Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act

OMB 0910-0732

This collection requires each tobacco product manufacturer or importer, or an agent, to report to FDA "all constituents, including smoke constituents, identified by [FDA] as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product." These entities must also provide similar information at least 90 days prior to introducing the product into interstate commerce.

The latest form for Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act expires 2022-08-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Roll Your Own Tobacco Product - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms Form and Instruction
Smokeless - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms Form and Instruction
Cigarette - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms / Testing of HPHC Form and Instruction

All Historical Document Collections

202410-0910-007	No material or nonsubstantive change to a currently approved collection	2024-10-25
202207-0910-001 Approved with change	Extension without change of a currently approved collection	2022-07-25
201909-0910-010 Approved without change	No material or nonsubstantive change to a currently approved collection	2019-09-27
201904-0910-006 Approved without change	Revision of a currently approved collection	2019-06-05
201603-0910-003 Approved without change	Extension without change of a currently approved collection	2016-03-21
201510-0910-010 Approved with change	No material or nonsubstantive change to a currently approved collection	2015-10-23
201410-0910-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2014-10-27
201208-0910-001 Approved with change	New collection (Request for a new OMB Control Number)	2012-08-01

OMB Details

Cigarette - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 3787g	Cigarette Smoke- Other Regimen Form FDA 3787g	Fillable Printable	Form and instruction
Form Form FDA 3787e	Cigarette Smoke- ISO Regimen Form FDA 3787e	Fillable Printable	Form and instruction
Form Form FDA 3787f	Cigarette Smoke- Intense Regimen Form FDA 3787f	Fillable Printable	Form and instruction
Form Form FDA 3787d	Product Indentification Form FDA 3787d	Fillable Printable	Form and instruction
Form Form FDA 3787a	Cigarette Report Form FDA 3787a	Fillable Printable	Form and instruction
Form Form FDA 3787h	Cigarette Filler Form FDA 3787h	Fillable Printable	Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.