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    Two hundred years ago today, in the City of Philadelphia, a convention was going on which would greatly affect the activities carried on by members of this Association.

    This then is the year when it is fitting and proper for us to look at the connections between consumer protection in 1987 and the basic law of our country -- the U.S. Constitution of 1787. And there is more than one such connection.

    But first let us look at the situation which confronted the 55 men who struggled to produce the document which made us "one nation, indivisible."  The country was operating under the Articles of Confederation, which described itself as a "firm league of friendship" with a one chamber Congress as its legislative and administrative authority, but was in fact, neither firm nor friendly. From the start of the Revolution it was evident that this was an impractical arrangement. The weakness of the Continental Congress had prolonged the war. Its performance under the Confederation was even more frustrating.

    The following description of the state of the Union in 1787 is from the official brochure on the celebration 100 years ago.

    "The moment the pressure of war was removed weakness manifested itself in every direction. The States became jealous and suspicious of each other and disregarded their obligations to contribute to the common burden. Industrial depression existed to an alarming degree. Although it was proposed to amend the Articles of Confederation by vesting in Congress the exclusive power to regulate trade and collect duties, the pro-position was rejected. . . . Between every citizen and Congress stood the sovereignty of his state . . . there was in fact no citizenship of the United States and there was no national government."

    Our Constitution was written by practical men to deal with very real problems. Besides a basic plan of government with adequate powers, there were specific needs such as prohibiting interstate tariffs, providing for national uniformity in weights and measures, a postal system, a national monetary system, uniform bankruptcy laws, and powers to levy taxes, pay debts and provide for the defense and general welfare of the United States. All of these are specifically covered in Article I, Section 8, and this also contains a provision that established a connection with the institution now known as the Food and Drug Administration. It said: "Congress shall have power . . . to promote the Progress of Science and useful arts, by securing for limited times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries."

    From this provision eventually came the U.S. Patent Office, of which the Food and Drug Administration is a direct descendant. This surprising bit of government genealogy has an interesting history. Patents originated during the Middle Ages, and most countries had patent laws when out Constitution was written. So did the American colonies. As early as 1641 Massachusetts granted a patent to Samuel Winslow for a process of manufacturing salt.

    Under the first U.S. patent law, passed in 1790, patents were issued without examination to anyone who applied. So many infringements and law suits resulted that in 1836 Congress revised the law and created the Patent Office. Agriculture was the biggest industry of the nation and there were many applications for agricultural inventions. So from the start, the Patent Office was particularly interested in the science and progress of agriculture. Distribution of promising varieties of seeds was an early, routine activity. An Agricultural Division was established. Beginning in 1842 annual "Agricultural Reports" were published, covering such timely topics as The Philosophy and Chemistry of Manures; Administering Medicines to Domestic Animals; Destruction of Noxious Insects (by means of the new pesticide pyrethrum); and Some Thoughts Upon Farm Houses (with pictures and plans).

    In 1861 Isaac Newton, a Pennsylvania dairy farmer who supplied butter to the White House, was appointed Superintendent of the Agricultural Division. Newton had been a delegate to meetings of the United States Agricultural Society, where he had repeatedly introduced resolutions calling on Congress to establish a department of Agriculture. When the Department was created the following year, President Lincoln appointed Newton as the first commissioner of Agriculture, with a staff of nine transferred from the Patent Office. At the same time, Lincoln appointed Charles M. Wetherill to be the Chemist of the new Department. It was Mr. Wetherill who thus became the first employee and head of the governmental unit now known as the Food and Drug Administration!ÝHe took over a laboratory and brought in his own equipment to the basement of the 1835 Patent Office building at 8th and G Streets, now the home of the National Portrait Gallery.

    Organizationally connected with the Constitution through the Patent Office, the FDA has other roots in that document which have great importance to the consumer of today. Were the framers of our Constitution conscious of being "consumers"?

    Very much so. Remember the Boston tea Party? And the other tea parties, from Maine to Maryland? From an economic standpoint, the American revolution was basically a consumer movement, being a revolt against the British colonial system under which American consumers were forced to buy manufactured products from England, at British monopoly prices, while paying for them with American commodities at world market prices. Taxation without representation was not the only grievance which caused the colonies to seek their independence.

    The economic conditions were reflected in the food laws enacted by the colonial legislatures. These were mainly trade laws establishing inspections and standards of weights, measures, and quality for exported products, an effort to protect American goods from being downgraded on arrival overseas. Other laws set up barriers against competition from products from adjoining colonies.

    But laws to protect individual consumers were also needed and enacted. Bread laws like the centuries old "assizes" of England fixed the weight of loaves to sell for a penny, adjusted with the price of flour, and provided for inspections to enforce them. And in 1785, two years before the Constitutional Convention in Philadelphia, Samuel Adams, of Boston tea party fame, affixed his signature on a Massachusetts law to ban all kinds of food adulteration.

    Drug laws were virtually unknown, but Massachusetts and New York had passed identical medical practice laws in 1649 and 1684 that foretold such modern requirements as "second opinions" and "patient consent". And medical fraud could be dealt with under the common law, as in the case of Nicholas Knopp, who was criminally prosecuted and fined by Massachusetts in 1630 for selling "a water of noe worth nor value" as a cure for the scurvy.

