| 1902 - "The BIOLOGICS CONTROL ACT
is passed to ensure purity and safety of serums, vaccines,
and similar products used to prevent or treat diseases
in humans." (FDA
website)
1905 - Pure Food and Drug Act (from full
text)
For preventing the manufacture,
sale, or transportation of adulterated or misbranded
or poisonous or deleterious foods, drugs, medicines,
and liquors, and for regulating traffic therein, and
for other purposes.
Provisions for drugs:
- That the term "drug," as used in this Act,
shall include all medicines and preparations recognized
in the United States Pharmacopoeia or National Formulary
for internal or external use, and any substance or
mixture of substances intended to be used for the cure,
mitigation, or prevention of disease of either man
or other animals.
- That for the purposes of this Act an article shall
be deemed to be adulterated: In case of drugs:
- First. If, when a drug is sold under or by a
name recognized in the United States Pharmacopoeia
or National Formulary, it differs from the standard
of strength, quality, or purity, as determined
by the test laid down in the United States Pharmacopoeia
or National Formulary official at the time of investigation:
Provided, That no drug defined in the United States
Pharmacopoeia or National Formulary shall be deemed
to be adulterated under this provision if the standard
of strength, quality, or purity be plainly stated
upon the bottle, box, or other container thereof
although the standard may differ from that determined
by the test laid down in the United States Pharmacopoeia
or National Formulary.
- Second. If its strength or purity fall below
the professed standard or quality under which it
is sold.
- That for the purposes of this Act an article shall
also be deemed to be misbranded: In case of drugs:
- First. If it be an imitation of or offered for
sale under the name of another article.
- Second. If the contents of the package as originally
put up shall have been removed, in whole or in
part, and other contents shall have been placed
in such package, or if the package fail to bear
a statement on the label of the quantity or proportion
of any alcohol, morphine, opium, cocaine, heroin,
alpha or beta eucaine, chloroform, cannabis indica,
chloral hydrate, or acetanilide, or any derivative
or preparation of any such substances contained
therein.
Copied from the history
section of the FDA website:
1912 - Congress enacts the SHERLEY AMENDMENT to
over come the ruling in U.S. v. Johnson. It prohibits
labeling medicines with false therapeutic claims intended
to defraud the purchaser, a standard difficult to prove.
1938 - THE FEDERAL FOOD, DRUG, AND COSMETIC
(FDC) ACT of
1938 is passed by Congress, containing new provisions:
- Extending control to cosmetics and therapeutic devices.
- Requiring new drugs to be shown safe before marketing-starting
a new system of drug regulation.
- Eliminating the Sherley Amendment requirement to prove
intent to defraud in drug misbranding cases.
- Providing that safe tolerances be set for unavoidable
poisonous substances.
- Authorizing standards of identity, quality, and fill-of-container
for foods.
- Authorizing factory inspections.
- Adding the remedy of court injunctions to the previous
penalties of seizures and prosecutions.
Under the WHEELER-LEA ACT, the Federal
Trade Commission is charged with overseeing advertising
associated with products otherwise regulated by FDA, with
the exception of prescription drugs.
1962
- KEFAUVER-HARRIS DRUG AMENDMENTS passed
to ensure drug efficacy and greater drug safety. For the
first time, drug manufacturers are required to prove to
FDA the effectiveness of their products before marketing
them. The new law also exempts from the Delaney proviso
animal drugs and animal feed additives shown to induce
cancer but which leave no detectable levels of residue
in the human food supply. |