Deck 21: Consumer Laws, Agencies, and Strategies

Question 1

Consumers need reliable and scientific information to make wise decisions regarding health products and service

Answer 1

True

Question 2

The Better Business Bureaus in the United States encourage truth in advertising and attempt to establish ethical business practices through self-regulation

Answer 2

True

Question 3

The National Health Information Center may refer callers to organizations that espouse unscientific methods.

Answer 3

True

Question 4

Consumer information is available on request from the regional and district offices of the Food and Drug Administration.

Question 5

FDA regulation of food additives that might cause cancer in laboratory tests is now based on risk-benefit analysis.

Question 6

The Delaney Amendment to the Food, Drug, and Cosmetic Act gave the FDA authority to protect consumers from the introduction of carcinogens into food products.

Question 7

In 1938, the Wheeler-Lea Amendment to the FTC Act provided for control of False advertising of foods, drugs, devices, and cosmetics.

Question 8

The federal Food, Drug, and Cosmetic Act established the U.S. Pharmacopoeia and the Homeopathic Pharmacopoeia of the U.S. as the official drug compendia.

Question 9

Approval of a new drug by the FDA requires filing an application and providing scientific evidence of safety and efficacy.

Question 10

The federal Food, Drug, and Cosmetic Act is the primary legislation in the United States that protects consumers in health matters.

Question 11

The federal Food, Drug, and Cosmetic Act prohibits the distribution and importation of adulterated and misbranded articles.

Question 12

The FTC is responsible for enforcement of laws relating to advertising of OTC drugs.

Question 13

Cosmetics that are claimed to prevent and cure ailments are subject to the drug provisions of the federal Food, Drug, and Cosmetic Act.

Question 14

Most manufacturers and distributors voluntarily recall products when requested to do so by the FDA.

Question 15

The main function of the FDA is to protect the public from hazardous foods, drugs, cosmetics, and medical devices.

Question 16

Advertising for prescription drugs is regulated by the FDA.

Question 17

Investigational drugs are new drugs intended solely for research use by experts.

Question 18

In health fraud cases identified by the FDA, warning letters and product recalls are frequently used, while criminal prosecutions are rare.

Question 19

Advertising played an important role in the growth of patent medicine sales in the United States in the nineteenth century.

Question 20

During the nineteenth century, testimonials were frequently used to support claims of effectiveness for patent medicines.

Question 21

Many patent medicines in the nineteenth century contained opiates.

Question 22

Before passage of the Kefauver-Harris Amendment in 1962, manufacturers could begin marketing drugs without proof that they were effective.

Question 23

Consumers should protest whenever they encounter a fraudulent health product and service.

Question 24

The FDA has established regulations to permit promising investigational drugs to be made available for serious and life-threatening conditions when no alternative is available.

Question 25

The 1996 Food Quality Protection Act replaced the Delaney Clause with a more flexible food safety requirement.

Question 26

The 1951 Durham-Humphrey Amendment was the first time a distinction was made between over-the-counter and prescription drugs.

Question 27

The first consumer protection act regarding drugs did not require them to be safe and effective.

Question 28

Pesticide residues must not exceed safe tolerances.

Question 29

The 1960 Federal Hazardous Substances Labeling Act requirements are enforced by the Consumer Product Safety Commission.

Question 30

New drugs were not required to be effective as well as safe until 1962.

Question 31

Drug manufacturers must notify the FDA whenever they become aware that an approved drug might have adverse effects.

Question 32

The Orphan Drug Act (1983) allows companies to claim half the cost of clinical drug trial costs as a tax credit.

Question 33

Hospitals and other health-care providers are required to report device-related deaths directly to the FDA.

Question 34

The FDA will allow the use of a food additive only if it concludes there is practical certainty that no harm will result from normal use over a lifetime.

Question 35

Injunction is a legal action that tells individuals or companies to discontinue illegal practices.

Question 36

The FDA considers issues limited to "economic frauds"low priorities.

Question 37

FTC investigations are limited by a lack of resources and the amount of time required to complete them.

Question 38

The Food, Drug, and Cosmetic Act (1938) required drugs and therapeutic devices to be safe and effective.

Question 39

Lobbies and special interests have not been successful in weakening consumer protection laws.

Question 40

The current Food, Drug, and Cosmetic Acts only apply to domestic products, not imported ones.

Question 41

Genetically engineered foods have few health benefits in light of the demonstrated hazards.

Question 42

There has been decreasing collaboration between federal and state consumer protection agencies.

Question 43

The FDA has banned the use of food irradiation except for hospital products.

Question 44

The Federal Trade Commission Act of 1914 was enacted to reduce competition in the business world.

Question 45

The 1976 Medical Device Amendments to the federal Food, Drug, and Cosmetic Act gave the FDA authority to ensure the safety and efficacy of all medical devices before they are marketed.

Question 46

The FDA has little responsibility for approving the safety and effectiveness of new drugs.

Question 47

The U.S. Postal Service does not have the authority to stop mail delivery when it suspects a fraud is being perpetrated on the public.

