Following extensive debate about the long-term impact of food additives on public health, the Delaney Amendment to the Food, Drug, and Cosmetic Act, passed by Congress, required safety clearance for food additives.
The use of chemical additives in food products as flavoring, as preservatives, or as part of packaging grew rapidly during the 1940’s. The long-term impact of these chemicals on public health, however, remained largely unknown. This period also witnessed a substantial increase in the agricultural use of commercial pesticides such as dichloro-diphenyl-trichloroethane (DDT); again, it was unclear whether the pesticides used in production of raw agricultural goods caused any harm.
Given the enormous public health implications of these issues, the U.S. House of Representatives formed a select committee to investigate the use of chemicals in foods in June, 1950. Until March, 1952, this committee (also known as the Delaney Committee
Chemical food additives can perform a wide variety of functions. Depending on the specific food product considered, additives serve to increase the acidity or alkalinity levels, preserve or age, increase or decrease water retention characteristics, enhance color or flavor appeal, and prevent spattering of cooking fats. Preservatives have been used widely to avoid or minimize the growth of microbes in foods over time. Antimycotic agents such as acetic acid and calcium propionate are employed to fight the growth of mold and other bacteria in bread; similarly, benzoic acid inhibits bacterial growth in pickles and fruit juices. Sulfur dioxide is a popular preservative for dried fruits. Antioxidants are often used in lard, crackers, and soup bases.
Another class of additives, called sequestrants, is used to retain the color, flavor, or texture of many products. Emulsifiers (such as lecithin, monoglycerides, diglycerides, and dioctyl sodium sulfosucinate) are added to food products to improve their texture or other physical characteristics: for example, enhancing the whipping attribute in frozen desserts or facilitating the dissolution of hot chocolate in cold milk. Other chemicals known as stabilizers, thickeners, buffers, and neutralizers are added to food products for a variety of purposes.
The Food, Drug, and Cosmetic Act
The Delaney Amendment of 1958 corrected this flaw by mandating premarket clearance of chemical additives that were not “generally recognized as safe” (GRAS). That is, if qualified scientists and experts believed that a given substance could be added safely to food products, the substance could be classified under the GRAS category and thereby exempted from the premarket clearance requirement. The inclusion of a new food additive under GRAS could be justified on the basis of scientific data; for food additives already in use before January 1, 1958, such justification could stem from prior safe-use experience in food products.
The Delaney Amendment, or clause, mandated the submission to the FDA of certain details concerning any new food additive—the formula depicting its chemical composition, a description of proposed usage characteristics, the procedure used for its manufacture, and the manner in which its presence in food products could be detected accurately at the expected levels of use. In addition, the prospective user of the new additive was required to furnish evidence that the additive accomplished the intended effects on food and that the degree of additive usage was not higher than necessary to achieve these effects.
More important, the user had to provide data documenting the safety of the proposed food additive. This evidence took the form of studies in which varying amounts of the additive were included in the intakes of at least two species of animals. Finally, even if the FDA approved the usage of a newly proposed food additive, it could limit the additive’s usage by specifying tolerances, which are commonly determined through animal feeding tests. These tests of an additive may show, for example, that a 1 percent residue of the chemical has no adverse effect. A pharmacologist in charge then may arbitrarily divide by one hundred and say that .01 percent is safe for humans. Tolerances rest on the tenuous assumption that small doses of poisonous chemicals are harmless even if ingested over a long period of time; therefore, it is possible that tolerances lend acceptability to additives that are inherently dangerous to public health.
During the congressional hearings on the Delaney Amendment, two issues caused significant debate. The first controversy centered on the Delaney anticancer clause, which declared that no food additive could be considered safe if it was found to induce cancer in humans or animals. This clause was opposed by several experts and even by the FDA, on the grounds that it was not in line with scientific judgment. For example, several individuals called into question the wisdom of banning the limited human consumption of food additives merely because they induced cancer in some animals. Others thought that it was inappropriate to focus on a specific disease (cancer) while establishing legislative standards. These objectives notwithstanding, the Delaney anticancer clause was incorporated into the 1958 amendment as signed into law.
The second issue involved sustained lobbying efforts by the food and chemical industries for the inclusion of a grandfather clause, a provision specifically exempting all chemical additives in use at that time from the mandatory testing requirement. Delaney strongly objected to this plea because the grandfather clause would render almost 150 chemical additives automatically acceptable without any rigorous scientific evidence on their safety. Although industry representatives argued that the food additives in use qualified for exemption because of their past record of safety during prolonged use, it was unclear what constituted an acceptable definition of prolonged use for each additive.
Some chemical food additives may require as long as twenty years before their cumulative health impact can be assessed. Furthermore, several chemical additives had been declared as unsafe only after they were used in food products for several years. For example, Anton Julius Carson, a medical expert from the University of Chicago, had testified before the Delaney Committee about the harmful effects of hydrofluoric acid and mineral oil, food additives that had been added routinely to beer and popcorn, respectively, for several years. Delaney also questioned the value of mandating public protection against new food additives through elaborate testing when “old” additives that were untested for safety were permitted in food products consumed by the public.
The grandfather clause was not incorporated into the 1958 amendment despite sustained efforts from the food and chemical industries. These industries, however, won other notable concessions. First, through a series of legislative measures, Congress gave the industry substantial time (until December, 1965) to finish safety evaluations of specific chemicals already in use. Second, the amendment did not incorporate the FDA viewpoint that chemical food additives should not only be harmless to humans but also must possess some functional value; the motivation was to discourage the use of additives that, while not considered unsafe, did not serve any useful purpose to consumers.
