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1. Action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.

Many agencies help to protect Americans in health matters. This chapter highlights the laws that control the two main federal consumer protection agencies: the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC). Information is also provided about other government agencies; voluntary, business, and professional groups; consumer education; and ac- tions that intelligent consumers can take to help protect themselves in the health marketplace. Additional trust- worthy sources of information and advice are listed in the Appendix and on the Consumer Health Sourcebook Web site (www.chsourcebook.com). Federal enforcement ac- tions described in other chapters are listed under each agency in the Index. State and local actions are indexed under “Enforcement actions.” u.s. Food and drug administration The FDA is part of the U.S. Public Health Service, which is a component of the Department of Health and Human Services. The FDA’s main function is to protect the public from health hazards involving foods, drugs, cosmetics, and medical devices. Approximately 20¢ of every consumer dollar in the United States is spent on FDA-regulated products.4 The FDA sets performance standards; conducts in- spections, surveys, and analyses to measure compliance with these standards; evaluates drugs, biologics, and devices that require premarket clearance; initiates en- forcement actions when necessary; and helps inform and educate industry, health professionals, and the public. In fiscal year 2010 (October 1, 2009, through September 30, 2010), the agency had about 12,000 full-time equivalent employees and a budget of $3.2 billion.4 The FDA’s headquarters offices are located in the Washington, D.C., area and include the Office of the Commissioner, Center for Food Safety and Applied Nutrition, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Vet- erinary Medicine, Center for Devices and Radiological Health, and Center for Tobacco Products. Another com- ponent, the National Center for Toxicological Research, is in Jefferson, Arkansas. The FDA Commissioner is appointed by the president and confirmed by the U.S. Senate. The FDA’s Office of Regulatory Affairs directs inspections and enforcement policy. It is organized into five regions with 20 district offices and many field offices located throughout the country.

• Many health-related consumer-protection laws emphasize the importance of science and scientific testing.
• The government agencies that regulate products and professionals have significant regulatory powers but encounter far more problems than they can possibly handle.
• The best protection against fraud is a consumer who is informed, skeptical, and assertive.

Keep these points in mind as you read this Chapter Key Concepts Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 505 Food and Drug Laws Many federal laws affect the marketing of health-related products. The principal laws are the following, listed in chronologic order. The original Pure Food and Drug Act (1906) was passed in response to public concern about the safety of foods and drugs (see Historical Perspective box). The act required that foods be pure and wholesome and that the ingredients of drugs be listed on their label. This law, initially administered by the Agriculture Department’s Bureau of Chemistry, did not require that drugs be safe or effective. In 1927 the act’s regulatory duties were transferred to the newly created Food, Drug, and Insecticide Administration, which was renamed Food and Drug Administration 3 years later. In 1940 the FDA became part of a new Federal Security Agency, which, in 1953, was elevated to cabinet status as the Department of Health, Education, and Welfare (DHEW). In 1979 DHEW became the Department of Health and Human Services (HHS). The Sherley Amendment to the Food and Drug Act (1912) prohibited the labeling of medicines with false therapeutic claims intended to defraud the purchaser. The Food, Drug, and Cosmetic (FD&C) Act (1938) replaced the 1906 law with new and stronger provisions:

• Foods in interstate commerce must be pure and wholesome, safe to eat, and produced under sanitary conditions.
• Drugs and therapeutic devices must be safe. • New drugs must be approved for safety by the FDA before

they can go on the market. (Products marketed before 1938 did not have to meet this requirement.)

• Cosmetics must be safe. • Labeling must be truthful and not misleading; common

names of all ingredients are required; quantities and pro- portions of potent and habit-forming narcotic and hypnotic substances must be given.

• Drug labeling must include warnings needed for safe use.
• Drugs not safe for self-treatment are restricted to sale by prescription.
• Drug-manufacturing plants must be registered and be in- spected by the FDA at least once every 2 years.
• Antibiotics, insulin, and colors used in foods, drugs, and cosmetics must be tested in FDA laboratories before they can go on sale.
• Chemicals added to foods must be proven safe before their use is allowed.
• Pesticide residues in or on raw crops must not exceed safe tolerances. (The Environmental Protection Agency now establishes the limits, and the FDA enforces them.)
• Penalties are heavier for second offenses and fraud. First offenses might bring up to 1 year in jail.
• The FDA no longer had to prove that defendants intended to defraud their customers. This was important because some promoters are misguided cranks who believe in their products.

