FDA’s Role: Tobacco and the Public Health

Tobacco products are a unique addition to FDA’s regulatory authorities because they are:
 

• Harmful yet widely used consumer products
• Responsible for severe health problems in both users and non-users, including cancer, lung disease, and heart disease, which often lead to death
   

FDA’s traditional “safe and effective” standard for evaluating medical products does not apply to tobacco. FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product on the population as a whole, including users and non-users.

• New Tobacco Product Review and Evaluation
• Substantial Equivalence
• Exemption from Substantial Equivalence
• Premarket Tobacco Product Application

FDA’s oversight of tobacco products is designed to save lives by reducing the number of Americans – currently more than 443,000 – who die prematurely each year due to tobacco use.¹

_{1 Centers for Disease Control and Prevention. Annual Smoking–Attributable Mortality, Years of Potential Life Lost, and Productivity Losses—United States, 2000-2004. Morbidity and Mortality Weekly Report. 2008; 57(45):1226-1228.}

Information for the Tobacco Industry

How do I get my tobacco product to market?

FDA currently regulates:

• Cigarettes
• Cigarette tobacco
• Roll-your-own tobacco
• Smokeless tobacco products

To legally market your new tobacco product, you must receive a written order from FDA permitting its marketing in the United States. The following tool may help you decide which of the three pathways is appropriate for your new tobacco product. 

What if my new tobacco product is already on the market?

New tobacco products may not be legally marketed in the United States unless FDA has issued an order permitting their marketing. However, if a new tobacco product was:

1. Commercially marketed after February 15, 2007 but before March 22, 2011
   
   AND
    
2. A Substantial Equivalence Report was submitted by March 22, 2011

Then this new tobacco product may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent to an appropriate predicate product.

How do I make a modified risk claim on my tobacco product?

To make a modified risk claim about your tobacco product, you must submit a Modified Risk Tobacco Product Application and obtain an order from FDA permitting the marketing of your modified risk product. You should submit this application if you plan to have the product’s label, labeling, or advertising say explicitly or implicitly that:

• Your tobacco product is less harmful than another tobacco product
• Your tobacco product has a lower risk of tobacco-related disease than another tobacco product
• Your tobacco product or its smoke does not contain or is free of a substance
• Your tobacco product or its smoke contains a reduced level of a substance
• Your tobacco product or its smoke presents a reduced exposure to a substance

You must also submit this type of application and obtain an order from FDA permitting marketing before using the descriptors ‘light,’ ‘mild,’ ‘low,’ or similar descriptors.

When did FDA begin regulating tobacco products?

FDA’s role in regulating tobacco products was established when the Federal Food, Drug and Cosmetic Act (FD&C Act) was amended by the Family Smoking Prevention and Tobacco Control Act in 2009. This amendment to the FD&C Act gave FDA the responsibility and authority to regulate the manufacture, marketing, and distribution of tobacco products.

This web content highlights provisions of the Food, Drug and Cosmetic Act (FD&C Act). It is not intended to be comprehensive or reflect FDA's interpretation of the Act. For complete information, you must read the entire law. For your convenience, the section number of the FD&C Act is referenced and relevant sections are linked to throughout the web content.