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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 [email protected].

How Do I Find Warning Letters Issued to Manufacturers of Unauthorized Tobacco Products?

From January 2021 through February 17, 2023, FDA has issued more than 550 warning letters to firms for manufacturing, selling, and/or distributing new tobacco products without marketing authorization from FDA.

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.

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 $19,192 for a single violation. However, the FD&C Act also allows for an enhanced penalty amount for certain intentional violations relating to tobacco products. FDA intends to seek the maximum allowed by law in CMP cases relating to unauthorized tobacco products.

Which Manufacturers Has CTP Filed CMP Complaints Against for Violations Relating 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. To date, CTP has filed CMP complaints against the following firms:  

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.

The complaints for permanent injunction were filed against the following defendants in their respective U.S. District Courts:

 

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