On May 31, 2023, the US Food and Drug Administration issued warning letters to 30 retailers, including a distributor, for illegally selling unauthorized tobacco products. Unauthorized products are various types of Puff and Hyde brand disposable e-cigarettes, which are the two most commonly used brands for adolescent e-cigarette users in 2022. Puff products include Puff Bar. Today's action highlights the agency's unwavering commitment to addressing the role of unauthorized tobacco product retailers and distributors in addressing public health issues faced by young people in the United States.

Protecting young people in our country from the hazards of tobacco products, including disposable e-cigarettes, is the FDA's top priority, "said FDA Commissioner Robert M. California, M.D.," We are committed to making all participants in the supply chain - not just manufacturers, retailers, and distributors - accountable to the law

Today's warning letter is the result of a nationwide crackdown on the sale of unauthorized e-cigarettes that are popular among young people, especially Puff and Hyde products. Blitzkrieg includes investigations into 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 e-cigarette product type among teenagers. According to the 2022 National Youth Tobacco Survey, Puff Bar and Hyde are the top and third largest brands reported by young people using e-cigarettes. About 20% of young e-cigarette users indicate that they will typically use Puff Bar or Hyde branded products in 2022.

Since becoming CTP director, I have always been very clear that when retailers and distributors try to profit from illegal sales of products that are well-known to attract young people, the FDA will not stand idly by, "said Dr. Brian King, MPH, director of the FDA Tobacco Products Center. Retailers and distributors play a crucial role in preventing unauthorized tobacco products from being put on the shelves, and if they do not do so, we will be committed to taking appropriate action

When e-cigarettes lack FDA marketing authorization, the Federal Food, Drug, and Cosmetic Act prohibits the sale or distribution of e-cigarettes to American consumers. The FDA usually issues a warning letter when illegal behavior is discovered during the first inspection or investigation, and gives the recipient 15 working days to respond to the steps they will take to correct the illegal behavior and prevent future illegal behavior. Most recipients of warning letters voluntarily correct the violation. However, failure to promptly correct violations may result in FDA taking other actions, such as injunctions, seizures, and/or civil fines. In addition to today's actions among retailers, the FDA also issued a warning letter to Puff Bar importers in October 2022; This investigation is still ongoing.

So far, the FDA has authorized 23 tobacco flavored e-cigarette products and devices. These are currently the only electronic 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.


The FDA has always been firmly committed to protecting young people from the hazards of tobacco products by ensuring that illegal products are not sold, sold, or distributed. These efforts include continuous monitoring of the market to identify non compliant products, including existing and emerging disposable e-cigarette products.

In February, the FDA filed a civil fine complaint against four e-cigarette manufacturers for the first time; So far, the FDA has filed civil penalty complaints against ten e-cigarette manufacturers. In October 2022, the first batch of permanent ban complaints were filed against six e-cigarette manufacturers. From January 2021 to May 2023, the FDA issued over 560 warning letters. All of these actions are part of the FDA's permanent compliance and enforcement portfolio, and the latest count of these actions will continue to be regularly reported. The FDA will continue to take action against anyone who manufactures, distributes, imports, or sells unauthorized e-cigarette products, especially those most commonly used by teenagers.