FDA bares teeth, requires tobacco companies to list levels of 20 hazardous chemicals
Uranium-235? Uranium-238? Vinyl acetate? Polonium-210? Mercury? Hydrogen cyanide? Coumarin? Formaldehyde? Did you even know that these chemicals exist in the cigarette you’re smoking?
Yes, they do — along with 93 other chemicals that the United States Food and Drug Administration classifies as “harmful and potentially harmful constituents (HPHCs)” in tobacco products and tobacco smoke under the Federal Food, Drug and Cosmetic Act.
And on March 30, the health regulator said it will begin requiring tobacco companies to report how much of the 20 harmful chemicals are in their products.
Cigarettes and other tobacco products like chewable tobacco and snus contain more than 7,000 chemicals, and the FDA has put together a list of 93 harmful chemicals that tobacco companies will be required to report. But it’s focusing initially on the 20 chemicals that are the easiest to test for immediately. Eventually, the FDA will make companies provide information for the full list of 93 chemicals.
Under the new guidelines, tobacco companies are required to tell the FDA whether their products contain any of these 20 harmful or potentially harmful ingredients, as well as amounts of each.
For example, breathing in carbon monoxide — present in tobacco smoke and produced when anything is burned — is known to increase the risk for lung cancer and heart disease, the FDA said.
“Cigarettes are the only mass-consumed product in this country for which consumers don’t know what’s in them, until now,” said Dr. Lawrence Deyton, director of FDA’s tobacco center, in an interview with the Associated Press. “Today, we are ending that era,” he told Reuters.
“For the first time, all tobacco manufacturers and importers will be required to report quantities of potentially harmful chemicals and chemical compounds in every regulated tobacco product they sell in the U.S,” Dr. Deyton tells WebMD.
About 443,000 Americans die each year from smoking-related causes such as lung cancer, and as many as eight million Americans have smoking-related illnesses. Smoking and other forms of tobacco use contribute about US$96 billion each year to health care costs, but the smoke-related ailments are completely preventable. Smoking and tobacco use is no. 1 preventable cause of illness and death in the U.S. — as well as the world.
There’s no deadline for when the documents will become final, and the FDA will take comments on the new guidance until June 4.
The harmful ingredients won’t be listed on packaging. Instead, the FDA will compile information for each product and provide it in a consumer-friendly form by April 2013. But it still hasn’t yet decided how it will present the information.
Just beginning to bare its teeth
The new FDA actions are part of its stricter enforcement of the Family Smoking Prevention and Tobacco Control Act. That law, passed in 2009, gave the agency broad authority to oversee the manufacturing and marketing of cigarettes and other tobacco products — short of banning nicotine. That law also granted the agency the power to set standards on levels of harmful ingredients in tobacco products — but the FDA hasn’t used this power just yet.
The agency said it hopes the rules would encourage tobacco companies– Altria Group, parent of Philip Morris USA, and Lorillard Inc. — to make their products safer and less addictive.
To date, no media company has been able to reach any tobacco company for comment.
The federal announcement comes a month after a U.S. District Court judge sided with tobacco companies, ruling that the labels were unconstitutional. This was a major setback for federal regulators who were trying to enforce another tobacco law requiring companies to put large graphic warnings on cigarette packaging. The government is appealing the decision.
Reduced risk products
Also on March 30, the FDA passed another draft rule that will force companies to prove that any “reduced harm” tobacco products they sell are actually safer for consumers.
This rule is meant to curtail misleading advertising that markets some tobacco products — such as “tar-free” or “light” — as less harmful than others without providing evidence that these products are really safer. The same law empowers the agency to approve new tobacco products that are marketed as safer than those currently for sale.
In the new guidance, the FDA said companies undertake and submit extensive tests before they can market a so-called modified-risk tobacco product. The data should include studies on health risks for users and non-users, behavioral changes and consumer understanding of marketing materials for new products.
“The law sets a high standard to make sure that tobacco products marketed to reduce risk actually reduce risk,” Dr. Deyton said.
Public health advocates and tobacco companies alike have anticipated this ruling on modified-risk products.
Studies have shown that up to 70 percent of smokers want to quit and many are looking to these modified risk products to help them kick the addictive habit — or at least lessen the health risks of their addiction. At the same time, the tobacco industry — facing declining cigarette demand due to tax increases, smoking bans and growing social stigma — is looking for new products to sell.
Many cigarette makers have focused on smokeless tobacco and other so-called “modified risk” products.
Some tobacco companies sell alternatives like dissolving tobacco — finely milled tobacco shaped into orbs, sticks and strips and snus — small pouches like tea bags that users stick between the cheek and gum. These products aren’t explicitly marketed as less risky than cigarettes. There is also a growing market in e-cigarettes being marketed as less harmful — even while the World Health Organization doesn’t say so.
