April 25, 1995
CITIZEN PETITION SEEKING LABELING OF NITRITE-PRESERVED HOT DOGS FOR CHILDHOOD CANCER RISK
David A. Kessler, M.D.
Commissioner, Food and Drug Administration, Room 1-23
12420 Parklawn Drive
Rockville, MD 20857
The undersigned submits on behalf of the Cancer Prevention Coalition, Inc. (CPC), Samuel S. Epstein, M.D., Chair, and on behalf of the Center for constitutional Rights, Michael Deutsch, Esq., Legal Director. This citizen petition is based on accumulating scientific information on excess risks of childhood brain tumors and leukemia from the consumption of hot dogs containing nitrite preservatives.
The undersigned submits this petition under 21 U.S.C. 321 (n), 361, 362, and 371 (a); and 21 CFR 740.1, 740.2 of 21 CFR 10.30 of the Federal Food, Drug, and Cosmetic Act to request the Commissioner of the Food and Drug Administration (FDA) to label hot dogs that contain nitrites with a cancer risk warning.
A. Agency Action Requested
This petition requests that FDA take the following action:
(1) Immediately require nitrite-containing hot dogs to be labelled with warnings such as Ahot dogs containing nitrites have been shown to pose risks of childhood cancer.@
(2) Pursuant to 21 CFR 10.30 (h) (2), a hearing at which time we can present our scientific evidence.
B. STATEMENT OF GROUNDS
Nitrites are widely used as preservatives in hot dogs, besides other meat products. Nitrites combine with amines naturally present in meat to form carcinogenic N-nitroso compounds. 1,2,3,4 N-nitrosodimethylamine has been identified in nitrite-preserved meat products. (5,6) There is overwhelming evidence on the carcinogenicity of N-nitrosodimmethylamine in animal experiments.(7) Furthermore, epidemiologic evidence has associated N-nitroso carcinogens with cancer of the oral cavity, urinary bladder, esophagus, stomach and brain. (8,9,10)
There is substantial evidence on the risks of childhood cancer from the consumption of meats containing nitrites. (11,12,13) In 1982, Preston-Martin, et al. found that Aconsumption during pregnancy of meats cured with sodium nitrite has been associated with development of brain tumors in the offspring.@ (14)
Recent case-control studies have confirmed the risks of cancer from consumption of hot dogs. Eating many hot dogs by children, as well maternal hot dog consumption during pregnancy, has been shown to be associated with brain cancer and leukemia in children. (15,16,17)
Bunin, et al. studied children who were diagnosed with brain cancer before age six, between 1986 and 1989. Of 53 foods and beverages and three alcoholic beverages consumed by mothers during pregnancy, only hot dogs were associated with an excess risk of childhood brain tumor. (18)
Sarusua and Savitz studied 234 childhood cancer cases in Denver and found a strong association between the consumption of hot dogs and brain cancer. Children born to mothers who consumed hot dogs one or more times per week during pregnancy had approximately double the risk of developing brain tumors. Children who ate hot dogs one or more times per week were also at higher risk of brain cancer. In addition, children who ate hot dogs and took no vitamins, which retard the formation of N-nitroso carcinogens, were more strongly associated with both acute lymphocytic leukemia (ALL) and brain cancer. (19) Sarusua and Savitz concluded:
"The results linking hot dogs and brain tumors (replicating an earlier study) and the apparent synergism between no vitamins and meat consumption suggest a possible adverse effect of dietary nitrites and nitrosamines.(20)
Peters, et al. studied the relationship between the intake of certain foods and the risk of leukemia in children from birth to age 10 in Los Angeles County between 1980 and 1987. The researchers found that children who ate 12 or more hot dogs per month had approximately nine times the normal risk for developing childhood leukemia. A strong risk for childhood leukemia also existed for those children whose fathers' intake of hot dogs was 12 or more per month. (21) Peters, et al. concluded:
"Our results provide evidence for an association between consumption of hot dogs and risk of childhood leukemia. Adjustments for all factors thought to be potential confounders did not affect these associations. Independent risks were associated with both children's and fathers' consumption...The findings, if correct, suggest that reduced consumption of hot dogs could reduce leukemia risks, especially in those consuming the most. (22)
These findings are of particular significance considering a 38 percent increase in the incidence of brain and nervous system cancers in children from 1973-1991. (23) Brain tumors account for about one in five childhood cancers. (24)
C. CLAIM FOR CATEGORICAL EXCLUSION
A claim for categorical exclusion is asserted pursuant to 21 CFR 25.24 (a) (11).
The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petitioner which are unfavorable to the petition.
This petition is submitted by:
Samuel S. Epstein, M.D.
Michael Deutsch, Esq. Legal Director, Center for Constitutional Rights, N.Y.
1. Lijinsky, W., Epstein, S., "Nitrosamines as environmental carcinogens,"Nature" 225(5227):21-12, 1970.
2. Anonymous. "Nitrates and nitrites in food, "Medical Letter on Drugs & Therapeutics. 16(18):75-6, 1974
3. Issenberg, P. "Nitrite, nitrosamines, and cancer, "Federation Proceedings, 35(6):1322-1326, 1976.
4. IARC, "Monograph on the evaluation of the carcinogenic risk of chemicals to humans: some N-nitroso compounds," 17:36-38, 136-144, 1978.
6. Issenberg, P., "Nitrite, nitrosamines, and cancer," Federation Proceedings 35 (6):1322-1326, 1976.
7. IARC, "Monograph on the evaluation of the carcinogenic risk of chemicals to humans: some N-nitroso compounds."
8. Fraser, P. "Nitrate and human cancer: A review of the evidence." Int. J. Epidemiol, 9:3-11, 1980.
9. Reed, P. I. "The role of nitrosamines in cancer formation." Biblthca. Ntur. Dieta. 37:130-8, 1986.
10. Craddock, V.M. "Nitrosamines, food and cancer: assessment in Lyon," Fd. Chem. Toxic., 28(1):63-65, 1990.
11. Preston-Martin, S. et al. "N-nitroso compounds and childhood brain tumors: A case-control study." Cancer Res. 1982; 42:5240-5.
12. Bunin, G.R., et al. "Relation between maternal diet and subsequent primitive neuroectodermal brain tumors in young children." N. Eng. J. Med., 3 29-536-41, 1993.
13. Bunin, G.R., et al. "Maternal diet and risk of astrocytic glioma in children: a report form the children's cancer group (United States and Canada)," Cancer Causes & Control. 5:177-87, 1994.
14. Preston-Martin, S., et al. "N-nitroso compounds and childhood brain tumors: A case- control study."
15. Bunin, G.R., et al. "Maternal diet and risk of astrocytic glioma in children."
16. Sarasua, S., Savitz, D. "Cured and broiled meat consumption in relation to childhood cancer: Denver, Colorado (United States)," Cancer Causes & Control, 5:141-8, 1994.
17. Peters, J., et al. "Processed meats and risk of childhood leukemia (California, USA)" Cancer Causes & Control 5:195-202, 1994.
18. Bunin, G.R., et al. "Maternal diet and risk of astrocytic glioma in children."
19. Sarasua, S., Savitz, D. "Cured and broiled meat consumption in relation to childhood cancer."
21. Peters, J., Preston-Martin, S., London S., et al. "Processed meats and risk of childhood leukemia (California, USA)"
23. Reis, L. et al., "Maternal diet and risk of astrocytic glioma in children," 177-87.
FDA Response (as of 2/16/99)