The Public Health Service Act (1944) contained two sections now enforced by the FDA. Their provi- sions cover the safety, purity, and potency of biologic products, such as vaccines, sera, and blood for interstate sale, and the safety of pasteurized milk and shellfish, as well as the sanitation of food, water, food services, and facilities for travelers on trains, airplanes, and buses. The Durham-Humphrey Amendment (1951) speci- fied that drugs that cannot be safely used without medi- cal supervision must be so labeled and be dispensed only by prescription of a licensed health practitioner. Thus a distinction was made between over-the-counter (OTC) and prescription drugs. Before this law took ef- fect, manufacturers decided whether to classify drugs as prescription or OTC. If the FDA disagreed, it could bring the case to court and charge that the product was misbranded. The Food Additives Amendment (1958) prohibited the use of new food additives until the manufacturer had established their safety. Its Delaney Clause gave the FDA additional authority to ban the use of food additives that can cause cancer in humans or animals. The Color Additive Amendments (1960) permitted the FDA to regulate the conditions for the safe use of color additives in foods, drugs, and cosmetics and to require manufacturers to make the necessary scientific investigations to establish safety. The Federal Hazardous Substances Labeling Act (1960) required that labels display prominent warnings regarding household products with hazardous chemicals. This is now enforced by the Consumer Product Safety Commission. The Kefauver-Harris Drug Amendments (1962) overhauled and strengthened the drug provisions of the FD&C Act of 1938. They came about as a result of the foresight of Dr. Frances Kelsey, an FDA medical officer who prevented the release of thalidomide on the U.S. market because of suspected side effects (see Historical Perspective box). Strong public support for strengthening the law resulted from news reports about deformed Ger- man babies whose mothers had taken thalidomide during their pregnancy. These 1962 amendments included the following provisions: • Manufacturers must provide substantial evidence that a new drug is effective as well as safe before it can be approved for marketing. Part Six Protection of the Consumer506 The Pure Food and Drug Act (1906) was passed in response to public concerns about the safety of foods and drugs. After the Spanish-American War it was discovered that the army had been supplied with spoiled canned meat and sawdust-adulter- ated flour. There were also reports that toxic chemicals such as formaldehyde had been used to preserve milk sold in neighbor- hood grocery stores. Two leaders in the struggle to enact the bill were Dr. Harvey W. Wiley, chief chemist for the Department of Agriculture, and his crusading journalist follower, Samuel Hopkins Adams. Wiley’s main concern was the prevalence of fraudulent food products, but he also fought hard for the regula- tion of patent medicines. Wiley believed that all remedies should have their formula on the label and that none containing alcohol or cocaine should be sold without a doctor’s prescription. In 1905 Collier’s Weekly magazine began a series of 10 articles by Adams titled “The Great American Fraud.” The series attacked nostrum evils and quackery and said that Americans were wasting more than $75 million annually on products con- taining large quantities of alcohol, opiates, and other question- able ingredients. He noted, for example, that Dr. King’s New Discovery for Consumption, which had been proclaimed as the world’s only sure cure for tuberculosis, contained morphine, chloroform, and 28% alcohol. The chloroform was to allay the cough while the morphine and alcohol drugged the patient into deceptive cheerfulness. The label did not reveal the nature of the ingredients or their possible hazardous effects. Adams explained that patent medicine testimonials were gathered from gullible ignoramuses or secured through various pressures from people in public life.5 The American Medical Association reprinted his articles as a 172-page booklet and sold nearly 500,000 copies, many of which were distributed by physicians to their patients. The final impetus to passage of the act was Upton Sinclair’s novel The Jungle, which was published near the end of 1905. Sinclair was a socialist who railed against American capitalism. His book was aimed at exposing the exploitation of immigrant laborers who were often forced to work long hours at low pay. The setting for his fiction was the meat-packing industry, where, said the book, rats, human fingers, and even whole bodies were processed along with animal parts into sausage and lard. There was no truth in such claims, but the public reacted with outrage—not at the exploitation of immigrants as Sinclair had intended, but at the imaginary conditions he described.6 Truth in Labeling The Pure Food and Drug Act required that medicine labels tell the truth, but not the whole truth. Labels had to indicate the presence and amount of alcohol, opiates, acetanilide, and several other potentially dangerous substances. It was not necessary to identify other ingredients. The label could not provide false or misleading statements about the medicine or its ingredients. The new law did not inhibit self-medication but attempted to make it safer. It