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Fifty Years of Progress in Food and Drug Protection
Wallace F. Janssen, Assistant to the Commissioner, Food and Drug Administration~ Department of Health .. Education and Welfare, discusses
Fifty Years of Progress in Food and Drug Protection
O
30, 1906, President Theodore Roosevelt signed the original "Pure Food and Drugs Act," sometimes referred to as the Wiley Law. Few, if any, events have had greater significance to the profession of pharmacy, or such far-reaching effects on the progress of rational therapeutics. It was not onJy a great victory for the cause of scientific pharmacy and medicine but signaled the beginning of an era of progress in these fields which has no counterpart in all previous history. N JUNE
Dr. Harvey Washington Wiley A large book could be written on the subject of this paper. Its central figure would be the towering one of Dr. Harvey Washington Wiley, one of the truly great personalities of his times. Born in a log cabin on a backwoods Indiana farm, Wiley had almost no formal education in his childhood but fortunately had a father who was a learned man. He taught his children Latin and Greek, and around the evening fire read to them aloud from the Bible, Shakespeare, and the Atlantic Monthly. At 19, dressed in a homespun suit and cowhide boots, young Harvey started across the fields to the new Hanover College, 5 miles away. Ten years later, this young man had graduated from Hanover, taken his M.A. degree, graduated from Indiana Medical College, served in the Union Army and become a Bachelor of Science of Harvard University. The latter degree was won in 17 days, during which Wiley passed the class examinations for all 4 years with flying colors. He had been in residence at Harvard for less than 6 months. In those 6 months, however, he had attended lectures by such great teaching personalities as Charles Edward Munroe, Louis Agassiz, and Charles W. Eliot, and their influence remained with him the rest of his life. Then followed a period in which Harvey Wiley himself became a teacher, an experience which helped greatly to fit him for the stormy years ahead. He taught chemistry at Indiana Medical College and Butler University-mornings at one and evenings at the other. In 1874, when Purdue University was founded, Wiley was its first professor of chemistry. Later he became state chemist of Presented to the Section on Historical Pharmacy and American Institute of the His tory of Pharmacy, A.PH.A ., Detroit Meeting, April 19 56. The author would like to express appreciation to Stephen Koelz of the Food and Drug Administration for research assistance and to George Griffenhagen of the Smithsoni a n Institution for s u ggestin g the s ubject of this p a p er .
May, 1956
Indiana. In 1878 he went to Berlin for advanced chemical studies and there became attached to the Imperial Board of Health . Returning from Germany he resumed his post at Purdue, where he received commendation for his teaching, but was formally censured for riding a high-wheel bicycle and playing baseball with the students. (I have heard this bicycle is still preserved with other Wiley relics at the University museum.) In 1883, after 9 years at Purdue, Dr. Wiley was invited to become chief chemist of the U.S. Department of Agriculture . He remained in this post for 29 years . Early in this period he began the famous crusade to curb abuses then current in the production and sale of foods and drugs. The 23 year campaign for the "pure food law" has tended to obscure Wiley's many scientific contributions while chief of the Bureau of Chemistry. Outstanding among these was his work in developing the beet sugar industry of the United States. For years this was one of his major interests, and today he is known as the father of the U.S. domestic sugar industry as well as the pure food law.
Conditions Prior to 1906 One of Wiley's first official acts was the assignment of several of his very small staff of chemists to study the adulteration of foods. Changes from an agricultural to an industrial economy had made it necessary to provide the rapidly increasing city population with food from distant areas. This led to a boom in commercial food processing. It also led to an extensive use of chemical preservatives such as borax, formaldehyde and salicylates in meats and canned foods. Compared to present knowledge, the technology of food preservation was in its infancy. Artificial colors and flavors were indiscriminately employed to enhance the attractiveness of the "embalmed" foods. Labeling gave no hint of the addition of these deleterious ingredients. While these practices were by no means universal, and many firms were putting out entirely wholesome products, Dr. Wiley 's chemists had no difficulty finding material for their investigations. Their studies were reported in the 1,400 pages of the famous "Chemistry Bulletin No. 13," which the Bureau issued in 10 parts over a period of 15 years. I t was this scientific report which documented Wiley's case for a Federal pure food law. In view of Dr. WHey's connection with the Department of Agriculture it is not surprIsing that he
339
JOURNAL OF THE AMERICAN PHARMACEUTICAL ASSOCIATION
at first showed no official interest in the problems of drug adulteration and misbranding. This was the heyday of the so-called "patent medicines" such as Kick-a-poo Indian Sagwa and Warner's Safe Cure for Diabetes. The existence of thousands of these products reflected both the limited medical knowledge of the period and public aquiescence in the doctrine that the buyer should look out for himself. Medicines containing such drugs as opium, morphine and cocaine were sold without restriction at almost any crossroads store. Otherwise innocuous preparations were labeled for the cure of every disease and symptom. Labels did not declare ingredients and warnings against misuse were unheard of. vVhat information the public got along these lines came from the physician or pharmacist, from hearsay, or sometimes from bitter experien~e. Yet even in these days pioneering drug firms were applying pharmaceutical science to the task of producing standardized medications for professional use.
