Maryland Department of Health
Behavioral Health Administration

Maryland FDA Tobacco Retailer and Enforcement Program

​The Behavioral Health Administration (BHA) has a contractual agreement with the Food and Drug Administration (FDA)  to conduct Undercover Buy, Advertising and labeling, and other directed Inspections on behalf of the FDA of Maryland Licensed Tobacco Retailers to ensure their compliance with the Family Smoking Prevention and Tobacco Control Act. The staff that perform these inspections are/must be FDA Commissioned Officers. The inspections are performed statewide (23 counties and Baltimore City). Inspections completed under this contract are submitted to the FDA for final review and enforcement action.  Violations may lead to Warning letters, Civil Money penalties and other enforcement actions.  Since FDA regulates all tobacco products, including e-cigarettes, hookah tobacco, and cigars, retailers selling tobacco products must comply with all applicable federal laws and regulations.   The BHA Commissioned Officer inspections include inspecting all items in the link below that describes the Retailer Overview of FDA Regulations for Selling Tobacco Products:
https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Retail/default.htm

Penalties for Non-Compliant Retailers include:

Warning Letters

The 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 Penalties or No-Tobacco-Sale Orders.
 

Civil Money Penalty Complaints

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                         $279

3 within a 24-month period                         $559

4 within a 24-month period                         $2,236

5 within a 36-month period                         $5,591

6 within a 48-month period                         $11,182


 

No-Tobacco-Sale Orders to Retailers

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.
  

The FDA’s Center for Tobacco Products (CTP)

 

FDA’s Vision Statement

To make tobacco-related death and disease part of America’s past, not America’s future and, by doing so; ensure a healthier life for every family.
 
The FDA Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law—commonly called the Tobacco Control Act — gives FDA broad authority to regulate the manufacturing, distribution, and marketing of tobacco products.
 

Visit the FDA’s Web Site to learn more about whom they are and what they do:

 
Visit the FDA’s Inspection database to view inspection results 

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