    The writers of the Constitution were inclined to leave such matters to the discretion of the individual states, but not all of them. No topic had higher priority than the need to "regulate commerce." Overwhelmed with debt, the country was going through an acute postwar depression. The states were turning against each other, seeking revenue and commercial advantages from discriminatory tariffs and regulations. James Monroe, writing to his friend James Madison, said that unless a way could be found to "regulate trade and commerce" the country would "infallibly tumble to pieces." The only way out was to promote a national economy. In 1787 this meant a lot of different things interstate roads, bridges and canals, as well as freedom from interstate trade barriers. At the same time, the delegates were irrevocably committed to preserving the sovereignty of the states they represented. Without this state sovereignty there could be no agreement on a national constitution. So, the language they used was carefully considered. It gave to Congress the power "to regulate Commerce with foreign nations, and amongst the several states, and with the Indian tribes"; (Article I, Sec., 8). This language would eventually become the basis of U.S. food and drug laws, both the original act of 1906 and the present law passed in 1938 and amended many time since.

    The majority of the delegates were lawyers and almost all had been or were members of state legislatures or the Continental Congress. They knew that many laws would be needed to carry out the objectives of the new constitution. They even provided a way to change the Constitution itself. As Thomas Jefferson put it:

    "Laws and institutions must go hand in hand with the progress of the human mind; as that becomes more developed, more enlightened, as new discoveries are made, new truths discovered and manners and opinions changed with the change of circumstances, institutions must advance also to keep pace with the times."²

    Having drafted the Constitution, the next step was to explain its provisions to the people and persuade at least 9 of the 13 states that it should be adopted. Three of the leading advocates, Alexander Hamilton, John Jay, and James Madison, undertook a major role in that effort. No source of American history has greater importance than the 85 short articles they wrote under the general title of The Federalist. In No. 22 of the Federalist papers, Hamilton discussed two related topics: why regulation of interstate commerce was a necessary federal function, and why a Supreme Court was necessary to ensure uniformity of justice. "Laws are a dead letter," he wrote, "without courts to expound and define their true meaning and operation." Hamilton was discussing Article II: "The Judicial power of the United States shall be vested in one supreme court, and in such inferior courts as the Congress may from time to time ordain and establish. Sec. 2 lists the kinds of cases to be handled by the federal courts. Many of these would involve "commerce". No part of the Constitution has turned out to be more important to consumers than Article III, creating an independent judiciary. Generations later this would be demonstrated by landmark decisions of the Supreme Court in cases to enforce the Pure Food and Drug Act of 1906 and its successor, the Federal Food, Drug and Cosmetic Act of 1938.

    These laws were products of a long evolution. The writers of the Constitution could not have imagined the ways "interstate commerce" would grow and change in the next century. But as we have seen, the constitutional authors knew that frauds could be committed in purveying foods and medicines as well as other goods, and they devised means for dealing with such matters. Many years would pass, however, before interstate business in misbranded or adulterated foods and drugs would set off a demand for federal regulations.

    Constitutionally, the Pure Food and Drug Act of 1906 was designed to prohibit interstate commerce in adulterated or misbranded foods and drugs. The law defined adulteration and misbranding, but the courts were made responsible for deciding whether a particular product was adulterated or misbranded. There were hundreds of court cases. After 10 years, in 1917, the Annual Report said this:

    "The constitutionality of the Act has been questioned repeatedly without success. These cases and many others have clarified most of the provisions . . . though certain other pro-visions such as those dealing with 'compounds', 'blends', and 'imitations' still await inerpretation . . . ."

    Another seven years later, in 1924, the Supreme Court provided such an interpretation in a case about vinegar labeled "Made from Selected Apples" but actually made from from chopped dried apples:

"The statute is plain and direct. Its comprehensive terms condemn every statement, design and device which may mislead or deceive. Deception may result from the use of statements not technically false or which may be literally true. The aim of the statute is to prevent that resulting from indirection and ambiguity, as well as from statements which are false. It is not difficult to choose statements, designs, and devices which will not deceive. Those which are ambiguous -- and liable to mislead should be read favorably to the accomplishment of the purpose of the act. The statute applies to food, and the ingredients and substances therein. It was enacted to enable purchasers to buy food for what it really is."

    Often quoted, this paragraph is not all of what Justice Pierce Butler said. He concluded, ' . . . the method of manufacture is not material . . . And it makes no difference whether vinegar made from dried apples is or is not inferior to apple cider vinegar."

    Could anything be more important to consumers than the safety of foods? The "pure food" law of 1906 outlawed ingredients that were "poisonous or deleterious", but what was poisonous? or deleterious? Back in 1914, the U.S. Supreme Court established a policy which continues to be the foundation of an elaborate system of control for a host of "food additives". The government chemists had found that nitrites were produced in the process for aging and bleaching flour 1.8 parts in a million of flour, an amount which must have seemed very small indeed in those days. But nitrites are poisonous. The case was complex, but the main con-clusion of the court was simple. Congress intended the law to prohibit adding of substances which may render a food injurious to health.

