The Legal Environment of Business 11th Edition by Roger E. Meiners Ringleb test bank

The Legal Environment of Business  11th Edition by Roger E. Meiners Ringleb  test bank
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Chapter 19

Consumer Protection

TEST BANK

1. The government agency charged with monitoring food and drug safety is the:
a. Food and Drug Administration
b. Food Safety Administration
c. Food and Drug Regulation Agency
d. Food and Dangerous Drug Administration
e. Consumable Products Administration

ANSWER: a (page 564)

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2. The government agency charged with monitoring food and drug safety is the:
a. Consumable Products Administration
b. Food Safety Administration
c. Food and Drug Regulation Agency
d. Food and Dangerous Drug Administration
e. none of the other choices are correct

ANSWER: e (page 564)

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3. The Food and Drug Administration has a ___________ annual budget.
a. $100 million
b. $40 million
c. $4 million
d. $4 billion
e. $400 billion

ANSWER: d (page 564)

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4. Which of the following is not a function of the Food and Drug Administration?
a. inspections of food and drug producing establishments
b. drug evaluation studies
c. food additives studies
d. study of veterinary products
e. all of the other choices are functions of the FDA

ANSWER: e (page 564)

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5. Which of the following is not a function of the Food and Drug Administration?
a. restaurant sanitation inspections
b. drug evaluation studies
c. food additives studies
d. study of veterinary products
e. all of the other choices are functions of the FDA

ANSWER: a (page 564)

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6. Which of the following is something the Food and Drug Administration devotes part of its annual budget to:
a. food sanitation and processing
b. studying biological products
c. studying veterinary products
d. studying the quality of marketed drugs
e. all of the other specific choices are correct

ANSWER: e (page 564)

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7. The Food and Drug Administration is NOT involved in:
a. food sanitation and processing
b. studying biological products
c. studying veterinary products
d. cleaning environmental contaminants from food processing plants
e. all of the other specific choices are correct

ANSWER: d (page 564)

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8. The Pure Food and Drug Act was passed in:
a. 1806
b. 1906
c. 1960
d. 1986
e. 1999

ANSWER: b (page 564)

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9. The Pure Food and Drug Act of 1906 was the first regulation of food and drugs. What sparked interest in this concern?
a. studies by a government chemist showed some food preservatives were harmful to humans
b. publication of Upton Sinclairs book The Jungle
c. deaths in the Spanish-American War from impure food
d. publication of Upton Sinclairs book The Jungle and deaths in the Spanish-American War from impure food
e. publication of Upton Sinclairs book The Jungle and deaths in the Spanish-American War from impure food and studies by a government chemist showed some food preservatives were harmful to humans

ANSWER: e (page 564)

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10. Which of the following was a factor in triggering the passage of the Pure Food and Drug Act:
a. studies by a government chemist showed some food preservatives were harmful to humans
b. publication of Rachel Carsons book Silent Spring
c. deaths WWI from impure food
d. deaths in WWII from impure drugs
e. all of the other specific choices are correct

ANSWER: a (page 564)

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11. Which of the following was a factor in triggering the passage of the Pure Food and Drug Act:
a. publication of Upton Sinclairs book The Jungle
b. publication of Rachel Carsons book Silent Spring
c. deaths WWI from impure food
d. deaths in WWII from impure drugs
e. all of the other specific choices are correct

ANSWER: a (page 564)

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12. Which of the following was a factor in triggering the passage of the Pure Food and Drug Act:
a. deaths in the Spanish-American War from impure food
b. publication of Rachel Carsons book Silent Spring
c. deaths in the Civil War from impure food
d. deaths in WWII from impure drugs
e. all of the other specific choices are correct

ANSWER: a (page 564)

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13. Which of the following was NOT a factor in triggering the passage of the Pure Food and Drug Act:
a. studies by a government chemist showed some food preservatives were harmful to humans
b. publication of Upton Sinclairs book The Jungle
c. deaths in the Spanish-American War from impure food
d. deaths in WWII from impure drugs
e. all of the other specific choices are correct

ANSWER: d (page 564)

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14. The Food and Drug Administration was created in:
a. 1906
b. 1927
c. 1938
d. 1958
e. 1967

ANSWER: b (page 564)

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15. Prior to the Food and Drug Administrations creation in 1927, the _______________ administered the Food and Drug Act.
a. Bureau of Chemistry of the Department of Agriculture
b. Bureau of Land Management
c. Bureau of Food and Drug Regulation
d. Bureau of Consumables of the Department of Agriculture
e. Bureau of Food of the Department of Agriculture

ANSWER: a (page 564)

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16. Prior to the Food and Drug Administrations creation in 1927, the _______________ administered the Food and Drug Act.
a. Bureau of Food of the Department of Agriculture
b. Bureau of Land Management
c. Bureau of Food and Drug Regulation
d. Bureau of Consumables of the Department of Agriculture
e. none of the other choices are correct

ANSWER: e (page 564)

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17. The Food, Drug and Cosmetics Act was passed in:
a. 1906
b. 1927
c. 1938
d. 1940
e. 1950

ANSWER: c (page 564)

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18. The Food, Drug and Cosmetics Act was passed in 1938 after:
a. a large outbreak of food poisoning
b. a large numbers of women suffered adverse reactions to a particular face cream
c. many people were poisoned by a non-prescription medicine
d. several people in Ohio died after eating an infected batch of ground beef
e. the drug companies requested an increase of regulation

ANSWER: c (page 564)

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19. The Food, Drug and Cosmetics Act was passed in 1938 after:
a. a large outbreak of food poisoning
b. a large numbers of women suffered adverse reactions to a drug-store brand of face cream
c. the drug companies requested an increase of regulation
d. several people in Ohio died after eating an infected batch of ground beef
e. none of the other choices

ANSWER: e (page 564)

