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Cosmetics and medical devices, which the Post Office Department
and the Federal Trade Commission had overseen to a limited extent
prior to 1938, came under FDA authority as well after 1938.
While pre-market approval did not apply to devices, in every
other sense the new law equated them to drugs for regulatory
purposes. As the FDA had to deal with both increasing medical
device quackery and a proliferation of medical technology in
the post-World War II years, Congress considered a comparable
device law when it passed the 1962 drug amendments.
Quack products were the subject of most of FDA's device
regulatory actions until the 1960s. Pictured here are
assorted versions of orgone accumulators, developed by
psychiatrist Wilhelm Reich to collect what he believed
was an ethereal substance in the atmosphere vital to health
and longevity. |
The legislation having failed to develop, the Secretary of
HEW commissioned the Study Group on Medical Devices, which recommended
in 1970 that medical devices be classified according to their
comparative risk, and regulated accordingly. The 1976 Medical
Device Amendments, coming on the heels of a therapeutic disaster
in which thousands of women were injured by the Dalkon Shield
intrauterine device, provided for three classes of medical devices,
each requiring a different level of regulatory scrutiny--up
to pre-market approval.
The 1938 act required colors to be certified as harmless and
suitable by the FDA for their use in cosmetics. The 1960 color
amendments strengthened the safety requirement for color additives,
necessitating additional testing for many existing cosmetics
to meet the new safety standard. The FDA attempted to interpret
the new law as applying to every ingredient of color-imparting
products, such as lipstick and rouge, but the courts rebuffed
this proposal.
Another agency responsibility, veterinary medicine, had been
stipulated since the 1906 act; foods included animal feed, and
drugs included veterinary pharmaceuticals. Likewise, animal
drugs were included in the provisions for new drugs under the
1938 law and the 1962 drug amendments. However, the Food Additives
Amendment of 1958 had an impact too, since drugs used in animal
feed were also considered additives--and thus subject to the
provisions of the food additive petition process. The Delaney
Clause prohibiting carcinogenic food additives was modified
by the DES proviso in 1962, named for diethylstilbestrol, a
hormone used against miscarriages in humans and to promote growth
in food-producing animals. The proviso permitted the use of
possible carcinogens in such animals as long as residues of
the product did not remain in edible tissues. The Animal Drug
Amendments of 1968 combined veterinary drugs and additives into
a unified approval process under the authority of the Bureau
of Animal Drugs in the FDA.
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TenDay Press-On Nail Polish generated
at least 700 consumer complaints in 1957, including several
cases in which the nails broke off or split down to the
quick. In February 1958, following an FDA press release
warning against these synthetic nails, the manufacturer
launched a nationwide recall of the goods. |
Next: Trends in the Last Quarter-Century
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