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 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
          Small Business Assistance for Tobacco Product IndustryCompliance, Enforcement & Training Small Business Assistance for Tobacco Product Industry
  
  					Find a list of resources OSBA offers and learn how to reach out for help with specific questions about your circumstances.
	
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Small tobacco product retailers and manufacturers, including vape shops, sometimes have fewer resources and face different challenges than larger businesses. Like large businesses, however, small tobacco retailers and manufacturers must comply with the Tobacco Control Act and related regulations. The Center for Tobacco Products’ Office of Small Business Assistance (OSBA) is available to help you understand and comply with FDA’s tobacco laws and regulations.

Compliance allows businesses to avoid regulatory actions such as warning letters, civil money penalties, and seizures and injunctions, and also protects the public health of the U.S. population, especially youth, from tobacco-related death and disease.

**Note:**In April 2021, FDA announced its plans to propose tobacco product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars. Read more.


How can we help?

Learn more about how the Office of Small Business Assistance can help you comply with tobacco laws. Find resources and read a feature article about the Office of Small Business Assistance and how it helps businesses comply.

Did you know?

Many small businesses came under FDA regulation for the first time after the 2016 deeming rule extended FDA’s authority to products such as e-cigarettes and hookah and pipe tobacco.

Resources for Small Businesses

FDA’s Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products: Provides an overview for retailers, manufacturers, or those who are both.
	Manufacturing: Read specific information about rules and requirements for manufacturers of tobacco products, including submission deadlines and other key resources.
	Market and Distribute a Tobacco Product: Learn more about the ways to obtain an FDA marketing order for your tobacco product.
	Retailer Education Materials: “This is Our Watch” Toolkit, FDA Age Calculator: Download or order “This Is Our Watch” print and other materials that can be voluntarily displayed in stores to inform owners, managers, and clerks, as well as customers, about the law and retailers’ important role. And, download the FDA Age Calculator, a voluntary smartphone application to help retailers comply with federal, state, and local age restrictions for selling tobacco products.
	Electronic Submissions for Tobacco Products: The FDA’s Center for Tobacco Products has several processes in place for manufacturers and other industry to submit regulatory information and correspondence about tobacco products using electronic methods.
	Guidances: Access final, draft, and revised guidance documents that reflect FDA’s current thinking on tobacco-related issues, including “small entity guides” that focus on helping small businesses understand and comply with tobacco law.
	Compliance Dates Under Deeming: Find information, including a chart, about important compliance-related dates.
	Compliance Webinars: Typically running about 30 minutes to an hour, these videos cover a wide variety of topics for retailers and manufacturers, especially small businesses, including:CTP Office of Small Business Assistance webinar thumbnail
Tobacco Registration and Product Listing Updates (11:09)***Download Slides***

CTP Office of Small Business Assistance webinar thumbnail
Office of Small Business Assistance (7:56)***Download Slides***

CTP Overview of Warning Letters for Online Retailers webinar thumbnail
Overview of Warning Letters for Online Retailers (30:39)***Download Slides***

Recent Changes that Impact the Sale of Tobacco Products in Retail Establishments
What a Brick and Mortar Tobacco Retailer Should Do After Receiving a Warning Letter (11:01) ***Download Slides***

Recent Changes that Impact the Sale of Tobacco Products in Retail Establishments
Tobacco 21: Update for Retailers (6:50)***Download Slides***

Gerie Voss
The Final “Deeming Rule”—All Tobacco Products Subject to the Federal Food, Drug, and Cosmetic Act (36:52)

David Keith
The “Deeming Rule”: New Regulatory Requirements for Vape Shops (26:22)

CTP - Ann Simoneau
The “Deeming Rule”: Requirements for Small Manufacturers, Importers, and Vape Shops That Manufacture or Import Newly Regulated Tobacco Products (63:06)



More Questions?

Contact Us

Please reach out by email, phone, or mail for technical assistance, help finding the right resources, and the opportunity to communicate your small-business viewpoint to FDA.

**Email:** 
SmallBiz.Tobacco@fda.hhs.gov

**Phone:**   1-877-287-1373 (Monday–Friday, 9:00 a.m.–4:00 p.m. Eastern Time)

**Mail:**   
FDA/CTP Office of Compliance and Enforcement
Document Control Center
Building 71, Room G335
10903 New Hampshire Ave.
Silver Spring, MD  20993

                                                                                  Content current as of:
      10/13/2021
              
              
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
 
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