Early Attelllpts at Legislative Control of Foods and Drugs The only Federal law at this time was one which provided for the inspection of imported drugs, not so much to detect adulteration as to classify them properly for customs purposes. In 1902 a bill was introduced in Congress authorizing the Secretary of Agriculture to investigate the adulteration of drugs in the United States. Its basis was the effect of such adulteration on domestic producers. The legislation was supported at the Senate hearings by a delegation headed by Charles R. Parmele, manufacturing chemist of New York. This bill became law on June 30, 1902. From 1879 to 1906 more than 100 food and drug bills were introduced in Congress. The first advocates of such legislation were the state chemists. They knew the problems and that the state laws, with their lack of uniformity, were inadequate to deal with them. Products banned in one state were legal in adjoining states. Dr. Wiley took his message to the public. He became a popular speaker to women's clubs and business organizations. A group of crusading writers joined in the campaign. Collier's Weekly, the Ladies' Home Journal, and Good Housekeeping magazines aroused public opinion with their cartoons, articles and editorials. Strenuous opposition came from many food manufacturers, as well as the makers of patent medicines who were then the largest advertisers in the country. Many of these men thought their business would be jeopardized by Federal regul.a tion. Beginning in 1903 Wiley captured the attention of the entire 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 determining whether these ingredients were injurious to 340
health. Even the popular song writers took an interest in these experiments, which continued over a 5-year period. For example, Lew Dockstader, the minstrel star, introduced a song dedicated to the "poison squad," which ran: "0, 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; 0, they may get over it but they'll never look the same." When the final vote came it was almost unanimous.
The Role of the Alllerican Pharlllaceu tical Association The AMERICAN PHARMACEUTICAL ASSOCIATION had also taken an active interest in this problem of drug adulteration. A committee on the subject, headed by E. L. Patch of Boston was making its own study, analyzing samples of various drugs. On September 10, 1902, at the 50th anniversary Convention in Philadelphia, Mr. Patch's committee submitted this report: "Your committee considers the establishment of the drug laboratory at Washington to be one of the most important events that have transpired in the history of American Pharmacy, and we recommend to the general session the consideration of the following resolutions in addition to that previously offered: "Whereas, we have learned that under authority of an Act of Congress the Secretary of Agriculture has established a laboratory with the Bureau of Chemistry, to study the composition and adulteration of drugs; therefore "1. Resolved, that the AMERICAN PHARMACEUTICAL ASSOCIATION offer to the Secretary of Agriculture its most cordial collaboration in this work, which promises so much benefit to the manufacturers of and dealers in drugs, as well as the consumers thereof. "2. Resolved, that this ASSOCIATION will use its influence with the Congress of the U.S. to secure a reasonable appropriation to properly carryon this work in a systematic and effective manner. "3. Resolved, that the President and Secretary of the ASSOCIATION be authorized to convey to the Secretary of Agriculture a minute of these proceedings, and to represent the ASSOCIATION before the Committee on Agriculture of the House and the Committee on Agriculture and Forestry of the Senate, when the next agricultural appropriation bill is under consideration ."
This report was received and approved. Thus, four years prior to the passage of the 1906 law the AMERICAN PHARMACEUTICAL ASSOCIATION gave its official support to Dr. Wiley's efforts. He was present at this session of the Convention. In a brief talk he said he was asking the ASSOCIATION'S help in finding a qualified pharmaceutical chemist to take the new job as chief of the Drug Laboratory.
Vol. XVII, No . 5
PRACTICAL PHARMACY EDITION
The following year at the 51st annual Convention at Mackinac Island, Dr. Lyman F. Kebler spoke at the opening general session to describe the beginning of his work as chief of this laboratory.
