06/07/2018 - Submit Comments on Tobacco Products

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

Young woman looking forward

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.

Submit Comments

Tobacco Product Standard for Nicotine Level of Combusted Cigarettes
Docket No: FDA-2017-N-6189
Date: Comment period extended through July 16, 2018
Summary: The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health.  


Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard
Docket No: FDA-2018-N-0529
Date: Comment period extended through July 16, 2018
Summary: The Food and Drug Administration (FDA) is announcing the availability of a draft concept paper entitled "Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard." FDA seeks public comment on the draft concept paper regarding the potential for illicit trade markets to develop in response to a tobacco product standard. This draft concept paper is offered to stimulate dialogue around the subject of possible illicit trade in connection with tobacco product standards.   


Regulation of Flavors in Tobacco Products
Docket No: FDA-2017-N-6565 
Date: Comment period extended through July 19, 2018
Summary: The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the role that flavors play in tobacco products.  Specifically, this ANPRM is seeking comments, data, research results, or other information about, among other things, how flavors attract youth to initiate tobacco product use and about whether and how certain flavors may help adult cigarette smokers reduce cigarette use and switch to potentially less harmful products.  FDA is seeking this information to inform regulatory actions FDA might take with respect to tobacco products with flavors, under 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).  Potential regulatory actions include, but are not limited to, tobacco product standards and restrictions on sale and distribution of tobacco products with flavors.


Regulation of Premium Cigars
Docket No:  FDA-2017-N-6107
Date: Comment period extended through July 25, 2018
Summary: 
The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking (ANPRM) to obtain information related to the regulation of premium cigars under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and regulations regarding the sale and distribution of 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 premium cigars. 


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:  Currently no deadline for public comments
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.


Modified Risk Tobacco Product Applications: Applications for IQOS System with Marlboro Heatsticks, IQOS System with Marlboro Smooth Menthol Heatsticks, and IQOS System with Marlboro Fresh Menthol Heatsticks Submitted by Philip Morris Products S.A.; Availability
Docket No: FDA‐2017‐D-3001
Date: Comment period extended
*Clarification: No Deadline Set for Public Comments on Philip Morris Products S.A. MRTP Applications
Summary: The FDA is announcing the availability for public comment of modified risk tobacco product applications (MRTPAs) for IQOS system with Marlboro Heatsticks, IQOS system with Marlboro Smooth Menthol Heatsticks, and IQOS system with Marlboro Fresh Menthol Heatsticks submitted by Philip Morris Products S.A. Due to the large size of these applications, FDA will post the application documents in batches 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.
Comments are closed