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20. The Food, Drug and Cosmetic Act of 1938 expanded the powers of the FDA to include:
a. the ability to set safe levels of additives in foods
b. new enforcement powers
c. prohibiting false advertising of drugs
d. inspection of drug producers
e. all of the other choices

ANSWER: e (page 564)

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21. The Food, Drug and Cosmetic Act of 1938 did not expand the powers of the FDA to include:
a. the ability to set safe levels of additives in foods
b. require nutrition labels on food
c. prohibiting false advertising of drugs
d. inspection of drug producers
e. new enforcement powers

ANSWER: b (page 564)

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22. The Food, Drug and Cosmetic Act of 1938 expanded the FDAs powers to include the power to allow it to do which of the following:
a. prohibit false advertising of drugs
b. regulate costs of essential food items
c. require quotas of essential food items to be produced
d. require quotas of essential drugs to be produced
e. all of the other specific choices are correct

ANSWER: a (page 564)

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23. The Food, Drug and Cosmetic Act of 1938 expanded the FDAs powers to include the power to allow it to do which of the following:
a. classify unsafe foods
b. regulate costs of essential food items
c. require quotas of essential food items to be produced
d. require quotas of essential drugs to be produced
e. all of the other specific choices are correct

ANSWER: a (page 564)

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24. The Food, Drug and Cosmetic Act of 1938 expanded the FDAs powers to include the power to allow it to do which of the following:
a. set the safe levels of additives in foods
b. regulate costs of essential food items
c. require quotas of essential food items to be produced
d. require quotas of essential drugs to be produced
e. all of the other specific choices are correct

ANSWER: a (page 564)

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25. Which of the following agencies has primary responsibility for sanitation of meat, poultry, and eggs:
a. U.S. Chemistry Bureau
b. U.S. Food Bureau
c. U.S. Department of Agriculture
d. U.S. Department of Food and Drugs
e. U.S. Department of Meat

ANSWER: c (page 564)

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26. The _____________ has primary responsibility for sanitation of meat, poultry, and eggs:
a. U.S. Chemistry Bureau
b. U.S. Food Bureau
c. U.S. Department of Agriculture
d. U.S. Department of Food and Drugs
e. U.S. Department of Meat

ANSWER: c (page 564)

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27. In U.S. v. LaGrou Distribution Systems, where LaGrou, a cold storage warehouse for commercial food, was charged with unsanitary conditions, the court held that the company:
a. could be fined, but the managers could not, because it was a corporate violation
b. could be convicted of a felony but the managers could not, as it was a corporate violation
c. could be convicted of a felony as could the managers who ran the operation
d. could not be held liable because the inspection was done without a proper warrant
e. none of the other choices

ANSWER: c (page 565)

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28. In U.S. v. LaGrou Distribution Systems, where LaGrou, a cold storage warehouse for commercial food, was charged with unsanitary conditions, the court held that the company:
a. could be fined, but the managers could not, because it was a corporate violation
b. could be convicted of a felony but the managers could not, as it was a corporate violation
c. could not be held liable, but the managers who ran the operation could be held responsible
d. could not be held liable because the inspection was done without a proper warrant
e. none of the other choices

ANSWER: e (page 565)

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29. In U.S. v. LaGrou Distribution Systems, where LaGrou, a cold storage warehouse for commercial food, was charged with unsanitary conditions, the appeals court:
a. dismissed the lower courts conviction of both the company and the managers based on the evidence of the many health violations
b. upheld the lower courts conviction of both the company and the managers based on the evidence of the many health violations
c. upheld the lower courts conviction of the company, but not of the managers based on the evidence of the managers attempts to fix the situation
d. dismissed the lower courts conviction of the company, but not of the managers based on the evidence of the managers failure to
e. dismissed the lower courts conviction of the company and of the managers based on the evidence of the managers attempts to fix the situation and the companys cooperation

ANSWER: b (page 565)

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30. In U.S. v. LaGrou Distribution Systems, where LaGrou, a cold storage warehouse for commercial food, was charged with unsanitary conditions, the appeals court:
a. dismissed the lower courts conviction of both the company and the managers based on the evidence of the many health violations
b. dismissed the lower courts conviction of the company and of the managers based on the evidence of the managers attempts to fix the situation and the companys cooperation
c. upheld the lower courts conviction of the company, but not of the managers based on the evidence of the managers attempts to fix the situation
d. dismissed the lower courts conviction of the company, but not of the managers based on the evidence of the managers failure to
e. none of the other choices are correct

ANSWER: e (page 565)

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31. The Food Additives Amendment (Delaney Clause) to the Food, Drug, and Cosmetic Act:
a. prohibited the use of food additives in food sold for consumption by humans
b. gave the U.S. Department of Agriculture the authority to study food additives and make the findings public
c. gave the FDA authority to set safe use levels of food additives
d. prohibited the FDA from regulating food additives
e. did none of the other choices

ANSWER: c (page 565)

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32. The Food Additives Amendment (Delaney Clause) to the Food, Drug, and Cosmetic Act:
a. prohibited the use of food additives in food sold for consumption by humans
b. gave the U.S. Department of Agriculture the authority to study food additives and make the findings public
c. prohibited the FDA from regulating natural foods
d. prohibited the FDA from regulating food additives
e. did none of the other choices

ANSWER: e (page 565)

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33. The Food Additives Amendment to the Food, Drug and Cosmetic Act is known as:
a. the Delaney Clause
b. the Harrison Clause
c. the Additive Clause
d. the Preservative Clause
e. the Additive Substances Clause

ANSWER: a (page 565)

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34. The Food Additives Amendment (Delaney Clause) to the Food, Drug, and Cosmetic Act was replaced by the Food Quality Protection Act in 1996 because the Delaney Clause:
a. was not strict enough
b. was too strict
c. only applied to food and drug producers contracting with the government
d. did not apply to food and drug producers contracting with the government
e. did not bring about the economic growth it was expected to spark

ANSWER: b (page 565)

