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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. 

FDA’s Tobacco Products Enforcement Priorities

Enforcing against unauthorized ENDS products, including unauthorized products popular with youth, are among our highest enforcement priorities.

A new tobacco product must have FDA authorization before it can be legally marketed, and generally, products without authorization are at risk of enforcement action.

FDA has not adopted a broad policy of enforcement discretion regarding tobacco products without marketing authorization. For the vast majority of unauthorized e-cigarettes on the market today, the pendency of an application does not create a legal safe harbor to sell that product. There are a few tobacco products that have received a marketing denial order (MDO) that are under further agency review and for which FDA has stated the Agency does not intend to pursue enforcement action during the pendency of the re-review. In addition, in a very limited number of instances, some courts have granted stays of MDOs pending judicial review in order to maintain the status quo, or FDA has administratively stayed MDOs. In those particular instances, FDA does not intend to take enforcement action.

The decision whether to take enforcement action will be made on a case-by-case basis, taking into account youth use and other risk factors. Before taking any such action, the Agency intends to follow its usual compliance and enforcement practices and will generally issue a warning letter before initiating enforcement action (such as civil money penalties, seizure, or injunction) and afford the recipient an opportunity to respond (although there is no legal requirement that FDA send a warning letter before the agency can initiate an enforcement action).

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?

To date, FDA has issued approximately 660 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 April 2024, FDA issued warning letters to three online retailers for selling unauthorized ZYN nicotine pouches. To date, FDA has issued more than 550 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:

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.

What Is a Civil Money Penalty (CMP)? 

A civil money penalty (CMP) is an administrative enforcement action that seeks to impose a fine for certain violations of the law. 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. FDA generally issues a warning letter for initial violations, and FDA’s prior warnings note that further violations could lead to enforcement action, including a CMP. If FDA’s follow-up inspection, surveillance, or investigation determines continued non-compliance, FDA may initiate a CMP.

In general, penalties for violating requirements of the FD&C Act (including premarket authorization requirements) 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. However, the FD&C Act also allows for an enhanced penalty amount for certain intentional violations relating to tobacco products. FDA may consider bringing an action for enhanced penalties if there is evidence of an intentional violation of the premarket authorization requirements, and certain other provisions. FDA intends to seek the maximum penalty allowed by law in CMP cases relating to unauthorized tobacco products.

Civil Money Penalty Process

FDA issues CMP complaints to manufacturers for manufacturing and selling tobacco products that lack the required marketing authorization and files the CMP complaints with the HHS Departmental Appeals Board. Manufacturers that have received CMP complaints can pay the penalty, request to negotiate a settlement amount based on mitigation factors, file an answer to the complaint and request a hearing, or request an extension of time to file an answer to the complaint. Companies that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.

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. To date, FDA has filed CMP complaints against 55 manufacturers.

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

To date, CTP has issued CMP complaints against 104 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.

Import Alerts

Tobacco products imported or offered for import into the United States must comply with all the applicable requirements of the FDA’s laws and regulations. In coordination with the U.S. Customs and Border Protection (CBP), FDA conducts import screening to ensure that tobacco products imported or offered for import into the United States comply with all applicable requirements of FDA’s laws and regulations.

An import alert places products that appear to be in violation of the FDA's laws and regulations on the red list, which makes them subject to Detention Without Physical Examination (DWPE) and allows the FDA to detain a product without physically examining it at the time of entry.

What Is an Injunction?

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. FDA generally issues a warning letter for initial violations, and such warning letters note that further violations could lead to enforcement action, including injunction. If FDA’s follow-up inspection, surveillance, or investigation determines that there is continued non-compliance, FDA may initiate an injunction.

Injunction Process

The U.S Department of Justice (DOJ) institutes judicial enforcement actions, such as injunctions, under the FD&C Act in federal court. Injunctions are filed by DOJ on behalf of the FDA against defendants in the U.S. District Court where the defendants do business. Complaints for permanent injunction request that the relevant courts, among other things, permanently enjoin defendants’ violative conduct.

In injunction cases, defendants have the opportunity to settle the matter by signing consent decrees of a permanent injunction, which prevent the defendant companies and individuals from violating federal law by directly or indirectly manufacturing, selling, or distributing tobacco products in violation of the FD&C Act and FDA’s implementing regulations, unless and until certain prerequisites are met. These prerequisites include that the tobacco products receive FDA marketing authorization, that the agency inspect the defendants’ facilities to determine compliance, and that the FDA notify defendants in writing that they appear to be in compliance with the law.

A consent decree is a written agreement, which is signed by the judge and entered as a court order, in which parties agree to certain terms and conditions to settle the lawsuit. FDA and the court monitor injunctions and determine whether the defendants comply with the terms of the consent decree. Consent decrees generally also provide, among other things, that: FDA, as and when it deems necessary, may inspect the defendants’ facilities, and all records relating to the manufacture, sale, and distribution of tobacco products, without prior notice to determine compliance; defendants must reimburse FDA for costs the agency incurs in evaluating defendants’ compliance; and defendants must destroy the unauthorized tobacco products in their possession, custody, or control under FDA supervision.

For those defendants who do not agree to consent decrees, the government can request that the relevant court enter an injunction preventing those defendants from directly or indirectly manufacturing, selling, and distributing tobacco products in violation of the FD&C Act and FDA’s implementing regulations. Defendants who violate the terms of a consent decree or order of permanent injunction risk court sanctions, which may include civil or criminal contempt.

Which Manufacturers Have 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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