By Harvey W. Wiley, MD
Summary: In 1906 the U.S. government passed the Pure Food and Drug Act, the first federal law aimed specifically at ensuring the purity of America’s food supply. It wasn’t long before the industrial food industry—with the help of its connections in the federal government—found its way around the legislation. In this letter to President Calvin Coolidge, Dr. Harvey W. Wiley, the chief chemist of the U.S. Department of Agriculture (USDA) charged with enforcing the act, calls the U.S. government to task for turning a blind eye to various cases that appeared to squarely violate the law. Dr. Wiley’s protestation (an expanded version of which appeared as “Dr. Wiley to the President” in the September 1925 issue of Good Housekeeping) caused such a stir that it prompted a reply to the president by the acting secretary of the USDA. Together, these two letters show precisely how food manufacturers and federal courts colluded to thwart the intent of America’s food purity law, allowing additives of unproven safety to become forever part of the nation’s food supply. 1925.
Enforcement of the Food Law[spacer height=”20px”]
By Dr. Harvey Wiley, June 3, 1925.
To the President:
Among the many fine things you said in your Memorial Day address, there was none that appealed to me so strongly as the following:
“It is senseless to boast of liberty when we find that to so shocking an extent it is merely the liberty to go ill governed. It is time to take warning that neither the liberties we prize nor the system under which we claim them are safe while such conditions exist.
“There is another responsibility of the states. It is quite aside from this one of jurisdiction. It is the subject of law enforcement. We are not a lawless people, but we are too frequently a careless one. The multiplicity of laws, the varied possibilities of appeals, the disposition to technicality in procedure, the delays and consequent expense of litigation that inevitably inure to the advantage of wealth and specialized ability—all these have many times been recounted as reproaches to us. It is strange that such laxities should persist in a time like the present, which is marked by a determined upward movement in behalf of the social welfare. But they do exist. They demonstrate a need for better, prompter, less irksome and expensive administration of the law.”
These words have made so strong an impression upon me that I am addressing this letter to you in regard to a “shocking” neglect on the part of the United States government to enforce the Food and Drugs Act [i.e., the Pure Food and Drug Act of 1906], for which I labored incessantly for twenty-five years and of which I was the administrator from the time the law went into effect on January 1st, 1907, until my retirement from the public service on the 15th of March 1912. During that interval the failures to administer the law by competent officials, my superiors in rank, were so “shocking” that, in sheer self-defense, I voluntarily retired from any further efforts looking to the administration of the law in the terms laid down by Congress.
The advent of your administration seemed to me so pertinent in its opportunity to better these conditions that I took the liberty of writing an article on the subject for Good Housekeeping, a copy of which I am leaving with your secretary, Mr. Sanders, in the hope that you will have time to look it over before you start on your well-earned summer vacation. I shall furnish Mr. Sanders with all the documentary evidence to show the pertinence of the items that I enumerate in this article. A mere word from you to the Secretary of [the U.S. Department of] Agriculture and to the [department’s] assistant secretary, who was associated with me in my great fight, will be sufficient to free the law from the illegal restrictions and the practical paralysis that have been inflicted upon it by the high officials in the Department of Agriculture to whom I have alluded.
In the investigations carried on by the Congress of the United States of the charges maliciously preferred against me for using $75.00 illegally in my efforts to enforce the law and for which, in a star chamber proceeding without any indication to me as to what was going on, I was convicted and sentenced to be dismissed in disgrace from the public service, the whole scheme was revealed in the most striking manner. So astounded was the [then] president of the United States, William Howard Taft, that he wrote a very pointed letter to the Secretary of Agriculture, who was guilty of this failure to enforce the law, demanding of him that he at once restore the law to its pristine vigor and take away all interference therewith of those who had been active in bringing these charges against me and in securing my conviction and my sentence of dismissal from the public service.
It was only after I learned that these orders of the president of the United States were not to be carried out that I decided to abandon any further efforts to enforce the law and retire to private life.