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35. The Food Additives Amendment (Delaney Clause) to the Food, Drug, and Cosmetic Act was replaced by the Food Quality Protection Act in 1996 because the Delaney Clause:
a. was not strict enough
b. did not bring about the economic growth it was expected to spark
c. only applied to food and drug producers contracting with the government
d. did not apply to food and drug producers contracting with the government
e. none of the other choices are correct

ANSWER: e (page 565)

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36. The Food Quality Protection Act expanded FDA jurisdiction to:
a. pesticides used in food production
b. veterinary products
c. pesticides used in textile material production
d. dog food
e. all of the other specific choices are correct

ANSWER: a (page 565)

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37. The Food Quality Protection Act requires that the FDA ensure a ____________ from any source that affects foods, raw or processed.
a. total certainty of no harm
b. complete certainty of no harm
c. relative certainty of no harm
d. reasonable certainty of no harm
e. possible certainty of no harm

ANSWER: d (page 565)

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38. The Food Quality Protection Acts definition of reasonable certainty of no harm means that there is ________________ from any source that affects foods, raw or processed.
a. no more than a one-in-a-million lifetime chance of cancer
b. no more than a one-in-ten lifetime chance of cancer
c. no chance of cancer under any circumstances
d. a minimal chance of cancer for otherwise healthy people
e. none of the other choices are correct

ANSWER: a (page 565)

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39. The Food Quality Protection Act holds that a substance may be approved for use in food if:
a. there is no risk
b. there is no risk it could induce cancer in humans
c. there is a de minimus risk of cancer in man or animals
d. there is a reasonable certainty of no harm
e. none of the other choices

ANSWER: d (page 565)

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40. The Food Quality Protection Act holds that a substance may be approved for use in food if:
a. there is no risk
b. there is no risk it could induce cancer in humans
c. there is an acceptable risk
d. there is a de minimus risk of cancer in man or animals
e. none of the other choices

ANSWER: e (page 565)

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41. The FDA began issuing regulations for nutrition labeling in:
a. 1909
b. 1940
c. 1970
d. 1973
e. 1990

ANSWER: d (page 566)

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42. The _________________ required the FDA to issue nutrition labels.
a. Nutrition Marking Act
b. Nutrition Announcement Act
c. Nutrition Content Communication Act
d. Nutrition Assurance Act
e. Nutrition Labeling and Education Act

ANSWER: e (page 566)

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43. The _________________ required the FDA to issue nutrition labels.
a. Nutrition Marking Act
b. Nutrition Announcement Act
c. Nutrition Content Communication Act
d. Nutrition Assurance Act
e. none of the other choices are correct

ANSWER: e (page 566)

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44. The Nutrition Labeling and Education Act applies:
a. to more than 250,000 products
b. only to nutritional supplements such as herbal remedies
c. primarily to foods with a high-fat content
d. only to inorganic produce
e. only to nutritional supplements such as vitamins

ANSWER: a (page 566)

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45. The Nutrition Labeling and Education Act applies:
a. only to nutritional supplements such as vitamins
b. only to nutritional supplements such as herbal remedies
c. only to foods with a high-fat content
d. only to fresh produce
e. none of the other choices

ANSWER: e (page 566)

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46. The intent of the Nutrition Labeling and Education Act is to:
a. make people eat healthier food
b. make people buy more packaged food
c. prevent misleading product claims
d. prevent consumers from making informed purchases
e. help companies sell their food products

ANSWER: c (page 566)

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47. The intent of the Nutrition Labeling and Education Act is to:
a. make people eat healthier food
b. make people buy more packaged food
c. help consumers make informed purchases
d. prevent consumers from making informed purchases
e. help companies sell their food products

ANSWER: c (page 566)

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48. The intent of the Nutrition Labeling and Education Act is to:
a. make people eat healthier food
b. make people buy more packaged food
c. help companies sell their food products
d. prevent consumers from making informed purchases
e. none of the other choices are correct

ANSWER: e (page 566)

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49. Nutrition labeling does not require which of the following to be listed per serving portion:
a. total fat
b. fiber
c. calcium
d. riboflavin
e. carbohydrates

ANSWER: d (page 566)

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50. Nutrition labeling does not require which of the following to be listed per serving portion:
a. total fat
b. fiber
c. calcium
d. carbohydrates
e. all of the other choices must be listed

ANSWER: e (page 566)

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51. Which of the following must be listed per serving portion on nutrition labels:
a. total calories and calories from fat
b. cholesterol
c. iron
d. protein
e. all of the other specific choices must be listed

ANSWER: e (page 566)

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52. Which of the following must be listed per serving portion on nutrition labels:
a. carbohydrates
b. calcium
c. fiber
d. sodium
e. all of the other specific choices must be listed

ANSWER: e (page 566)

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53. Under FDA regulations, vitamins such as thiamin, riboflavin and niacin:
a. may not occur in more than trace amounts in packaged food
b. may not be present even in trace amounts in packaged food
c. need not be listed on nutrition labels
d. must be listed on nutrition labels
e. must be clearly advertised on the package of any commercially available food

ANSWER: c (page 566)

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54. Under FDA regulations, vitamins such as thiamin, riboflavin and niacin:
a. may not occur in more than trace amounts in packaged food
b. may not be present even in trace amounts in packaged food
c. must be clearly advertised on the package of any commercially available food
d. must be listed on nutrition labels
e. none of the other choices are correct

ANSWER: e (page 566)

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55. Which of the following is not required to be listed on nutrition labels by the FDA because there is no shortage of it in American diets:
a. sodium
b. riboflavin
c. vitamin A
d. vitamin C
e. none of the other choices are correct

ANSWER: b (page 566)

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56. Which of the following is not required to be listed on nutrition labels by the FDA because there is no shortage of it in American diets:
a. sodium
b. thiamin
c. vitamin A
d. vitamin C
e. none of the other choices are correct

ANSWER: b (page 566)

