FDA Warns Puff Bar and Issues Denial to Hyde, Two of the Most Popular Brands with Youth
Today, the U.S. Food and Drug Administration, in coordination with the Centers for Disease Control and Prevention (CDC), released federal data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth. The findings, published in Morbidity & Mortality Weekly Report, show that youth use of e-cigarettes remains high, with 2.5 million (9.4%) of the nation’s middle and high school students reporting current e-cigarette use.
“The FDA remains deeply concerned about e-cigarette use among our nation’s youth. It’s clear that we still have a serious public health problem that threatens the years of progress we have made combatting youth tobacco product use,” said FDA Commissioner Robert M. Califf, M.D. “We cannot and will not let our guard down on this issue. The FDA remains steadfast in its commitment to using the full range of our authorities to address youth e-cigarette use head-on.”
The study, which was conducted January-May 2022 using an online survey, shows that overall about 1 in 10 U.S. middle (3.3%) and high (14.1%) school students reported current (in the past 30 days) e-cigarette use. Among these youth e-cigarette users, nearly 85% reported using flavored e-cigarettes, and more than 1 in 4 (27.6%) reported daily use of an e-cigarette. Due to changes in methodology, including differences in survey administration and data collection procedures in recent years due to the COVID-19 pandemic, the ability to compare estimates from 2022 with those from prior NYTS waves is limited; differences between estimates might be due to changes in methodology, actual behavior, or both.
Among current youth e-cigarette users, the most commonly used device type was disposables. The top three brands that current youth e-cigarette users reported “usually” using were Puff Bar (14.5%), Vuse (12.5%), and Hyde (5.5%). While Puff Bar and Vuse were pre-specified response options on the survey, Hyde was not. Students wrote in Hyde as their preferred brand, and because of this, the reported percentage of use is likely an underestimate.
Steps to Address Brands Popular among Youth
The FDA also announced additional steps it has taken today to address brands popular among youth.
First, the agency issued a warning letter to EVO Brands LLC and PVG2, LLC, doing business as Puff Bar, for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. The FDA has requested a response from the companies within 15 working days of receiving the letter detailing how they intend to address the agency’s concerns, including the dates on which they discontinued the sale and/or distribution of these tobacco products, and plans for maintaining compliance with the Federal Food, Drug & Cosmetic Act. Failure to promptly address any violations puts the manufacturer at risk of regulatory action such as a civil money penalty, product seizure, and/or injunction. In addition, products that appear to be misbranded or adulterated that are offered for import into the U.S. are at risk of being detained or refused admission. The Puff products subject to this warning letter are non-tobacco nicotine (NTN) products. In response to the increase of NTN in popular tobacco products, Congress passed a federal law which went into effect on April 14, 2022, clarifying the FDA’s authority to regulate tobacco products containing nicotine from any source, including NTN or synthetic nicotine.
Second, after reviewing premarket tobacco applications for 32 Hyde e-cigarettes, the FDA issued marketing denial orders (MDO) for these applications submitted by Magellan Technology Inc. In conducting its scientific review, the FDA determined that the applications lacked sufficient evidence demonstrating that these flavored e-cigarettes would provide a benefit to adult users that would be adequate to outweigh the risks to youth. Therefore, the FDA has determined that permitting the marketing of these products would not be appropriate for the protection of the public health. The company must stop selling and distributing these products, and those currently on the market must be removed or risk enforcement action. No Hyde products have received marketing authorization orders from the FDA.
All e-cigarettes on the market without the statutorily required premarket authorization are marketed unlawfully and risk FDA enforcement action, including Puff Bar and Hyde. It is illegal for a retailer or distributor to sell or distribute e-cigarettes that the FDA has not authorized, and those who engage in such conduct are at risk of FDA enforcement, such as a seizure, injunction, or civil money penalty. All authorized e-cigarettes are posted on the FDA’s Tobacco Product Marketing Orders page. The FDA encourages the public to submit potential violations to us through our online form.
“Congress gave the FDA authority to hold manufacturers and retailers who violate the law accountable," said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “FDA is actively working to identify violations and to swiftly seek corrective actions, particularly for products popular among youth. We will use all compliance and enforcement tools available to us, as appropriate, to protect our nation’s youth."
The steps FDA has taken today are a continuation of the FDA’s efforts to address e-cigarettes that appeal to youth. Firms submitting premarket tobacco applications must provide evidence that an e-cigarette will meet the public health standard, taking into account, among other things, the degree to which it promotes youth use of the product. Earlier this year, the FDA also issued marketing denial orders to multiple flavored Vuse e-cigarettes. The FDA regularly monitors compliance with these orders.
Use of tobacco products in any form – including e-cigarettes – is unsafe, especially among youth. Keeping tobacco products out of the hands of youth remains a top priority for the FDA, and the steps the FDA has taken today mark important progress toward achieving that goal.
Related Information
|
