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                Rules, Regulations and Guidance

Rules, Regulations and Guidance

                        Rules and Regulations
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          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview Home
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          Rules, Regulations and Guidance
          Family Smoking Prevention and Tobacco Control Act - An OverviewRules, Regulations and Guidance Family Smoking Prevention and Tobacco Control Act - An Overview
  
  	
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    PrintTo protect the public health of the U.S. population and create a healthier future, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), signed into law on June 22, 2009, gives FDA authority to regulate the manufacture, distribution, and marketing of tobacco products.

Smiling mother and child
**The Tobacco Control Act:**

Restricts Tobacco Marketing and Sales to Youth
	Requires Smokeless Tobacco Product Warning Labels
	Ensures “Modified Risk” Claims are Supported by Scientific Evidence
	Requires Disclosure of Ingredients in Tobacco Products
	Preserves State, Local, and Tribal AuthorityRestricts Tobacco Marketing and Sales to Youth

The Tobacco Control Act puts in place specific restrictions on marketing tobacco products to children and gives FDA authority to take further action in the future to protect public health. These provisions ban:

sales to minors
	vending machine sales*
	the sale of packages of fewer than 20 cigarettes
	tobacco-brand sponsorships of sports and entertainment events or other social or cultural events
	free giveaways of sample cigarettes and brand-name non-tobacco promotional items*except in adult-only facilities

Requires Smokeless Tobacco Product Warning Labels

The Tobacco Control Act requires that smokeless tobacco packages and advertisements have larger and more visible warnings. Smokeless tobacco includes tobacco products such as moist snuff, chewing tobacco, and snus. Every smokeless tobacco package and advertisement will include one of the following warning label statements:

**WARNING**: This product can cause mouth cancer.
	**WARNING**: This product can cause gum disease and tooth loss.
	**WARNING**: This product is not a safe alternative to cigarettes.
	**WARNING**: Smokeless tobacco is addictive.

For smokeless tobacco packaging, the warning label statement must be located on the two principal sides of the package and cover at least 30% of each side.

For advertisements, the warning label statements must cover at least 20% of the area of the ad.

These changes aim to increase awareness of the health risks associated with smokeless tobacco use and improve the public health.

Ensures "Modified Risk" Claims are Supported by Scientific Evidence

The landmark law prohibits tobacco companies from making reduced harm claims like “light,” “low,” or “mild,” without filing an application for a modified risk tobacco product and obtaining an order to market as such.

Requires Disclosure of Ingredients in Tobacco Products

Tobacco companies must provide FDA with detailed information about the ingredients in their products.

Preserves State, Local, and Tribal Authority

The Tobacco Control Act preserves the authority of state, local, and tribal governments to regulate tobacco products in specific respects.

Additional Authorities

The Tobacco Control Act gives FDA authority to help protect the public and create a healthier future for all Americans. For example, the Tobacco Control Act:

Requires tobacco company owners and operators to register annually and open their manufacturing and processing facilities to be subject to inspection by FDA every two years.
	Allows FDA to implement standards for tobacco products to protect public health. For example, FDA has the authority to regulate nicotine and ingredient levels.
	Bans cigarettes with characterizing flavors, except menthol and tobacco.
	Funds FDA regulation of tobacco products through a user fee on the manufacturers of certain tobacco products sold in the United States, based on their U.S. market share.The Tobacco Control Act does not:

The law makes clear that FDA's role is to regulate and protect the public health, but it places a few restrictions on FDA's powers. FDA cannot:

Require prescriptions to purchase tobacco products.
	Require the reduction of nicotine yields to zero.
	Ban face-to-face sales in a particular category of retail outlets.
	Ban certain classes of tobacco products.Search the Act

Sections of the Tobacco Control Act***NOTE****: This overview highlights some of the provisions of the Tobacco Control Act and is not intended to be a comprehensive guide or to reflect FDA's interpretation of the Tobacco Control Act.  For complete information, you must read the entire law.*

Additional Resources

CTP Newsroom
	Rules and Regulations
	Reports to Congress

                                                                                  Content current as of:
      06/03/2020
              
              
Regulated Product(s)
		 TobaccoRules, Regulations and Guidance

          
                        Rules and Regulations
          Guidance
          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview
 
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