was assumed that the average person was intelligent enough to avoid risks when ingredients were known. Products were not required to be effective. Many product labels changed drastically after 1906. When the law was violated, the government occasionally went to court, where it usually would prevail. However, fines were usually $50 or less, sometimes as low as one cent. The first court trial under the Pure Food and Drug Act was brought against Cuforhedake Brane-Fude, a product that contained acetanilide (an analgesic and antipyretic), antipyrine, caffeine, sodium and potassium bromide, and alcohol. The label stated that the product contained 30% alcohol and 16 grams of acetanilide, but Wiley’s analysis revealed only 24% alcohol. The product was claimed to offer “a most wonderful certain and harmless relief” and to contain “no . . . poisonous ingredients of any kind.” The government charged that this was misleading. Wiley noted that the product’s name appeared to be an evasive spelling for a headache cure and that none of the ingredients was food for the brain. One of Adams’s magazine articles had identified 22 headache-remedy users alleged to have had died from acetanilide poisoning. The manufacturer was found guilty of misbranding, fined $700, and forced to relabel the product. Some 2 million bottles had been sold for $1 each before the 1908 verdict. This illustrates how the selling of a quack remedy can be extremely profitable despite government enforcement action—a situation that holds true today. Although Cuforhedake Brane-Fude is no longer with us, products named after an ailment, body part, or body function are still abundant. Truth in Advertising The Pure Food and Drug Act had little effect on misleading advertising. In 1911 the Supreme Court ruled that the act’s prohibition against false labeling did not apply to therapeutic claims, because the misbranding section of the law did not explicitly refer to curative promises. Congressman Swager Sherley of Kentucky sought to correct this problem by obtaining passage in 1912 of an amendment stating that an article would be misbranded “if its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein which is false and fraudulent.”6 By 1915 the food and drug laws still had not controlled the problem of false and misleading advertising of patent medicines. Observers who claimed that conditions had worsened noted that: the job was too big for a small regulatory staff; fines were small and often unpaid; second offenders could be sent to jail for 1 year, but none had ever been sent; many dangerous drugs were not covered by the law; and newspaper advertisements were still misleading. Safety Requirements Added In 1938 the Food, Drug, and Cosmetic Act replaced the 1906 law with new and stronger provisions. As with the original law, public indignation was aroused by a book, 100 Million Guinea Pigs, by Arthur Kallet and F.J. Schlink. (The book’s title referred to the U.S. population at that time.) Several trag- edies had occurred, but the most outrageous was the mounting death toll from elixir of sulfanilamide, a product sold over the counter for treating infections, especially gonorrhea. It was the first antibiotic drug and at first was considered a miracle drug. Unfortunately, it contained the toxic substance diethylene glycol Historical Perspective A Brief History of Federal Consumer Protection Laws Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 507 Historical Perspective A Brief History of Federal Consumer Protection Laws—Cont’d. and had not been tested for safety. In 1937, 107 people, many of them children, died. The 1938 law increased public protection but did not clearly distinguish between drugs requiring medical supervision and those suitable for self-medication. New drugs would have to be proven safe before marketing, but proof of effectiveness was still not required. The hazard of permissive refills of prescribed drugs also remained. In the Midwest, a mother of three children was discovered upon admission to a hospital to be a barbiturate addict. She had received a prescription for 30 capsules that had been refilled 16 times within 3 months. Another woman with mild high blood pressure was found dead in her bed. During the preceding 6 months she had received 23 refills of a prescription for 20 bar- biturate capsules. Such evidence led to passage in 1951 of the Durham-Humphrey Amendment, which prohibited the refilling of prescriptions without specific authorization of the physician. It also gave the FDA the power to classify drugs as prescription drugs. Young7 called the 25-year period following passage of the 1938 Act “the chemotherapeutic revolution.” Its impact on self-medication was enormous. Americans spent less than $200 million per year for nonprescription medications in the 1930s, but by 1957 the sum had reached $2 billion. (Today it is more than $19 billion.) This increase was partially due to extensive advertising. Unscrupulous promoters of pseudomedicine were prevalent during this period and their appeals became more sophisticated. Promotions included pamphlets, newspapers, roadside signs, lecturers (some speakers collected $25,000 weekly from fees and sales), and door-to-door salespeople. Critics charged in 1961 that the chemotherapeutic revo- lution had produced a therapeutic nightmare, especially with respect to prescription medications. Although many new