PPLE MODULE 2
The sulfanilamide elixir tragedy of 1937 resulted in the government passing the Food,
Drug and Cosmetic Act (FDCA) of 1938 that specified which one of the following: -
answer That new drugs must have FDA approval prior to marketing
Which of the following accurately describe(s) the FDA today? - answer The agency
regularly relies on advice from outside experts
The agency is housed under DHHS
A manufacturer of an industrial solvent promoted that its product when applied to the
skin would cure eczema, but specifically proclaimed that its product is a solvent, not a
drug. The FDA is investigating whether the product should be considered as a drug.
Which of the following would be the best answer regarding the claim to cure eczema. -
answerThe claim to cure eczema would likely make the product a drug and the
proclamation is irrelevant
Assume in the above example that the manufacturer made no claim or representation
about its product for the use in eczema, but rather a consumer accidently found it
effective for treating eczema and advertised this result on the Internet. Which would be
correct? - answerThe FDA would not likely regard the product as a drug
Part C of the drug definition excludes food from articles intended to affect the function or
structure of the body. Congress likely intended which of the following by this exclusion: -
answerThat foods are only excluded when used for their ordinary purpose as foods
Infant formulas best fit under the definition of: - answerSpecial dietary food
A manufacturer made a powder from corn stalks and compressed it into tablets for oral
use. The manufacturer made no claims or representations about the product. This
product could best be described as: - answerDietary supplement
8: In the above example, assume that the manufacturer promoted the product for the
purpose of improving gastric motility. This claim would likely mean that the product
would be considered: - answerA dietary supplement
A manufacturer made a health claim for its dietary supplement product that has never
been approved by the FDA by regulation or through the significant scientific agreement
test. Evidence does exist, however, to support the claim. Which of the following would
be correct as a result of the Pearson decision? - answerThe FDA would not allow the
claim
The sulfanilamide elixir tragedy of 1937 resulted in the government passing the Food,
Drug and Cosmetic Act (FDCA) of 1938 that specified which one of the following: -
answer That new drugs must have FDA approval prior to marketing
Which of the following accurately describe(s) the FDA today? - answer The agency
regularly relies on advice from outside experts
The agency is housed under DHHS
A manufacturer of an industrial solvent promoted that its product when applied to the
skin would cure eczema, but specifically proclaimed that its product is a solvent, not a
drug. The FDA is investigating whether the product should be considered as a drug.
Which of the following would be the best answer regarding the claim to cure eczema. -
answerThe claim to cure eczema would likely make the product a drug and the
proclamation is irrelevant
Assume in the above example that the manufacturer made no claim or representation
about its product for the use in eczema, but rather a consumer accidently found it
effective for treating eczema and advertised this result on the Internet. Which would be
correct? - answerThe FDA would not likely regard the product as a drug
Part C of the drug definition excludes food from articles intended to affect the function or
structure of the body. Congress likely intended which of the following by this exclusion: -
answerThat foods are only excluded when used for their ordinary purpose as foods
Infant formulas best fit under the definition of: - answerSpecial dietary food
A manufacturer made a powder from corn stalks and compressed it into tablets for oral
use. The manufacturer made no claims or representations about the product. This
product could best be described as: - answerDietary supplement
8: In the above example, assume that the manufacturer promoted the product for the
purpose of improving gastric motility. This claim would likely mean that the product
would be considered: - answerA dietary supplement
A manufacturer made a health claim for its dietary supplement product that has never
been approved by the FDA by regulation or through the significant scientific agreement
test. Evidence does exist, however, to support the claim. Which of the following would
be correct as a result of the Pearson decision? - answerThe FDA would not allow the
claim