Short list of 20 hazardous chemicals in tobacco products
9. Nicotine (total)
17. Carbon monoxide
93 hazardous chemicals in tobacco products
The established list of 93 chemicals and chemical compounds the FDA has identified as harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke. These may be carginogens (CA), toxic to the respiratory system or respiratory toxicants (RT), toxic to the heart or cardiovascular toxicants(CT), toxic to the reproductive system or to development — Reproductive or Developmental Toxicant (RDT), or addictive (AD).
1. Acetaldehyde — CA, RT, AD
2. Acetamide — CA
3. Acetone — RT
4. Acrolein — RT, CT
5. Acrylamide — CA
6. Acrylonitrile — CA, RT
7. Aflatoxin — B1, CA
8. 4-Aminobiphenyl — CA
9. 1-Aminonaphthalene — CA
10. 2-Aminonaphthalene — CA
11. Ammonia — RT
12. Anabasine — AD
13. o-Anisidine — CA
14. Arsenic — CA, CT, RDT
15. A-α-C (2-Amino-9H-pyrido[2,3-b]indole) — CA
16. Benz[a]anthracene — CA, CT
17. Benz[j]aceanthrylene — CA
18. Benzene — CA, CT, RDT
19. Benzo[b]fluoranthene — CA, CT
20. Benzo[k]fluoranthene — CA, CT
21. Benzo[b]furan — CA
22. Benzo[a]pyrene — CA
23. Benzo[c]phenanthrene — CA
24. Beryllium –CA
25. 1,3-Butadiene –CA, RT, RDT
26. Cadmium –CA, RT, RDT
27. Caffeic acid — CA
28. Carbon monoxide — RDT
29. Catechol –CA
30. Chlorinated dioxins/furans — CA, RDT
31. Chromium — CA, RT, RDT
32. Chrysene — CA, CT
33. Cobalt — CA, CT
34. Coumarin — Banned in food
35. Cresols (o-, m-, and p-cresol) — CA, RT
36. Crotonaldehyde — CA
37. Cyclopenta[c,d]pyrene — CA
38. Dibenz[a,h]anthracene — CA
39. Dibenzo[a,e]pyrene — CA
40. Dibenzo[a,h]pyrene — CA
41. Dibenzo[a,i]pyrene — CA
42. Dibenzo[a,l]pyrene — CA
43. 2,6-Dimethylaniline — CA
44. Ethyl carbamate (urethane) — CA, RDT
45. Ethylbenzene — CA
46. Ethylene oxide — CA, RT, RDT
47. Formaldehyde — CA, RT
48. Furan — CA
49. Glu-P-1 (2-Amino-6-methyldipyrido[1,2-a:3′,2′-d]imidazole) — CA
50. Glu-P-2 (2-Aminodipyrido[1,2-a:3′,2′-d]imidazole) — CA
51. Hydrazine — CA, RT
52. Hydrogen cyanide — RT, CT
53. Indeno[1,2,3-cd]pyrene — CA
54. IQ (2-Amino-3-methylimidazo[4,5-f]quinoline) — CA
55. Isoprene — toxic to the respiratory system, CA
56. Lead — CA, CT, RDT
57. MeA-α-C (2-Amino-3-methyl)-9H-pyrido[2,3-b]indole) — CA
58. Mercury — CA, RDT
59. Methyl ethyl ketone — RT
60. 5-Methylchrysene — CA
61. 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) — CA
62. Naphthalene — CA, RT
63. Nickel — CA, RT
64. Nicotine — RDT, AD
65. Nitrobenzene — CA, RT, RDT
66. Nitromethane — CA
67. 2-Nitropropane — CA
68. N-Nitrosodiethanolamine (NDELA) — CA
69. N-Nitrosodiethylamine — CA
70. N-Nitrosodimethylamine (NDMA) — CA
71. N-Nitrosomethylethylamine — CA
72. N-Nitrosomorpholine (NMOR) — CA
73. N-Nitrosonornicotine (NNN) — CA
74. N-Nitrosopiperidine (NPIP) — CA
75. N-Nitrosopyrrolidine (NPYR) — CA
76. N-Nitrososarcosine (NSAR) — CA
77. Nornicotine — AD
78. Phenol — RT, CT
79. PhIP (2-Amino-1-methyl-6-phenylimidazo[4,5-b]pyridine) — CA
80. Polonium-210 — CA
81. Propionaldehyde — RT, CT
82. Propylene oxide — CA, RT
83. Quinoline — CA
84. Selenium — RT
85. Styrene — CA
86. o-Toluidine — CA
87. Toluene — RT, RDT
88. Trp-P-1 (3-Amino-1,4-dimethyl-5H-pyrido[4,3-b]indole) — CA
89. Trp-P-2 (1-Methyl-3-amino-5H-pyrido[4,3-b]indole ) — CA
90. Uranium-235 — CA, RT
91. Uranium-238 — CA, RT
92. Vinyl acetate — CA, RT
93. Vinyl chloride — CA