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Constituents in Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the Federal Food, Drug, and Cosmetic Act Draft Guidance for Industry April 2012

GUIDANCE DOCUMENT

• Docket Number: FDA-2012-D-0049
• Issued by: Center for Tobacco Products

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 In recognition of this, the draft guidance identifies 20 HPHCs from the full list of 93 HPHCs, for which testing methods are well established and widely available.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The abbreviated list of 20 HPHCs is included in the draft guidance and listed below. 

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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 For purposes of this draft guidance, we intend cigarette filler to mean the cut, ground, powdered, or leaf tobacco that is a component of a cigarette.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

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Dockets Management
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