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Statement for the Record by the Food and Drug Administration on Section 4 (Betel Nuts) of H.R. 2462 the Guam Omnibus Opportunities Act
Food and Drug Administration
U.S. Department of Health and Human Services

Before the House Committee on Resources
April 13, 2000

Mr. Chairman:

The Food and Drug Administration (FDA) appreciates the opportunity to present its views on H.R. 2462 the Guam Omnibus Opportunities Act, and specifically section 4, Betel Nuts. Section 4 would amend the Federal Food, Drug, and Cosmetic (FD&C;) Act to exempt betel nuts from being considered adulterated under sections 402 and 801 of the FD&C; Act if possessed by an individual for personal consumption by the individual.

The adulteration provisions of the FD&C; Act are intended to protect consumers from unsafe foods and food additives. Under current law, it is a violation to introduce unsafe food into interstate commerce. The act of importation is considered an introduction into commerce, whether or not the food is intended for the marketplace or for personal use. Exempting an unsafe food like betel nuts from these provisions undermines the important public health purpose of the FD&C; Act.

Betel nuts and betel leaves contain arecoline, an alkaloid that has been demonstrated to cause cancer in animals, and for which epidemiological evidence of human carcinogenicity exists in those who habitually consume betel nuts. Similarly, epidemiological surveys have revealed a close relationship between carcinoma of the upper gastrointestinal tract and the habit of chewing betel "Quid," which is a combination of betel leaves, betel nuts, and lime.

In light of the toxicological evidence demonstrating the risk of betel nuts and leaves, FDA must oppose section 4 of H.R. 2462.