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U.S. Department of Health and Human Services

Tobacco Products

Comment Opportunities

The Center for Tobacco Products (CTP) uses public dockets through the Federal Register to solicit information from all stakeholders on a number of specific issues related to implementation of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).  Learn More About Dockets, Guidance, Laws, and Regulations.

 

OPEN DOCKETS FOR PUBLIC COMMENT: 

NAME: Draft Guidances for Industry and Staff: Substantial Equivalence Reports; Manufacturer Requests for Extensions or to Change the Predicate Tobacco Productdisclaimer icon
Docket No. FDA–2014–D–0800
DATES: Submit either electronic or written comments on the draft guidance by September 15, 2014.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “Substantial Equivalence Reports: Manufacturer Requests for Extensions or To Change the Predicate Tobacco Product.” This draft guidance provides information to tobacco product manufacturers about FDA's policies on manufacturer requests for extensions of time to respond to deficiencies that FDA has identified, and manufacturer requests to change the predicate tobacco product, in substantial equivalence (SE) reports.


NAME: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act
Docket No. FDA-2014-N-0189-0001
DATES: Submit either electronic or written comments on the proposed rule by August 8, 2014.
SUMMARY: The Food and Drug Administration (FDA) is proposing to deem products meeting the statutory definition of "tobacco product," except accessories of a proposed deemed tobacco product, to be 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).  The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law.  Option 1 of the proposed rule would extend the Agency's "tobacco product" authorities in the FD&C Act to all other categories of products, except accessories of a proposed deemed tobacco product, that meet the statutory definition of "tobacco product" in the FD&C Act.  Option 2 of the proposed rule would extend the Agency's "tobacco product" authorities to all other categories of products, except premium cigars and the accessories of a proposed deemed tobacco product, that meet the statutory definition of "tobacco product" in the FD&C Act.  FDA also is proposing to prohibit the sale of "covered tobacco products" to individuals under the age of 18 and to require the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements.  FDA is taking this action to address the public health concerns associated with the use of tobacco products. 


 

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