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57. Which of the following is not required to be listed on nutrition labels by the FDA because there is no shortage of it in American diets:
a. sodium
b. niacin
c. vitamin A
d. vitamin C
e. none of the other choices are correct

ANSWER: b (page 566)

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58. Which of the following does not conform to FDA standards for food labels:
a. fresh means the food is raw or unprocessed
b. light means the product has less than one-half the calories of a comparable product per serving per 100 grams
c. low calorie means the product has less than 40 calories per serving per 100 grams
d. low fat means the product has 3 grams or less of fat per 100 gram serving
e. all of the other choices are correct

ANSWER: b (page 567)

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59. Which of the following does not conform to FDA standards for food labels:
a. fresh means the food is raw or unprocessed
b. light means at least one-tenth fewer calories per serving than the regular serving
c. low calorie means the product has less than 40 calories per serving per 100 grams
d. low fat means the product has 3 grams or less of fat per 100 gram serving
e. all of the other choices are correct

ANSWER: e (page 567)

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60. According to FDA standards, food that is labeled as fresh must NOT have been:
a. processed
b. frozen
c. preserved
d. all of the other specific choices are correct
e. none of the other specific choices are correct

ANSWER: d (page 567)

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61. According to FDA standards, food that is labeled as low fat must:
a. have fewer than 2 grams of fat per serving
b. have 3 or fewer grams of fat per serving
c. not have been processed in more than one way
d. not contain trans fats
e. have fewer than 40 calories per serving

ANSWER: b (page 567)

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62. According to FDA standards, food that is labeled as low fat must:
a. have fewer than 2 grams of fat per serving
b. have fewer than 40 calories per serving
c. not have been processed in more than one way
d. not contain trans fats
e. none of the other choices are correct

ANSWER: e (page 567)

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63. According to FDA standards, food that is labeled as low calorie must:
a. never have been frozen
b. have 3 or fewer grams of fat per serving
c. not have been processed in more than one way
d. not contain trans fats
e. have fewer than 40 calories per serving

ANSWER: e (page 567)

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64. According to FDA standards, food that is labeled as low calorie must:
a. never have been frozen
b. have 3 or fewer grams of fat per serving
c. not have been processed in more than one way
d. not contain trans fats
e. none of the other choices are correct

ANSWER: e (page 567)

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65. Old South potato chips claim to have that old-fashioned, deep-down satisfyin taste. They also claim to be low-fat and low-calorie. According to standards created by the FDA, these chips must:
a. have less fat and fewer calories than their nearest competitor
b. contain fewer than 40 calories per serving
c. contain fewer than 10 grams of fat per serving
d. all of the other specific choices must be met
e. none of the other choices; such rules do not apply to snack foods

ANSWER: b (page 567)

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66. Which of the following food health claims may be made on labels:
a. the connection between calcium and the prevention of osteoporosis
b. the connection between fiber and reduced risk of heart disease
c. the connection between calcium and the ability to run fast
d. the connection between sodium and strong teeth
e. the connection between fiber and reduced risk of cancer

ANSWER: a (page 567)

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67. Which of the following health claims may NOT be made on food labels without sufficient documentation by the seller:
a. the connection between calcium and the prevention of osteoporosis
b. the connection between fat and heart disease
c. the connection between fiber and reduced risk of heart disease
d. the connection between fat and cancer
e. all of the other specific choices may be mentioned on food labels without any extra documentation

ANSWER: c (page 567)

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68. Which of the following health claims may NOT be made on food labels without sufficient documentation by the seller:
a. the connection between calcium and the prevention of osteoporosis
b. the connection between fat and heart disease
c. the connection between sodium and high blood pressure
d. the connection between fat and cancer
e. all of the other specific choices may be mentioned on food labels without any extra documentation

ANSWER: e (page 567)

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69. Comparing regulation of drugs to other countries, the U.S. is:
a. not very strict compared to nations of Europe
b. not very strict compared to most underdeveloped nations
c. one of the strictest nations but has little impact on the world market
d. one of the strictest nations and has great impact on the world market
e. none of the other choices

ANSWER: d (page 567)

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70. One reason foreign countries adopt FDA standards for drug production is that they want to:
a. export their products to the U.S.
b. export their products to the EU countries
c. import drugs from the U.S.
d. maintain a reputation for low-cost drugs
e. export their products to the EU countries and import drugs from the U.S.

ANSWER: a (page 567)

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71. A possible benefit of drug regulations in place in many European nations is that:
a. new drugs are introduced to the market more quickly
b. many more drugs may be purchased without a prescription
c. companies wishing to sell in Europe do not need be licensed in each individual country
d. pharmaceutical may be less expensive because companies spend less time getting through administrative hurdles
e. all of the other choices may be benefits of the European system

ANSWER: e (page 567)

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72. Drug regulation in China can be problematic because:
a. the Chinese FDA is too strict
b. the Chinese FDA is known to take bribes
c. the Chinese FDA is overstaffed
d. no one in China cares about drug safety
e. none of the other choices are correct

ANSWER: b (page 567)

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73. The Food, Drug, and Cosmetic Act as passed in 1938:
a. repealed the 1906 Pure Food and Drug Act
b. gave the FDA responsibility to restrict the levels of food additives used
c. allowed the FDA to approve drugs for sale as prescription or non-prescription drugs
d. allowed the FDA to prohibit drugs not demonstrated to be effective
e. all of the other choices

ANSWER: c (page 567)

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74. The Food, Drug, and Cosmetic Act as passed in 1938:
a. repealed the 1906 Pure Food and Drug Act
b. gave the FDA responsibility to restrict the levels of food additives used
c. required the FDA to monitor nutrition information on food products
d. allowed the FDA to prohibit drugs not demonstrated to be effective
e. none of the other choices

ANSWER: e (page 567)