The Food and Drug Act of 1906 The 1906 law was a strong one for its times and brought a great improvement in products and labeling during its early years. Names of products involved in the early court actions are revealing. The first reported case concerned a drug called "Cuforhedake." Others had such interesting names as "Lee's Save the Baby," "A Texas Wonder," and "Mrs. Moffat's Shoo-Fly Powders for Drunkenness." Many medicines were labeled as cures and specifics for different diseases. William W. Goodrich, in a recent paper to the New York State Bar Association,l points out that the modern representations of drugs "as an aid" and "for temporary relief" would have been hopelessly outclassed by such competition. To quote Mr . Goodrich: "It was not long before the entire program against misbranded drugs came a cropper at judicial hands. Mr. Justice Holmes, speaking for a divided Supreme Court in U.S. v. Johnson, held that Congress in 1906 had not intended to 'throw the risk on shippers by making them answerable for what the court characterized as 'mistaken praise.' " Johnson could not be punished for selling his 'Mild Combination Treatment for Cancer,' even though it was charged that he falsely represented the treatment to the public and that he knew the claims were false. The dissenters, led by Justice Hughes, vainly protested that the decision opened the way for sale of fake cures for a multitude of serious ills, including diphtheria, pneumonia, diabetes and Bright's disease. So it did. "President Taft very promptly called for an amendment. He said: 'There are none so credulous as sufferers from disease. The need is urgent for legislation which will prevent the raising of hopes of speedy cures of serious ailments by misstatement of facts as to worthless mixtures on which the sick will rely while their disease progresses unchecked.' "
Congress quickly passed the Sherley Amendment prohibiting false and fraudulent claims of curative and therapeutic effects for drugs. This was upheld on constitutional grounds but had the effect of restricting enforcement for many years to cases charging that fraud was intended. "The more ignorant the promoter of drugs the greater were his chances of avoiding the law."2 Typical of the enforcement problem was the famous B & M Case, which began in 1919 and finally terminated in 1932 with a verdict in favor of the Government. The promoter was a court stenographer who learned of the treatment from a 1 William W. Goodrich, "Judicial Highlights of 50 Years, Enforcement," Food, Dl'ug, Cosmetic Law Journal, 11, Feb ruary 1956 . 2 Ibid .
MaYJ 1956
man who said he got it from a race track veterinarian. The promoter claimed he had been cured of rheumatism by the drug, but he sold it for tuberculosis, pneumonia and many other diseases. The fraud was finally exposed only through the most comprehensive of FDA investigations, the marshaling of overwhelming medical support, and the outstanding efforts of a young United States Attorney who today is Solicitor General of the United States. 3
Food and Drug Legislation, 1938 to 1956 In 1938, after a 5-year legislative struggle, a new and stronger law was enacted. This retained the best features of the 1906 law and added important new provIsions. Among these were stronger controls to insure safety and eftlcacy of drugs . regulation of therapeutic de-vices and cosmetics, authority to set standards for basic foods, and compulsory inspection of establishments processing or handling foods, drugs, devices and cosmetics . On June 30, 1940, the Food and Drug Administration was transferred from the Department of Agriculture to the Federal Security Agency. On December 22, 1941, the insulin amendment was passed providing for the testing and certification of all batches of this important drug. This was the first application to drugs of the principle of certification. World War II gave the FDA laboratories the job of testing drugs for the armed forces. including the new "miracle" drug pencillin. By 1945 the supply of pencillin had become sufrlcient for civilian distribution, and the law was amended to require certification of the safety and efficacy of this product. Later amendments extended certification to four other antibiotics. In 1948 the Supreme Court handed dovl'n the Sullivan decision, which held that a pharmacist violated the Federal law when he sold a restricted drug without a doctor's prescription. This decision ultimately led in 1951 to the Durham-Humphrey amendment, which defined the types of drugs which ' must be labeled for sale exclusively upon prescription. In 1950 the House Select Committee To Investigate the Use of Chemicals in Foods and Cosmetics began a 2-year study of the adequacy of controls over ingredients of unproved safety. This led in 1954 to the Miller pesticide amendment, which provides for establishment of safe limits on residues of pesticide chemicals used on food crops, thus carrying out, in part, the recommendations of the House Select Committee. On December 8, 1952, the Supreme Court ruled that the factory inspection power in the law was unenforceable. President Eisenhower called for corrective legislation, and this was passed and signed by the President on August 7, 1953. 3
Ibid.
