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National Research Council (US) Committee on Diet, Nutrition, and Cancer. Diet, Nutrition, and Cancer. Washington (DC): National Academies Press (US); 1982.

Cover of Diet, Nutrition, and Cancer

Diet, Nutrition, and Cancer.

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THE DELANEY CLAUSE AND OTHER REGULATORY ACTIONS

The regulation of carcinogens has been a matter of special concern because it is covered by the Delaney Clause 1 of the Federal Food, Drug, and Cosmetic Act. The amendment prohibits the FDA from approving the use of any food additive found to cause cancer in animals or humans. It has been criticized as being too restrictive by setting a zero level of risk. In fact, it applies only to approximately 400 of the 2,700 substances intentionally added to foods, many of which are GRAS. If any GRAS substance is found to be carcinogenic, it would no longer be considered GRAS and would fall under the legal definition of a food additive, thereby becoming subject to the Delaney Clause.

In addition to the Delaney Clause, numerous amendments to the Federal Food, Drug, and Cosmetic Act have been made since the early 1960's (U.S. Department of Health and Human Services, 1980). It appears that the statutory provisions governing food safety are a patchwork of divergent, sometimes carefully considered, but sometimes offhand, legislative policies that invite uneven monitoring of different substances in foods and inconsistent treatment of comparable risks from different categories of food additives.

Recognizing the need to acquire better data and to standardize testing procedures and the criteria for acceptability, the FDA has recently initiated a review of direct food additives (U.S. Department of Health and Human Services, 1981). Similarly, the FAO/WHO Joint Expert Committee on Food Additives acknowledged that the safety of a large number of food additives remains to be examined or needs to be reevaluated (World Health Organization, 1980).

Many factors complicate the assessment of nonnutritive dietary constituents.

  • Some food constituents are discrete chemical entities that are easy to test, whereas others are complex, poorly defined mixtures of natural origin.
  • Although the Federal Food, Drug, and Cosmetic Act defines various categories of food ingredients, it is frequently difficult to determine how to classify certain substances that meet the definitions of more than one category (Code of Federal Regulations, 1981). Information about contaminants is even less precise.
  • Although most additives and the known contaminants are present in minute quantities in the diet, little is known about the chronic effects of low levels of chemicals on human health, and even less is known about the potential for synergistic and/or antagonistic interactions among most of these substances in foods or in the body.
TABLE B-1. The Federal Food, Drug, and Cosmetic Act : Categories of Food Constituents.

TABLE B-1

The Federal Food, Drug, and Cosmetic Act : Categories of Food Constituents.

Footnotes

1

Sec. 409(c)(1)(A)

Copyright © National Academy of Sciences.
Bookshelf ID: NBK216642

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