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75. The _________________ prohibits the sale of any drug until the FDA approves the application submitted by the manufacturer.
a. Food and Medicine Act
b. Food, Drug, and Cosmetic Act
c. Food and Drug Regulation Act
d. Regulation of Food and Drug Act
e. Drug Control Act

ANSWER: b (page 567)

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76. The _________________ prohibits the sale of any drug until the FDA approves the application submitted by the manufacturer.
a. Food and Medicine Act
b. Drug Control Act
c. Food and Drug Regulation Act
d. Regulation of Food and Drug Act
e. none of the other choices are correct

ANSWER: e (page 567)

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77. Applicants who want to sell a drug in the U.S. market must:
a. submit evidence that the drug is safe for its intended use
b. pay a fee
c. submit evidence that the drug is reasonable for its intended use
d. make the drug affordable for everyone who needs it
e. none of the other choices are correct

ANSWER: a (page 567)

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78. Nutritional supplements are:
a. subject to the same regulations as drugs
b. subject to stricter regulations than drugs
c. subject to fewer regulations than drugs
d. more expensive than drugs
e. illegal in many states

ANSWER: c (page 567)

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79. Before passage of the 1938 Food, Drug, and Cosmetic Act, drugs were:
a. all prescribed by physician only
b. all prescribed by pharmacists and physicians
c. regulated by the FDA only if they posed serious risks to human health
d. either legal or illegal
e. completely unregulated, you could buy anything

ANSWER: d (page 568)

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80. Before passage of the 1938 Food, Drug, and Cosmetic Act, drugs were:
a. all prescribed by physician only
b. all prescribed by pharmacists and physicians
c. regulated by the FDA only if they posed serious risks to human health
d. completely unregulated, you could buy anything
e. none of the other choices

ANSWER: e (page 568)

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81. A prescription drug is one that:
a. has serious side effects
b. is expensive
c. requires insurance to purchase
d. may only be used with the permission of a physician
e. may be purchased by anyone

ANSWER: d (page 568)

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82. A prescription drug is one that:
a. has serious side effects
b. is expensive
c. requires insurance to purchase
d. may be purchased by anyone
e. none of the other choices are correct

ANSWER: e (page 568)

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83. A drug that may only be used with the permission of a physician is designated as a(n):
a. special drug
b. regulated drug
c. prescription drug
d. formulated drug
e. regulated drug

ANSWER: c (page 568)

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84. A drug that may only be used with the permission of a physician is designated as a(n):
a. special drug
b. regulated drug
c. regulated drug
d. formulated drug
e. none of the other choices are correct

ANSWER: e (page 568)

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85. Prescription drugs can only be bought at:
a. a pharmacy, with a physicians permission
b. a pharmacy, if the consumer is over 18
c. a pharmacy, if the consumer is over 21
d. a licensed dealer
e. an herbal remedies shop

ANSWER: a (page 568)

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86. The Food and Drug Administration:
a. prohibits the sale of any drug without a prescription
b. prohibits the sale of drugs without FDA approval
c. prohibits the sale of prescription drugs to anyone under age 19 without parental consent
d. prohibits the sale of any drug without a prescription and prohibits the sale of drugs without FDA approval
e. prohibits the sale of any drug without a prescription and prohibits the sale of drugs without FDA approval and prohibits the sale of prescription drugs to anyone under age 19 without parental consent

ANSWER: b (page 568)

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87. The Food and Drug Administration:
a. inspects drug manufacturing facilities
b. prohibits the sale of drugs without FDA approval
c. prohibits the sale of prescription drugs to anyone under age 19 without parental consent
d. inspects drug manufacturing facilities and prohibits the sale of drugs without FDA approval
e. inspects drug manufacturing facilities and prohibits the sale of drugs without FDA approval and prohibits the sale of prescription drugs to anyone under age 19 without parental consent

ANSWER: d (page 568)

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88. The Food and Drug Administration does not have which of the following powers:
a. to restrict false advertising of drugs
b. to inspect factories where drugs are manufactured
c. to set the levels of additives that may be used in food
d. to seize drugs that have been approved to be on the market
e. all of the other choices are FDA powers

ANSWER: e (page 568)

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89. The Food and Drug Administration does not have which of the following powers:
a. to restrict false advertising of drugs
b. to inspect factories where drugs are manufactured
c. to prosecute physicians who violate the learned intermediary rule
d. to seize drugs that have been approved to be on the market
e. all of the other choices are FDA powers

ANSWER: c (page 568)

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90. The Food and Drug Administration does not have which of the following powers:
a. to restrict false advertising of drugs
b. to inspect plants where drugs are manufactured
c. to decide which drug company will develop which kinds of new drugs
d. to seize drugs that have been approved to be on the market
e. all of the other choices are FDA powers

ANSWER: c (page 568)

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91. The 1962 Kefauver Amendment to the Food and Drug Act gave the FDA authority for the first time to:
a. approve drugs based on their proven effectiveness
b. license the use of drugs in physician offices
c. determine which drugs are to be prescription drugs
d. approve drugs based on their safety
e. none of the other choices

ANSWER: a (page 568)

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92. The 1962 Kefauver Amendment to the Food and Drug Act gave the FDA authority for the first time to:
a. ban hard drugs such as heroin
b. license the use of drugs in physician offices
c. determine which drugs are to be prescription drugs
d. approve drugs based on their safety
e. none of the other choices

ANSWER: e (page 568)

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93. The 1962 Kefauver Amendment to the Food and Drug Act gave the FDA authority for the first time to:
a. approve drugs based on their proven effectiveness
b. license the use of drugs in physician offices
c. determine which drugs are to be prescription drugs
d. approve drugs based on their safety
e. all of the other choices

ANSWER: a (page 568)

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94. The ________________ to the Food and Drug Act gave the FDA authority for the first time to approve drugs based on their proven effectiveness.
a. Kefauver Amendment of 1962
b. Food, Drug and Cosmetics Amendment of 1964
c. Effectiveness Amendment of 1962
d. Maddison Amendment of 1962
e. Drug Efficacy Amendment of 1964