Of all the interference with the functioning of the law as Congress intended, the most amazing example was an attempt by the high officials of the Department of Agriculture to coerce the state of Indiana from its purpose of properly enforcing the state law by sending to Indianapolis, at the expense and under the orders of the Department of Agriculture, a large body of experts—paid from the monies appropriated by Congress for the enforcement of the national pure-food law—to prevent, or seek to prevent, the state of Indiana from properly enforcing its own food law. In spite of this effort, the federal courts upheld the right of Indiana to enforce her own food law in her own way. These illegal indulgences, these willful departures from the plain letter of the law, the neglect of supplementing the rulings of the courts, and especially of the Supreme Court, are still in operation.
Your observation “It is strange that such laxities should persist in a time like the present which is marked by a determined upward movement in behalf of the social welfare” is exactly to the point in this matter. The proper enforcement of the Food and Drugs Act is intimately related to the public health. By reason of the existence of these “laxities,” the health and efficiency of our citizens are continually threatened. Flour from which our bread, the staff of life, is made is whitened by toxic substances, oxides of nitrogen. Coca-Cola, a habit-forming beverage, goes unrestricted from state to state. Both these substances, after fair trial, have been pronounced adulterated and misbranded under the [Pure Food and Drugs] Act. Alum is used in foods under the protection of the very law that was enacted to keep it out. The same is true of benzoate of soda and of sulfur dioxide. The time has fully come for these monstrosities to disappear.
It is the crowning ambition of my career, before I die, to see these illegal restrictions, which now make a prisoner of the Food Law, removed and the law restored to the functional activity that Congress prescribed for its enforcement at the time of its enactment.
I have the honor to be,
(Signed) H.W. Wiley
[Letter in response to Dr. Wiley’s letter, by the assistant secretary of the USDA:]
Letter of Acting Secretary Dunlap to the President
The White House
Dear Mr. President:
I wish to acknowledge Mr. Sanders’s letter of June 13 transmitting a communication addressed to you under date of June 3, 1925, by Dr. Harvey W. Wiley. Dr. Wiley alleges certain laxities in the enforcement of the Federal [Pure] Food and Drugs Act and encloses exhibits bearing on the charges that he has made. The substance of his allegations appears to be covered by the suggested executive order that is included in the concluding portion of his article entitled “A Job for the New Administration,” published in the Good Housekeeping magazine for June 1925. That suggested order proposes the repeal of certain previous orders, regulations, food-inspection decisions, and other pronouncements that according to Dr. Wiley have permitted the continued use in foods of benzoate of soda, sulfur dioxide and sulfites, saccharin, and alum, and the continued traffic in bleached flour and Coca-Cola, which Dr. Wiley holds to be violative of the Food and Drugs Act.
The allegations that Dr. Wiley makes are serious. Because of his eminence as an advocate of the purity of the food-and-drug supply of the nation and because of great service rendered by him in helping to bring about the enactment of the Food and Drugs Act—one of the most beneficent pieces of legislation ever passed by Congress—his statements are deserving of the most careful and respectful attention. I have taken occasion since receipt of this communication to have made a careful review of the history of the enforcement work under the Food and Drugs Act insofar as it relates to the particular items mentioned by Dr. Wiley. I know that I am voicing the feeling of the Bureau of Chemistry as well as my own when I say that there is the utmost sympathy between the officials of that bureau in charge of the enforcement of the Food and Drugs Act and the higher administrative officers of this Department [of Agriculture] who are called upon to review in a general way actions taken in connection with the Food and Drugs Act. It is not my purpose to hamper the Bureau of Chemistry by any restrictions that will prevent the literal application of the terms of the law to food and drug products brought within the jurisdiction of the act. The department and the Bureau of Chemistry share Dr. Wiley’s view that the use of substances such as benzoate of soda, sulfur dioxide and sulfites, saccharin, alum, chemical bleaches in flour, and added caffeine in beverages is for the most part undesirable from the broad general standpoint of human health and nutrition. The elimination of these extraneous substances from the food supply is an object greatly to be desired. We differ from Dr. Wiley only in our view as to the adequacy of existing means that may be employed to attain these ends. Dr. Wiley’s view appears to be that there is sufficient evidence now available to warrant the institution of proceedings under the Food and Drugs Act looking to the elimination of all of these substances from the nation’s food supply. A review of the department’s actions may demonstrate why the department is obliged to differ with Dr. Wiley.
