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  1. Compliance, Enforcement & Training

Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products

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To protect the health of future generations, FDA closely monitors industry compliance with tobacco laws and regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and takes action when violations occur. FDA regulates tobacco products containing nicotine from any source, including non-tobacco nicotine (NTN), such as synthetic nicotine.

Which Products Are Subject to FDA Enforcement Action?

Before introducing a new tobacco product to the U.S. market, a company must submit a marketing application, such as a premarket tobacco product application (PMTA), to FDA and receive authorization. 

New tobacco products on the market without the required premarket authorization are adulterated and misbranded under the FD&C Act and are subject to FDA enforcement action.

To date, 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.  

Currently, no NTN product has received marketing authorization. 

Warning Letters

Generally, when companies are manufacturing, selling, and/or distributing unauthorized tobacco products in the United States, FDA will typically first issue a warning letter in an attempt to achieve voluntary compliance with the law.  

If you have received a warning letter, you should follow the instructions provided to respond to the warning letter within 15 working days.  Additional compliance education and information, including information about responding to warning letters issued to tobacco manufacturers for violations, are available on FDA’s Tobacco Compliance Webinars page.  If you have questions, contact the Center for Tobacco Products at CTPCompliance@fda.hhs.gov.

How Do I Find Warning Letters Issued to Manufacturers, Importers, and Distributors of Unauthorized Tobacco Products?

As of November 2023, FDA has issued approximately 640 warning letters to firms for manufacturing, selling, and/or distributing new tobacco products without marketing authorization from FDA, with more than 100 of these warning letters to firms for unauthorized non-tobacco nicotine products. 

On FDA’s warning letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.

How Do I Find Warning Letters Issued to Retailers for Selling Unauthorized Tobacco Products?

In November 2023, FDA issued warning letters to seven online retailers for selling and/or distributing unauthorized e-cigarettes packaged to look like youth-appealing toys and drink containers, including milk cartons, soft drink bottles, and slushies. To date, FDA has issued more than 400 warning letters to retailers, including brick and mortar and online, for selling unauthorized tobacco products. For more information about warning letters issued to brick and mortar retailers, use CTP’s Compliance Check Inspection database. There you may search by several fields including tobacco retailer name, city, state, zip code, inspection result, or decision date. 

See sample warning letter issued to brick and mortar retailers.

FDA continues to issue warning letters, when appropriate, to retailers that have failed to comply with the FD&C Act and applicable regulations. Recent examples include: 

  • On September 28, 2023, FDA issued 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products.
  • On May 31, 2023, FDA announced that it had issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products, specifically various types of Puff and Hyde disposable e-cigarettes, two of the most commonly reported brands used by youth e-cigarette users in 2022. 
  • On June 22, 2023, the agency announced it issued warning letters to 189 retailers for illegally selling unauthorized products, specifically Elf Bar and Esco Bars products that appeal to youth.
  • On September 14, 2023, FDA issued warning letters to 15 online retailers and 3 manufacturers and/or distributors for illegally selling or distributing unauthorized e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech. These products were identified through rapid surveillance and a data-driven approach to investigations.

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.

If you have any questions about warning letters issued to retailers, contact the Center for Tobacco Products (CTP) at 1-877-CTP-1373 or via email: CTP-WL@fda.hhs.gov or CTPCompliance@fda.hhs.gov.

Civil Money Penalty Complaints  

FDA has authority to assess CMPs for violations of the FD&C Act relating to tobacco products. This includes failing to obtain the required marketing authorization for new tobacco products.

In general, penalties for violating requirements of the FD&C Act may not exceed the statutory maximum set by law. Currently, the maximum penalty amount for violating a requirement of the FD&C Act relating to tobacco products is $20,678 for a single violation. FDA intends to seek the maximum allowed by law in CMP cases relating to unauthorized tobacco products. However, the FD&C Act also allows for an enhanced penalty amount for certain intentional violations relating to tobacco products.

Which Manufacturers Have Received CMP Complaints for Violations Related to Unauthorized Tobacco Products?

On February 21, 2023, CTP filed CMP complaints against four manufacturers for manufacturing and selling tobacco products that lacked the required marketing authorization. This was the first time CTP filed CMP complaints against tobacco product manufacturers for their failure to comply with the premarket review requirements.

CTP continues to file CMP actions when appropriate against manufacturers that have failed to comply with the FD&C Act and applicable regulations.

Which Retailers Have Received CMP Complaints for Violations Related to Unauthorized Tobacco Products?

To date, CTP has issued CMP complaints against 63 brick and mortar and 4 online retailers for selling unauthorized tobacco products for the maximum statutory amount.

Retailers That Received CMP Complaints

Please note: CTP provides access to information regarding the results of brick and mortar retailer inspections on CTP’s Compliance Check Inspection database. This information includes links to CMP complaints issued to retailers. The Compliance Check Inspection database is updated monthly, so recent complaints may not yet be available for viewing.  

To find CMPs issued to brick and mortar retailers, use CTP’s Compliance Check Inspection database. There you may search by several fields including tobacco retailer name, city, state, zip code, inspection result, or decision date. 

Injunctions

An injunction is a civil judicial process initiated to stop current violations of the law and prevent them going forward, halt the flow of violative products in interstate commerce, and correct the conditions that caused the violation to occur. 

Which Manufacturers Has CTP Initiated Permanent Injunction Actions Against Relating to Their Continued Manufacture of Unauthorized Tobacco Products?

On Oct. 18, 2022, the U.S. Department of Justice (DOJ), on behalf of the U.S. Food and Drug Administration, filed complaints for permanent injunction in federal district courts against six e-cigarette manufacturers for continued violations relating to their manufacture, sale, and/or distribution of unauthorized new tobacco products. These cases represent the first time FDA has initiated injunction proceedings to enforce the premarket review requirements for new tobacco products. FDA will continue to pursue injunction actions when appropriate.

 

 
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