HEALTH NEWS and VIEWS
by
Theron G. Randolph, MD

Now is the Time to Demand a New Food and Drug Law, Before the Next Scandal

"The time has come," the buyer said
"To talk of many things;
Of foods – and drugs – and cosmetics –
Of chemicals – and kings – . . ."

(Apologies to "Lewis Carroll"
From the Walrus and the Carpenter).

The US Congress passed the first Food, Drug and Cosmetic Act in 1906 to prevent adulterated, misbranded, poisonous or deleterious foods, drugs and liquors from entering interstate commerce.

It is significant that this event occurred early in the course of the transfer of food processing from a home to a commercial industry. Since one of the first food operations to be taken over commercially was the slaughtering of animals and the processing of meats, it was not surprising that abuses in the meat packing industry led to this law. More specifically, the unnecessary use of chemical preservatives in meats as revealed by the observations of Harvey W. Wiley and his "Poison Squad" and Upton Sinclair’s expose of other unsavory practices in "Packingtown" described in his book, The Jungle, galvanized public support for this legislation. It is also noteworthy that this event took place only seven years after the development of aspirin, the first drug to be synthesized from coal-tar sources. Needless to say, cosmetics were not in wide use at this time. With amendments from time to time, this Act served for a generation.


. . . there was little prospect of Congressional action . . . until the product, Elixir of Sulfanilamide caused 100 deaths. The new 1938 Food, Drug and Cosmetic Act was passed promptly.


The need for further protective legislation – first appreciated as a part of the social changes of the depression years – prompted President Franklin D. Roosevelt in 1933 to authorize a revision of the Food and Drug Act. However, there was little prospect of Congressional action after five years of study, hearings, and discussion until the product, Elixir of Sulfanilamide caused 100 deaths. The new 1938 Food, Drug and Cosmetic Act was passed promptly. The concept of established safety before marketing, demanded by the new Act, was slow to be applied.

A span of 48 years has now elapsed since the enactment of the 1938 Food, Drug and Cosmetic Act under which we are still operating. Due to the increased tempo of change occurring since this time, the present law is even more archaic than was the 1906 law when superseded by the 1938 Act.

The home production of meals from primary food sources – the rule in 1906 and still a common practice in 1938 – has all but ceased to exist in 1986. Attractively packaged and merchandized food mixtures, many pre-cooked and ready to eat except for warming, now dominate the food market. Ultimates in this direction are TV dinners and the fact that the kitchens of some hospitals and other institutions where meals are served have degenerated into "warming up stations" for the offerings of commercial caterers. Should the eater in such an establishment desire to know the ingredients of the conglomeration set in front of him, he does not even have the chance to see the label on the "mix" from which the meal was prepared.

A woman unadorned by numerous cosmetics is something of a freak in 1986. Men are not far behind. Natural body odors have long since yielded to perfumes and deodorants, the natural body appearance has been further transformed since 1938 by hair sprays and eye make-up. All of these practices have been accompanied by serious medical complications.


. . . kitchens of some hospitals and other institutions where meals are served have degenerated into "warming up stations" for the offerings of commercial caterers. Should the eater in such an establishment desire to know the ingredients of the conglomeration set in front of him, he does not even have the chance to see the label on the "mix" from which the meal was prepared.


Since the present Food, Drug and Cosmetic Act was enacted in 1938, the specialty of allergy has become more important and the broader subject of clinical ecology has developed. In view of the findings in the latter field, it is unfortunate that chemists rather than biologists have dominated the commercial production of foods, drugs, cosmetics, pesticides, and other materials meeting human needs. As a result of the ability of chemists to analyze substances into basic units and to synthesize new materials from them, we find ourselves, belatedly, saddled with a chemically contaminated intake and surroundings to which an apparently increasing sector of the population has become susceptible, and from which many persons are being made chronically or acutely ill. This rapidly developing chemicalization of man’s intake of foods, beverages, drugs, and water supplies as well as such topical and/or inhaled materials as cosmetics, clothing, household furnishings, cleaning agents, janitorial supplies, etc., occurring since the turn of the century, caught almost everyone off guard. The medical profession and governmental regulatory agencies were caught especially short.