Legal action under the Food and Drugs Act has been brought against Coca-Cola, against bleached flour, and against saccharin. No such action under the act has been instituted against benzoate of soda, alum, sulfur dioxide, and sulfites.
In the action against Coca-Cola, the principal cause for complaint was the presence in this product of the substance caffeine, which the department held to be an added deleterious ingredient. Expert testimony intended to establish the deleterious character of caffeine was introduced by the department in connection with a seizure instituted in the Eastern District of Tennessee in October 1909. Contrary expert testimony was introduced by claimant. The court, however, held as a matter of law that caffeine in the product in question was not an added ingredient within the meaning of the statute and directed a verdict in favor of the claimant. The [federal] government took an appeal in this case to the Circuit Court of Appeals for the 6th Circuit, which sustained the judgment of the district court. The case was then carried by the government to the Supreme Court of the United States upon a writ of error. In a decision rendered May 22, 1916 (241 U.S. 265), the Supreme Court reversed the lower courts and remanded the case for retrial. The Supreme Court’s decision substantially established that caffeine in this product was an added ingredient and left for retrial in the lower court the question of fact of whether the added ingredient was an added poisonous or deleterious ingredient that may render such article injurious to health. The respondent thereupon changed the formula for its product so as to reduce materially the amount of caffeine in the finished article. Holding that a decision of the question at issue, in view of the reduction of the amount of caffeine in the product, would not be conclusive in any future proceedings, the claimant withdrew its claim and all other pleadings and consented to the entry of a judgment in the case.
There had in the meantime been handed down by the Supreme Court in February 1914 (232 U.S. 399) a decision in the bleached-flour case to the effect that the burden was on the government—with reference to the section of the act relating to the addition of a poisonous or deleterious ingredient—of establishing, in order to prove adulteration, that there is a possibility, when the facts are reasonably considered, that the food product by reason of the presence of the added poisonous ingredient in the amount found may injure the health of some consumer. Before this decision was rendered, enforcing officials—including, we believe, Dr. Wiley—had assumed that it was necessary to establish only that the ingredient was added and was in itself of an injurious character in order to prove adulteration within the meaning of the law. By reason of the reduction of the amount of caffeine in the formula, of the Supreme Court’s decision in the bleached-flour case, and because, as will later be developed, of the difficulty of establishing harmful effect by expert testimony, the department has never felt that it has had available sufficient evidence of the deleterious character of Coca-Cola to warrant it in bringing action against the product, as now manufactured, on the charge that it is adulterated—within the meaning of the Food and Drugs Act—because of the presence of added caffeine.
Reference has been made to the bleached-flour case. An action was instituted on or about April 1, 1910, against a shipment of bleached flour alleged to be adulterated and misbranded. Among the charges of adulteration was one alleging that “it contained added poisonous or other added deleterious ingredients, to wit, nitrites or nitrite reacting material, nitrogen peroxide gas and other poisonous and deleterious ingredients, and substances that may render said flour injurious to health.” These ingredients were present as a result of the treatment of the flour by an electrical bleaching process known as the Alsop process.
The trial lasted for five weeks, during which the [federal] government and the claimant introduced expert evidence on the physiological action of the various ingredients present as the result of the bleaching operation. There were two separate special verdicts—one that the flour was adulterated and the other that it was misbranded. The claimants took the case to the Circuit Court of Appeals for the Eighth Circuit. That court found error in the instructions of the lower court to the jury as to the interpretation of the clause of the [Pure Food and Drugs] Act relating to deleterious ingredients. The Supreme Court, on a writ of certiorari, reviewed the decision of the Court of Appeals as to the construction of the clause of the statute that declares an article of food adulterated if it contains any added poisonous or deleterious ingredients that may render it injurious to health. This was the solo question considered by the Supreme Court. It held that the instructions of the trial court with reference to this particular clause of the statute were erroneous or at least misleading and remanded the case for retrial. The Supreme Court’s decision, as already stated, was that “if it cannot by any possibility, when the facts are reasonably considered, injure the health of any consumer, then such flour, though having a small addition of poisonous or deleterious ingredients, may not be condemned under the Act.”
