NIH: Office of Disease Prevention

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What is the Tobacco Control Act?

The Family Smoking Prevention and Tobacco Control Act (FSPTCA), also known as the Tobacco Control Act, became law on June 22, 2009. It gives the Food and Drug Administration (FDA) the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. The Tobacco Control Act gave the FDA immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. For other kinds of tobacco products, the statute authorizes the FDA to issue regulations "deeming" them to be subject to such authorities. Consistent with the statute, once a tobacco product is deemed, the FDA may put in place "restrictions on the sale and distribution of a tobacco product," including age-related access restrictions as well as advertising and promotion restrictions, if the FDA determines the restrictions are appropriate for the protection of the public health.

For more information about the Tobacco Control Act, visit the FDA Center for Tobacco Products site:

Deeming Rule

The deeming rule issued on May 5, 2016, will extend the FDA’s tobacco product authorities to additional categories of products that meet the statutory definition of a tobacco product, including Electronic Nicotine Delivery Systems or ENDS (e.g., e-cigarettes, vape pens), cigars, pipe tobacco, gels, hookah (waterpipe) tobacco, and future tobacco products, but not including accessories of newly deemed products. The final deeming rule triggers automatic provisions and contains additional restrictions.

Deeming Rule - Automatic Provisions

Newly deemed tobacco products automatically are required to comply with all provisions regarding “tobacco products” found in the Federal Food, Drug, and Cosmetic (FD&C) Act. These automatic provisions require industry, which includes manufacturers and retailers, to take certain actions, such as:

  • Ensure that tobacco products are not adulterated or misbranded. For example, a tobacco product is adulterated if the product is marketed with an unauthorized modified risk claim on its label, labeling, or advertisements. An example of a misbranded tobacco product is one where the manufacturer of the product fails to include a required warning on the label of the product package.
  • Provide the FDA with ingredient listings for all tobacco products.
  • Register manufacturing establishments and provide FDA with product listings for all tobacco products.
  • Obtain premarket authorization for newly deemed products that meet the definition of “new tobacco product” via one of the pathways specified in the FD&C Act (e.g., Substantial Equivalence or SE, Premarket Tobacco Application or PMTA, Exemption from Substantial Equivalence).

Deeming Rule - Additional Restrictions

The final rule establishes the following three additional restrictions for “covered tobacco products,” which includes all newly deemed tobacco products except those components and parts that are not made or derived from tobacco:

  • Requirement for a minimum age of purchase and verification of age via photographic identification. Retailers may not sell newly deemed tobacco products to individuals under 18 years of age; retailers must verify the age of any person who is 26 years of age or younger. States may require a higher minimum age for purchase of tobacco products.
  • Prohibition of vending machine sales, unless the vending machine is located in a facility where the retailer ensures that individuals under 18 years of age are prohibited from entering at any time.
  • Health warnings for product packages and advertisements.

For more information about Deeming Tobacco Products to be subject to the Federal Food, Drug, and Cosmetic Act as Amended by the Family Smoking Prevention and Tobacco Control Act, visit the FDA Center for Tobacco Products website.

Public Health Objectives of the Tobacco Control Act

To help make tobacco-related death and disease a part of America’s past, not its future, the FDA is committed to educating the public—especially young people—about the harms of tobacco products, keeping tobacco products out of the hands of America’s youth, and dramatically reducing the appeal of these deadly products. Everything the FDA does is designed to reduce the impact of tobacco on public health, including our top three goals to:

  • Prevent Americans—especially youth–from starting to use tobacco
  • Encourage current users to quit
  • Decrease the harms of tobacco product use

FDA Center for Tobacco Products

The Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. Some of the CTP’s responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.

For more information about the CTP, visit the CTP's website or view the fact sheet (PDF - 132 KB).