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.
Tobacco Product Standard for N-nitrosonornicotine (NNN) Level in Finished Smokeless Tobacco Products
Docket No: FDA‐2016‐N-2527-0001
Date: Submit comments by April 10, 2017
Summary: FDA is proposing a tobacco product standard that would establish a limit of N-nitrosonornicotine (NNN) in finished smokeless tobacco products sold in the United States. NNN is a potent carcinogenic agent found in smokeless tobacco products and is a major contributor to the elevated cancer risks associated with smokeless tobacco use. By FDA's estimates, in the 20 years following implementation of the proposed product standard, approximately 12,700 new cases of oral cancer and approximately 2,200 oral cancer deaths would be prevented in the United States because of this rule. Moreover, during that 20-year period, FDA estimates that approximately 15,200 life years would be gained as a result of the proposed standard. Because oral cancer is associated with significant health and economic impacts, we expect positive public health benefits due to prevention of new and fatal cancer cases. For the reasons discussed in the preamble of this rule, FDA finds that the proposed standard would be appropriate for the protection of the public health.
Battery Safety Concerns in Electronic Nicotine Delivery Systems (ENDS); Public Workshop; Establishment of a Public Docket; Request for Comments
Docket No: FDA-2016-N-4232-0001
Date: Submit comments by May 22, 2017
Summary: The FDA is announcing a two-day public workshop on ENDS batteries and safety hazards. The workshop will include presentations and panel discussions about ENDS battery safety concerns as well as how potential safety hazards and risks are communicated to consumers and the general public. In conjunction with the public workshop, FDA is establishing a public docket to gather data and information on hazards and risks associated with the use of batteries in ENDS. Regardless of attendance at the public workshop, interested parties are invited to submit comments, including data and research, to the public docket.
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.