It was not by chance that physicians dealing with highly susceptible persons were the first to recognize the over-all hazards of man’s relatively new chemical environment, inasmuch as individual susceptibility greatly enhances the impact of dosage. Despite the occurrence of reactions to synthetically derived drugs and various other man-made chemical exposures, the totality of the impact of the chemical environment on the health and behavior of individuals has only been appreciated in recent years. Once susceptibility has become established to one facet of this chemical environment, the ease with which cross-reactions occur to materials of common genesis has also not been well understood. And in view of the speed with which chemicalization of the environment is occurring, chronic illnesses presented by today’s chemically susceptible persons are to be regarded as mere curtain-raisers for tomorrow’s far more generalized and endemic environmentally related health problems.


This rapidly developing chemicalization of man’s intake of foods, beverages, drugs, and water supplies as well as such topical and/or inhaled materials as cosmetics, clothing, household furnishings, cleaning agents, janitorial supplies, etc., occurring since the turn of the century . . . [caught us off guard, and] . . . in view of the speed with which chemicalization of the environment is occurring, chronic illnesses presented by today’s chemically susceptible persons are to be regarded as mere curtain-raisers for tomorrow’s far more generalized and endemic environmentally related health problems.


The more rapid the absorption of materials through the gastrointestinal tract, respiratory system, or skin, the more potentially dangerous various substances may be to specifically susceptible persons. This holds both for materials of chemical and biological origin. As far as ingested substances are concerned, alcoholic beverages and sugars are especially hazardous, yet the presence of these materials are regulated least well by the present Food, Drug and Cosmetic Act. Responsibility for labeling alcoholic beverages has been abdicated by the FDA and taken over, ironically, by the Bureau of Internal Revenue of the US Treasury. The Food and Drug Administration is content to label specific sugars (sucrose of beet or cane origin) merely as sugars, despite testimony submitted to the FDA as to the hazards to consumers of such a practice. Even though an educated and informed consumer is familiar with the Law and a particular Standard, he often does not know whether a given permitted ingredient has or has not been used in the manufacture of a standardized product.

The 1938 Food, Drug and Cosmetic Act is outmoded because it no longer provides adequate protection of the consumer under present conditions, despite its amendments. For instance, persistent hydrocarbon pesticides of the DDT series were first used extensively after the Second World War. Yet the Food Additives Amendment of 1958 states that the term "food additive," does not include a pesticide chemical used in or on a raw agricultural commodity, although the Miller Amendment of 1954 established a procedure for setting up safe limits or "tolerances" for residues of pesticides which may remain on fresh fruits or vegetables when shipped. In a brochure supposedly designed to assuage consumers’ fears, the FDA makes the additional statement: "And of course pesticide chemicals used on growing crops do not have to be declared."


The 1938 Food, Drug and Cosmetic Act is outmoded because it no longer provides adequate protection of the consumer under present conditions. . . [Despite heavy DDT use since WW II] . . . the Food Additives Amendment of 1958 states that the term "food additive," does not include a pesticide chemical used in or on a raw agricultural commodity, although the Miller Amendment of 1954 established a procedure for setting up safe limits or "tolerances" for residues of pesticides which may remain on fresh fruits or vegetables when shipped.


We need a new law with specific and mandatory labeling of all food ingredients entering the production of all processed food and beverages. More specifically:

    1. The innovation of Standards of Identity in the 1938 Act should be abandoned or modified so as to indicate to the consumer of a processed food at hand all he is about to consume before he consumes it.
    2. Although the labeling of specific sugars would be desirable, this has become virtually impossible because of the practice of adding liquid sugars consisting of multiple sugars to most food processing lines.
    3. The FDA should reassert its supervision of the regulation of alcoholic beverages, indicating on the label the identity of all foods entering their manufacture.
    4. The whole area of chemicalization of the food supply, including additives, as now defined, as well as the pesticides and other additives and contaminants in the broader sense should be reevaluated and more carefully regulated. To do this, a new philosophy of labeling and consumer protection would seem to be in order.

 


. . . in the German Food Law of 1959. Non-nutritive additions are not allowed unless expressly permitted in the official regulations. The precise food additives used must be stated. This full disclosure of chemicals on the label has simplified the work of public analysts and has made law enforcement easier.


