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			Draft Guidance for Industry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


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2012-D-0049
	    	    		    Issued by:
		    Guidance Issuing Office
          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 In recognition of this, the draft guidance identifies 20 HPHCs from the full list of 93 HPHCs, for which testing methods are well established and widely available.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The abbreviated list of 20 HPHCs is included in the draft guidance and listed below.

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
			AmmoniaAcrolein
			Arsenic
			ArsenicAcrylonitrile
			Benzo[a]pyrene
			Cadmium4-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-ButadieneCarbon monoxideCrotonaldehydeFormaldehydeIsopreneNicotine (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 For purposes of this draft guidance, we intend *cigarette filler* to mean the cut, ground, powdered, or leaf tobacco that is a component of a cigarette.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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						All written comments should be identified with this document's docket number: FDA-2012-D-0049.



  
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      02/13/2020
         
                  
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