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FDA Violation of the Rule of Law - Emord & Associates
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FDA VI OLATI ON OF THE RULE OF LAW [ 1]
By Jonathan W. Emord

Many thanks to the Richmond Health Freedom Expo for inviting me to speak and to the Talk Star Radio Network for broadcasting and webcasting this presentation live over that network. Today we discuss the Food and Drug Administration's violations of the rule of law.

The FDA is an executive branch agency, the beneficiary of vast legislative powers delegated to it by Congress. It is also the repository of powers not delegated by Congress that FDA has usurped beyond the limits of its enabling statute throughout its 68 year history. The Commissioner of FDA sits at the pleasure of the President. The FDA is one of the largest and most powerful federal

bureaucracies. It regulates over $1 trillion dollars of goods. The products under its jurisdiction
account for 25 cents of every dollar spent by American consumers. FDA has approximately ten
thousand employees and 26 district offices across the United States. The United States Attorneys
and federal marshals are at its disposal and can obtain search and seizure warrants to be
exercised without any advance notice against any company that sells a food, dietary supplement,
drug, or medical device in the United States.
To understand how FDA has acquired so much power in a government designedly of limited

powers, we have to appreciate the agency's place in history. Indeed, we have to start with the
origins of American constitutional government, 151 years before the FDA came into existence, to
appreciate the perversion of the Framers' plan effected by the modern FDA. We must follow
America's late 18th Century rejection of the arbitrary will of King George III, its embrace of a
written Constitution where the law and a system of separation of powers and checks and balances
were supposed to prevent the accumulation of tyrannical power in any one set of hands. We must
then observe the rise of independent regulatory commissions in the Twentieth Century and how
those commissions united legislative, executive, and judicial powers into single hands in violation
of our founding principles. We must then come to see how FDA in particular exemplifies the
arbitrary rule of people in power over the rule of law.

The Framers of our Constitution prohibited the federal government from delegating legislative
power from the duly elected representatives of Congress to any other entity. They warned that if
legislative power were combined with executive power, or if legislative power were combined with
judicial power, our republic would become an oligarchy and the rights of the people would be
sacrificed to achieve the selfish ends of those who govern.

In February of 1776, a pamphlet came to be published in Philadelphia that would outsell every
other up to that time in the American colonies and would achieve resounding popularity
throughout Europe. It was Common Sense. Written anonymously by Thomas Paine, that
pamphlet became the most influential tract in revolutionary America. In it Paine explained the
quintessential defining principle of our polity, the very reason why we could not endure the
arbitrary will of King George III and would rebel to form a new nation. He begged for revolution
against Great Britain because the King had usurped rights and powers of the people and had
replaced the rule of law with his arbitrary will. Paine wrote:

But where . . . is the King of America? I'll tell you Friend, he reigns above, and
doth not make havoc of mankind like the Royal Brute of Britain. Yet that we may
not appear to be defective in earthly honors, let a day be solemnly set apart for
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FDA Violation of the Rule of Law - Emord & Associates
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proclaiming the charter. . . . that in America the law is King. For as in absolute governments the King is law, so in free countries the law ought to be King; and there ought to be no other.

The defining principle of the American republic was that governments are instituted among men
to protect the rights of the governed, that to accomplish that task governmental powers must be

limited and defined in written law and separated in the hands of independent legislative,
executive, and judicial departments with a system of checks and balances to prevent the
accumulation of the separate powers into any single department. The French philosopher
Montesquieu argued for the separation of powers in his 1748 treatise The Spirit of the Laws. That
book greatly influenced the founding fathers, as did endorsements of the doctrine by John Locke
and other British Whig writers of the 18th Century. Historian Forrest McDonald explains that all
leading politicos of the Founding Era "could recite central points of Montesquieu's doctrine of
separation of powers as if it had been a catechism." In The Spirit of the Laws Montesquieu wrote:

[ T] here is no liberty if the power of judging be not separated from the legislative
and executive powers. Were it joined with the legislative, the life and liberty of
the subject would be exposed to arbitrary control, for the judge would then be the
legislator. Were it joined to the executive power, the judge might behave with all
the violence of an oppressor. . . . There would be an end of everything were the
same man, or the same body . . . to exercise those three powers . . . of enacting
laws . . . of executing [ laws] . . . and . . . of judging the crimes or differences of

individuals. . . .

In Federalist No. 47, James Madison argued for the rule of law over the arbitrary will of those in
power, explaining that our Constitution would define "a government of laws and not of men." The
phrase, common among the founding generation, meant that there was to be no place in
government for the exercise of arbitrary will over the lives, liberties, or properties of the
American people. Just as we were to be ruled by laws, our law itself was to be the product of
separate, competing legislative, executive, and judicial power centers; never were any two of
those powers to be combined in a single center. Madison wrote, "[ t] he accumulation of all
powers, legislative, executive, and judicial, in the same hands, whether of one, few, or many, and
whether hereditary, self-appointed, or elected, may justly be pronounced the very definition of
tyranny." Typical of the Federalists who advocated ratification of the Constitution, Alexander
Hamilton explained that the separation of powers was "itself, in every rational sense, and to
every useful purpose, A BILL OF RIGHTS." It would deny a single department autonomous
governance. It would keep abuse of power in check by humbling those in government with the
need to satisfy the dictates of competing power centers.