Both Delaney and George P. Larrick, the FDA commissioner, vehemently argued for the functional value provision. Larrick defined functional value as stemming from any characteristic of the food additive that directly benefited consumers by enhancing convenience or indirectly benefited consumers during the process of product distribution. Further, he provided several examples in which chemical additives had been added to food products only because it was profitable or convenient for the industry to do so, and not because they served any consumer interest. His list included the following:
using boric acid to preserve codfish and whole eggs in an attempt to conceal poor manufacturing or storage practices
relying on fluorine chemicals in alcoholic beverages such as wine and beer to curb fermentation, a result better accomplished through pasteurization
including monochloracetic acid in carbonated beverages as a substitute for proper sanitation practices
adding salicylates in shrimp sauce to inhibit decomposition processes triggered by poor manufacturing or holding practices.
Larrick argued in vain that the safe but unnecessary use of chemical additives should not be a prerogative of the food industry.
The 1958 amendment played a major role in promoting long-term public health primarily because of two features. First, it extended the premarket clearance requirement to food additives, and second, it prohibited the addition to foods of any chemicals shown to be animal carcinogens
To appreciate the impact of the Food Additives Amendment, it is useful to study its interpretation and enforcement over the years. The anticancer clause applies to both direct and indirect food additives. The latter comprise chemicals that migrate into food from food packaging material. In addition, more than one hundred drugs used in food-producing animals are subject to the clause.
Three important practical issues arise from the clause. First, although it appears to categorically prohibit the addition of carcinogenic chemicals to foods, there appears to be considerable leeway in deciding whether a substance is carcinogenic. As one example, there was an intense debate as to whether saccharin is carcinogenic. Other fairly common additives are the subject of the same question. Second, a proviso in the clause specifically exempts carcinogenic food and animal drugs added to the feed of food-producing animals. That is, if chemical additives in animal feed do not harm the animal and do not leave any residue on the edible parts of the animal (intended for human consumption), such additives are exempt from the scope of the clause. Finally, no chemical food additive is strictly free from all carcinogens. Certain carcinogens, such as lead and halogenated compounds, contaminate all chemicals, including food additives, at minute levels.
Moreover, subsequent to the 1958 amendment, it has become technologically feasible to analyze chemical substances at extremely low trace levels, measurable in parts per million or parts per billion. For these reasons, the FDA developed a constituent policy in March, 1982, that states that a food additive can include carcinogens as long as the degree of risk associated with the extent of the carcinogenic presence is acceptably low. This is in keeping with the spirit of the 1958 amendment, although it is a reversal of the letter of the Delaney clause. In defining what constitutes an acceptably low standard, the FDA has used an upper limit of one case of cancer following the exposure of a million people to a food additive.
In the early 1980’s, several bills introduced in Congress contained language that would have revised the food safety legislation that had prevailed for several decades. These bills called for revisions of the Delaney clause to avoid the ban of a carcinogenic additive if scientific evidence suggests that the human risks involved under intended conditions of use are negligible. None of the bills passed.
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Flamm, W. G. “Food-Borne Carcinogens.” In Chemical Safety Regulation and Compliance, edited by Freddy Homburger and Judith K. Marquis. Basel, Switzerland: S. Karger, 1985. Discusses this class of carcinogens. -
Kleinfeld, Vincent A., and Alan H. Kaplan. Federal Food, Drug, and Cosmetic Act: Judicial and Administrative Record 1961-1964. Chicago: Commerce Clearing House, 1965. Part of the Food Law Institute series. A useful source on laws related to food and drugs. Contains the text of the Food, Drug, and Cosmetic Act and its amendments as well as the details of legislative and judicial activities initiated in connection with the act between 1961 and 1964. -
Kokoski, C. J. “Regulatory Food Additive Toxicology.” In Chemical Safety Regulation and Compliance, edited by Freddy Homburger and Judith K. Marquis. Basel, Switzerland: S. Karger, 1985. Discusses testing methods for food additives. -
Mooney, Booth. The Hidden Assassins. Chicago: Follett, 1966. Provides an informative overview of the hearings conducted by the Delaney Committee and describes how these hearings led to the 1958 Food Additives (Delaney) Amendment. -
Rados, Carol. “GRAS: Time-Tested, and Trusted, Food Ingredients.” FDA Consumer 38, no. 2 (2004): 20-21. A brief look at the FDA’s “generally recognized as safe” category established under the 1958 act. Defines GRAS substances and discusses why substances are added to foods. -
Shan, Yaso. “Going Organic: Is It Nutritionally Better?” Primary Health Care 16, no. 3 (2006): 37-40. Article from a health-practice journal that considers whether organic foods, that is, foods grown without additives, are indeed better than nonorganic foods nutritionally. -
Skinner, K. “Scientific Change and the Evolution of Regulation.” In Chemical Safety Regulation and Compliance, edited by Freddy Homburger and Judith K. Marquis. Basel, Switzerland: S. Karger, 1985. Describes how advances in science have affected regulation and testing. -
U.S. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment. A Brief Legislative History of the Food, Drug, and Cosmetic Act. Washington, D.C.: Government Printing Office, 1974. A comprehensive account of the historical circumstances that led to the Food, Drug, and Cosmetic Act of 1938. Also discusses the circumstances surrounding the formation of the Delaney Committee and how this committee’s findings eventually led to the 1958 amendment. Several other amendments to the act are also discussed.
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