FDA warns against Hyde and Puff Bar e-cigarettes
Time： 2023-06-01
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The FDA issued warning letters to 30 retailers, including a distributor, for illegally selling unauthorized tobacco products.
The unauthorized products were va...
The FDA issued warning letters to 30 retailers, including a distributor, for illegally selling unauthorized tobacco products.
The unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, the two most commonly used brands by teenage vapers in 2022. Puff products include Puff Bar.
The FDA's press release said it issued warning letters today to 30 businesses selling unauthorized products. However, as of 1:45 p.m., only 14 letters dated May 31 were listed on the FDA Warning Letters website. The companies currently involved are:
Empire Imports, LLC (Vapor Empire, LLC) – Puff Plus
JTBC Holdings LLC (Disposable305) – Puff Plus
NAKV Enterprises, Inc. (Fat Puff Wholesale) – Puff Plus
MDM Group Inc. (Eliquidstop.com) – Puff Plus
Sooner Distributor & Wholesalers International Inc – Puff XXL
The Drip Ship LTD (buycbdcigarettes) – Puff Bar
Vaperistas, LLC – Hyde Edge, Hyde Rebel
TheSY, LLC (Element Vape) – Hyde Rebel, Hyde Retro, and Hyde Edge
Huff and Puffers, LLC – Puff Xtra Limited
Mr. Smokey Tobacco Corp (Smoke Shop/The Boss Tobacco) – Puff Plus
Vape4Style, Inc – Puff Bar
Mr. Smokey Tobacco Corp. (Hqdpods.com) – Puff Plus
Superpuff Inc. (MyVapor) – Hyde Retro
E-Juice Vapor, Inc. – Puff Bar
Today's action underscores the agency's unwavering commitment to addressing the role unauthorized retailers and distributors of tobacco products play in the public health problems facing America's youth, the FDA said.
"Protecting our nation's youth from the harms of tobacco products -- including disposable e-cigarettes -- is a top priority for FDA," said FDA Commissioner Robert M. Califf, MD. — not just manufacturers but also retailers and distributors — are accountable to the law.”
Today's warning letters are the result of a nationwide crackdown on the sale of unauthorized e-cigarettes - specifically Puff and Hyde products - popular with young people. The blitz included surveys of hundreds of retailers and distributors across the country. The products mentioned in the warning letter are all disposable e-cigarettes, which are the most commonly used type of e-cigarette products by teenagers.
According to the 2022 National Youth Tobacco Survey, Puff Bar and Hyde were the No. 1 and No. 3 brands used by youth reporting vaping. Among youth vapers, about 20% said they typically use Puff Bar or Hyde brand products in 2022.
“Since becoming director of the CTP, I have been very clear that the FDA will not stand idly by while retailers and distributors try to profit from the illegal sale of products that are known to appeal to youth,” said Dr. Brian King, director of the FDA’s Center for Tobacco Products. "Retailers and distributors play a key role in keeping unauthorized tobacco products off our shelves, and if they fail to do so, we are committed to taking appropriate action."
The federal Food, Drug, and Cosmetic Act prohibits the sale or distribution of e-cigarettes to U.S. consumers when they lack an FDA marketing authorization. FDA typically issues a warning letter when an initial inspection or investigation finds a violation and gives recipients 15 business days to respond with the steps they will take to correct the violation and prevent future violations. Recipients of most warning letters will voluntarily correct the stated violations. However, failure to correct violations in a timely manner may result in additional FDA action, such as injunctions, seizures, and/or civil monetary penalties.
In addition to today's action among retailers, the FDA issued warning letters to importers of Puff Bar in October 2022, and the investigation is still ongoing.
To date, the FDA has authorized 23 tobacco-flavored vaping products and devices. These are currently the only vaping products that can be legally sold in the United States. Distribution or sale of illegally marketed products will be subject to enforcement action.
FDA remains deeply committed to protecting youth from the harms of tobacco products by ensuring that illicit products are not sold, marketed, or distributed. These efforts include ongoing monitoring of the market to identify noncompliant products, including existing and emerging disposable vaping products.
In February, FDA filed its first civil penalty complaints against four e-cigarette manufacturers; to date, FDA has filed civil penalty complaints against ten e-cigarette manufacturers.
In October 2022, the first permanent injunction complaints were filed against six e-cigarette manufacturers. From January 2021 to May 2023, the FDA issued more than 560 warning letters.
All of these actions are part of FDA's standing compliance and enforcement portfolio, and updated counts of these actions will continue to be reported regularly. FDA will continue to take action against anyone who manufactures, distributes, imports or sells unauthorized vaping products, especially those most commonly used by youth.
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