FDA Warns Makers of Puff Bar, Hyde Vapor Devices

Survey finds about 9.4% of middle, high school students use e-cigarettes
Vapor devices
Photograph: Shutterstock

SILVER SPRING, Md. —About 9.4% of middle and high school students, or 2.5 million youth, report using e-cigarettes, according to new data. And the U.S. Food and Drug Administration is cracking down on the companies selling some of the brands these students said they smoke.

The FDA, in coordination with the Centers for Disease Control and Prevention, released federal data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth. 

The online study, conducted from January through May, shows that about 33% of middle school students and 14% of high school students reported current e-cigarette use, which it defines as using in the past 30 days. Among those users, nearly 85% reported using flavored e-cigarettes, the report found, and more than one in four reported daily use of an e-cigarette.

Among current youth e-cigarette users, the most used device type was disposables. The top three brands were:

  • Puff Bar: 14.5%
  • Vuse: 12.5%
  • Hyde: 5.5%

While Puff Bar and Vuse were pre-specified response options on the survey, Hyde was not. Students wrote Hyde as their preferred brand, so the reported percentage of use is likely understated, the FDA said.

“The FDA remains deeply concerned about e-cigarette use among our nation’s youth,” FDA Commissioner Robert Califf said. “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. 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.”

FDA Sends Warnings

The FDA issued warning letters to EVO Brands LLC and PVG2 LLC, doing business as Puff Bar, for receiving and delivery e-cigarettes in the United States without a marketing authorization order. If the company does not respond to the FDA within 15 working days of receiving the letter detailing how it will address the agency’s concerns, Puff Bar risks enforcement action.

The Puff Bar products subject to this warning letter are non-tobacco nicotine products, which the FDA was given control over on April 14.

The FDA also denied premarket tobacco product applications (PMTAs) for 32 Hyde e-cigarettes, submitted by Magellan Technology Inc., Buffalo, N.Y. The agency said it determined the applications lacked sufficient evidence demonstrating that these flavored e-cigarettes would provide a benefit to adult users that would outweigh the risks to youth. The company must stop selling these products and remove those on the market or risk enforcement action, the FDA said.

“Congress gave the FDA authority to hold manufacturers and retailers who violate the law accountable,” FDA’s Center for Tobacco Products Brian King said. “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.”

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