While the Department of Agriculture in the original trial of the bleached-flour case was able to advance what it believed to be evidence of the deleterious character of the various bleaching agents found residual in the flour, it was forced to recognize that in the existing state of the science of toxicology, it would be impossible to produce evidence to support the charge in court that the seized flour contained deleterious ingredients that might render it injurious to health within the meaning of the statue as construed by the Supreme Court. It therefore advised the Department of Justice that in its opinion the charge that the flour contained an added deleterious ingredient that might render it injurious to health should be eliminated from the libel. The libel was amended in accordance with this recommendation. Thereupon the claimant withdrew its claim, answer, and appearance, and a decree was entered ordering that the amended libel be taken pro confesso, the cause heard ex parte, and all the allegations of the amended libel found to be true. Thus the charges upon which the case was finally determined bore no relation whatever to the deleterious character of the added ingredients present as a result of bleaching.
Following such termination the Bureau of Chemistry—in a Service and Regulatory Announcement issued December 30, 1920, copy enclosed (Items 350)—announced that “no action would be taken at the present time on the ground that bleaching introduces into the flour a substance that may be injurious to health provided [that] as a result of bleaching there is not introduced such a quantity of the bleaching agent as may render the flour injurious as indicated in the decision of the Supreme Court. Should evidence later become available that the bleaching of flour introduces an ingredient in minute quantities that has the effect of rendering the article injurious to health, then announcement of the fact will be made and appropriate action will be taken…” The last sentence of this announcement was based on the realization that under the existing methods of physiological experimentation, sufficient evidence of the harmful character of the food product was not attainable but with the thought that adequate methods of demonstrating harm might later be devised by some experimenter. To date neither the bureau nor other experimenters have reported such findings.
The department’s attitude on saccharin is clearly shown by the enclosed Food Inspection Decision 142, approved February 29, 1912, by Secretary of Agriculture Wilson and Secretary of Commerce and Labor Nagel. The then secretary of the treasury dissented from this announcement.
It was held in this decision that foods containing saccharin are adulterated because they contain an added deleterious ingredient and because the use of saccharin lowers the quality of the food. This decision was based on the investigations made by the Referee Board of Consulting Scientific Experts, referred to in Dr. Wiley’s article as the Remsen Board. This board was appointed at the direction of President Roosevelt after it had become evident that in the enforcement of the act repeated questions regarding the physiological action of various food ingredients were arising. The board was presided over by Dr. Ira Remsen, a distinguished organic chemist, then President of John Hopkins University, and its personnel consisted of men almost universally recognized as the leading physiological chemists of the country, namely, Professor Russell H. Chittenden of Yale University, Professor John H. Long of Northwestern University, Dr. C.H. Herter of Columbia University, and Professor Alonzo E. Taylor, then of the University of California.
The attitude expressed in Food Inspection Decision 142 represents the present attitude of the department. It has nevertheless been unable to maintain this attitude in the courts. A criminal action under Section 2 of the Food and Drugs Act was instituted in St. Louis against the Monsanto Chemical Co., one of the leading manufacturers of saccharin offered for use as a food sweetener. The product was labeled in part as positively harmless, and the issue was practically narrowed by the court through the elimination of charges based on other statements upon the label to a determination whether the statement “positively harmless” was false and misleading and a misbranding under the Food and Drugs Act. This restricted the issue to the establishment of the injuriousness to health of the substance saccharin.
The government presented what it considered to be, and still considers, satisfactory evidence of its deleterious character. The case was strongly contested and on two separate occasions resulted in a mistrial. It is understood that the juries in both trials divided seven to five in favor of the government. The trials were extremely expensive. The first trial cost the Bureau of Chemistry $28,038.68, and the second $8,278.19, both amounts being exclusive of the cost of general administrative overhead and preliminary laboratory work. The expense incurred by the Department of Justice is not known but was large, especially in the first trial owing to the employment of special counsel.
Upon the failure to reach a definite conclusion after the second trial, conferences were had with the Department of Justice, and it was determined that the government could not hope to prevail in the trial of this issue upon the facts and under the conditions presented. The Department of Justice Concluded the expenditure of additional public funds for the purpose of attempting to retry this case to be inadvisable, and the action was dismissed.
