Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Products, Guidance & Regulations

Products, Guidance & Regulations

                        Submit Comments on Tobacco Regulatory Activities
          Tobacco Products-Related Citizen Petitions
          Importing and Exporting
          Tobacco Product Standards


                        Market and Distribute a Tobacco Product
          Advertising and Promotion
          Labeling and Warning Statements for Tobacco Products
          Products, Ingredients & Components
          Rules, Regulations and Guidance Home
          Tobacco Products
          Products, Guidance & Regulations
          Tobacco Product StandardsProducts, Guidance & Regulations Tobacco Product Standards
  
  	
    Share
    Post
    Linkedin

    Email
    Print**On this page:**

What Is a Tobacco Product Standard?

	What Are the Family Smoking Prevention and Tobacco Control Act Special Rules?
	What Is the Process for Developing a Product Standard?
	What Gives FDA the Authority to Set Tobacco Product Standards?What Is a Tobacco Product Standard?

A tobacco product standard is a rule that sets requirements for how a tobacco product can be made. It is based on rigorous evaluation of scientific evidence and FDA’s determination that the product standard is appropriate for the protection of the public health. For example, a product standard could include reducing or eliminating certain ingredients or chemicals in tobacco products or limiting nicotine levels of tobacco products.

Tobacco product standards are a powerful regulatory tool because they have the ability to significantly reduce tobacco-related disease and death by addressing the addictiveness, toxicity, and appeal across a whole product category.

What Are the Family Smoking Prevention and Tobacco Control Act’s Special Rules?

The 2009 Family Smoking Prevention and Tobacco Control Act (or TCA) established two tobacco product standards, known as “Special Rules”:

A product standard to prohibit cigarettes with characterizing flavors other than tobacco or menthol, such as fruit and chocolate, which are known to appeal to youth and young adults.1
	A product standard prohibiting the use of tobacco containing a pesticide chemical residue that is at a level greater than is specified by any tolerance applicable under Federal law to domestically grown tobacco.“Special Rules” are rules set forth by Congress in statute, as opposed to rules FDA may issue through the notice-and-comment rulemaking process.

What Is the Process for Developing a Product Standard?

A product standard is a rule, and therefore developing a product standard requires FDA to follow the notice-and-comment rulemaking process.

The rulemaking process typically starts with identifying a need for a rule, gathering information for a proposed rule, and writing a proposed rule (known as a Notice of Proposed Rulemaking or NPRM). Once the proposed rule is reviewed by the appropriate departments and agencies (e.g., HHS, OMB, and others), it is published in the Federal Register and made available for public comment. The public usually has 60-90 days to submit comments on the proposed rule. Public comments may include data, research, or other information, pointing out parts of a proposed rule that may be confusing or suggesting different wording.

CTP then reviews all public comments, analyzes the issues raised and prepares a final rule that provides the basis and the purpose of the rule. The final rule also responds to public comments and provides an effective date for the rule. The final rule is published in the Federal Register and made publicly available. It becomes legally binding and must be followed like a law.

What Gives FDA the Authority to Set Tobacco Product Standards?

Section 907 of the Federal Food, Drug, and Cosmetic Act gives FDA the authority to propose and adopt, through notice-and-comment rulemaking, tobacco product standards. Once effective, these product standards have the full force of the law and must be adhered to.

References
	1. U.S. Department of Health and Human Services (USDHHS). A Report of the Surgeon General: Preventing Tobacco Use Among Youth and Young Adults: We CAN Make the Next Generation Tobacco-Free (Consumer Booklet). Atlanta, GA: US Dept of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2012.

                                                                                  Content current as of:
      12/14/2023
              
              
Regulated Product(s)
		 TobaccoProducts, Guidance & Regulations

          
                        Submit Comments on Tobacco Regulatory Activities
          Tobacco Products-Related Citizen Petitions
          Importing and Exporting
          Tobacco Product Standards


                        Market and Distribute a Tobacco Product
          Advertising and Promotion
          Labeling and Warning Statements for Tobacco Products
          Products, Ingredients & Components
          Rules, Regulations and Guidance
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop