FDA issues warnings to 30 retailers of Hyde and Puff Bar e-cigarettes
Today, on June 1, the U.S. Food and Drug Administration (FDA) issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products.<\/p>
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The unauthorized products are various types of PUFF and Hyde brand disposable e-cigarettes, which were the two most commonly used brands among youth e-cigarette users in 2022. The puff products include Puff Bar.<\/p>
The FDA's press release stated that it issued warning letters today to 30 businesses selling unauthorized products. However, as of 1:45 PM, only 14 letters dated May 31 were listed on the FDA warning letter website. The companies involved include:<\/p>
Empire imports, LLC (Vapor Empire, LLC) – Puff Plus<\/p>
JTBC Holdings LLC (Disposable305) – Puff Plus<\/p>
NAKV Enterprises, Inc. (Fat Puff Wholesale) – Puff Plus<\/p>
MDM Group Inc. (Eliquidstop.com) – Puff Plus<\/p>
Sooner Distributor & Wholesalers International Inc – Puff XXL<\/p>
The Drip Ship LTD (buyCBDcigarettes) – Puff Bar<\/p>
Vaperistas, LLC – Hyde Edge, Hyde Rebel<\/p>
TheSY, LLC (Element Vape) – Hyde Rebel, Hyde Retro, and Hyde Edge<\/p>
Huff and Puffers, LLC – Puff Xtra Limited<\/p>
Mr. Smokey Tobacco Corp (Smoke Shop/The Boss Tobacco) – Puff Plus<\/p>
Vape4Style, Inc – Puff Bar<\/p>
Mr. Smokey Tobacco Corp. (HQDpods.com) – Puff Plus<\/p>
Superpuff Inc. (MyVapor) – Hyde Retro<\/p>
E-Juice Vapor, Inc. – Puff Bar<\/p>
The FDA stated that today's actions highlight the agency's unwavering commitment to addressing the role of unauthorized tobacco product retailers and distributors in the public health crisis facing youth in the United States.<\/p>
"Protecting our nation's youth from the harms of tobacco products, including disposable e-cigarettes, is the FDA's top priority," said FDA Commissioner Robert M. Califf, M.D. "We are committed to holding all participants in the supply chain— not just manufacturers but also retailers and distributors— accountable to the law."<\/p>
Today's warning letters are the result of a nationwide crackdown on the sale of unauthorized e-cigarettes popular among youth— particularly Puff and Hyde products. This blitz includes investigations of hundreds of retailers and distributors nationwide. The products mentioned in the warning letters are all disposable e-cigarettes, which are the type most commonly used by youth.<\/p>
According to the 2022 National Youth Tobacco Survey, Puff Bar and Hyde were the first and third most used brands among youth reporting e-cigarette use. Among youth e-cigarette users, about 20% reported typically using Puff Bar or Hyde brand products in 2022.<\/p>
"Since becoming the director of CTP, I have been very clear that the FDA will not sit idly by when retailers and distributors try to profit from the illegal sale of products that are known to attract youth," said Dr. Brian King, director of the FDA's Center for Tobacco Products. "Retailers and distributors play a critical role in preventing unauthorized tobacco products from reaching the market, and if they do not do so, we are committed to taking appropriate action."<\/p>
When e-cigarettes lack FDA marketing authorization, the Federal Food, Drug, and Cosmetic Act prohibits the sale or distribution of e-cigarettes to consumers in the United States. The FDA typically issues warning letters when it first discovers violations during inspections or investigations, giving recipients 15 business days to respond with steps they will take to correct the violations and prevent future violations. Most recipients of warning letters voluntarily correct the cited violations. However, failure to timely correct violations may result in the FDA taking further action, such as injunctions, seizures, and/or civil monetary penalties.<\/p>
In addition to today's actions among retailers, the FDA also issued a warning letter to the importer of Puff Bar in October 2022, and that investigation is still ongoing.<\/p>
So far, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are currently the only e-cigarette products that can be legally sold in the United States. The distribution or sale of illegally marketed products will be subject to enforcement actions.<\/p>
The FDA remains steadfastly committed to protecting youth from the harms of tobacco products by ensuring that illegal products are not sold, marketed, or distributed. These efforts include ongoing market surveillance to identify violative products, including existing and emerging disposable e-cigarette products.<\/p>
In February, the FDA filed civil monetary penalty complaints against four e-cigarette manufacturers for the first time; to date, the FDA has filed civil monetary penalty complaints against ten e-cigarette manufacturers.<\/p>
In October 2022, the first batch of permanent injunction complaints was filed against six e-cigarette manufacturers. From January 2021 to May 2023, the FDA issued over 560 warning letters.<\/p>
All these actions are part of the FDA's ongoing compliance and enforcement strategy, and the latest counts of these actions will continue to be reported regularly. The FDA will continue to take action against anyone who manufactures, distributes, imports, or sells unauthorized e-cigarette products, especially those e-cigarette products most commonly used by youth.<\/p>
