FDA Violation of the Rule of Law - Emord & Associates
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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