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.
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 Americans, especially youth, from tobacco-related disease and death.
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 app to help retailers comply with federal, state, and local age restrictions for tobacco sales.
- Commonly Asked Questions: Get answers to common questions such as: Are vape shops considered to be manufacturers? Are retailers allowed to charge customers a “sampling fee” to try an e-liquid? And what about charging for a “membership” to try an e-liquid?
- 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:
What a Brick and Mortar Tobacco Retailer Should Do After Receiving a Warning Letter (11:01)
The “Deeming Rule”: Requirements for Small Manufacturers, Importers, and Vape Shops That Manufacture or Import Newly Regulated Tobacco Products (63:06)
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.
1-877-287-1373 (Monday–Friday, 9:00 a.m.–4:00 p.m. Eastern Time)
FDA/CTP Office of Compliance and Enforcement
Document Control Center
Building 71, Room G335
10903 New Hampshire Ave.
Silver Spring, MD 20993