    Flour may be used in many ways, the court said, "by the strong and the weak, the young and the old, the well and the sick, and it is intended that if any flour, because of any added poisonous or other deleterious ingredient, may possibly injure the health of any of these, it shall come within the ban of the statute." But this famous quotation, cited hundreds of times in briefs and court decisions then goes on to say: "If it cannot by any possibility, when the facts are reasonably considered, injure the health of any consumer, such flour, though bearing a small addition of poisonous or deleterious ingredients may not be condemned under the Act."

    This scientifically oriented decision provides a legal foundation for a great deal of modern food technology. No history of food regulation in the United States is complete without the story of U.S. v. Lexington Mill and Elevator Company.

    In 1943 the Supreme Court ruled that a drug company executive could be held personally responsible for violations by the corporation. Some very famous words were used in this opinion by Justice Felix Frankfurter:

    "The Food and Drug Act of 1906 was an exertion by Congress of its power to keep impure and adulterated food and drugs out of the channels of commerce. By the Act of 1938, Congress extended the range of its control over illicit and noxious articles and stiffened the penalties for disobedience. The purposes of this legislation thus touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words. . . . Such legislation dispenses with the conventional requirement for criminal conduct awareness of some wrongdoing. In the interest of the larger good it puts the burden of acting at hazard upon a person otherwise innocent but standing in responsible relation to a public danger."

    "Hardship there doubtless may be under a statute which thus penalized the transaction, though consciousness of wrongdoing may be totally wanting. Balancing relative hardship, Congress has preferred to place it upon those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers rather than to throw the hazard on the innocent public who are wholly helpless."

    Writers of the Constitution, at least some of them, would have found this strange doctrine. Today, in the "circumstances of modern industrialism" it is generally accepted that industry management has the primary responsibility for consumer protection under the food and drug law. Management is expected to anticipate that things can go wrong, and to take reasonable precautions to prevent such happenings. Regulations spell out the procedures.

    Many other cases could be cited to illustrate how the constitutional power to interpret the law in the light of changing conditions has enhanced consumer protection. Even the decisions which went against the Government have promoted the protection of the consumer by causing Congress to make needed changes.

    The powers which the Constitution reserved to the States or the people are very important. When signed at Philadelphia the Constitution did not contain the first 10 amendments known as the "Bill of Rights". The debates over ratification soon made it clear that the people demanded these guarantees of the liberties they had fought for in the Revolution. Fresh in their minds were such abuses as the quartering of British troops in private homes and suppression of rights to jury trials, free speech, and press. And, to guarantee the powers of the states, Amendment 10 declares that "the powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people."

    One power that the states have is the police power. Under this power, each state has the authority to enact and enforce statutes, such as food and drug laws, for the health, safety and welfare of its citizens, as long as those statutes do not conflict with federal law. Constitutionally, state governments can do anything that the Federal Food and Drug Administration does and a great deal more. The states can act directly and immediately against harmful products under their police power. For example, "embargo" power, inherited from colonial times, enables the states to give invaluable aid to the FDA by detaining suspected products until the federal authorities are able to act.

    In the event of a conflict between state and federal law, Article VI, Clause 2 of the Constitution (the so called "Supremacy Clause") dictates that the federal law is the supreme law of the land. In addition, courts sometimes, under the commerce clause, strike down inconsistent state laws that are an unreasonable burden on interstate commerce. In making these decisions, reviewing courts examine the legislative history and the purpose effect of the statute in question. In determining whether state laws are preempted, courts also pay attention to the express intentions of the agency in promulgating regulations under the statute and to the pervasiveness of the resulting regulatory scheme.

    Nowhere in the Constitution can one find the word "health", though people at the time were profoundly concerned about all sorts of health problems. For example, quarantine laws were a common defense against contagious diseases,Ýand smallpox inoculations were authorized by law and conducted on a mass basis. Today we continue to depend on the states to carry on numerous activities to protect the public health establishing educational qualifications and licensing health professionals of every kind; protecting and regulating public water supplies, milk producers, public eating places, and retail food establishments. True, there are problems of overlapping jurisdiction but on the whole these are insignificant in view of the effectiveness of federal state cooperation.

    Frequently it is said that the Revolution gave us freedom, and the Constitution is the means to keep it. Why is this so?ÝWhat makes our Constitution so special?ÝCertainly one reason is the fact that it has become a living constitution -- one that enriches our daily lives by enabling us to devise new solutions and resolve our differences. The fundamental fact is that FDA started life as a scientific institution. When Harvey W. Wiley became chief of the Division of Chemistry in 1883, its research was almost entirely aimed at product development. Dr. Wiley became and will forever be remembered as the father of the U.S. food and drug law. But his predecessors should no be forgotten. If the Agency were to adopt a motto, it could well read "Science Working Through Law to Protect Consumers". For its basic mission is still one found in the Constitution: "To Promote the Progress of Science and the useful Arts."
 

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1 Presented at the 91st Annual Meeting of the Association of Food & Drug Officials, Tulsa, Oklahoma, June 24, 1987.

2 Jefferson was not a delegate.