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While
Wiley was stumping for a law, muckraking journalists such as
Samuel Hopkins Adams exposed in vivid detail the hazards of
the marketplace. In fact, the nauseating condition of the meat-packing
industry that Upton Sinclair captured in The Jungle
was the final precipitating force behind both a meat inspection
law and a comprehensive food and drug law. (A poster of the
1913 movie adaptation of Sinclair's novel is pictured at right,
courtesy of the Sinclair Archives, Lilly Library, Indiana University,
through James Harvey Young's Pure Food: Securing the Federal
Food and Drugs Act of 1906.) Since 1879, nearly 100 bills
had been introduced in Congress to regulate food and drugs;
on 30 June 1906 President Roosevelt signed the Food and Drugs
Act, known simply as the Wiley Act, a pillar of the Progressive
era.
This act, which the Bureau of Chemistry was charged to administer,
prohibited the interstate transport of unlawful food and drugs
under penalty of seizure of the questionable products and/or
prosecution of the responsible parties. The basis of the law
rested on the regulation of product labeling rather than pre-market
approval. Drugs, defined in accordance with the standards of
strength, quality, and purity in the United States Pharmacopoeia
and the National Formulary, could not be sold in any
other condition unless the specific variations from the applicable
standards were plainly stated on the label. Foods were not defined
according to analogous standards, but the law prohibited the
addition of any ingredients that would substitute for the food,
conceal damage, pose a health hazard, or constitute a filthy
or decomposed substance. Interpretations of the food provisions
in the law led to many, sometimes protracted, court battles.
If the manufacturer opted to list the weight or measure of a
food, this had to be done accurately. Also, the food or drug
label could not be false or misleading in any particular, and
the presence and amount of eleven dangerous ingredients, including
alcohol, heroin, and cocaine, had to be listed.
The bureau's regulatory emphasis under Wiley centered on foods,
which he believed posed a greater public health problem than
adulterated or misbranded drugs. Wiley generally held a dim
view of chemical additives to foods, championing an approach
that considered most to be unnecessary adulterants. On this
he clashed often with Secretary of Agriculture James Wilson,
and on occasion President Roosevelt himself had to decide government
policy on food regulation. Wiley's personal administrative authority
under the act was diluted early on when Wilson created a Board
of Food and Drug Inspection in 1907 to establish agency policy
in enforcing the law. Similarly, the creation of the Referee
Board of Consulting Scientific Experts in the following year
to advise the department on safety issues associated with food
additives undercut Wiley's scientific authority. The bureau
had been developing informal standards for many foods in collaboration
with outside experts since 1903, an activity that continued
after the 1906 act. However, courts differed on the role these
informal standards could play in cases. Separate laws established
standards for some specific foods, such as apples and butter,
as well as for canned foods.
Burton J. Howard, chief of the Bureau of Chemistry's
microchemical laboratory, is shown in the right foreground
in this photo from the 1920s. Howard developed a quantitative
method to detect mold in ketchup that proved to be indispensable
in establishing food adulteration in court. |
After Wiley's resignation in 1912, the bureau devoted more effort
to drug regulation, with some emphasis on the so-called patent
medicines. While the law was much clearer about drug standards
than standards for foods, misbranding was the source of considerable
controversy in the regulation of drugs. A year earlier the Supreme
Court ruled that the law did not--contrary to the government's
interpretation--apply to false therapeutic claims. An amendment
in the year of Wiley's resignation attempted to correct the
language of the law. But it put the bureau in the difficult
position of attempting to prove in court that manufacturers
of drugs labeled with false therapeutic claims intended to defraud
consumers. The bureau lost several cases against egregious products,
but seizures of misbranded and adulterated drugs nevertheless
increased in the 1920s and 1930s.
Next: The 1938 Food, Drug, and Cosmetic
Act
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