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FDA Calls on Retailers to Remove Illegal E-Cigarettes from Shelves, Will Send List of Legal Products to 300,000 Stores

Oct.08.2025
FDA Calls on Retailers to Remove Illegal E-Cigarettes from Shelves, Will Send List of Legal Products to 300,000 Stores
FDA launches national retail compliance initiative to combat illegal e-cigarette sales targeting youth, issuing guidance materials to over 300k retailers.

Key points:

 

Action Background: The Director of the FDA, Marty Makary, has announced the launch of a nationwide retailer compliance initiative.

 

Market situation: According to the FDA's estimate, approximately 54% of e-cigarette products on the U.S. market are illegal, with some specifically designed for teenagers, containing flavors such as fruit and candy, and even featuring built-in Bluetooth speakers or gaming capabilities.

 

Health Risk Alert: Industrial chemicals detected in illegal e-cigarettes. These substances are commonly used in the manufacturing of textiles, plastics, and insecticides, and prolonged inhalation may pose serious risks to human health.

 

Key regulatory measures: The FDA will send guidance materials to over 300,000 retail establishments across the United States.

  1. The guidance includes a list of 39 approved e-cigarette products and 20 nicotine pouch products; 
  2. an introduction to the FDA's new "Tobacco Product Search Database" covering over 17,000 legal products; 
  3. retail education materials such as posted reminders that customers must be 21 years old or older to purchase tobacco products.

 

2Firsts, October 8, 2025 - According to the official website of the US Food and Drug Administration (FDA), in an effort to crack down on illegal e-cigarette products and protect the health of young people, FDA Director Marty Makary issued a statement on September 30, officially launching a new initiative aimed at retailers, calling on retail channels including e-cigarette stores, convenience stores, and gas stations to voluntarily cease the sale of illegal e-cigarette products.

 

This initiative aims to enhance retailers' awareness of the legal range of products for sale. The FDA stated that many retailers in communities are still selling illegal e-cigarettes specifically targeted at teenagers with fruit or candy flavors, and even products with built-in video games or Bluetooth speakers. These products are largely unauthorized by the FDA and primarily come from illegal imports from China.

 

According to the FDA's estimate, approximately 54% of e-cigarette products sold in the United States are illegal.

 

These illegal products often contain harmful substances such as formaldehyde, lead, and acetaldehyde, which are commonly used in industrial textiles or insecticides. Prolonged use of these ingredients can pose serious health risks to the human body.

 

In order to help retailers clarify the boundaries between legal and illegal products, the FDA will be sending guidance materials to over 300,000 retail outlets nationwide. The contents include:

 

  • Currently, there are 39 e-cigarette products and 20 nicotine pouch products approved for sale in the US market. This list includes a QR code link to the FDA website for real-time updates. 
  • The FDA has recently launched a Tobacco Product Database, which covers over 17,000 legally marketed tobacco products, including cigarettes, cigars, hookah, and e-cigarettes. 
  • The latest educational materials for retailers, such as calendar-style reminders, emphasize that tobacco products can only be sold to customers aged 21 and above, and photo identification must be checked for customers under the age of 30.

 

Commissioner Makari emphasized:

 

We know that most businesses have a willingness to comply with the law. The goal of this new initiative is to eliminate information blind spots and leave retailers no excuse to sell illegal products.

 

He expressed a particular hope to curb the circulation and sale of illegal e-cigarette products through this action, as these products are currently widely used among young people.

 

References:
[1] A Statement From FDA Commissioner Marty Makary, M.D., M.P.H.: Encouraging Retailers to Stop Selling Illegal Vapes
Also Read:
[1] The U.S. Department of Justice and FDA seized 2.1 million e-cigarettes and 12 distributors and retailers were sued
[2] U.S. CBP and FDA Seize 165,000 Illicit E-Cigarette Products; Total Value Exceeds $1.47 Million
[3] US FDA releases MRTP renewal application materials for IQOS heated tobacco product and will hold an expert meeting in October

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2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

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