The best example of such a truly protective philosophy appeared in the German Food Law of 1959. Non-nutritive additions are not allowed unless expressly permitted in the official regulations. The precise food additives used must be stated. This full disclosure of chemicals on the label has simplified the work of public analysts and has made law enforcement easier. Also, any restaurant that uses colorings, flavorings, or other additives must give notice to that effect and also explain specifically by code number what the additives are and in which items on their menu. The health effects of the law have been greater than even the most radical reformers had dared to hope. Because of public pressure against chemical additives, many caterers now select plain foods as their ingredients. In this way they avoid the trouble of declaring chemical additives and the public gets much healthier natural foods.


The health effects of the law have been greater than even the most radical reformers had dared to hope. Because of public pressure against chemical additives, many caterers now select plain foods as their ingredients. In this way they avoid the trouble of declaring chemical additives and the public gets much healthier natural foods.


It is of interest to report briefly how this new law came about. As described by Mr. Fliess in the article cited below, the demand for a new law was initiated by a "Nitrit Skandal" and other published instances of food adulteration and food poisoning. Shortly before a general election, consumer organizations and women’s organizations, supported by a sector of the press, joined forces under the slogan "The Truth on the Label." None of the political parties dared openly to defy this mass of public opinion and the new law was enacted.

The time has come for a similar revamping of food and drug laws in America.

_________________

REFERENCES:

  1. Randolph, T. G., Human Ecology and Susceptibility to the Chemical Environment, Springfield, Illinois, Thomas, 1962.
  2. Randolph, T. G., Human Susceptibility to Pesticide Exposures. Interagency Coordination in Environmental Hazards (Pesticides); Hearings, Subcommittee on Reorganization and International Organizations of the Committee on Government Operations, US Senate, 88th Congress, Part II, July, 1963.
  3. Randolph, T. G. and Yeager, L. B., "Corn Sugar as Allergen," Ann Allergy, Vol. 7, pp. 651-661, Sept. – Oct., 1949.
  4. Randolph, T. G. and Rollins, J. P., "Allergic Reactions from Ingestion or Intravenous Injections of Cane Sugar (Sucrose)," J. Lab & Clin. Med., Vol. 36, pp. 242-248, Aug., 1950.
  5. Randolph, T. G., Rollins, J. P., and Walter, C. K., "Allergic Reactions Following Intravenous Injection of Corn Sugar (Dextrose)," Arch. Surg., Vol. 61, pp. 554-564, Sept., 1950.
  6. Randolph, T. G., "Descriptive Features of Food Addiction, Addictive Eating and Drinking," Quart. J. Stud. Alcohol, Vol. 17, pp. 198-224, June, 1956.
  7. Randolph, T. G., "Clinical Ecology as It Affects the Psychiatric Patient," Internat. J. Soc. Psychiatry, Vol. 12, pp. 245-254, Autumn, 1966.
  8. Rinkel, H. J., Randolph, T. G., and Zeller, M., Food Allergy, Appendix, The Food, Drug and Cosmetic Act. Springfield, Illinois, Thomas, 1951, pp. 382-478.
  9. Randolph, T. G., "Unlabeled Allergenic Constituents of Commercial Foods and Drugs; Critique of Food, Drug and Cosmetic Act," Ann Allergy, Vol. 9, pp. 151-163, March - April, 1951.
  10. Randolph, T. G., Ingredients of Bread. Testimony in the Matter of a Definition and Standard of Identity for Bread and Related Products, Docket No. FDC-31(b), Before the Administrator, Federal Security Agency, Aug. 3, 1949, pp. 14,596-14,628.
  11. Randolph, T. G., Ingredients of Peanut Butter. Testimony in the Matter of a Definition and Standard of Identity for Peanut Butter, Docket No. FDC-76, Before the Administrator, Federal Security Agency, Feb. 17-18, 1966, pp. 6511-6727.
  12. Filess, Walter, "The German Food Laws, Healthy Effects of Requiring 'The Truth on the Label,'" Mother Earth, Journal of the Soll Association, October, 1962.

Article from NOHA NEWS, Vol. XI, No. 3, Summer 1986, pages 1-4.