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.
Premarket Tobacco Product Applications and Record keeping Requirements; Reopening of the Comment Period
Docket No: FDA-2019-N-2854
Comment Period End Date: April 9, 2020
Summary: The Food and Drug Administration (FDA) is reopening the comment period only for the agency information collection activity associated with proposed rule making entitled “Premarket Tobacco Product Applications and Record keeping Requirements,” which appeared in the Federal Register of September 25, 2019. FDA is not reopening the comment period associated with any other aspects of the proposed rule making. The Agency is taking this action to seek comment on an additional proposed form to collect information that would be required under certain provisions of the proposed rule. This proposed form would allow for easier identification of each new tobacco product contained in a grouped submission of premarket tobacco product applications (PMTAs). FDA is reopening the comment period only on the proposed agency information collection activity to allow interested persons additional time to submit comments on this form.
Request for Information on Vaping Products Associated With Lung Injuries
Docket No: FDA-2020-N-0597
Comment Period End Date: April 20, 2020
Summary: The Food and Drug Administration (FDA) is opening a docket to obtain data and information related to the use of vaping products that are associated with recent lung injuries. This request for information (RFI) responds to direction from Congress to gather information from the public that could help identify and evaluate additional steps the Agency could take to “address the recent pulmonary illnesses reported to be associated with the use of e-cigarettes and vaping products.” FDA is seeking information on product design and potential ways to prevent consumers from modifying or adding substances to these products that are not intended by the manufacturers. In particular, FDA is seeking data and information in the form of reports and manuscripts that are unpublished or not available through indexed bibliographic databases. FDA has searched the publicly available scientific literature and is now seeking to supplement that with information not included in the published scientific literature.
Modified Risk Tobacco Product Applications for VLN™ King, VLN™ Menthol King, Combusted, Filtered Cigarettes, Submitted by 22nd Century Group Inc.
Docket No: FDA-2019-N-0994
Comment Period End Date: Currently no deadline for public comments
Summary: The FDA is announcing the availability for public comment of modified risk tobacco product applications for VLNTM King and VLNTM Menthol King, combusted, filtered cigarettes, submitted by 22nd Century Group Inc. FDA will post the application materials on a rolling basis as they are redacted in accordance with applicable laws.
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.