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.
Modified Risk Tobacco Product Applications: Applications for 10 Products Submitted by Swedish Match North America, Inc.; Reopening of Comment Period
Docket No.: FDA-2014-N-1051
Dates: Submit comments by August 31, 2015.
Summary: FDA is reopening the period for public comment on modified risk tobacco product applications (MRTPAs) submitted by Swedish Match North America, Inc. for 10 tobacco products. These applications were first announced in the Federal Register on August 27, 2014. In that notice, FDA requested comments on the 10 originally filed MRTP applications that are posted on regulations.gov and FDA’s website. The Agency is taking this action to permit the public to review and comment on amendments made to the MRTPAs submitted by Swedish Match North America, Inc.
Nicotine Exposure Warnings and Child-Resistant Packaging for Liquid Nicotine, Nicotine-Containing E-Liquid(s), and Other Tobacco Products
Docket No.: FDA-2015-N-1514
Dates: Submit comments by September 30, 2015 (reflects extended comment period).
Summary: The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of “tobacco products” subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and restrictions regarding the sale and distribution of such tobacco products. Specifically, this ANPRM is seeking comments, data, research results, or other information that may inform regulatory actions FDA might take with respect to nicotine exposure warnings and child-resistant packaging for liquid nicotine and nicotine-containing e-liquid(s) that are made or derived from tobacco and intended for human consumption, and potentially for other tobacco products including, but not limited to, novel tobacco products such as dissolvables, lotions, gels, and drinks.
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.