(Continued on page 353)
341
PRACTICAL PHARMACY EDITION
Approximately 100 members of the University of Texas Student Branch visited A.PH.A. Headquarters on April 6. Many of them brought their wives on their eastern educational tour. Accompanying them were faculty members D1'. David M. Stuart and Professor Kenneth Tiemann. Another March event featuring the popular Parke-Davis film "Going Our Way" was the joint meeting of the University of Toledo Student Branch and the pharmaceutical fraternities, Kappa P si and Alpha Zeta Omega. Branch officers for the year 1956- 57 are as follows: James Guemenden, president; Allen Baer, vice president; Joan Parrott, secretary, and Clayton Umbles, treasurer. Dr. Kenneth H. Stahl is faculty advisor. The University of Utah Student Branch held its second annual Student Branch Convention on May 4 at the Hotel Utah in Salt Lake City. Students presented papers before the various Sections patterned after the annual A.PH.A. Convention. Co-chairmen of the meeting were Paul Oelsner and Glade Watkins. Dr. ElP.!art A. Swinyard served as faculty advisor. The Washington State College Student Branch heard William Felter, editor of Pacific Drug Review, discuss "Ethical Responsibilities of the Individual Pharmacist" when it met in March . Newly elected officers of the University of Washington Student Branch are Dick Price, president; Ed Scheinost, vice president; Carol Morris, secretary; and Charles Nunn, treasurer. Dr. Edward Krupski is faculty advisor. Lawrence Brown presided at the March meeting of the Wayne University Student Branch which included the presentation of the Squibb and Sons' film entitled "And the Earth Shall Give Back Life."
Straigh t From Headquarters • • • • • • • • • • • • • from page 289
The ASSOCIATION has been electing its officers by a mail ballot since 1906, thus giving every member of the ASSOCIATION who cares to exercise the right to vote, an opportunity to do so. While this may be considered by some to be a cumbersome procedure, it is a system which has served the ASSOCIATION well for the past fifty years and the members in attendance at the Detroit Convention let it be known in no uncertain terms that they do not desire any change. There is undoubtedly a better way of making nominations than is provided under the present amended by-laws, but this can be provided, after proper study and submission of new proposals to the membership at large, without tampering with the greatest symbol of democracy, namely, the right of the individual to take part in the election of those who are to carryon the work of the ASSOCIA TION.
May, 1956
Fifty Years of Progress • • • • • • • • • • • • • frorn page 341
These and other amendments have shown the inclination of Congress to keep the 1938 law abreast of changing conditions. It consequently seems probable that another general overhauling of the law such as occurred in the 30's will not be required, at least for many years.
Expansion of the Food and Drug Adlllinis tra tion The changes and growth of the law, together with a great expansion of the food, drug and cosmetic industries, have raised serious problems in regard to the adequacy of the administrative organization. This was one of the questions faced by Secretary Oveta Culp Hobby when the Federal Security Agency became a cabinet department. In J anuary 1955 Mrs. Hobby appointed a committee of distinguished citizens to make a comprehensive study of the adequacy of the staff and facilities of the Food and Drug Administration. Among the well-known figures in the drug and cosmetic industries who served upon this committee was Dean Charles F. Poe of the College of Pharmacy, University of Colorado. On June 30, 1955, the committee rendered its report. In broad terms it found that the Food a nd Drug Administration was at a crossroads. The growth of industry and the increasingl y complex technology of food and drug protection had made its job too big for its facilities. The committee recommended a three- to fourfold increase in the FDA organization, to be accomplished over a period of 5 to 10 years .
Benefits Derived fro III the Food and Drug Laws It would be a great mistake to say that the progress made by medicine and pharmacy in the past half century is due to any Federal law. Nevertheless, it is clear that the Federal pure food and drug laws, both of 1906 and 1938, have had an important influence on the general progress made in these fields. These laws, like healthy competition, have accelerated progress. Standards of conduct and performance are set first by the leaders of the industries and professions. But when enacted into law these accomplishments become the norm. By this means, the less progressive are compelled to improve their practices. From the standpoint of pharmacy the power of the law has been put behind the ethics of the profession. The physician, the pharmacist, and the patient have been provided with a sound basis for confidence in the products of drug manufacturers. The latter are protected against unethical competition. Pharmaceutical research has received a powerful stimulation. These are some of the contributions which the law has made to 50 years of progress in food and drug protection.