ANSWER: a (page 568)

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95. The average cost of developing a new drug and clearing all FDA regulations to get the drug to market are about a billion dollars and are:
a. paid by the FDA only if the drug is approved
b. paid by the FDA only if the drug is not approved
c. paid by the FDA whether or not the drug is approved
d. paid by the drug companies
e. paid by the National Institute of Health

ANSWER: d (page 568)

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96. The average cost of developing a new drug and clearing all FDA regulations to get the drug to market are about a billion dollars and are:
a. paid by the FDA only if the drug is approved
b. paid by the FDA only if the drug is not approved
c. paid by the FDA whether or not the drug is approved
d. paid by the National Institute of Health
e. none of the other choices

ANSWER: e (page 568)

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97. The current cost of developing a new drug and clearing all the FDA hurdles to market it is about:
a. $100,000
b. $1 million
c. $5 million
d. $10 billion
e. $1 billion

ANSWER: e (page 568)

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98. The current time frame for developing a new drug and clearing all the FDA hurdles to market it is about:
a. 5 to 10 years
b. 12 to 15 years
c. 15 to 20 years
d. 1 to 5 years
e. 30 years

ANSWER: b (page 568)

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99. The main reason that drug companies today produce only about half as many new drugs each year compared to previous decades is:
a. there are fewer diseases that drugs can be made for
b. people are turning to natural medicine rather than drugs
c. the high cost and long time frame involved in clearing all the FDA hurdles to market a new drug
d. the lack of science majors graduating in the United States
e. the economic downturn

ANSWER: c (page 568)

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100. Making a new substance that might one day become a marketable drug takes an average of:
a. 2 years
b. 3 years
c. 5 years
d. 7 years
e. 10 years

ANSWER: d (page 568)

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101. About ____________ new compounds make it to Phase I of the tests required to earn FDA approval for the market.
a. 1 in 2,000
b. 1 in 50
c. 1 in 60,000
d. 1 in a million
e. 1 in 450

ANSWER: c (page 568)

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102. About ____________ of new compounds initially tested in the lab make it to the market.
a. 1 in 2,000
b. 1 in 50
c. 1 in 60,000
d. 1 in a million
e. 1 in 100

ANSWER: c (page 568)

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103. About _____________ of the drugs that make it to Phase III of the tests required to earn FDA approval for the market do not then get final FDA approval.
a. 10%
b. 20%
c. 50%
d. 80%
e. 90%

ANSWER: e (page 568)

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104. A __________ is an instrument, machine, implant, or other article used in the diagnosis or treatment of a disease in humans or animals.
a. medical device
b. medical instrument
c. surgical tool
d. drug device
e. none of the other choices are correct

ANSWER: a (page 568)

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105. ____________ medical devices are things presenting minimal potential for harm to the user and are usually of simple design, such as bandages and gloves.
a. Class I
b. Class II
c. Class III
d. Generic
e. Common

ANSWER: a (page 568)

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106. Which of the following is true about class I medical devices:
a. the makers are registered with the FDA
b. the goods must be properly manufactured
c. the goods must be properly labeled
d. the goods are not subject to extensive controls
e. all of the other specific choices are correct

ANSWER: e (page 568)

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107. Which of the following is an example of a class I medical device:
a. gloves
b wheelchairs
c. x-ray machines
d. surgical materials
e. heart valves

ANSWER: a (page 568)

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108. Which of the following is an example of a class I medical device:
a. bandages
b wheelchairs
c. x-ray machines
d. surgical materials
e. heart valves

ANSWER: a (page 568)

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109. Which of the following is an example of a class II medical device:
a. surgical materials
b wheelchairs
c. x-ray machines
d. all of the other specific choices are correct
e. none of the other specific choices are correct

ANSWER: d (page 568)

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110. The most heavily controlled medical devices are:
a. class I
b. class II
c. class III
d. restricted class
e. high class

ANSWER: c (page 568)

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111. Which of the following is an example of a class III medical device:
a. bandages
b. wheelchairs
c. x-ray machines
d. surgical materials
e. heart valves

ANSWER: e (page 568)

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112. Which of the following is an example of a class III medical device:
a. bandages
b. wheelchairs
c. x-ray machines
d. surgical materials
e. bone implants

ANSWER: e (page 568)

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113. Which of the following is an example of a class III medical device:
a. bandages
b. wheelchairs
c. x-ray machines
d. surgical materials
e. pacemakers

ANSWER: e (page 568)

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114. Which of the following is an example of a class III medical device:
a. heart valves
b. pacemakers
c. bone implants
d. all of the other specific choices are correct
e. none of the other specific choices are correct

ANSWER: d (page 568)

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115. Every year millions of children are vaccinated against polio. For reasons that are unclear, some children contract polio from the vaccine, even though their dose was no different than the others. Assume that child who contracts polio after receiving a vaccine sues the vaccine maker for damages. The likely result of the case will be that:
a. no liability will be imposed because of the public health benefits from the polio vaccine campaign
b. no liability will be imposed because the FDA Act prohibits liability from being imposed on drug producers who sell FDA approved drugs
c. if the FDA has approved the vaccine, liability may not be imposed due to the learned intermediary doctrine
d. it is uncertain if liability will be imposed; FDA approval is not a shield against liability
e. even if the FDA has approved the vaccine, the rule of strict liability makes the producer legally liable for all damages

ANSWER: d (page 568)

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116. In Wyeth v. Levine, where Levine sued the drug developer Wyeth for failure to warn after she lost her forearm and hand after being given a drug by IV-push, a method known to have risks, the U.S. Supreme Court:
a. dismissed the state courts judgment for Levine because it was impossible for Wyeth to comply with both federal and state labeling regulations
b. dismissed the state courts judgment for Levine because it was not impossible for Wyeth to comply with both federal and state labeling regulations
c. upheld the state courts judgment for Levine because it was not impossible for Wyeth to comply with both federal and state labeling regulations
d. awarded Levine additional damages
e. reversed the state courts decision for Levine and ordered her to pay Wyeths attorney fees

