About the Tobacco Regulatory Science Program (TRSP)
What Is TRSP?
TRSP implements the trans-HHS collaborative research effort between the Institutes and Centers of the National Institutes of Health (NIH) and the Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP).
With the passage of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA acquired the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. Within the framework of the Tobacco Control Act, the NIH and FDA formed this partnership to foster tobacco regulatory research.
The NIH has the infrastructure for the solicitation, review, and management of scientific research, and several NIH Institutes and Centers have long supported tobacco-related research as part of their missions. The FDA has expertise in tobacco regulatory science and the authority and resources to support research responsive to FDA’s regulatory authority. NIH biomedical, behavioral, and social sciences research supported via funding from FDA will provide the scientific evidence needed to better inform FDA’s regulatory authorities.
What Is the Tobacco Control Act?
The Tobacco Control Act became law on June 22, 2009. It gives the FDA the authority to regulate the manufacture, distribution, and marketing of 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.
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 goals to:
- Prevent Americans—especially youth—from starting to use tobacco.
- Encourage current users to quit.
- Decrease the harms of tobacco product use
What is the Deeming Rule?
The final deeming rule issued on May 5, 2016, extends 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 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 deeming 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.
What Is the FDA Center for Tobacco Products (CTP)?
The CTP oversees the implementation of the Tobacco Control Act. Some of the CTP’s responsibilities under the law include setting performance standards, reviewing pre-market applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.