FDA Cracks Down on Illegal Sales of Popular E-Cigarettes
On May 31st, Eastern Standard Time, the U.S. Food and Drug Administration (FDA) issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products.
The unauthorized products in question are various types of disposable electronic cigarettes under the brands Puff and Hyde, with Puff Bar being the most well-known disposable electronic cigarette from Puff. Puff and Hyde are the two most commonly used brands by teenage e-cigarette users in 2022.
Robert Califf, an FDA official, stated, "Protecting our nation's youth from the influence of tobacco products, including disposable e-cigarettes, is the FDA's top priority." He emphasized, "We are committed to holding all participants in the supply chain, not just manufacturers, but also retailers and distributors, accountable to the law."
This FDA crackdown includes investigations into hundreds of retailers and distributors nationwide.
All the products mentioned in the warning letters are disposable e-cigarettes, which are the most commonly used type of e-cigarette among teenagers.
According to the 2022 National Youth Tobacco Survey, Puff Bar and Hyde are in the top three brands reported by teenagers who use e-cigarettes. Approximately 20% of youth e-cigarette users reported regularly using Puff Bar or Hyde brand products in 2022.
Brian King, the Director of the FDA's Center for Tobacco Products, stated in the announcement, "Since becoming Director of CTP, I have been clear that the FDA will not stand idly by when retailers and distributors attempt to attract youth with illicit products for sale." King emphasized that retailers and distributors play a critical role in removing unauthorized tobacco products from the market and that the FDA "will be committed to taking appropriate action" if they fail to do so.
When e-cigarettes lack FDA marketing authorization, the FDA has the authority, under the Federal Food, Drug, and Cosmetic Act, to prohibit their sale or distribution to consumers in the United States.
The FDA typically issues warning letters when violations are discovered during inspections or investigations, giving recipients 15 working days to respond and outline the corrective actions they will take to address the violations and prevent future ones.
Most recipients of warning letters voluntarily correct the cited violations.
However, failure to promptly correct the violations may result in the FDA taking additional actions, such as injunctions, seizures, and/or civil monetary penalties.
The FDA reiterated in the announcement that it has currently authorized only 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarette products legally available for sale in the United States. Distributing or selling unauthorized products will be subject to enforcement actions.
In February of this year, the FDA issued its first set of civil money penalty complaints against four e-cigarette manufacturers, and to date, the FDA has issued civil money penalty complaints against ten e-cigarette manufacturers.
In October 2022, the first set of permanent injunction complaints was filed against six e-cigarette manufacturers. From January 2021 to May 2023, the FDA has issued over 560 warning letters. All of these actions are part of the FDA's ongoing combination of compliance and enforcement efforts, with the latest counts of these actions to be periodically reported. The FDA will continue to take action against anyone manufacturing, distributing, importing, or selling unauthorized e-cigarette products, especially those most commonly used by young people.
As of now, only 14 letters dated May 31st are listed on the FDA's warning letter website. The companies currently involved are:
- E-Juice Vapor, Inc.
- Vaperistas, LLC
- Empire Imports, LLC d/b/a Vapor Empire, LLC
- NAKV Enterprises, Inc. d/b/a Fat Puff Wholesale
- MDM Group Inc. d/b/a Eliquidstop.com
- Sooner Distributor & Wholesalers International Inc
- The Drip Ship LTD d/b/a buycbdcigarettes
- TheSY, LLC d/b/a Element Vape
- Mr. Smokey Tobacco Corp d/b/a Smoke Shop/The Boss Tobacco
- Mr. Smokey Tobacco Corp. d/b/a Hqdpods.com
- Huff and Puffers, LLC
- JTBC Holdings LLC d/b/a Disposable305
- Superpuff Inc. d/b/a MyVapor
- Vape4Style, Inc
