U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Tobacco Products
  3. Products, Guidance & Regulations
  4. Market and Distribute a Tobacco Product
  5. Regulatory Science Policy Memoranda about FDA Review of Tobacco Product Applications
  1. Market and Distribute a Tobacco Product

Regulatory Science Policy Memoranda about FDA Review of Tobacco Product Applications

FDA’s science policy memoranda were developed to assist FDA reviewers with the evaluation of new tobacco product applications. FDA has put these documents on this site in response to public interest. 

These memos provide a snapshot of CTP’s internal thinking on certain aspects of tobacco regulatory science. The information in them is subject to change, such as based on changes in policy, the regulatory framework, or regulatory science. Some of the memos may have been withdrawn or may not be current practice. FDA’s review of tobacco product applications is based on the specific facts presented in each application, and is documented in reviews particular to each application.

Importantly, these documents should not be used as a tool, guide, or manual for the preparation of applications or submissions to FDA. Instead, all interested persons should refer to the Federal Food, Drug, and Cosmetic Act (FD&C Act), and its implementing regulations, as well as guidance documents prepared by FDA, for information on FDA’s tobacco authorities and regulatory framework. FDA also regularly posts additional resources for applicants, such as webinars and application tips, on its website and social media.

Chemistry 

Toxicology 

Review Process

General

Acceptance and Filing Review Process

Marketing Information Review

Flavored ENDS Review Process

Environmental Assessment

FDA recommends the following tools serve as resources for the preparation of SE Reports, requests for Exemption from SE, or Premarket Tobacco Product Applications:

FDA oversees all pathways to legally market and distribute tobacco products in the U.S. Learn more about the various pathways to legally market and distribute a tobacco product.

Note: Documents include the outdated CTP terminology "grandfathered tobacco product." In August 2022, FDA updated the term "grandfathered tobacco product" to "pre-existing tobacco product."

Back to Top