ANSWER: c (page 569)

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117. In Wyeth v. Levine, where Levine sued the drug developer Wyeth for failure to warn after she lost her forearm and hand after being given a drug by IV-push, a method known to have risks, the U.S. Supreme Court:
a. dismissed the state courts judgment for Levine because it was impossible for Wyeth to comply with both federal and state labeling regulations
b. dismissed the state courts judgment for Levine because it was not impossible for Wyeth to comply with both federal and state labeling regulations
c. reversed the state courts decision for Levine and ordered her to pay Wyeths attorney fees
d. awarded Levine additional damages
e. none of the other choices are correct

ANSWER: e (page 569)

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118. The learned intermediary doctrine:
a. shields a physician from liability because of a drug companys mistake in dosage instructions
b. is invoked by regulatory agencies in their arguments in court arguments in support of new regulations
c. shields a drug manufacturer from liability when the doctor is liable for misuse of the drug
d. holds that the FDA has gone too far in preventing new, effective drugs from reaching the market in less time
e. holds federal regulatory agencies supreme in all matters regarding control of product safety

ANSWER: c (page 570)

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119. The learned intermediary doctrine:
a. shields a physician from liability because of a drug companys mistake in dosage instructions
b. is invoked by regulatory agencies in their arguments in court arguments in support of new regulations
c. holds federal regulatory agencies supreme in all matters regarding control of product safety
d. holds that the FDA has gone too far in preventing new, effective drugs from reaching the market in less time
e. none of the other choices

ANSWER: e (page 568)

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120. The _______________ shields drug manufacturers from liability in cases where doctors misuse drugs.
a. learned intermediary doctrine
b. medical intermediary doctrine
c. misuse doctrine
d. professional intermediary doctrine
e. physician intermediary doctrine

ANSWER: a (page 570)

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121. The _______________ shields drug manufacturers from liability in cases where doctors misuse drugs.
a. physician intermediary doctrine
b. medical intermediary doctrine
c. misuse doctrine
d. professional intermediary doctrine
e. none of the other choices are correct

ANSWER: e (page 570)

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122. In addition to having the power to decide when foods and drugs will be allowed to be marketed, the FDA can remove products from the market. An example of the FDAs use of its power to remove products from the market is the:
a. recall of GM trucks from the market
b. removal of certain orange juice from the market
c. removal of high-fat pork products from the market
d. removal of low-SPF tanning products from the market
e. removal of animal-tested cosmetics from the market

ANSWER: b (page 570)

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123. In addition to having the power to decide when drugs and certain food products will be marketed, the FDA can remove products from the market. An example of the FDAs use of its power to remove products from the market is the:
a. recall of GM trucks from the market
b. removal of animal-tested cosmetics from the market
c. removal of high-fat pork products from the market
d. removal of low-SPF tanning products from the market
e. none of the other choices

ANSWER: e (page 570)

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124. A noteworthy change at the FDA in recent years is its:
a. greater reluctance to approve drugs for use in life-threatening situations due to high toxicity of such drugs
b. regulation of the sale of fish and shellfish
c. increased inspection of foreign fruit shipments
d. allowing quicker approval for use of drugs that show promise in treating life-threatening diseases
e. dropping the quarantine requirements that apply to animals brought into the U.S.

ANSWER: d (page 571)

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125. A noteworthy change at the FDA in recent years is its:
a. greater reluctance to approve drugs for use in life-threatening situations due to high toxicity of such drugs
b. regulation of the sale of fish and shellfish
c. increased inspection of foreign fruit shipments
d. dropping the quarantine requirements that apply to animals brought into the U.S.
e. none of the other choices

ANSWER: e (page 571)

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126. The Federal Trade Commission was established in:
a. 1909
b. 1915
c. 1920
d. 1937
e. 1950

ANSWER: b (page 572)

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127. The Federal Trade Commission regulates:
a. deceptive business practices
b. false advertising claims
c. unfair business practices
d. deceptive business practices and false advertising claims
e. deceptive business practices and false advertising claims and unfair business practices

ANSWER: e (page 572)

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128. The Federal Trade Commission regulates:
a. deceptive business practices
b. false advertising claims
c. highly risky stock deals
d. deceptive business practices and false advertising claims
e. deceptive business practices and false advertising claims and highly risky stock deals

ANSWER: d (page 572)

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129. The Federal Trade Commission investigates:
a. unfair and deceptive practices
b. tax evasion practices
c. profitable practices
d. legal practices
e. drug development

ANSWER: a (page 572)

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130. FTC staff members propose complaints to:
a. five executives
b. ten commissioners
c. five commissioners
d. district courts
e. the U.S. Supreme Court

ANSWER: c (page 572)

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131. For a complaint proposed to the five commissioners by an FTC staff member to be officially issued:
a. there must be unanimous agreement
b. at least 2 commissioners must vote for it
c. at least 3 commissioners must vote for it
d. at least 1 commissioner must vote for it
e. 4 out of 5 commissioners must vote for it

ANSWER: c (page 572)

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132. FTC consent decrees agreed to by firms accused of illegal trade practices:
a. contain the terms of a settlement
b. may include redress for consumers
c. include possible payment of civil penalties
d. contain the terms of a settlement and may include redress for consumers
e. contain the terms of a settlement and may include redress for consumers and include possible payment of civil penalties

ANSWER: e (page 572)

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133. FTC consent decrees agreed to by firms accused of illegal trade practices:
a. contain the terms of a settlement
b. may include redress for consumers
c. may include prison time for scam operators
d. contain the terms of a settlement and may include redress for consumers
e. contain the terms of a settlement and may include redress for consumers and may include prison time for scam operators

ANSWER: d (page 572)

