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  1. Rules, Regulations and Guidance

Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke: Established List

April 2012 

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 Smoke

Constituent Carcinogen (CA), Respiratory Toxicant (RT), Cardiovascular Toxicant (CT), Reproductive or Developmental Toxicant (RDT), Addictive (AD)

Acetaldehyde

CA, RT, AD

Acetamide

CA

Acetone

RT

Acrolein

RT, CT

Acrylamide

CA

Acrylonitrile

CA, RT

Aflatoxin B1

CA

4-Aminobiphenyl

CA

1-Aminonaphthalene

CA

2-Aminonaphthalene

CA

Ammonia

RT

Anabasine

 AD

o-Anisidine

CA

Arsenic

CA, CT, RDT

A-α-C (2-Amino-9H-pyrido[2,3-b]indole)

CA

Benz[a]anthracene

CA, CT

Benz[j]aceanthrylene

CA

Benzene

CA, CT, RDT

Benzo[b]fluoranthene

CA, CT

Benzo[k]fluoranthene

CA, CT

Benzo[b]furan

CA

Benzo[a]pyrene

CA

Benzo[c]phenanthrene

CA

Beryllium

CA

1,3-Butadiene

CA, RT, RDT

Cadmium

CA, RT, RDT

Caffeic acid

CA

Carbon monoxide

RDT

Catechol

CA

Chlorinated dioxins/furans

CA, RDT

Chromium

CA, RT, RDT

Chrysene

CA, CT

Cobalt

CA, CT

Coumarin

Banned in food

Cresols (o-, m-, and p-cresol)

CA, RT

Crotonaldehyde

CA

Cyclopenta[c,d]pyrene

CA

Dibenz[a,h]anthracene

CA

Dibenzo[a,e]pyrene

CA

Dibenzo[a,h]pyrene

CA

Dibenzo[a,i]pyrene

CA

Dibenzo[a,l]pyrene

CA

2,6-Dimethylaniline

CA

Ethyl carbamate (urethane)

CA, RDT

Ethylbenzene

CA

Ethylene oxide

CA, RT, RDT

Formaldehyde

CA, RT

Furan

CA

Glu-P-1 (2-Amino-6-methyldipyrido[1,2-a:3',2'-d]imidazole)

CA

Glu-P-2 (2-Aminodipyrido[1,2-a:3',2'-d]imidazole)

CA

Hydrazine

CA, RT

Hydrogen cyanide

RT, CT

Indeno[1,2,3-cd]pyrene

CA

IQ (2-Amino-3-methylimidazo[4,5-f]quinoline)

CA

Isoprene

CA

Lead

CA, CT, RDT

MeA-α-C (2-Amino-3-methyl)-9H-pyrido[2,3-b]indole)

CA

Mercury

CA, RDT

Methyl ethyl ketone

RT

5-Methylchrysene

CA

4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone  (NNK)

CA

Naphthalene

CA, RT

Nickel

CA, RT

Nicotine

RDT, AD

Nitrobenzene

CA, RT, RDT

Nitromethane

CA

2-Nitropropane

CA

N-Nitrosodiethanolamine (NDELA)

CA

N-Nitrosodiethylamine

CA

N-Nitrosodimethylamine (NDMA)

CA

N-Nitrosomethylethylamine

CA

N-Nitrosomorpholine (NMOR)

CA

N-Nitrosonornicotine (NNN)

CA

N-Nitrosopiperidine (NPIP)

CA

N-Nitrosopyrrolidine  (NPYR)

CA

N-Nitrososarcosine (NSAR)

CA

Nornicotine

AD

Phenol

RT, CT

PhIP (2-Amino-1-methyl-6-phenylimidazo[4,5-b]pyridine)

CA

Polonium-210   

CA

Propionaldehyde

RT, CT

Propylene oxide

CA, RT

Quinoline

CA

Selenium

RT

Styrene

CA

o-Toluidine

CA

Toluene

RT, RDT

Trp-P-1 (3-Amino-1,4-dimethyl-5H-pyrido[4,3-b]indole)

CA

Trp-P-2 (1-Methyl-3-amino-5H-pyrido[4,3-b]indole )

CA

Uranium-235

CA, RT

Uranium-238

CA, RT

Vinyl acetate

CA, RT

Vinyl chloride      

CA


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