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.
Compliance Policy for Required Warning Statements on Small-Packaged Cigars: Draft Guidance
Docket No: FDA-2017-D-0121
Date: Submit comments by Feb 16, 2017
Summary: This guidance document is intended to assist any person who manufacturers, packages, sells, offers to sell, distributes, or imports cigars in small packages with respect to the warning statement requirements in Title 21, Code of Federal Regulations (CFR), part 1143 (21 CFR part 1143) for product packaging. This guidance document discusses, among other things:
- The regulatory requirements to place specific warnings on cigar packaging
- FDA’s compliance policy for cigars in small packaging
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
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
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 FDA-2016-N-4232 on regulations.gov or by mail to the FDA address listed in the Federal Register notice. As always, those interested in meeting with FDA to discuss ENDS battery safety concerns are welcome to submit a direct request for an informal meeting with FDA.
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.