The three cases just cited, namely, the Coca-Cola case, the bleached-flour case, and the saccharin case, are illustrative of the extreme difficulty that is encountered in establishing by the introduction of technical scientific evidence that the addition of deleterious ingredients to food in the small amounts in which they are present may render the foods injurious to health. In contested actions such as those described, it is always possible for the opponents of the government to secure evidence of a kind almost if not quite as convincing as that procured by the government and in opposition to it. The evidence is highly scientific and presents extreme difficulties for the average jury. The government must, moreover, prove its case in criminal actions beyond a reasonable doubt and in civil cases by a preponderance of evidence.
In the case of benzoate of soda, sulfur dioxide, and sulfites, investigations have been made both by the Bureau of Chemistry and by the above-mentioned Referee Board of Consulting Scientific Experts for the purpose of determining whether these substances may be regarded, when used in foods, as added deleterious ingredients. Alum was studied by the Referee Board but not by the Bureau of Chemistry. The departmental orders relating to benzoate of soda and sulfur dioxide—to which Dr. Wiley refers as blocking action and which he asks be rescinded—are respectively Food Inspection Decision 104 and Food Inspection Decision 89, enclosed. The first named decision, based on the findings of the Referee Board of Consulting Scientific Experts, holds that sodium benzoate may be used in food products if its presence and amount are declared upon the label. The Referee Board found no evidence of physiological harm through the use of foods containing sodium benzoate.
Although these findings were at variance with those obtained by Dr. Wiley in the Bureau of Chemistry, they were sufficient to lead the Bureau of Chemistry to believe that it could not successfully maintain a case in the courts against a food containing sodium benzoate. Food Inspection Decision 104 stands as an expression of departmental and bureau opinion today, and were it rescinded, the Bureau of Chemistry would not be in a position to take successful legal action against sodium benzoate as an added deleterious ingredient that might render the food in which it is used injurious to health.
The only pertinent portion of Food Inspection Decision 89 is the paragraph relating to sulfur dioxide, which permits the presence of this substance in the usual amounts in foods if its presence is declared on the label. The extensive physiological investigations of the Referee Board and of later investigators failed to demonstrate conclusively the adverse physiological action of sulfur dioxide or sulfites. We have recently had these reports reviewed by the United States Public Health Service, which confirms the conclusion reached by the Referee Board that there is no evidence that sulfur dioxide in the usual amounts is an added deleterious ingredient that may render the food injurious to health. As in the case of Food Inspection Decision 104, even were Food Inspection Decision 89 rescinded, the Bureau of Chemistry would not be in a position to take successful action against food containing sulfur dioxide, and this is notwithstanding the fact that investigations carried on by the Bureau of Chemistry under Dr. Wiley’s direction established to his satisfaction that sulfur dioxide was injurious.
No departmental order on alum has been issued, but Department Bulletin No. 103, enclosed, contains a summary of the results obtained on the study of this substance by the Referee Board. That board did not find evidence establishing that foods containing added alum might be regarded as containing an added deleterious ingredient that might render them injurious to health. In view of the findings of that board and because of the judicial decision in the bleached-flour case, action against foods containing alum has not been instituted.
In conclusion it may be stated that the attitude of the department is not based upon any favorable consideration of these substances but upon a recognized lack of power under this statute, as interpreted by the Supreme Court, to prevent their use in food. Since it is necessary to show that these products are not only themselves poisonous but that as ingredients in food they are present in sufficient quantity to make consumption of this food of possible injury to health, it is obvious that an attempt at prosecution with respect to the substances found by the Referee Board to be without adverse physiological action would result in defeat for the government. This would be likely to stimulate more widespread use then now prevails.
The department’s course in these matters is influenced by the limitations of existing methods of physiological experimentation. We are not convinced that deleterious results are not produced in some degree by the consumption of these extraneous substances. While we feel that from the broad standpoint of human health and nutrition their presence in foods is undesirable, it will be impossible to compel their exclusion unless the future should develop refinements in methods of physiological experimentation greater than now exist by which their possible injurious effect upon health may be established. In such circumstances their exclusion at this time can be effected by legislative action alone.
(Signed) R.W. Dunlap
By R.W. Dunlap, Assistant Secretary of the U.S. Department of Agriculture, June 13, 1925.