To protect the health of future generations, FDA closely monitors retailer, manufacturer, importer, and distributor compliance with Federal tobacco laws and regulations and takes corrective action when violations occur.
On this page:
- Compliance Check Inspections
- Warning Letters
- Civil Money Penalty Complaints
- No-Tobacco-Sale Order (NTSO) Complaints
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, 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 minor and inspector will not identify themselves.
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. You can also search using an interactive map by state or region. Those businesses where FDA has completed compliance check inspections will be displayed as pins on the map.
Note: Absence of a retail establishment from this database does not imply compliance with all applicable statutory and regulatory requirements.
We issue 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 Penalties or No-Tobacco-Sale Orders. 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letters issued as the result of compliance check inspections of tobacco retailers prior to October 1, 2016, have been archived via the FDA Web Archive.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 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.
A Civil Money Penalty (CMP) Complaint is used to initiate an administrative legal action against a retailer 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 are:
|Number of Regulation Violations||CMP Amount|
|1||$0 (CTP will send a Warning Letter)|
|2 within a 12-month period||$285|
|3 within a 24-month period||$570|
|4 within a 24-month period||$2,282|
|5 within a 36-month period||$5,705|
|6 within a 48-month period||$11,410|
Under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. No. 114-74), 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 2018 adjusted amounts.
FDA files Civil Money Penalty Complaints against tobacco retailers when subsequent violations of the tobacco regulations and/or other requirements relating to tobacco products in the Federal Food, Drug, and Cosmetic Act are observed during a compliance check inspection.
If you are a retail establishment that has received a Civil Money Penalty Complaint and wish to settle the case, you can submit the Acknowledgement Form and pay your Civil Money Penalty online.
Under the law, the FDA may pursue a No-Tobacco-Sale Order (NTSO) 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 a No-Tobacco-Sale Order, the 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 Order, the results are not included in the searchable inspection database.
For more information about NTSOs, view our guidance documents and webinars.
FDA Age Calculator
The FDA released a voluntary smartphone application, “FDA Age Calculator,” to help retailers comply with federal, state, and local age restrictions for selling tobacco products. With the “FDA Age Calculator,” retailers can use their personal smartphones to help determine if a customer is old enough under federal law to buy tobacco products.