drugs could save lives and reduce pain and suffering, many were improperly used, and drug-induced ailments occurred with increasing frequency. Some blame was attributed to physicians because (a) drugs were sometimes prescribed when none was needed, (b) new therapeutic agents were sometimes used with- out considering their potential dangers, and (c) physicians at times relied too much on the claims of drug manufacturers and salespeople. Efficacy Requirements Added . . . and Partly Waived The marketing of thalidomide as a sleeping tablet, sedative, and antiemetic for pregnant women began in West Germany in 1957. Three years later, the manufacturer sought permission to sell it within the United States by submitting a new drug application to the FDA. But Dr. Frances O. Kelsey, an FDA physician, suspected that the drug was hazardous to the unborn child. As a result of her action, the application was withdrawn. It soon became clear that babies born to mothers who took thalidomide during pregnancy had a high incidence of serious birth defects of their arms and legs. The drug was never marketed in the United States, but some Americans obtained it in Europe. The thalidomide tragedy led to passage in 1962 of the Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act. It provided that no new drug could be released to the public unless the manufacturer provided evidence acceptable to the FDA that the drug was effective as well as safe. Drug companies also had to notify the FDA whenever they became aware that an approved drug might have adverse effects. Prior to passage of this law the FDA bore the burden of proving ineffectiveness. The Dietary Supplement Health and Education Act of 1994, passed in response to an aggressive campaign by the health-food industry, weakened the FDA’s ability to protect consumers from misleading promotions for vitamins, minerals, amino acids, herbs, and various other substances marketed as “dietary supplements.” Postal Laws The Mail Fraud Statute (1872) was enacted to combat a rash of swindles that had erupted after the Civil War. Prior to passage of this law, con artists who used the mail to defraud people were virtually safe from prosecution because local law-enforcement officials were unable to obtain jurisdiction over distant swindlers. By 1895 the Postal Service could stamp letters “fraudulent” and return them to senders, but it was not until 1901 that the Postmaster General, with Dr. Wiley’s help, began acting against patent-medicine frauds. Postal authorities assailed the most outrageous quacks who promised sure cures for such problems as cancer, consumption (tuberculosis), epilepsy, blindness, deaf- ness, a drug habit, a tobacco habit, “lost manhood,” and “failing womanhood.” Proving fraud was easiest against devices said to restore lost manhood or cure all human ills. During the 1920s, frauds involving nostrums for tuberculosis and venereal disease were common. Most current health-related mail frauds involve “miracle” diets and products claimed to enhance beauty, sexual function, or athletic prowess. The Mail Order Consumer Protection Amendments of 1983 enable the Postal Service to seek large civil penalties for repeat offenders. This law was passed after Consumer Reports publi- cized an investigation by Dr. Stephen Barrett that demonstrated that almost every health-related product sold by mail through magazine advertising was misrepresented.8 Before that time, swindlers could remain in business indefinitely by modifying products, making new advertising claims, or operating under new company names. Unfortunately, the agency has not tried to stop false advertising of any health product since 1991. FTC Laws The Federal Trade Commission Act (1914) was intended to preserve competition in the growing industrial society by pro- viding safeguards against business monopoly. It was designed to prevent unfair methods of competition in commerce by making unfair practices unlawful, thereby protecting consumers as well as other entrepreneurs. The FTC was given authority to investigate, publicize, and prohibit such procedures. The first five commissioners were sworn into office in 1915. The Wheeler-Lea Amendment (1938) provided for regulation of advertising of all health-related products except prescription drugs. The Fair Packaging and Labeling Act (1966) gave the FTC primary jurisdiction over package and label claims in all areas except food, drugs, devices, and cosmetics, which are still delegated to the FDA. Part Six Protection of the Consumer508

• Previously cleared new drugs may be ordered off the mar- ket immediately if new information indicates an imminent hazard to health, and any prior approval may be withdrawn.
• Manufacturers are required to get the patient’s consent if experimental drugs are to be used, unless this is not feasible or the investigator believes that obtaining such consent would be contrary to the patient’s best interest.
• All drug products must be registered annually with the FDA, and each establishment will be inspected at least once every 2 years.
• The FDA was given broad inspection authority over pre- scription drugs.
• Prescription drug advertisements must include a summary of side effects, contraindications, and effectiveness.
• All drug labels must bear the established generic name of the drug, and prescription drug labels must list the quantity of each active ingredient.
