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

OMB 0910-0732

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.

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 3787gCigarette Smoke- Other Regimen Form FDA 3787gFillable PrintableForm and instruction
Form Form FDA 3787eCigarette Smoke- ISO Regimen Form FDA 3787eFillable PrintableForm and instruction
Form Form FDA 3787fCigarette Smoke- Intense Regimen Form FDA 3787fFillable PrintableForm and instruction
Form Form FDA 3787d Product Indentification Form FDA 3787d Fillable PrintableForm and instruction
Form Form FDA 3787aCigarette Report Form FDA 3787aFillable PrintableForm and instruction
Form Form FDA 3787hCigarette Filler Form FDA 3787hFillable PrintableForm and instruction

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


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