The U.S. Food and Drug Administration (FDA) has issued warning letters to 29 retailers and 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, according to the agency. The Puff products include Puff Bar.
The FDA issued a warning letter to an importer of Puff Bar in October 2022; that investigation remains ongoing.
The May 31 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, the FDA said.
All products cited in the warning letters are disposable e-cigarettes, which are the most commonly used e-cigarette product type among youth, said the agency. 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% reported usually using Puff Bar or Hyde brand products in 2022.
The 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,” the FDA said.
“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, director of the FDA’s Center for Tobacco Products (CTP). “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.”
FDA Commissioner Robert Califf said, “Protecting our nation’s youth from tobacco products, including disposable e-cigarettes, is a top priority for the FDA. We’re committed to holding all players in the supply chain—not just manufacturers but also retailers and distributors—accountable to the law.”
When e-cigarettes lack a marketing authorization order from the FDA, selling or distributing them to consumers in the United States 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. Most recipients of warning letters voluntarily correct the stated violation, the FDA said; however, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure or civil money penalties.
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 United States.
The distribution or sale of unlawfully marketed products is subject to enforcement action.
The FDA remains committed to protecting youth by ensuring illegal products are not marketed, sold or distributed, it said. These efforts include ongoing surveillance of the marketplace to identify products that violate the law, including existing and emerging disposable e-cigarette products.
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