Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Compliance, Enforcement & Training

Compliance, Enforcement & Training

                        Advisory and Enforcement Actions Against Industry for Selling Tobacco Products to Underage Purchasers
          Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products
          Compliance and Enforcement Report
          FDA Tobacco Compliance Webinars
          Report Potential Tobacco Product Violation
          Small Business Assistance for Tobacco Product Industry


                        Tobacco Retailer Warning Letters
          Manufacturing
          Retail Sales of Tobacco Products
          State, Local, Tribal and Territorial Governments Home
          Tobacco Products
          Compliance, Enforcement & Training
          Advisory and Enforcement Actions Against Industry for Selling Tobacco Products to Underage PurchasersCompliance, Enforcement & Training Advisory and Enforcement Actions Against Industry for Selling Tobacco Products to Underage Purchasers
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintTo 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.

CTP - Rebranding - Compliance and Enforcement Mast Head
**On this page:**

Compliance Check Inspections

	How Do I Find Results from Compliance Check Inspections?
	Warning Letters
	How Do I Search for Warning Letters?
	Civil Money Penalty (CMP) Complaints
	No-Tobacco-Sale Order (NTSO) ComplaintsCompliance Check Inspections

FDA conducts inspections of tobacco product retailers to determine a retailer's compliance with federal laws and regulations, including the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, and our rules and regulations.

During Undercover Buy Inspections, the retailer is unaware an inspection is taking place. The inspector and underage purchaser will not identify themselves. Additional compliance education and information for retailers and small businesses are available on FDA’s Tobacco Compliance Webinars page.

**Did You Know?**
It is illegal for a retailer to sell any tobacco product – including cigarettes, cigars, and e-cigarettes – to anyone under 21.



CTP Undercover Buy Inspection Flowchart


How Do I Find Results from Compliance Check Inspections?

Results from compliance check inspections of tobacco retailers are available in a searchable retailer inspection database.

The database lists which inspected retailers received a warning letter, a civil money penalty, a no-tobacco-sale order, or were found to have no observable violations. You can search by tobacco retailer name, city, state, zip code, or decision date.

***Note****: Absence of a retail establishment from this database does not imply compliance with all applicable statutory and regulatory requirements.*

Warning Letters

FDA issues warning letters to traditional “brick and mortar” retail stores nationwide as well as online retailers and manufacturers the first time a tobacco compliance check inspection reveals a violation of the federal tobacco laws and regulations that FDA enforces. Failure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may lead to enforcement actions, including civil money penalty or no-tobacco-sale order complaints. All warning letters issued as the result of compliance check inspections of tobacco retailers prior to October 1, 2016, have been archived via the FDA Web Archive.

If you have any questions about warning letters, contact the Center for Tobacco Products (CTP) at 1-877-CTP-1373 or via email to the address listed in your warning letter: CTP-Compliance-WL-Correspondence@fda.hhs.gov or CTPCompliance@fda.hhs.gov.

How Do I Search for Warning Letters?

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 (CMP) Complaints

A civil money penalty (CMP) complaint is used to initiate an administrative legal action against a tobacco product retailer or manufacturer that can result in a monetary penalty, called a civil money penalty.

The Tobacco Control Act provides that the amount of a CMP for violations of the regulations in part 1140 shall not exceed certain amounts, depending on the number of previous violations, the time period in which the violations occurred, and other factors (see section 103(q)(2)(A) of the Tobacco Control Act). The current maximum amounts for retailer CMPs are:

Number of Regulation Violations
			CMP Amount1
			$0 (CTP will send a Warning Letter)2 within a 12-month period
			$3453 within a 24-month period
			$6874 within a 24-month period
			$2,7575 within a 36-month period
			$6,8926 within a 48-month period
			$13,785

Under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. No. 114-74), the Department of Health and Human Services (HHS) is required to adjust the amounts annually for inflation no later than January 15th each year. Read the rule, Adjustment of Civil Monetary Penalties for Inflation, for more information. See the Federal Register notice with the 2023 adjusted amounts.

FDA files CMP complaints against retailers and manufacturers when subsequent violations of the tobacco regulations and/or other requirements relating to tobacco products in the FD&C Act are observed during an inspection.

All tobacco retail CMP complaints filed by CTP are listed in the searchable compliance check inspection database. Additionally, tobacco product manufacturer CMP complaints are listed for violations related to unauthorized tobacco products.

If you are a retail establishment or manufacturer that has received a CMP complaint and wish to settle the case, you can submit the Acknowledgement Form and pay your CMP online.

For more information about CMP complaints, view FDA guidance documents and webinars.

No-Tobacco-Sale Order (NTSO) Complaints

Under the law, the FDA may pursue a no-tobacco-sale order (NTSO) complaint against retailers that have a total of five or more repeated violations of certain restrictions within 36 months. Retailers are prohibited from selling regulated tobacco products at the specified location during the period of the NTSO.

Retailers who receive an NTSO complaint from the FDA may either:

Enter into a settlement agreement with the agency that results in a final order issued by the Administrative Law Judge (ALJ), or
	Respond to the court with an Answer and choose to go to a full hearing before an ALJ.In determining the period of an NTSO, FDA considers the nature, circumstances, extent, and gravity of the violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require.

When FDA conducts unannounced compliance check inspections during the period of the NTSO, for the limited purpose of confirming the retailer’s compliance with the NTSO complaint, the results are not included in the searchable inspection database.

View a list of all NTSOs imposed by an ALJ, along with the effective dates of each NTSO.

For more information about NTSOs, view FDA guidance documents and webinars.

FDA Age Calculator

Download the “FDA Age Calculator,” a voluntary smartphone application to help retailers comply with federal, state, and local age restrictions for selling tobacco products.

Additional Resources

Retailer Training and Enforcement
	Retailer education materials and information
	Fact sheet on collaboration between SAMHSA's Synar Program and FDA's Tobacco Retail Compliance Inspection Contracts
	Compliance and Enforcement Reports
	Enforcement Actions Against Illegally Marketed Tobacco Products

                                                                                  Content current as of:
      11/14/2023
              
              
Regulated Product(s)
		 TobaccoCompliance, Enforcement & Training

          
                        Advisory and Enforcement Actions Against Industry for Selling Tobacco Products to Underage Purchasers
          Advisory and Enforcement Actions Against Industry for Unauthorized Tobacco Products
          Compliance and Enforcement Report
          FDA Tobacco Compliance Webinars
          Report Potential Tobacco Product Violation
          Small Business Assistance for Tobacco Product Industry


                        Tobacco Retailer Warning Letters
          Manufacturing
          Retail Sales of Tobacco Products
          State, Local, Tribal and Territorial Governments
 Subscribe to CTP News
                        Receive tobacco product news as it happens, including information about regulations, guidances, enforcement actions, and other announcements from the Center for Tobacco Products.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop