Retailer Regulations and Guidance
FDA helps retailers better understand their responsibilities for complying with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and its implementing regulations by issuing guidance and education materials.
On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available, and the information on this page will be updated accordingly in a timely manner.
Why is the Tobacco Control Act So Important?
The landmark Tobacco Control Act aims to make tobacco products less accessible and less attractive to our children and youth. Each day in the United States, about 2,000 youth try their first cigarette and more than 300 become daily cigarette smokers.1 Many of these children will become addicted before they are old enough to understand the risks, and many will ultimately die of tobacco-related diseases. Tobacco retailers play an important role in protecting children and adolescents from the harms of tobacco by complying with federal laws.
Under the Tobacco Control Act, FDA has broad authority to regulate the sale and marketing of tobacco products to improve public health, and protect children and adolescents from the harms of tobacco use. Retailers can play an important role by complying with federal regulations on the sale, distribution, and marketing of tobacco products. Read a summary of the federal rules for tobacco retailers.
To help retailers understand the regulations and different aspects of the law as well as their responsibilities for complying with the Tobacco Control Act, FDA issues guidance documents, which describe the Agency’s current thinking on regulatory issues. These documents are not legally binding on the public or FDA.
- Guidance: Prohibition of Distributing Free Samples of Tobacco Products
- Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
- Determination of the Period Covered by a No-Tobacco-Sale Order and Compliance With an Order
- Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
- Guidance: Enforcement Policy for Certain (Provisional) Tobacco Products the FDA Finds Not Substantially Equivalent
- Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco
- General Questions and Answers on the Ban of Cigarettes that Contain Certain Characterizing Flavors (Edition 2)
- Tobacco Retailer Training Programs
- Civil Money Penalties and No-Tobacco-Sale Orders For Tobacco Retailers
- Civil Money Penalties for Tobacco Retailers - Responses to Frequently Asked Questions
- Compliance Check Inspections of Tobacco Product Retailers
- Required Warning Statements on Tobacco Product Packaging and Advertising
- Retailer Education Materials
- Retailer Training and Enforcement
- SAMHSA's Synar Program and FDA's Tobacco Retail Compliance Inspection Contracts
- Warning Letters to Tobacco Retailers
- State Tobacco Control Laws
1. Substance Abuse and Mental Health Services Administration (SAMHSA). 2017 National Survey on Drug Use and Health: Detailed Tables. Rockville, MD: U.S. Department of Health and Human Services, SAMHSA, Center for Behavioral Health Statistics and Quality; 2018. https://www.samhsa.gov/data/sites/default/files/cbhsq-reports/NSDUHDetailedTabs2017/NSDUHDetailedTabs2017.pdf. Accessed October 12, 2018. (Original Data Source: NSDUH 2017, Table 4.10A)