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134. Which of the following is often contained in consent decrees agreed upon by the parties charged in an FTC complaint:
a. terms of a settlement
b. redress for consumers
c. payment of civil penalties
d. prohibition of certain practices
e. all of the other specific choices are correct

ANSWER: e (page 572)

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135. Which of the following is not part of the FTC policy statement for determining if a practice is deceptive?
a. there is a misrepresentation or omission of information in a communication to consumers
b. the deception is likely to mislead a reasonable consumer
c. there is proximate cause between the deception and the losses suffered by consumers who are misled
d. the deception is materiallikely to mislead the consumer to his or her detriment
e. all of the other choices are a part of the deception standard

ANSWER: c (page 572)

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136. Which of the following is part of the FTC policy statement for determining if a practice is deceptive?
a. there is a representation or omission of information in a communication to consumers
b. the deception is likely to mislead a reasonable consumer
c. the deception is materiallikely to mislead the consumer to his or her detriment
d. there is a representation or omission of information in a communication to consumers and the deception is likely to mislead a reasonable consumer
e. there is a representation or omission of information in a communication to consumers and the deception is likely to mislead a reasonable consumer and the deception is materiallikely to mislead the consumer to his or her detriment

ANSWER: e (page 572)

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137. Which of the following is part of the FTC policy statement for determining if a practice is deceptive?
a. there is a representation or omission of information in a communication to consumers
b. the deception is likely to mislead a reasonable consumer
c. the deception may cause physical harm to consumers
d. there is a representation or omission of information in a communication to consumers and the deception is likely to mislead a reasonable consumer
e. there is a representation or omission of information in a communication to consumers and the deception is likely to mislead a reasonable consumer and the deception may cause physical harm to consumers

ANSWER: e (page 572)

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138. Which of the following is part of the FTCs three part test for deciding whether a particular act or practice is deceptive:
a. there is a misrepresentation or omission of information in a communication to consumers
b. the deception is likely to mislead a reasonable consumer
c. the deception is material
d. all of the other specific choices are correct
e. none of the other specific choices are correct

ANSWER: d (page 572)

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139. A material deception is one that:
a. is likely to be misleading to the detriment of consumers
b. involves the material used to make the product
c. involves the production process
d. leads the consumer to believe the product is cheaper than it is
e. none of the other choices are correct

ANSWER: a (page 573)

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140. Advertisements directed at children or ill people:
a. are held to a lower standard than other ads
b. are held to a tougher standard than other ads
c. are less common than other ads
d. are unregulated
e. may not contain bad language

ANSWER: b (page 573)

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141. Which type of advertisement would be held to a tougher standard than the others:
a. ads directed at children
b. ads directed at middle aged consumers
c. ads directed at doctors
d. ads directed at reasonable persons
e. ads directed at professors

ANSWER: a (page 573)

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142. Which type of advertisement would be held to a tougher standard than the others:
a. ads directed at ill people
b. ads directed at middle aged consumers
c. ads directed at doctors
d. ads directed at reasonable persons
e. ads directed at professors

ANSWER: a (page 573)

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143. A company mails consumers cards telling them they have won valuable prizes. When a consumer attempts to collect her prize, she discovers that she must pay $500 to collect the goods. In this case the FTC is likely to:
a. seek a consent decree to end the practice
b. only allow consumers to use credit cards, not cash, to purchase the goods
c. have nothing to do with this case, it falls with the jurisdiction of the FBI
d. any of the other choices
e. none of the other choices are correct

ANSWER: a (page 573)

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144. Which of these is most likely to be attacked by the FTC as a deceptive business practice?
a. selling stock to investors in a company for three times its true value
b. charging 25% interest on consumer loans when the market rate of interest is 10%
c. mailing office supplies to corporations that did not order them, but then pay the bill because they thought they did order them
d. telling consumers that a brand of jeans is special and selling them for double what other jeans sell for, when they are the same as other jeans except for the name
e. all of the other choices

ANSWER: c (page 573)

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145. Which of these is most likely to be attacked by the FTC as a deceptive business practice?
a. selling stock to investors in a company for three times its true value
b. charging 25% interest on consumer loans when the market rate of interest is 10%
c. selling original art to consumers at prices significantly above market value
d. telling consumers that a brand of jeans is special and selling them for double what other jeans sell for, when they are the same as other jeans except for the name
e. none of the other choices

ANSWER: e (page 573)

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146. An art gallery sells fake authorized Vincent Van Gogh prints to clients for $50,000 each, telling buyers their purchases are good investments. If the FTC sues, the gallery will:
a. win because purchasing the prints did not harm the clients
b. win because the doctrine of caveat emptor applies to art
c. win because the purchasers are sophisticated art investors
d. lose because its actions meet the FTC test for deception
e. lose because Van Gogh is currently out of vogue

ANSWER: d (page 573)

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147. The FTC test for unfairness does not include which of the following elements, as applied to business practice?
a. it causes substantial harm to consumers
b. consumers cannot reasonably avoid the injury
c. consumers cannot sue the business because the losses per person are too small
d. the injury is harmful in its net effects
e. all of the other choices are required elements

ANSWER: c (page 573)

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148. The FTC test for unfairness does not include which of the following elements, as applied to business practice?
a. it causes substantial harm to consumers
b. consumers cannot reasonably avoid the injury
c. the injury is harmful in its net effects
d. it causes substantial harm to consumers and consumers cannot reasonably avoid the injury
e. it causes substantial harm to consumers and consumers cannot reasonably avoid the injury and the injury is harmful in its net effects

ANSWER: e (page 573)

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149. According to the FTC, which of the following things would indicate a unfair act or practice:
a. the act or practice causes substantial harm to consumers
b. consumers cannot reasonabl

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Welcome to Test bank Fan

 

Once the order is placed, the order will be delivered to your email less than 24 hours, mostly within 4 hours. 

If you have questions, you can contact us here