353
Fifty Years of Progress in Food and Drug Protection
O
30, 1906, President Theodore Roosevelt signed the original "Pure Food and Drugs Act," sometimes referred to as the Wiley Law. Few, if any, events have had greater significance to the profession of pharmacy, or such far-reaching effects on the progress of rational therapeutics. It was not onJy a great victory for the cause of scientific pharmacy and medicine but signaled the beginning of an era of progress in these fields which has no counterpart in all previous history. N JUNE
Dr. Harvey Washington Wiley A large book could be written on the subject of this paper. Its central figure would be the towering one of Dr. Harvey Washington Wiley, one of the truly great personalities of his times. Born in a log cabin on a backwoods Indiana farm, Wiley had almost no formal education in his childhood but fortunately had a father who was a learned man. He taught his children Latin and Greek, and around the evening fire read to them aloud from the Bible, Shakespeare, and the Atlantic Monthly. At 19, dressed in a homespun suit and cowhide boots, young Harvey started across the fields to the new Hanover College, 5 miles away. Ten years later, this young man had graduated from Hanover, taken his M.A. degree, graduated from Indiana Medical College, served in the Union Army and become a Bachelor of Science of Harvard University. The latter degree was won in 17 days, during which Wiley passed the class examinations for all 4 years with flying colors. He had been in residence at Harvard for less than 6 months. In those 6 months, however, he had attended lectures by such great teaching personalities as Charles Edward Munroe, Louis Agassiz, and Charles W. Eliot, and their influence remained with him the rest of his life. Then followed a period in which Harvey Wiley himself became a teacher, an experience which helped greatly to fit him for the stormy years ahead. He taught chemistry at Indiana Medical College and Butler University-mornings at one and evenings at the other. In 1874, when Purdue University was founded, Wiley was its first professor of chemistry. Later he became state chemist of Presented to the Section on Historical Pharmacy and American Institute of the His tory of Pharmacy, A.PH.A ., Detroit Meeting, April 19 56. The author would like to express appreciation to Stephen Koelz of the Food and Drug Administration for research assistance and to George Griffenhagen of the Smithsoni a n Institution for s u ggestin g the s ubject of this p a p er .
May, 1956
Indiana. In 1878 he went to Berlin for advanced chemical studies and there became attached to the Imperial Board of Health . Returning from Germany he resumed his post at Purdue, where he received commendation for his teaching, but was formally censured for riding a high-wheel bicycle and playing baseball with the students. (I have heard this bicycle is still preserved with other Wiley relics at the University museum.) In 1883, after 9 years at Purdue, Dr. Wiley was invited to become chief chemist of the U.S. Department of Agriculture . He remained in this post for 29 years . Early in this period he began the famous crusade to curb abuses then current in the production and sale of foods and drugs. The 23 year campaign for the "pure food law" has tended to obscure Wiley's many scientific contributions while chief of the Bureau of Chemistry. Outstanding among these was his work in developing the beet sugar industry of the United States. For years this was one of his major interests, and today he is known as the father of the U.S. domestic sugar industry as well as the pure food law.
Conditions Prior to 1906 One of Wiley's first official acts was the assignment of several of his very small staff of chemists to study the adulteration of foods. Changes from an agricultural to an industrial economy had made it necessary to provide the rapidly increasing city population with food from distant areas. This led to a boom in commercial food processing. It also led to an extensive use of chemical preservatives such as borax, formaldehyde and salicylates in meats and canned foods. Compared to present knowledge, the technology of food preservation was in its infancy. Artificial colors and flavors were indiscriminately employed to enhance the attractiveness of the "embalmed" foods. Labeling gave no hint of the addition of these deleterious ingredients. While these practices were by no means universal, and many firms were putting out entirely wholesome products, Dr. Wiley 's chemists had no difficulty finding material for their investigations. Their studies were reported in the 1,400 pages of the famous "Chemistry Bulletin No. 13," which the Bureau issued in 10 parts over a period of 15 years. I t was this scientific report which documented Wiley's case for a Federal pure food law. In view of Dr. WHey's connection with the Department of Agriculture it is not surprIsing that he
339
JOURNAL OF THE AMERICAN PHARMACEUTICAL ASSOCIATION
at first showed no official interest in the problems of drug adulteration and misbranding. This was the heyday of the so-called "patent medicines" such as Kick-a-poo Indian Sagwa and Warner's Safe Cure for Diabetes. The existence of thousands of these products reflected both the limited medical knowledge of the period and public aquiescence in the doctrine that the buyer should look out for himself. Medicines containing such drugs as opium, morphine and cocaine were sold without restriction at almost any crossroads store. Otherwise innocuous preparations were labeled for the cure of every disease and symptom. Labels did not declare ingredients and warnings against misuse were unheard of. vVhat information the public got along these lines came from the physician or pharmacist, from hearsay, or sometimes from bitter experien~e. Yet even in these days pioneering drug firms were applying pharmaceutical science to the task of producing standardized medications for professional use.