Question 48

The FDA has little interest in receiving complaints from consumers about unsafe, ineffective, or mislabeled products.

Question 49

The 1990 Safe Medical Devices Act to the Food, Drug, and Cosmetic Act did little to strengthen FDA's ability to monitor the marketplace and order recalls.

Question 50

Advertisers are prevented from continuing lucrative promotions because of the fast action taken by the FTC when advertising violations occur.

Question 51

The 1983 Orphan Drug Amendment discouraged manufacturers from developing new drugs for rare diseases.

Question 52

Consumers need not take an active role in the health marketplace, because federal, state, and local agencies and organizations provide adequate protection.

Question 53

The GRAS list refers to food additives that have been found to be unsafe.

Question 54

Few professional, volunteer, or business organizations are involved in health-related consumer protection activities.

Question 55

Violation of a consent agreement or cease-and-desist order issued by the FTC can trigger a penalty of up to $1,000 per day per violation.

Question 56

Which should be done first when a consumer wishes to register a complaint about a health product or service?

A) Call the FDA or FTC.
B) Contact the Better Business Bureau.
C) Request satisfaction by complaining at the source.
D) Submit complaint to small claims court.

Question 57

The least important action by the intelligent health consumer is to

A) be analytical and critical of advertising.
B) use reliable sources of information.
C) be aware of the signs of health frauds and quackery.
D) locate a reliable primary care provider.
E) keep a watchful eye on regulatory agencies.

Question 58

The last-resort action when a consumer has a complaint is to

A) file a lawsuit.
B) register the complaint at the source.
C) put the complaint in writing and send it to the company president.
D) contact a voluntary consumer organization.

Question 59

Which of the following consumer protection organizations is primarily supported by business and professional firms?

A) Health Research Group
B) National Consumers' League
C) Consumer Federation of America
D) Better Business Bureau
E) National Council Against Health Fraud

Question 60

The first action against the manufacturer taken by the FTC when it locates a misleading or incorrect advertisement is to

A) request corrective advertising.
B) request voluntary compliance with modification.
C) issue a cease and desist order.
D) issue a preliminary injunction.

Question 61

Possible FDA actions against law violators include all the following except

A) seizing the product.
B) seeking an injunction.
C) levying a fine on manufacturer.
D) initiating criminal prosecution.
E) asking the manufacturer to recall the product.

Question 62

The first action for a manufacturer desiring FDA approval for a new drug is to

A) submit a notice of clinical investigation exemption.
B) perform tests on animals.
C) perform tests on human beings.
D) submit a new drug application.
E) advertise to invite health professionals to report their experiences.

Question 63

Food additives are used for all the following except

A) increasing cooking time.
B) making products more nutritious.
C) preserving product shelf life.
D) adding flavor to products.
E) preventing the growth of mold in food.

Question 64

The FDA's functions and responsibilities include all the following except

A) assurance of safety and purity of drugs and cosmetics.
B) regulations for proper labeling.
C) regulating advertising of OTC products.
D) inspection of plants where foods and drugs are produced.
E) evaluating how physicians prescribe drugs.

Question 65

What does the 1962 Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act require?

A) Homeopathic drugs must be proved effective to remain on the market.
B) New drugs must be proved safe and effective before marketing.
C) Patients' consent is usually needed to use experimental drugs.
D) Drug labels must include generic names of drugs.
E) None of these choices.

Question 66

Federal law requires drugs labels to include all the following except

A) active ingredients and quantity.
B) adequate directions for use.
C) price.
D) warnings when necessary.

Question 67

FDA laws and regulations state that food is misbranded under all the following circumstances except when

A) labeling is not conspicuously displayed for easy reading.
B) labeling is false and misleading.
C) container size, shape, or filling misrepresents the quantity of contents.
D) artificial coloring and preservatives are not listed.
E) pesticide residues are not identified on the label.

Question 68

The FDA considers a medicinal substance to be a new drug under all the following circumstances except that

A) it contains a newly developed chemical.
B) it contains a chemical not previously used in medical practice.
C) a previously marketed brand-name product has had its name changed.
D) it is not generally recognized as safe and effective by experts.

Question 69

Which of the following influenced passage of the Kefauver-Harris Amendment in 1962?

A) Drugs were very expensive.
B) Collier's Weekly magazine published a series of articles exposing quack practices.
C) The drug industry was perceived as a monopoly.
D) The thalidomide tragedy called attention to the weakness of existing law.

Question 70

Which of the following problems existing in 1915 are not yet resolved today?

A) inadequate numbers of regulatory staff
B) small fines relative to the harm caused
C) advertisements are misleading
D) all of the choices are not yet resolved
E) all of the choices are resolved

Question 71

Which of the following was not a feature of the 1976 Medical Device Amendments?

A) allowed the FDA to require pre-market approval
B) extended FDA authority over device safety
C) extended FDA authority over device effectiveness
D) allowed the FDA to require performance standards
E) all of the choices are correct