettes.
Among current young electronic cigarette users, the most commonly used device type is disposable devices. Young electronic cigarette users report the top three brands they most often use are Puff Bar (14.5%), Vuse (12.5%), and Hyde (5.5%). While Puff Bar and Vuse were listed as predetermined options in the survey, Hyde was not. Students use Hyde as their preferred brand, therefore, the reported usage percentage may be underestimated.
Brands that are popular among young people are being addressed/solved.
The FDA also announced other measures it took today to address brand popularity among young people.
The FDA has issued a warning letter to EVO Brands LLC and PVG2, LLC, two companies doing business with Puff Bar. The FDA has asked these companies to respond within 15 working days outlining their plans to address the FDA's concerns, including a date for when they plan to stop selling and/or distributing these tobacco products and their plan to comply with the Federal Food, Drug, and Cosmetic Act. Failure to promptly address any violations may result in regulatory action against the manufacturer, such as civil fines, product seizures, and/or injunctions. In addition, seemingly branded or counterfeit products imported into the United States may be rejected or even detained. The products affected by this warning letter are non-tobacco nicotine (NTN) products. To address the increasing prevalence of NTN in popular tobacco products, Congress passed a federal law that clarifies the FDA's power to regulate any nicotine-containing tobacco product from any source, including NTN or synthetic nicotine, which takes effect on April 14, 2022.
Secondly, after reviewing the PMTA applications of 32 Hyde electronic cigarettes, the FDA issued marketing denial orders (MDO) for these applications submitted by the company. During scientific review, the FDA found that these applications lacked sufficient evidence to demonstrate that flavored electronic cigarettes would benefit adult users and that these benefits would outweigh the risks to young people. Therefore, the FDA has determined that these products are not appropriate for protecting public health, and the company must stop selling and distributing these products. Products currently on the market must be removed or subject to risk enforcement actions. No Hyde product has received marketing authorization from the FDA.
All electronic cigarettes that have not been authorized for market before the legal deadline are being sold illegally and face the potential for FDA enforcement actions, which includes Puff Bar and Hyde brands. It is illegal for retailers or distributors to sell or distribute electronic cigarettes that have not been authorized by the FDA, and those who engage in such activities risk enforcement actions by the FDA, such as seizure, injunctions, or civil penalties. All authorized electronic cigarettes are listed on the FDA's Tobacco Product Marketing Orders page. The FDA encourages the public to report potential violations through our online form.
Using any form of tobacco products, including electronic cigarettes, is unsafe, particularly among young people. Excluding tobacco products from the hands of young people remains the FDA's top priority, and the steps taken by the FDA today represent significant progress towards achieving this goal.
Source: FDA
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