Like Montesquieu, the Framers viewed political liberty as a condition in which
citizens are free from arbitrary power and can expect to be secure in their
persons and property. As Montesquieu put it in The Spirit of the Laws, "[ t] he
political liberty of the subject is a tranquility of mind, arising from the opinion
each person has of his safety." Concentration of two or more of the three classes
of power--legislative, executive, judicial--in a single organ of government would
destroy that tranquility for reasons that John Adams expressed succinctly in a

pamphlet published in 1776: "Because a single assembly, possessed of all the
powers of government, would make arbitrary laws for their own interest, execute
all laws arbitrarily for their own interest, and adjudge all controversies in their
own favor."

Indeed, liberty depends on the secure knowledge that the rule of law governs over the arbitrary will of those in power. The separation of powers assures that no single power center may create, execute, and judge the law but must obtain the consent of the other, independent power centers to achieve those ends. When the separation of powers and the system of checks and balances is gone, so is the security needed for the preservation of liberty from the arbitrary will of those in government.

From 1787 until 1937, the constitutional law of this country prohibited administrators from

possessing combined legislative, executive, and judicial powers, but for the last 69 years, the
Separation of Powers doctrine has been largely abandoned in favor of oligarchic rule by the
independent regulatory commissions. That rule has produced rights violations, massive transfers
of wealth from private to public hands, government protectionism for industry leaders over new

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market entrants, vast corruption, and explosive growth in the size and scope of the federal
government. The independent regulatory commissions, and the FDA in particular, are destroying
free enterprise and individual liberty in America.

So what happened in 1937 to undue the Framers' constitutional design, the separation of powers
doctrine?
Accepting the Republican nomination for President in 1928, Herbert Hoover with great

exuberance and confidence predicted, "We in America today are nearer to the final triumph over
poverty than ever before in the history of any land. The poorhouse is vanishing from us." Eight
months later, on October 29, 1929, the stock market crashed signaling the start of the Great
Depression, an economic collapse that reverberated worldwide. From 1929 to 1933, the United
States gross national product declined from $104 billion to $56 billion. By 1933, unemployment
reached 33% (roughly 16 million Americans out of work). President Hoover lost his re-election bid

to Franklin Delano Roosevelt on Roosevelt's promise of a New Deal to end widespread poverty
through government largesse.

Shortly after his inauguration in March of 1933, President Roosevelt proposed laws that granted
sweeping legislative, executive, and judicial powers to new executive branch agencies. Although
the Supreme Court upheld many of these laws, it refused to do so in the 1935 A.L.A. Schechter
Poultry Corp. v. U.S. decision. Schechter Poultry struck down Roosevelt's National Industrial
Recovery Act of 1933. A unanimous Court held that Title I of the NIRA constituted an
"unconstitutional delegation of legislative power to the executive." Chief Justice Charles Evans

Hughes wrote for the Court: "Congress is not permitted to abdicate or to transfer to others the

essential legislative function with which it is thus vested." In a concurrence, Justice Benjamin
Cardozo referred to the industrial code provisions of the NIRA as "delegation [ of power] running
riot." The Court thus demanded adherence to the separation of powers doctrine embodied in the

Constitution.
The Court's actions did not sit well with President Roosevelt. Following his re-election to office and
preceding his plans for the enactment of additional executive branch agencies invested with
legislative, executive, and judicial powers, President Roosevelt proposed the Judiciary

Reorganization Act of 1937. The Act would give President Roosevelt the power to appoint an extra
Supreme Court Justice for every sitting Justice over the age of 70 and six months. Six of the
Justices on the High Court were over 70 and six months. The Justices predisposed against
delegation had held a slim one vote majority (5 to 4). Roosevelt's threatened court packing plan
never was enacted but the threat alone provoked the desired response. It produced what the
media of that day referred to as "the switch in time that saved nine." Justice Owen J. Roberts who
favored the conservative wing of the Court (the so-called Four Horsemen, Justices James Clark
McReynolds; George Sutherland; Willis Van DeVanter; and Pierce Butler) voted with the liberal
wing of the Court (the so-called Three Musketeers, Justices Louis Brandeis; Benjamin Cardozo;
and Harlan Stone). Within a year, conservative Justices Van DeVanter and Sutherland retired,

replaced by the pro-New Deal Justices Hugo Black and Stanley Reed.

That shift in the Court's alignment led to the near total erosion of the separation of powers
doctrine, resulting in massive legislative delegations of power to independent regulatory
commissions, among them the U.S. Food and Drug Administration.

Over the years independent regulatory commissions have not only come to exercise powers
intended to be vested in Congress but they have also become legislatures themselves--
promulgating regulations that exceed statutory limits and running roughshod over individual
liberties designedly protected by the Bill of Rights. The rule of law has been replaced by the
arbitrary will of unelected and unaccountable federal bureaucrats. The FDA is an excellent case in
point.
Congressional delegations of legislative power to FDA, and FDA usurpations of power, often occur
following either a real or supposed public health crisis involving a regulated product.
Federal drug regulation was of trifling import until 1937. In that year an attempt by the
Massengill Company to reformulate a sulfa drug into a liquid form resulted in the deaths of 107
children. The company sold the liquid drug in a syrup that included diethylene glycol as a solvent.
That is anti-freeze. Although Massengill was convicted of gross negligence, the Roosevelt
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There is no remedy in sight. Sorry for the typos. It's been a long day. patrons99

You may wish to see my recent postings to scribd. They support your dissertation. Their is no remedy in site. Governments should fear their People. Perhaps we should talk. patrons99

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