Early Attelllpts at Legislative Control of Foods and Drugs The only Federal law at this time was one which provided for the inspection of imported drugs, not so much to detect adulteration as to classify them properly for customs purposes. In 1902 a bill was introduced in Congress authorizing the Secretary of Agriculture to investigate the adulteration of drugs in the United States. Its basis was the effect of such adulteration on domestic producers. The legislation was supported at the Senate hearings by a delegation headed by Charles R. Parmele, manufacturing chemist of New York. This bill became law on June 30, 1902. From 1879 to 1906 more than 100 food and drug bills were introduced in Congress. The first advocates of such legislation were the state chemists. They knew the problems and that the state laws, with their lack of uniformity, were inadequate to deal with them. Products banned in one state were legal in adjoining states. Dr. Wiley took his message to the public. He became a popular speaker to women's clubs and business organizations. A group of crusading writers joined in the campaign. Collier's Weekly, the Ladies' Home Journal, and Good Housekeeping magazines aroused public opinion with their cartoons, articles and editorials. Strenuous opposition came from many food manufacturers, as well as the makers of patent medicines who were then the largest advertisers in the country. Many of these men thought their business would be jeopardized by Federal regul.a tion. Beginning in 1903 Wiley captured the attention of the entire 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 determining whether these ingredients were injurious to 340
health. Even the popular song writers took an interest in these experiments, which continued over a 5-year period. For example, Lew Dockstader, the minstrel star, introduced a song dedicated to the "poison squad," which ran: "0, 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; 0, they may get over it but they'll never look the same." When the final vote came it was almost unanimous.
The Role of the Alllerican Pharlllaceu tical Association The AMERICAN PHARMACEUTICAL ASSOCIATION had also taken an active interest in this problem of drug adulteration. A committee on the subject, headed by E. L. Patch of Boston was making its own study, analyzing samples of various drugs. On September 10, 1902, at the 50th anniversary Convention in Philadelphia, Mr. Patch's committee submitted this report: "Your committee considers the establishment of the drug laboratory at Washington to be one of the most important events that have transpired in the history of American Pharmacy, and we recommend to the general session the consideration of the following resolutions in addition to that previously offered: "Whereas, we have learned that under authority of an Act of Congress the Secretary of Agriculture has established a laboratory with the Bureau of Chemistry, to study the composition and adulteration of drugs; therefore "1. Resolved, that the AMERICAN PHARMACEUTICAL ASSOCIATION offer to the Secretary of Agriculture its most cordial collaboration in this work, which promises so much benefit to the manufacturers of and dealers in drugs, as well as the consumers thereof. "2. Resolved, that this ASSOCIATION will use its influence with the Congress of the U.S. to secure a reasonable appropriation to properly carryon this work in a systematic and effective manner. "3. Resolved, that the President and Secretary of the ASSOCIATION be authorized to convey to the Secretary of Agriculture a minute of these proceedings, and to represent the ASSOCIATION before the Committee on Agriculture of the House and the Committee on Agriculture and Forestry of the Senate, when the next agricultural appropriation bill is under consideration ."
This report was received and approved. Thus, four years prior to the passage of the 1906 law the AMERICAN PHARMACEUTICAL ASSOCIATION gave its official support to Dr. Wiley's efforts. He was present at this session of the Convention. In a brief talk he said he was asking the ASSOCIATION'S help in finding a qualified pharmaceutical chemist to take the new job as chief of the Drug Laboratory.
Vol. XVII, No . 5
PRACTICAL PHARMACY EDITION
The following year at the 51st annual Convention at Mackinac Island, Dr. Lyman F. Kebler spoke at the opening general session to describe the beginning of his work as chief of this laboratory.
