Food Drug and Cosmetic Act Flashcards
pure food and drug act
aka the wiley act
attempted to prohibit the adulteration and misbranding of foods and drugs in interstate commerce, but unfortunately, it did not provide complete protection and it did not provide the FDA the ability to ban unsafe drugs
sherley amendment to pure food and drug act
prevented false or misleading label claims of therapeutic effectiveness
sulfanilamide tragedy of 1937
antibiotic mixed with diethylene glycol (poisonous to humans, used in antifreeze)
caused 107 deaths
sulfanilamide tragedy led to the passing of
food drug and cosmetic act of 1938
sulfanilamide tragedy was an example of misbranding or adulteration
misbranding
(stated it was an elixir, but it did not contain alcohol)
misbranding
(stated it was an elixir, but it did not contain alcoho
federal food and drug cosmetic act (FDCA)
requirements of FDCA
- no new drugs can be marketed until proven safe under conditions on label and approved
- misbranding/adulteration requirements
- authority for factory inspections/enforcement
- includes devices and cosmetics
- Pre 1938 drugs exempt
drug definition
Articles intended for use in the diagnosis, cure,mitigation, treatment, or prevention of disease in manor other animals by affecting the structure or anyfunction of the body
device definition
Instrument, apparatus, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis of disease or other conditions, orin the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its primary intended purposes through chemical action within or on the body.
cosmetic definition
Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance and articles intended for use as a component of such articles, butnot including soap
is soap a cosmetic
no
food definition
Raw, cooked, or processed edible substance, ice,beverage, or ingredient used or intended for use or for sale in whole or in part for human consumption, or chewing gum
is chewing gum a food
yes
drug means
- (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
- (B) articles intended for use in the diagnosis,cure, mitigation, treatment, or prevention of disease in man or other animals; and
- (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
- (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).
t/f definition of a drug depends on its actual use, not its intended use
t/f definition of a drug depends on its actual use, not its intended use
the critical issue in determining whether a product is a drug is..
if the supplier made a health claim
t/f cigarettes are drugs
t/f cigarettes are drug
how does the court determine the suppliers intent?
claims on labeling, claims while advertising, if product is marketed as a injection, capsule, or tablet
t/f drugs can be chemical or nonchemical
t
dietary supplement health and education act (DSHEA)
Created a category for dietary supplements and specifiesFDA’s authority to regulate them as a special type of foodinstead of a drug
Created a category for dietary supplements and specifiesFDA’s authority to regulate them as a special type of foodinstead of a drug
food
T/F FDA can not require premarket approval for dietary supplements
T
T/F the fda is responsible for determining if a dietary supplement is safe and if its claims are substantiated by adequate evidence
false
the manufacturer is responsible
in order to remove a dietary supplement from the market the _____ must prove it is unsafe
fda
definition of a dietary supplement under DSHEA
A product that is intended for ingestion, is intended to supplement the diet and containsany one or more of the following:
- A vitamin
- A mineral
- An herb or other botanical
- An amino acid
- A dietary substance for use by humans to supplement the diet by increasing the total dietary intake
- A concentrate, metabolite, constituent,extract, or combination of the previous
is the following a drug or dietary supplement:
cranberry tablets increase the acidity of urine and. help maintain a healthy urinary tract
dietary supplement
is the following a drug or dietary supplement:
cranberry tablets prevent UTIs
drug
label definition
The term “label” means a display of written, printed, or graphic matter upon the immediate container of any article;and a requirement made by or under authority of this chapter that any word,statement, or other information appear on the label shall not be considered to be complied with unless such word,statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
labeling definition
The term “labeling” means all labels and other written, printed, or graphic matter
* (1) upon any article or any of its containers or wrappers, or
* (2) accompanying such article.
