Food Drug and Cosmetic Act

Question 1

pure food and drug act
aka the wiley act

Answer 1

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

Question 2

sherley amendment to pure food and drug act

Answer 2

prevented false or misleading label claims of therapeutic effectiveness

Question 3

sulfanilamide tragedy of 1937

Answer 3

antibiotic mixed with diethylene glycol (poisonous to humans, used in antifreeze)
caused 107 deaths

Question 4

sulfanilamide tragedy led to the passing of

Answer 4

food drug and cosmetic act of 1938

Question 5

sulfanilamide tragedy was an example of misbranding or adulteration

Answer 5

misbranding
(stated it was an elixir, but it did not contain alcohol)

Question 6

misbranding
(stated it was an elixir, but it did not contain alcoho

Answer 6

federal food and drug cosmetic act (FDCA)

Question 7

requirements of FDCA

Answer 7

1. no new drugs can be marketed until proven safe under conditions on label and approved
2. misbranding/adulteration requirements
3. authority for factory inspections/enforcement
4. includes devices and cosmetics
5. Pre 1938 drugs exempt

Question 8

drug definition

Answer 8

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

Question 9

device definition

Answer 9

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.

Question 10

cosmetic definition

Answer 10

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

Question 11

is soap a cosmetic

Answer 11

no

Question 12

food definition

Answer 12

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

Question 13

is chewing gum a food

Answer 13

yes

Question 14

drug means

Answer 14

• (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).

Question 15

t/f definition of a drug depends on its actual use, not its intended use

Answer 15

t/f definition of a drug depends on its actual use, not its intended use

Question 16

the critical issue in determining whether a product is a drug is..

Answer 16

if the supplier made a health claim

Question 17

t/f cigarettes are drugs

Answer 17

t/f cigarettes are drug

Question 18

how does the court determine the suppliers intent?

Answer 18

claims on labeling, claims while advertising, if product is marketed as a injection, capsule, or tablet

Question 19

t/f drugs can be chemical or nonchemical

Answer 19

t

Question 20

dietary supplement health and education act (DSHEA)

Answer 20

Created a category for dietary supplements and specifiesFDA’s authority to regulate them as a special type of foodinstead of a drug

Question 21

Created a category for dietary supplements and specifiesFDA’s authority to regulate them as a special type of foodinstead of a drug

Answer 21

food

Question 22

T/F FDA can not require premarket approval for dietary supplements

Answer 22

T

Question 23

T/F the fda is responsible for determining if a dietary supplement is safe and if its claims are substantiated by adequate evidence

Answer 23

false
the manufacturer is responsible

Question 24

in order to remove a dietary supplement from the market the _____ must prove it is unsafe

Answer 24

fda

Question 25

definition of a dietary supplement under DSHEA

Answer 25

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

Question 26

is the following a drug or dietary supplement:

cranberry tablets increase the acidity of urine and. help maintain a healthy urinary tract

Answer 26

dietary supplement

Question 27

is the following a drug or dietary supplement:

cranberry tablets prevent UTIs

Answer 27

drug

Question 28

label definition

Answer 28

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.

Question 29

labeling definition

Answer 29

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.