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U.S. Department of Health and Human Services
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FDA Consumer
June 1981

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The Story Of The Laws Behind The Labels

Part I
1906 Food and Drugs Act

Staff of the Division of Chemistry
Dr. Wiley and the Division of Chemistry Staff in 1883

Table of Contents

  1. 1906 Food and Drugs Act
  2. 1938 Federal, Food, Drug, and Cosmetic Act
  3. 1962 Drug Amendments

The history of the Food and Drug Administration is also the history of consumer protection as applied to food, drugs, cosmetics, and other products now regulated by the Agency. That history began long before the initials f, d, and a became household words, as this article points out. Wallace F. Janssen began writing about FDA as a trade journal editor in 1931. He joined the Agency in 1951 as assistant to the commissioner for public information and continued to be its information chief until 1966. He now serves as FDA's historian.

By Wallace F. Janssen
FDA Historian

How old is the FDA?

There are two answers to this frequent question: as a law enforcement organization its 75th anniversary year is 1981, but as a scientific institution it dates from 1862 when Charles M. Wetherill, first chemist of the new Department of Agriculture, set up a laboratory and began at once to analyze samples of food, soils, fertilizers, and other agricultural substances. The first reported project -- a chemical study of grape juice for winemaking -- dealt with, among other topics, the question whether adding sugar to increase the alcohol content would constitute "adulteration." It was concluded that the practice was legitimate. (Forty-six years later the first Notice of Judgment under the new 1906 Food and Drugs Act reported a court ruling to the contrary. Cider made harder by adding sugar was found adulterated.)

Being engaged primarily in agricultural research and development, the early FDA scientists inevitably became involved in matters of food safety. The 1862 report referred also to problems of food preservation and uses of chemical preservatives. The report of 1873 contains analysis of cereals, wine, and opium. In 1874 the adulteration of milk with water and chemicals was discussed, along with experiments on the effects of arsenic and copper pesticides on plants and the possibility of harm to humans.

Federal concern for drugs started with the establishment of U.S. customs laboratories to administer the Import Drugs Act of 1848. The United States had become the world's dumping ground for counterfeit, contaminated, diluted, and decomposed drug materials -- a dangerous situation. American troops in Mexico had suffered from spurious medication for malaria. Pharmacists and the new American Medical Association joined forces to secure the legislation. The mission of the new Customs laboratories was to enforce the purity and potency standards of the U.S. Pharmacopeia, established by trade and professional leaders in 1820. But support dwindled and the program gradually faded away. No organizational connection has been found with the agency now known as the FDA.

The United States was very slow to recognize the need for a national food and drug law. Frederick Accum's "Treatise on Adulterations of Food and Methods of Detecting Them" had been published in London and Philadelphia in 1820, and Great Britain's first national food law was passed in 1860. In the United States a variety of State laws dated from colonial times. Enacted mainly to serve the needs of trade, these laws set standards of weight and measure, and provided for inspections of exports like salt meats, fish and flour, to promote foreign sales. But there were also local bread inspection laws to insure consumer protection as well as fair competition between bakers.

After the War of Independence the States continued to pass laws that varied greatly, reflecting their special interests. Not until interstate commerce began its great expansion after the Civil War did the need for federal rulemaking become widely realized. The Pure Food Movement -- a grass roots phenomenon that germinated in the 1870's -- was the original and principal source of political support for the Food and Drugs Act of 1906. It was originally a trade movement. Long before Upton Sinclair's THE JUNGLE exposed insanitation in the Chicago stockyards; even before Harvey Wiley's arrival in Washington to head the Division of Chemistry, food industry members had begun to advocate a Federal law against adulteration. Trade interest arose from two causes: first, competition from a new breed of food products -- glucose as a replacement of sugar, "lard" made from cottonseed oil, and oleomargarine, a threat to butter; and second, intolerable variations in the laws of the states. "As it is now," to quote one food packer, "we have to manufacture differently for every state."

In 1879 Peter Collier, the fifth head of the Division of Chemistry, urged Federal legislation to make food adulteration a crime.

Dr. Wiley Comes to Washington

Staff of the Division of Chemistry Is This A Time For Sleep?
Staff of the Division of Chemistry shortly after Dr. Harvey Wiley took command in 1883. Wiley, third from right, was 37.

1883 was also the year when Robert Koch discovered the germ of cholera and that it was transmitted by water and food. Koch's vaccine could not be obtained quickly enough. "Science," relied on for protection, was rebuked for inaction in this cartoon from LIFE magazine titled: "Is This A Time For Sleep?"

