Tobacco Products

Submit Comments on Tobacco Products

Make your voice heard and be part of our ongoing effort to improve public health in the United States.

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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.


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Public Scientific Workshop and Request for Comment Youth Tobacco Cessation: Science and Treatment Strategies
Docket No:
FDA-2019-N-1107
Date: 
May 31, 2019
Summary:
FDA is announcing the following public scientific workshop entitled “Youth Tobacco Cessation: Science and Treatment Strategies.”  The purpose of the workshop is to discuss the unique challenges associated with youth tobacco addiction and cessation, and the current science regarding youth tobacco use and addiction as well as treatment strategies to support youth tobacco cessation.  

Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports; Proposed Rule
Docket No:
FDA-2016-N-3818
Date:
June 17, 2019
Summary:
The Food and Drug Administration (FDA) is issuing a proposed rule to establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product (SE Reports). The proposed rule would establish the information an SE Report must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE Reports, including procedures that would address communications with the applicant and the confidentiality of data in an SE Report. The proposed rule is intended to provide more clarity to applicants and support efficient and predictable reviews of SE Reports.

Modified Risk Tobacco Product Applications: Applications for Six Camel Snus Smokeless Tobacco Products Submitted by the R.J. Reynolds Tobacco Company; Availability
Docket No: FDA-2017-N-4678-0001
Date:  May 13, 2019
Summary: FDA is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for six Camel Snus smokeless tobacco products submitted by R.J. Reynolds Tobacco Company.

Draft Guidance: Modifications to Compliance Policy for Certain Deemed Tobacco Products
Docket No: FDA-2019-D-0661
Date: April 30, 2019
Summary: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Modifications to Compliance Policy for Certain Deemed Tobacco Products." The draft guidance discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products and describes how FDA intends to prioritize its enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization.

Enforcement Policy for Certain Marketed Tobacco Products; Draft Guidance
Docket No
: FDA-2018-D-3244
Date: April 30, 2019
Summary:  The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Enforcement Policy for Certain Marketed Tobacco Products.” FDA is issuing this draft guidance to provide information regarding FDA’s enforcement policy for certain marketed tobacco products that become the subject of a not substantially equivalent (NSE) order. This policy primarily involves “provisional” tobacco products that become subject to NSE orders issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) (provisional tobacco products are tobacco products that were first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, and for which a substantial equivalence report (SE Report) was submitted no later than March 22, 2011). The draft guidance also provides information on FDA’s enforcement policy when an applicant files a request for supervisory review of an NSE order.  

Use of Investigational Tobacco Products
Docket No: FDA‐2014‐D-1939
Date:  April 22, 2019
Summary: The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry and investigators entitled “Use of Investigational Tobacco Products.” The revised draft guidance replaces the draft guidance of the same title announced in the Federal Register of September 24, 2015 (September 2015 draft guidance). The revised draft guidance, when finalized, will describe FDA’s current thinking regarding the definition of “investigational tobacco product” and will discuss the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations governing the use of investigational tobacco products become effective or FDA provides written notice of its intent to change its enforcement policy.

Modified Risk Tobacco Product Applications for Snus Products Submitted by Swedish Match USA, Inc.; Reopening of the Comment Period
Docket No: FDA‐2014‐N-1051
Date: May 13, 2019
Summary: FDA is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for eight Swedish Match USA, Inc. (previously known as Swedish Match North America, Inc.), General Snus smokeless tobacco products submitted.

Modified Risk Tobacco Product Applications: Application for Copenhagen Snuff Fine Cut submitted by U.S. Smokeless Tobacco Company; Availability
Docket No: FDA‐2018‐N-3261
Date: Currently no deadline for public comments
Summary: The FDA is announcing the availability for public comment of a modified risk tobacco product (MRTP) application for Copenhagen Snuff Fine Cut, a loose moist snuff tobacco product submitted by U.S. Smokeless Tobacco Co. LLC. 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:
    • data
    • research
    • analysis
  • 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:

  1. Rule/ Regulation Proposed
    We publish a proposed rule in the Federal Register.
  2. Public Comments Considered
    Our proposals generally have a 60-90 day review period.
  3. Final Rule Issued
    After considering all comments, we issue a final rule.
  4. Compliance with New Rule Enforced
    We must ensure that retailers and businesses comply with the regulation.

 

Page Last Updated: 04/12/2019
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