Citizen Petition Seeking Labeling of Nitrate Preserved Hot Dogs for Childhood Cancer Risks

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Citizen Petition Seeking Labeling of Nitrate-Preserved Hot Dogs for Childhood

Cancer Risk

 

April 25, 1995

 

David A. Kessler, M.D.

Commissioner, Food and Drug Administration, Room 1-23

12420 Parklawn Drive

Rockville, MD 20857

 

http://www.preventcancer.com/press/petitions/april25_95.htm

 

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:

 

Immediately require nitrite-containing hot dogs to be labelled with warnings

such as hot dogs containing nitrites have been shown to pose risks of childhood

cancer. 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 consumption 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).

 

D. CERTIFICATION

 

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.

 

REFERENCES

 

 

Lijinsky, W., Epstein, S., " Nitrosamines as environmental

carcinogens, " Nature " 225(5227):21-12, 1970.

Anonymous. " Nitrates and nitrites in food, " Medical Letter on Drugs &

Therapeutics. 16(18):75-6, 1974

Issenberg, P. " Nitrite, nitrosamines, and cancer, " Federation Proceedings,

35(6):1322-1326, 1976.

IARC, " Monograph on the evaluation of the carcinogenic risk of chemicals to

humans: some N-nitroso compounds, " 17:36-38, 136-144, 1978.

Ibid.

Issenberg, P., " Nitrite, nitrosamines, and cancer, " Federation Proceedings 35

(6):1322-1326, 1976.

IARC, " Monograph on the evaluation of the carcinogenic risk of chemicals to

humans: some N-nitroso compounds. "

Fraser, P. " Nitrate and human cancer: A review of the evidence. " Int. J.

Epidemiol, 9:3-11, 1980.

Reed, P. I. " The role of nitrosamines in cancer formation. " Biblthca. Ntur.

Dieta. 37:130-8, 1986.

Craddock, V.M. " Nitrosamines, food and cancer: assessment in Lyon, " Fd. Chem.

Toxic., 28(1):63-65, 1990.

Preston-Martin, S. et al. " N-nitroso compounds and childhood brain tumors: A

case-control study. " Cancer Res. 1982; 42:5240-5.

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.

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.

Preston-Martin, S., et al. " N-nitroso compounds and childhood brain tumors: A

case- control study. "

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.

Peters, J., et al. " Processed meats and risk of childhood leukemia

(California, USA) " Cancer Causes & Control 5:195-202, 1994.

Bunin, G.R., et al. " Maternal diet and risk of astrocytic glioma in

children. "

Sarasua, S., Savitz, D. " Cured and broiled meat consumption in relation to

childhood cancer. "

Ibid.

Peters, J., Preston-Martin, S., London S., et al. " Processed meats and risk

of childhood leukemia (California, USA) "

Ibid.

Reis, L. et al., " Maternal diet and risk of astrocytic glioma in children, "

177-87.

 

 

 

FDA Response (as of 2/16/99)

 

None.

 

 

 

 

 

 

 

 

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