Department of Agriculture building When Harvey W. Wiley came to Washington to head the Division of Chemistry, its laboratories were in the basement of the 1867 Department of Agriculture building on the Mall where the white marble USDA Administration Building now stands [photo on left]. Located here from 1869, "the chemist" had previously been housed at various locations, beginning in 1862 in the Patent Office building, now the National Portrait Gallery.
A laboratory fire, during a visit by Secretary of Agriculture Norman J Coleman, prompted him to arrange separate quarters for his chemists in an old house across the street from USDA headquarters [photo on right]. Here at 14th and B Street (now Independence Avenue) the Division of Chemistry remained from 1890 to 1898. Division of Chemistry facility from 1890 to 1898
Leased headquarters of the Bureau of Chemistry from 1899 to 1910, located at 1366 B Street, S. W. (now Independence Avenue). Dr. Wiley may be seen in the doorway, wearing his tall, silk stovepipe hat. [photo on right] Bureau of Chemistry headquarters from 1899 to 1910
bureau of chemistry location from 1910 to 1935 Rented buildings at 212-220 Thirteenth Street, S.W., where the Bureau of Chemistry and its successor, the Food and Drug administration, were located from 1910 to 1935. [photo on left]

In 1883 Dr. Harvey W. Wiley, State chemist of Indiana and professor of chemistry at the new Purdue University, was appointed to succeed Collier.

Conditions in the U.S. food and drug industries a century ago can hardly be imagined today. Use of chemical preservatives and toxic colors was virtually uncontrolled. Changes from an agricultural to an industrial economy had made it necessary to provide the rapidly increasing city population with food from distant areas. But sanitation was primitive in the light of modern standards. Ice was still the principal means of refrigeration. The great pioneers of bacteriology were just starting their string of victories over infectious diseases. Milk was still unpasteurized. Cows were not tested for tuberculosis.

In the same era, thousands of so called "patent" medicines such as "Kick-a-poo Indian Sagwa" and "Warner's Safe Cure for Diabetes" reflected both the limited medical capability of the period and public acceptance of the doctrine that the buyer could and should look out for himself. Medicines containing such drugs as opium, morphine, heroin, and cocaine were sold without restriction. Labeling gave no hint of their presence. Otherwise harmless preparations were labeled for the cure of every disease and symptom. Labels did not list ingredients and warnings against misuse were unheard of. What information the public received came frequently from bitter experience.

The medicine men competed with the circuses, the minstrel shows, and "wild west" performers to entertain the public -- and sell their products. Hamlin's Wizard Oil had one of the most popular and spectacular of the big touring medicine shows. For minor aches and pains, this liniment continued to be sold for many years after the shows had ceased. Hamlin's Wizard Oil
sale of patent medicine
A center spread in COLLIER's for December 1, 1905,
told a pathetic story of the harm done by narcotic
"tonics" sold to trusting women. Labels, generally,
said nothing about the ingredients in the patent curealls.
1906 cartoon about the "Wiley Act" J. F. McPhee's 1906 cartoon reflected the public's expections concerning the "Wiley Act." The new law, it was hoped, would put a stop to food adulteration and quack remedies -- the two major evils and targets of a 20-year crusade for Federal regulation of foods and drugs.
WILEY PAPERS, Library of Congress)

While such practices were by no means universal, and many firms were producing reliable and wholesome products, Dr. Wiley's chemists had no difficulty getting material for their investigations and reports. Wiley took their findings to the public, becoming a popular speaker at women's clubs, civic and business organizations. Crusading writers joined in the campaign. National magazines, such as COLLIER'S WEEKLY, the LADIES HOME JOURNAL, and GOOD HOUSEKEEPING, aroused public opinion with their cartoons, articles, and editorials.

Dr. Wiley's most effective supporters Three of Dr. Wiley's most effective supporters: Mrs. Walter McNab Miller, president of the General Federation of Women's Clubs; Dr. Edward F. Ladd, of North Dakota, a leader among the State food and drug officials; and Miss Alice Lakey, of the National Consumers League. Historians and Dr. Wiley himself credit the club women of the country for turning the tide of public opinion in favor of the "pure food" bill.
cartoon depicting Dr. Wiley's retirement Millions of consumers heard with dismay of Dr. Wiley's retirement from the Federal service. Who would fill his shoes? (A Berryman cartoon from the WASHINGTON STAR, March 15, 1912)

In 1903, Wiley captured the attention of the country by establishing a volunteer "poison squad" of young men who agreed to eat only foods treated with measured amounts of chemical preservatives, with the object of demonstrating whether these ingredients were injurious to health.

"O, they may get over it but they'll never look the same,
That kind of bill of fare would drive most men insane.
Next week he'll give them mothballs, a la Newburgh or else plain;
O, they may get over it but they'll never look the same."