• Regulatory authority over the advertising of prescription drugs was passed from the FTC to the FDA. (The FTC still has regulatory authority over OTC drugs.)
• Pharmaceutical manufacturers must comply with the Code of Good Manufacturing Practices in testing, processing, packaging, and holding drugs.

The Drug Abuse Control Amendments (1965) were enacted to control the manufacture and distribution of depressants, stimulants, and hallucinogens. The amend- ments required wholesalers and jobbers of these drugs to register annually with the FDA. The agency was also authorized to seize illegal supplies, serve warrants, ar- rest violators, and require all legal handlers of controlled drugs to keep records of their supplies and sales. A new Bureau of Drug Abuse Control (BDAC) was established for these purposes. In 1968, to consolidate the policing of illegal drug traffic, BDAC was transferred from the FDA to the new Bureau of Narcotics and Dangerous Drugs in the Department of Justice (now called the Drug Enforcement Administration). The Fair Packaging and Labeling Act (1966) pro- vided additional support for the FDA to ensure that food, drugs, medical devices, and cosmetics were honestly and informatively labeled. It required more complete information on labels and packages. The information was to be clearly and prominently stated in terms that would enable consumers to make value comparisons between competing products. Food package labels were required to contain the identity of the food; the name and address of the manufacturer, packer, or distributor; the net quantity of the contents; and an ingredient list. The FTC retained jurisdiction over OTC drug advertising. The Radiation Control for Health and Safety Act (1968) was designed to protect the public from unnec- essary exposure to radiation from electronic products such as color television sets, microwave ovens, and x-ray machines. The FDA sets performance standards for these and similar products. The Poison Prevention Act (1970) required special packaging to protect children from accidentally ingesting toxic substances. Poisons identified by the Secretary of Health, Education, and Welfare must be packaged so that most children younger than 5 will find them difficult to open. The Medical Device Amendments (1976) supple- mented the 1938 FD&C Act, which permitted action only if a defect in a product was discovered after the product was in use. The amendments gave new authority over the safety and effectiveness of devices. They enabled the FDA to require premarket approval for some items and performance standards for others. The Proxmire Amendment (1976) prohibited the FDA from limiting the potency of ingredients of vitamin and mineral products that are not inherently dangerous. This bill prevents the FDA from ridding the marketplace of useless “dietary supplement” ingredients and irrational combinations of ingredients. The bill was passed because the health-food industry misled many of its customers into believing that the FDA intended to greatly restrict the sale of supplement products. More than 1 million protest messages poured into Congress as a result. The Infant Formula Act (1980) requires strict controls to ensure the nutritional content and safety of commercial baby foods. The Orphan Drug Act (1983) was passed to facilitate the development of new drugs for more than 5000 rare diseases affecting as many as 20 million Americans. A disease is considered “rare” if it affects fewer than 200,000 people. Drug companies can now claim half of clinical trial costs as a credit against taxes owed. Compa- nies might otherwise be reluctant to develop such drugs and gain FDA approval because the cost is prohibitive. The legislation also authorized grants to fund research to discover useful substances. Following approval the manufacturer is entitled to 7 years of marketing exclu- sivity. So far, more than 350 orphan products have been approved.9 The Drug Price Competition and Patent Term Res- toration Act (1984) permits the FDA to approve generic versions of previously approved new drugs without requiring their sponsors to duplicate the costly human tests required for the original drugs (see Chapter 17). It allows the term of patents on medicines (17 years) to be extended up to 5 years to compensate for the time required to get FDA approval. The Prescription Drug Marketing Act (1988) pro- hibits selling; buying; trading; or offering to sell, buy, or trade prescription drug samples. Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 509 The Safe Medical Devices Act (1990) gave the FDA the power to (a) obtain earlier knowledge of serious device problems, (b) order recalls to quickly remove defective products from the marketplace, (c) track de- vices from the manufacturer to the consumer, and (d) apply large civil penalties for violations of the act. The act requires hospitals and other health-care providers to report device-related deaths directly to the FDA instead of to the device manufacturer. Additional provisions are discussed in Chapter 20. The Nutrition Labeling and Education Act (1990) provided for (a) mandatory labeling on most food products; (b) standardization of portion sizes; (c) more appropriate disclosure of fat and cholesterol contents; (d) determination of whether disease-prevention claims can be made for various nutrients; and (e) voluntary guidelines to