The Food and Drug Act of 1906 The 1906 law was a strong one for its times and brought a great improvement in products and labeling during its early years. Names of products involved in the early court actions are revealing. The first reported case concerned a drug called "Cuforhedake." Others had such interesting names as "Lee's Save the Baby," "A Texas Wonder," and "Mrs. Moffat's Shoo-Fly Powders for Drunkenness." Many medicines were labeled as cures and specifics for different diseases. William W. Goodrich, in a recent paper to the New York State Bar Association,l points out that the modern representations of drugs "as an aid" and "for temporary relief" would have been hopelessly outclassed by such competition. To quote Mr . Goodrich: "It was not long before the entire program against misbranded drugs came a cropper at judicial hands. Mr. Justice Holmes, speaking for a divided Supreme Court in U.S. v. Johnson, held that Congress in 1906 had not intended to 'throw the risk on shippers by making them answerable for what the court characterized as 'mistaken praise.' " Johnson could not be punished for selling his 'Mild Combination Treatment for Cancer,' even though it was charged that he falsely represented the treatment to the public and that he knew the claims were false. The dissenters, led by Justice Hughes, vainly protested that the decision opened the way for sale of fake cures for a multitude of serious ills, including diphtheria, pneumonia, diabetes and Bright's disease. So it did. "President Taft very promptly called for an amendment. He said: 'There are none so credulous as sufferers from disease. The need is urgent for legislation which will prevent the raising of hopes of speedy cures of serious ailments by misstatement of facts as to worthless mixtures on which the sick will rely while their disease progresses unchecked.' "
Congress quickly passed the Sherley Amendment prohibiting false and fraudulent claims of curative and therapeutic effects for drugs. This was upheld on constitutional grounds but had the effect of restricting enforcement for many years to cases charging that fraud was intended. "The more ignorant the promoter of drugs the greater were his chances of avoiding the law."2 Typical of the enforcement problem was the famous B & M Case, which began in 1919 and finally terminated in 1932 with a verdict in favor of the Government. The promoter was a court stenographer who learned of the treatment from a 1 William W. Goodrich, "Judicial Highlights of 50 Years, Enforcement," Food, Dl'ug, Cosmetic Law Journal, 11, Feb ruary 1956 . 2 Ibid .
MaYJ 1956
man who said he got it from a race track veterinarian. The promoter claimed he had been cured of rheumatism by the drug, but he sold it for tuberculosis, pneumonia and many other diseases. The fraud was finally exposed only through the most comprehensive of FDA investigations, the marshaling of overwhelming medical support, and the outstanding efforts of a young United States Attorney who today is Solicitor General of the United States. 3
Food and Drug Legislation, 1938 to 1956 In 1938, after a 5-year legislative struggle, a new and stronger law was enacted. This retained the best features of the 1906 law and added important new provIsions. Among these were stronger controls to insure safety and eftlcacy of drugs . regulation of therapeutic de-vices and cosmetics, authority to set standards for basic foods, and compulsory inspection of establishments processing or handling foods, drugs, devices and cosmetics . On June 30, 1940, the Food and Drug Administration was transferred from the Department of Agriculture to the Federal Security Agency. On December 22, 1941, the insulin amendment was passed providing for the testing and certification of all batches of this important drug. This was the first application to drugs of the principle of certification. World War II gave the FDA laboratories the job of testing drugs for the armed forces. including the new "miracle" drug pencillin. By 1945 the supply of pencillin had become sufrlcient for civilian distribution, and the law was amended to require certification of the safety and efficacy of this product. Later amendments extended certification to four other antibiotics. In 1948 the Supreme Court handed dovl'n the Sullivan decision, which held that a pharmacist violated the Federal law when he sold a restricted drug without a doctor's prescription. This decision ultimately led in 1951 to the Durham-Humphrey amendment, which defined the types of drugs which ' must be labeled for sale exclusively upon prescription. In 1950 the House Select Committee To Investigate the Use of Chemicals in Foods and Cosmetics began a 2-year study of the adequacy of controls over ingredients of unproved safety. This led in 1954 to the Miller pesticide amendment, which provides for establishment of safe limits on residues of pesticide chemicals used on food crops, thus carrying out, in part, the recommendations of the House Select Committee. On December 8, 1952, the Supreme Court ruled that the factory inspection power in the law was unenforceable. President Eisenhower called for corrective legislation, and this was passed and signed by the President on August 7, 1953. 3
Ibid.