Chorus from "Song of the Poison Squad,"
Lew Dockstader's Minstrels, October 1903

The Dining Room of 'The Posion Squad'

The Dining Room of "The Poison Squad"

In 1902 Dr. Wiley started research with human volunteers to determine the effects of food preservatives on digestion and health. Overnight the press made the "Poison Squad" a national sensation. Even the minstrel shows had songs about the squad -- offically designated the "Hygienic Table." Chemicals fed to the young men included borax; salicylic, sulphurous, and benzoic acids; and formaldehyde. The experiments went on for 5 years. Wiley and the public became convinced that chemical preservatives should be used in food only when necessary; that the burden of proving safety should fall on the producer; and that none should be used without informing the consumer on the label -- basic principles of today's law and regulations.
William R. Carter, hired in 1902 as a cook and waiter for the Poison Squad, earned a degree in pharmaceutical chemistry and served 43 years in the FDA laboratories. (Obituary in the WASHINGTON POST, April 28, 1946) William R. Carter

Strenuous opposition to Wiley's campaign for a Federal food and drug law came from whiskey distillers and the patent medicine firms, who were then the largest advertisers in the country. Many of these men thought they would be put out of business by Federal regulation. In any case, it was argued, the Federal Government had no business policing what people ate, drank, or used for medicine. On the other side were strong agricultural organizations, many food packers, State food and drug officials, and the health professions. But the tide was turned, according to historians and Dr. Wiley himself, when the voteless but militant club women of the country rallied to the pure food cause.

Final action followed a sensational portrayal of insanitary conditions in the Chicago meatpacking industry. A single chapter in Upton Sinclair's novel, THE JUNGLE, precipitated legislation expanding Federal meat regulation to provide continuous inspection of all red meats for interstate distribution, a far more rigorous type of control than that provided by the pure food bill. Both measures became law the same day, June 30, 1906.

fake medical device ads. Promoters of fake medical devices exploited the new wonders of electricity to bilk a trusting and gullible public. By 1906 the mail fraud law was occasionally used against such swindlers, but they otherwise escaped control until 1938.
The "patent medicines" were a constant danger to millions who believed their false promises but had little else to rely on for serious ailments. Typical products claimed to "renovate" the stomach, liver, and kidneys, and to cure cancer, diabetes, gallstones, and weak hearts. patent medicines

Administration of the new law was assigned to the Bureau of Chemistry. The young men and women recruited by Wiley and his successors quickly developed an efficient organization. They continued the development of scientific methods of analysis -- the foundation of food and drug protection. They worked out the legal procedures and the techniques of inspection, and applied them in hundreds of hard-fought court cases. And they won scores of judicial decisions which strengthened the law and also uncovered its weaknesses. Many found such satisfaction that they made FDA their life work.

The Food Standards Committee The Food Standards Committee, authorized by a 1902 appropriation, was the first FDA advisory committee. Members were State agriculture officials and scientists. From the left: M. A. Scovell, Kentucky; H. A. Weber, Ohio; William Frear, Pennsylvania; Dr. Wiley; and E. H. Jenkins, Connecticut. The committee met for days at a time, considering the needs and problems of food regulation on a national basis. It continued in operation until the passage of the Federal Advisory Committee Act of 1972.
In 1907 Walter G. Campbell (left) was one of the first 28 food and drug inspectors (over 2,000 took the civil service examination). Selected by Dr. Wiley as chief inspector, he devised the legal process for the first seizure of a violative product (still used), wrote the first Inspector's Manual (1908), and set up FDA's first project system to ensure uniform enforcement while giving top priority to health hazards. Campbell remained in charge of enforcement for 37 years, becoming the first "Commissioner of Food and Drugs" in 1940. A lawyer by training, Campbell was the leading architect of the present Federal Food, Drug, and Cosmetic Act, passed in 1938. He differed sharply from Wiley in his belief that court proceedings were not the only proper way to secure compliance. Walter G. Campbell

Carl L. Alsberg Wiley's succesor, Carl L. Alsberg, was previously a research biologist with the Department of Agriculture. Research, education, and cooperation with State and local officials were basic elements in Dr. Alsberg's policy of administration. For the clever cheaters he sought the full penalties of the law. Retiring in 1921, he became director of the Food Research Institute at Stanford University.
Dr. Wiley's key men Key men of the organization created by Dr. Wiley, with their new chief, Dr. Carl L. Alsberg (front row, third from left) in 1913. At Alsberg's left is W.P. Bigelow, assistant chief and director of the food laboratories. Others are field district chiefs and heads of the specific divisions.

The Bureau of Chemistry enforced the 1906 law until 1927 when it was reorganized. Law enforcement functions were separated from agricultural research in order to emphasize and secure better funding for the latter. The Food, Drug, and Insecticide Administration was formed, to be renamed in 1931 as the Food and Drug Administration. In 1940, to prevent recurring conflicts between producer interests and consumer interests, FDA was transferred from the U.S. Department of Agriculture to the Federal Security Agency which, in 1953, became the Department of Health, Education, and Welfare -- now the Department of Health and Human Services.

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