retailers for nutrition information on raw fruits, vegetables, and fish. Chapter 10 discusses how these provisions have been implemented. The Dietary Supplement Health and Education Act (DSHEA) of 1994 was passed following a massive lobby- ing campaign by the health-food industry. (See Chapter 11.) This law (a) broadened the term “dietary supple- ments” to include herbs and many other substances that lack nutritional value, (b) shifted the burden of proof of safety on the FDA, (c) set standards for the distribu- tion of third-party literature, (d) allows statements of “nutritional support” under certain circumstances, (e) specified the ingredient and nutritional label informa- tion, (f) requires good manufacturing practices, and (g) established the NIH Office of Dietary Supplements to oversee research and provide advice to other federal agencies. DSHEA greatly weakened the ability of the FDA to protect consumers against unsubstantiated claims made in product labeling or advertising.10 Final regula- tions covering the law’s requirements for supplement labeling, health claims, and “statements of nutritional support” took effect in 2000.11 The Food Quality Protection Act (1996) replaced the Delaney Clause (see page 505) with a more flexible requirement that additives be safe (defined as “reason- able certainty” that no harm will result from their use). The FDA Modernization Act (1997) codified or extended regulations intended to (a) accelerate review of new drugs and devices, (b) increase patient access to experimental drugs and devices, and (c) permit pharma- cists to compound certain categories of drug products not commercially available. Food, Drug, and Cosmetic Act The Food, Drug, and Cosmetic Act, including amend- ments, is the primary federal consumer protection law in the United States.12 It deals with imported products as well as domestic ones. Its purpose is to ensure that foods are safe to eat, drugs and health devices are safe and effective for their intended uses, and cosmetics are safe and properly labeled. The following are its main provisions. Food provisions. Food is considered adulterated if it contains (a) poisonous or deleterious substances that are injurious to health; (b) filthy, putrid, or decomposed substances or substances prepared and packed under unsanitary conditions; or (c) unsafe color additives. Food is said to be misbranded when: (a) the label- ing is false and misleading; (b) the food is offered for sale under the name of another food; (c) the food is an imitation of a food and the label does not bear the word “imitation”; (d) the container is so made, formed, or filled as to be misleading about its contents; (e) the food is represented for special dietary use without the label bearing information about the product’s vitamin, min- eral, and dietary properties; (f) the food contains artificial flavoring, artificial coloring, or chemical preservatives that are not listed on the labels; or (g) the labeling is not conspicuously displayed in terms that consumers are likely to read and understand. Regulations that took effect in 1994 require manu- facturers to provide nutrition information on product labels. The required nutrition panel must state the typical serving size, the amounts per serving of several impor- tant nutrients, and Percent Daily Values that indicate how the food fits into the overall diet of people at specified calorie levels. The regulations also permit health claims to be made for certain types of food. Chapter 11 covers the new labeling regulations in detail. Food additives. Additives must be supported by evidence substantiating their safety before they may be included in a product. The Food Additives Amendment of 1958 authorized the FDA to establish the quantities of certain substances that could be added safely. The FDA categorizes additives either as regulated food additives or as GRAS (generally recognized as safe) substances. Several thousand compounds can be classified as additives. Regulated food additives are substances that can be added directly to food (such as vitamins to milk or bread) or that get into food from its surroundings, including packaging, manufacturing equipment, and other sources. The GRAS list includes about 700 additives that scientists recognize as safe be- cause of long-established use without evidence of harm to individuals. Many additives come from food itself. Lecithin, for example, is found in all plants and animals. It is obtained primarily from soybeans and is used mostly Part Six Protection of the Consumer510 as an emulsifier to keep ingredients in processed foods from separating. Calcium and sodium propionate are used in the cheese industry, but propionate also occurs naturally in Swiss cheese. Propionate is used primarily as a mold inhibitor in baked goods. Sodium benzoate prevents mold growth in margarine. Added vitamins and minerals are identical to those found naturally in food. Food additives are used as (a) nutrient supplements (such as vitamins and minerals used for enrichment or fortification), (b) nonnutritive sweeteners (sugar substi- tutes), (c) preservatives (to prevent microbial spoilage and oxidative chemical change), (d) stabilizers and thickeners (as in ice cream, candy, frozen desserts, jams, jellies, and gelatin), (e) flavors or flavoring agents (such as spices, liquid derivatives of onion and garlic, and the flavor