Consumer protection is a general concept that involves protecting people frombuying things and services that are unsafe or fraudulent. The best know consumer protection organization in the United States is the Consumer Product Safety Commission (CPSC). The CPSC is an independent federal regulatory agency created by Congress in 1972. Its charter is to "protect the public against unreasonable risks of injuries and deaths associated with consumer products."
The CPSC has jurisdiction over about 15,000 types of products--everything from appliances to toys. It helps manufacturers develop voluntary standards to prevent accident and injury, enforces government determined mandatory standards, issues recalls of unsafe products, does research into potential product hazards, and educates consumers to choose safer products and report accidents and injuries related to consumer products.
In addition to the CPSC, in the United States several other agencies are responsible for protecting the public. The U.S. Department of Transportation regulates car, truck, and motorcycle safety. The U.S. Department of the Treasuryregulates alcohol, tobacco, and firearms. The U.S. Food and Drug Administration (FDA) is responsible for the safety and efficacy (whether a product actually does what it says it does) of prescription and over-the-counter drugs, medical devices, cosmetics, and food. In the field of health care, the FDA is the major agency responsible for consumer protection.
Keeping food and drugs pure and safe is an old problem. As long ago as 1202,King John of England proclaimed a law that prohibited bread from being adulterated (contaminated) with any ingredients such as ground peas or beans. In 1785, Massachusetts was the first state to pass a food adulteration law. In 1820, a group of well-known physicians met in Washington D.C. to establish the U.S. Pharmacopeia. This was a list of standards (purity and content) that alldrugs had must meet. The U.S. Pharmacopeia is still in existence today. Sometimes on drug labels you will see the letters USP after the drug name. This means that the drug conforms to the standards and formulas of the U.S. Pharmacopeia.
Federal regulation of drugs began in 1848 with a law that sought to prohibitthe entry of adulterated drugs into the United States. In 1862, President Lincoln established the Bureau of Chemistry, a division of the Department of Agriculture that later to become the Food and Drug Administration. In the firstten years of the twentieth century, Congress passed a series of laws to insure the purity of serums and vaccines, prohibit the interstate transport of adulterated or mislabeled food, drinks, and drugs, and to require federal inspection of meat packers. These laws were passed to eliminate such dangerous practices as using poisonous preservatives and dyes in meat and manufactured foods, and to restrict false claims made for worthless or dangerous patent medicines.
Today the FDA's jurisdiction extends to foods, drugs, cosmetics, and medicaldevices. These products must be proven safe and effective before they can besold in the United States. Companies wanting to sell a new food product mustprove that their manufacturing process destroys harmful bacteria and adds noharmful chemicals to the food. The FDA also regulates the labeling of food and is responsible for the truth of such claims as "low fat" or "cholesterol free" on labels. Currently, naturally occurring herbal supplements do not fallunder the control of the FDA. As these supplements become increasingly popular, there is debate in the health care community about whether they should beregulated in a way similar to over-the-counter drugs in order to protect consumers from contaminated products and false claims.
In the area of drugs and medical devices, the FDA requires both animal and human testing before a product can be licensed and sold. Drugs and devices mustnot only not hurt patients, they must actually do what they claim to do. Inother words, if a medicine claims to heal ulcers, the company intending to manufacture it must show through extensive studies that it actually does heal ulcers in most patients. The FDA also protects people from dangerous medical devices such as x-ray machines by setting standards of operation. It also setsstandards for handling blood and other body fluid and tissues that may transmit disease.
Because the FDA requires human testing of experimental drugs before they canbe licensed and sold to the public, the United States has signed the Declaration of Helsinki, a human rights document that assures that the rights of patients receiving experimental drugs are protected. The FDA enforces that all organizations testing drugs in the United States abide by the conventions of the Declaration of Helsinki. The basic provisions include:
- 1. Drugs should not be tested on people until they have been adequately tested on animals.
- 2. An independent committee, called an Institutional Review Board inthe United States, must approve each separate experimental study involving people.
- 3. People conducting the study must be scientifically qualified and approved.
- 4. Every participant in the study has the right to understand the expected goals, risks, benefits, and potential hazards of participating in the study, and may withdraw from the study at any time for any reason. This is called "informed consent."
- 5. The participant's privacymust be maintained in any published information arising from the study.
- 6. The organization performing the study must accept financial responsibility for treating any serious or unexpected problems arising from a person's participation in the study.
The United States food and drug laws provide some of the highest level of consumer protection in the world. In addition to federal regulations, state andlocal health boards also inspect and enforce laws related to food preparationin restaurants and public places, as well as health risks of public swimmingpools, the disposal of garbage and animal wastes, the sanitary conditions ofplaces like kennels and animal shelters, and a myriad of other health related situations.
Another aspect of consumer protection in the health field has come to prominence in the late 1990s. With the popularity of managed health care plans and the rise of for-profit health care organizations, the question has arisen overwhether federal legislation is needed to establish a patient's bill rights.Such legislation would seek to strengthen consumer confidence in the health care system by ensuring that the system is fair and responsive to consumers' needs, by reaffirming the importance of the physician-patient relationship, and by setting forth the rights and responsibilities of all Americans in improving their own health. As of 1999, no legislative action had been taken on this issue, however, some health maintenance organizations (HMOs) and insurers had begun voluntarily modifying their regulations to provide consumers with more avenues of appeal in the event treatment was denied. In the absence of federal legislation, laws governing consumer protection in the health arena areimplemented on a state-by-state basis.
Unfortunatley fraud in the health care industry occurs with sufficient frequency that The Food and Drug Administration has prepared a list of the top 10 health frauds. These are: fraudulent arthritis products, spurious cancer clinics, bogus AIDS cures, instant weight-loss schemes, fraudulent sexual aids, quack baldness remedies or appearance modifiers, false nutritional schemes, unproven claims for a muscle stimulators, and so-called cures for Candidiasis hypersensitivity.
Dishonest promoters frequently promise quick or painless cures; promote products made from a special or secret formula; present testimonials from satisfied patients, claim their products are effective for a wide variety of ailments; and claim to have the cure for a disease that is not yet understood by medical science. The National Council Against Health Fraud can help the public take legal action against such fraudulent schemes. This organization offers referral to lawyers, a registry of expert witnesses, information on defense witnesses, and maintains a list of unproven, fraudulent, and potentially dangerous treatments.