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With
the election of Franklin Roosevelt and the death in 1930 of
the embodiment of the 1906 act--Wiley--the FDA now had a receptive
ear to petition for needed changes in the law: legally mandated
quality and identity standards for foods, prohibition of false
therapeutic claims for drugs, coverage of cosmetics and medical
devices, clarification of the FDA's right to conduct factory
inspections, and control of product advertising, among other
items. A new generation of muckraking journalists and consumer
protection organizations aided in pushing a reluctant Congress
to sponsor a bill to replace the old law. The FDA itself exemplified
the state of affairs in the marketplace by assembling a collection
of products that illustrated shortcomings in the 1906 law.
It included Banbar, a worthless "cure" for diabetes that the
old law protected; Lash-Lure, an eyelash dye that blinded
some women (see illustration at right); numerous examples
of foods deceptively packaged or labeled; Radithor, a radium-containing
tonic that sentenced users to a slow and painful death; and
the Wilhide Exhaler, which falsely promised to cure tuberculosis
and other pulmonary diseases. A reporter dubbed this exhibit "The
American Chamber of Horrors," a title not far from the truth
since all the products exhibited were legal under the existing
law.
Languishing in Congress for five years, the bill that would
replace the 1906 was ultimately enhanced and passed in the wake
of a therapeutic disaster in 1937. A Tennessee drug company
marketed a form of the new sulfa wonder drug that would appeal
to pediatric patients, Elixir
Sulfanilamide. However, the solvent in this untested product
was a highly toxic chemical analogue of antifreeze; over 100
people died, many of whom were children. The
public outcry not only reshaped the drug provisions of the new
law to prevent such an event from happening again, it propelled
the bill itself through Congress. This was neither the first
nor the last time Congress presented a public health bill to
a president only after a therapeutic disaster. FDR (pictured
at left) signed the Food, Drug, and Cosmetic Act on 25 June
1938.
The new law brought cosmetics and medical devices under control,
and it required that drugs be labeled with adequate directions
for safe use. Moreover, it mandated pre-market approval of all
new drugs, such that a manufacturer would have to prove to FDA
that a drug were safe before it could be sold. It irrefutably
prohibited false therapeutic claims for drugs, although a separate
law granted the Federal Trade Commission jurisdiction over drug
advertising. The act also corrected abuses in food packaging
and quality, and it mandated legally enforceable food standards.
Tolerances for certain poisonous substances were addressed.
The law formally authorized factory inspections, and it added
injunctions to the enforcement tools at the agency's disposal.
Next: Drugs and Foods Under the 1938
Act and Its Amendments
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