Make your voice heard and be part of our ongoing effort to improve public health in the United States.
We solicit information and comments, announced in the Federal Register and posted in dockets on Regulations.gov, from concerned citizens, industry, and organizations on a wide range of issues related to implementation of the Tobacco Control Act.
Request for Information on Psychosocial Predictors of Uptake of Tobacco and Other Products
Docket No.: FDA-2016-N-0073
Dates: Submit comments by March 4, 2016.
Summary: FDA/CTP is opening a docket to obtain data and information related to psychosocial predictors of uptake and continued use of tobacco products, including specific categories of tobacco products and specific individual tobacco products, as well as other products from which predictors may be adapted for or extrapolated to tobacco products. The purpose of this request for information is to gather additional information that could help identify and evaluate predictors of consumer initiation, uptake, and use of tobacco products.
Use of Investigational Tobacco Products
Docket No.: FDA-2014-D-1939
Dates: Submit comments by November 23, 2015
Summary:This draft guidance describes FDA's current thinking regarding the definition of "investigational tobacco product" and discusses the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations are issued and become effective or FDA provides written notice of its intent to change its enforcement policy.
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Reopening of the Comment Period
Docket No.: FDA‐2015‐N‐2002
Dates: Submit comments by December 30, 2015
Summary: The Food and Drug Administration (FDA) is reopening the comment period for the notice of proposed rulemaking (NPRM) that appeared in the Federal Register on September 25, 2015. In the NPRM, FDA requested comments on the proposed regulation that describes the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
What makes an effective and useful comment?
Our decisions are based on science and law. We look for logic, good science, and other evidence in the comments we evaluate.
- Provide a clear statement of whether you support or oppose the proposed rule or guidance.
- Include any of the following that support your position:
- Read more tips for submitting effective comments on the regulations.gov website.
Your role in shaping tobacco regulation
Our regulatory process generally follows these steps:
- Rule/ Regulation Proposed
We publish a proposed rule in the Federal Register.
- Public Comments Considered
Our proposals generally have a 60-90 day review period.
- Final Rule Issued
After considering all comments, we issue a final rule.
- Compliance with New Rule Enforced
We must ensure that retailers and businesses comply with the regulation.