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GUIDANCE DOCUMENT

Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act Draft Guidance for Industry April 2012

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act

Issued by:
Guidance Issuing Office
Center for Tobacco Products

Comment Opportunity: Harmful and Potentially Harmful Constituents

FDA seeks public input on 19 proposed additions to the tobacco harmful and potentially harmful constituents (HPHCs) established list as well as new HPHC determining criterion. Submit comments before October 4, 2019.

March 2012

This document, when finalized, will provide guidance on how companies can comply with the requirement to report on the quantities of harmful and potentially harmful constituents (HPHCs) in tobacco products.

FDA recognizes that industry may be unable to meet the deadline due to current testing limitations. In recognition of this, the draft guidance identifies 20 HPHCs from the full list of 93 HPHCs, for which testing methods are well established and widely available. FDA is currently exercising enforcement discretion to require reporting about these 20 constituents. 

The abbreviated list of 20 HPHCs is included in the draft guidance and listed below. 


Table 1. Abbreviated List of Harmful and Potentially Harmful Constituents

HPHCs in Cigarette Smoke

HPHCs in Smokeless Tobacco

HPHCs in Roll-your-own Tobacco and Cigarette Filler

Acetaldehyde

Acetaldehyde

Ammonia

Acrolein

Arsenic

Arsenic

Acrylonitrile

Benzo[a]pyrene

Cadmium

4-Aminobiphenyl

Cadmium

Nicotine (total)

1-Aminonaphthalene

Crotonaldehyde

NNK*

2-Aminonaphthalene

Formaldehyde

NNN**

Ammonia

Nicotine (total and free)

 

Benzene

NNK*

 

Benzo[a]pyrene

NNN**

 

1,3-Butadiene

 

 

Carbon monoxide

 

 

Crotonaldehyde

 

 

Formaldehyde

 

 

Isoprene

 

 

Nicotine (total)

 

 

NNK*

 

 

NNN**

 

 

Toluene

 

 

1 - Roll-your-own tobacco is defined in section 900(15) of the FD&C Act to mean “any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.” The term cigarette filler is not defined in the FD&C Act. For purposes of this draft guidance, we intend cigarette filler to mean the cut, ground, powdered, or leaf tobacco that is a component of a cigarette.

*4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone

** N-nitrosonornicotine


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.