(Continued on page 353)
341
PRACTICAL PHARMACY EDITION
Approximately 100 members of the University of Texas Student Branch visited A.PH.A. Headquarters on April 6. Many of them brought their wives on their eastern educational tour. Accompanying them were faculty members D1'. David M. Stuart and Professor Kenneth Tiemann. Another March event featuring the popular Parke-Davis film "Going Our Way" was the joint meeting of the University of Toledo Student Branch and the pharmaceutical fraternities, Kappa P si and Alpha Zeta Omega. Branch officers for the year 1956- 57 are as follows: James Guemenden, president; Allen Baer, vice president; Joan Parrott, secretary, and Clayton Umbles, treasurer. Dr. Kenneth H. Stahl is faculty advisor. The University of Utah Student Branch held its second annual Student Branch Convention on May 4 at the Hotel Utah in Salt Lake City. Students presented papers before the various Sections patterned after the annual A.PH.A. Convention. Co-chairmen of the meeting were Paul Oelsner and Glade Watkins. Dr. ElP.!art A. Swinyard served as faculty advisor. The Washington State College Student Branch heard William Felter, editor of Pacific Drug Review, discuss "Ethical Responsibilities of the Individual Pharmacist" when it met in March . Newly elected officers of the University of Washington Student Branch are Dick Price, president; Ed Scheinost, vice president; Carol Morris, secretary; and Charles Nunn, treasurer. Dr. Edward Krupski is faculty advisor. Lawrence Brown presided at the March meeting of the Wayne University Student Branch which included the presentation of the Squibb and Sons' film entitled "And the Earth Shall Give Back Life."
Straigh t From Headquarters • • • • • • • • • • • • • from page 289
The ASSOCIATION has been electing its officers by a mail ballot since 1906, thus giving every member of the ASSOCIATION who cares to exercise the right to vote, an opportunity to do so. While this may be considered by some to be a cumbersome procedure, it is a system which has served the ASSOCIATION well for the past fifty years and the members in attendance at the Detroit Convention let it be known in no uncertain terms that they do not desire any change. There is undoubtedly a better way of making nominations than is provided under the present amended by-laws, but this can be provided, after proper study and submission of new proposals to the membership at large, without tampering with the greatest symbol of democracy, namely, the right of the individual to take part in the election of those who are to carryon the work of the ASSOCIA TION.
May, 1956
Fifty Years of Progress • • • • • • • • • • • • • frorn page 341
These and other amendments have shown the inclination of Congress to keep the 1938 law abreast of changing conditions. It consequently seems probable that another general overhauling of the law such as occurred in the 30's will not be required, at least for many years.
Expansion of the Food and Drug Adlllinis tra tion The changes and growth of the law, together with a great expansion of the food, drug and cosmetic industries, have raised serious problems in regard to the adequacy of the administrative organization. This was one of the questions faced by Secretary Oveta Culp Hobby when the Federal Security Agency became a cabinet department. In J anuary 1955 Mrs. Hobby appointed a committee of distinguished citizens to make a comprehensive study of the adequacy of the staff and facilities of the Food and Drug Administration. Among the well-known figures in the drug and cosmetic industries who served upon this committee was Dean Charles F. Poe of the College of Pharmacy, University of Colorado. On June 30, 1955, the committee rendered its report. In broad terms it found that the Food a nd Drug Administration was at a crossroads. The growth of industry and the increasingl y complex technology of food and drug protection had made its job too big for its facilities. The committee recommended a three- to fourfold increase in the FDA organization, to be accomplished over a period of 5 to 10 years .
Benefits Derived fro III the Food and Drug Laws It would be a great mistake to say that the progress made by medicine and pharmacy in the past half century is due to any Federal law. Nevertheless, it is clear that the Federal pure food and drug laws, both of 1906 and 1938, have had an important influence on the general progress made in these fields. These laws, like healthy competition, have accelerated progress. Standards of conduct and performance are set first by the leaders of the industries and professions. But when enacted into law these accomplishments become the norm. By this means, the less progressive are compelled to improve their practices. From the standpoint of pharmacy the power of the law has been put behind the ethics of the profession. The physician, the pharmacist, and the patient have been provided with a sound basis for confidence in the products of drug manufacturers. The latter are protected against unethical competition. Pharmaceutical research has received a powerful stimulation. These are some of the contributions which the law has made to 50 years of progress in food and drug protection.
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