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                Rules, Regulations and Guidance

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          Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke: Established ListRules, Regulations and Guidance Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke: Established List
  
  	
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Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke; Established List

FDA has established a list of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke (the established HPHC list) as required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

The established list of 93 HPHCs is included in the notice and in the table below.

Table 1.--Established List of the Chemicals and Chemical Compounds Identified by FDA as Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco SmokeConstituent
			Carcinogen (CA), Respiratory Toxicant (RT), Cardiovascular Toxicant (CT), Reproductive or Developmental Toxicant (RDT), Addictive (AD)Acetaldehyde
			CA, RT, ADAcetamide
			CAAcetone
			RTAcrolein
			RT, CTAcrylamide
			CAAcrylonitrile
			CA, RTAflatoxin B1
			CA4-Aminobiphenyl
			CA1-Aminonaphthalene
			CA2-Aminonaphthalene
			CAAmmonia
			RTAnabasine
			ADo-Anisidine
			CAArsenic
			CA, CT, RDTA-α-C (2-Amino-9H-pyrido[2,3-b]indole)
			CABenz[a]anthracene
			CA, CTBenz[j]aceanthrylene
			CABenzene
			CA, CT, RDTBenzo[b]fluoranthene
			CA, CTBenzo[k]fluoranthene
			CA, CTBenzo[b]furan
			CABenzo[a]pyrene
			CABenzo[c]phenanthrene
			CABeryllium
			CA1,3-Butadiene
			CA, RT, RDTCadmium
			CA, RT, RDTCaffeic acid
			CACarbon monoxide
			RDTCatechol
			CAChlorinated dioxins/furans
			CA, RDTChromium
			CA, RT, RDTChrysene
			CA, CTCobalt
			CA, CTCoumarin
			Banned in foodCresols (o-, m-, and p-cresol)
			CA, RTCrotonaldehyde
			CACyclopenta[c,d]pyrene
			CADibenz[a,h]anthracene
			CADibenzo[a,e]pyrene
			CADibenzo[a,h]pyrene
			CADibenzo[a,i]pyrene
			CADibenzo[a,l]pyrene
			CA2,6-Dimethylaniline
			CAEthyl carbamate (urethane)
			CA, RDTEthylbenzene
			CAEthylene oxide
			CA, RT, RDTFormaldehyde
			CA, RTFuran
			CAGlu-P-1 (2-Amino-6-methyldipyrido[1,2-a:3',2'-d]imidazole)
			CAGlu-P-2 (2-Aminodipyrido[1,2-a:3',2'-d]imidazole)
			CAHydrazine
			CA, RTHydrogen cyanide
			RT, CTIndeno[1,2,3-cd]pyrene
			CAIQ (2-Amino-3-methylimidazo[4,5-f]quinoline)
			CAIsoprene
			CALead
			CA, CT, RDTMeA-α-C (2-Amino-3-methyl)-9H-pyrido[2,3-b]indole)
			CAMercury
			CA, RDTMethyl ethyl ketone
			RT5-Methylchrysene
			CA4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone  (NNK)
			CANaphthalene
			CA, RTNickel
			CA, RTNicotine
			RDT, ADNitrobenzene
			CA, RT, RDTNitromethane
			CA2-Nitropropane
			CAN-Nitrosodiethanolamine (NDELA)
			CAN-Nitrosodiethylamine
			CAN-Nitrosodimethylamine (NDMA)
			CAN-Nitrosomethylethylamine
			CAN-Nitrosomorpholine (NMOR)
			CAN-Nitrosonornicotine (NNN)
			CAN-Nitrosopiperidine (NPIP)
			CAN-Nitrosopyrrolidine  (NPYR)
			CAN-Nitrososarcosine (NSAR)
			CANornicotine
			ADPhenol
			RT, CTPhIP (2-Amino-1-methyl-6-phenylimidazo[4,5-b]pyridine)
			CAPolonium-210
			CAPropionaldehyde
			RT, CTPropylene oxide
			CA, RTQuinoline
			CASelenium
			RTStyrene
			CAo-Toluidine
			CAToluene
			RT, RDTTrp-P-1 (3-Amino-1,4-dimethyl-5H-pyrido[4,3-b]indole)
			CATrp-P-2 (1-Methyl-3-amino-5H-pyrido[4,3-b]indole )
			CAUranium-235
			CA, RTUranium-238
			CA, RTVinyl acetate
			CA, RTVinyl chloride
			CA

Additional Resources

Harmful and Potentially Harmful Constituents - Overview
	Draft Guidance: Reporting HPHCs in Tobacco Products and Tobacco Smoke

                                                                                  Content current as of:
      10/07/2019
              
              
Regulated Product(s)
		 TobaccoRules, Regulations and Guidance

          
                        Rules and Regulations
          Guidance
          Center for Tobacco Products’ Regulation and Guidance Policy Agenda
          Family Smoking Prevention and Tobacco Control Act - An Overview
 
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