For Immediate Release: May 31, 2023
Today, the U.S. Food and Drug Administration issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products. The unauthorized products were various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022. The Puff products include Puff Bar. Today’s action underscores the agency’s unwavering commitment to addressing the role retailers and distributors of unauthorized tobacco products play in this concerning public health issue facing America’s youth.
“Protecting our nation’s youth from tobacco products – including disposable e-cigarettes – is a top priority for the FDA,” said FDA Commissioner Robert M. Califf, M.D. “We’re committed to holding all players in the supply chain – not just manufacturers but also retailers and distributors – accountable to the law.”
Today’s warning letters are a result of a nationwide blitz to crack down on the sale of unauthorized e-cigarettes that are popular with youth – specifically Puff and Hyde products. The blitz included investigations of hundreds of retailers and distributors across the country. All products cited in the warning letters are disposable e-cigarettes, which are the most commonly used e-cigarette product type among youth. Puff Bar and Hyde were the first and third most popular brands used by youth who reported using e-cigarettes, according to the 2022 National Youth Tobacco Survey. Among youth e-cigarette users, about 20 percent reported usually using Puff Bar or Hyde brand products in 2022.
“Since becoming director of CTP, I’ve been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well-known to appeal to youth,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “Retailers and distributors play a key role in keeping unauthorized tobacco products off the shelves, and if they fail to do so, we’re committed to taking appropriate action.”
When e-cigarettes lack a marketing authorization order from the FDA, selling or distributing them to consumers in the U.S. is prohibited under the Federal Food, Drug, and Cosmetic Act. The FDA generally sends warning letters the first time an inspection or investigation reveals a violation of the law, and recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. A majority of recipients of warning letters voluntarily correct the stated violation. However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties. In addition to today’s actions among retailers, the FDA issued a warning letter to an importer of Puff Bar in October 2022; that investigation remains ongoing.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully sold in the U.S. The distribution or sale of unlawfully marketed products is subject to enforcement action.
The FDA remains steadfast in its commitment to protecting youth from the harms of tobacco products by ensuring illegal products are not marketed, sold, or distributed. These efforts include ongoing surveillance of the marketplace to identify violative products, including existing and emerging disposable e-cigarette products.
In February, FDA filed the agency’s first civil money penalty complaints against four e-cigarette manufacturers; to date, FDA has filed civil money penalty complaints against ten e-cigarette manufacturers. And in October 2022, the first complaints for permanent injunctions were filed against six e-cigarette manufacturers. From January 2021 through May 2023, FDA issued more than 560 warning letters. All of these actions are part of FDA’s standing compliance and enforcement portfolio, and the latest counts of these actions will continue to be reported on a routine basis. FDA will continue to take action against anyone making, distributing, importing, or selling unauthorized e-cigarette products, especially those most used by youth.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.