enhancer monosodium glutamate made from corn, beets, or soybeans), (f) bleaching and maturing agents (which speed the aging process of flour), and (g) colors. There are other functional uses, and several additives serve more than one purpose. Ascorbic acid (vitamin C), for example, is a nutrient, an acidifying agent, an antioxidant, and a microbial inhibitor. Any new substance proposed for addition to food must undergo rigid testing. The FDA also requires information about the chemical composition of the sub- stance, how it is manufactured, and the methods used to detect it and to measure it at the expected levels of use. Data must show that the proposed testing methods are sensitive enough to determine compliance with estab- lished regulations. Finally, proof must be provided that the substance is safe for its intended use. This requires tests that administer the additives in various concentra- tions in the diets of two or more species of animals. The FDA will allow the use of a food additive only if it concludes there is practical certainty that no harm will result from its normal use over a lifetime. In recent years, the FDA has been concerned about the addition of caffeine to alcoholic beverages (see Per- sonal Glimpse box). Food irradiation. Irradiation (sometimes called “cold sterilization”) can make food safer by killing harmful pathogens, spoilage microorganisms, para- sites, and insects and can also extend the shelf-life of fruits, vegetables, and certain other foods by retarding enzymatic spoilage. The FDA regulates food irradiation as an additive, even though it does not “add” anything to food. The process is accomplished by treating foods with ionizing radiation (gamma rays) from radioactive cobalt or cesium or from devices that generate electron beams (beta rays) or x-rays. During the 1960s irradiation was approved for use on potatoes to control sprout growth and for insect disinfestation of wheat and wheat flour. Later it was approved for pork (1985), herbs, spices, fresh fruits, and dry vegetable substances (1986), meat and poultry products (1990, 1992, 1995, 1997, 2000), fresh shell eggs (2000), and seeds for sprouting (2000). Irradiation can kill Salmonella bacteria in poultry and trichinosis organisms in pork and can retard spoil- age of fruits and vegetables. Extensive studies indicate Figure 25-1. International food irradiation symbol. Personal Glimpse FDA Attacks Caffeinated Alcohol Drinks13 Caffeinated alcoholic beverages (CABs) are alcoholic beverages that contain caffeine as an additive and are packaged in combined form. Caffeine can mask sensory cues that people may rely on to determine how intoxi- cated they are. This means that people drinking these beverages may consume more alcohol and become more intoxicated than they realize. Studies suggest that drinking caffeine and alcohol together can lead to hazardous behaviors, including alcohol poisoning, sexual assault, and riding with a driver who is under the influence of alcohol. Malt versions of premixed alcoholic beverages come in containers holding between 12 and 32 liquid ounces. Some may also contain stimulant ingredients in addition to caffeine. Their advertised alcohol-by- volume value is as high as 12%, compared to standard beer’s usual value of 4 to 5%. These beverages are available in many states in convenience stores and other outlets. They often come in large, boldly colored cans comparable in size to “tall” cans of beer—or in containers resembling regular beer bottles. In November 2010, theFDA notified four compa- nies that make malt versions of these beverages that the marketing of these beverages is illegal because, under the law, the added caffeine is an “unsafe food additive.” Chapter Twenty-Five Consumer Laws, Agencies, and Strategies 511 that foods exposed to low doses of irradiation are safe to eat.14 The foods do not become radioactive or undergo significant changes in nutrient composition. Some irradi- ated foods have better flavor and texture than their heat- treated counterparts because, unlike heating, irradiation does not cook the foods. Irradiation is also used to steril- ize medical instruments and to prepare special foods for astronauts, military personnel, and cancer patients with impaired immunity. Since 1986 the labels of irradiated foods have been required to carry the internationally used logo of the stylized rose with two petals (Figure 25-1). Genetically engineered foods. The FDA’s policy for genetically engineered foods covers all foods produced by any method of plant breeding. Although GRAS sub- stances are excluded from the requirement for premarket approval, new substances introduced via breeding must be approved as food additives. Genetically engineered food crops that do not contain substances significantly different from those already in the diet do not require ap- proval as food additives, but they are required to undergo extensive testing for quality and safety. These products are also referred to as genetically modified organisms (GMOs). So far, more than 40 genetically modified crops have been FDA-approved. The FDA has also approved the use of bovine somatotropin (BST), a genetically engineered animal growth hormone that increases milk production in cows. Genetically engineered BST, which supplements the cow’s natural supply, does not alter the milk and presents no health risk to consumers.15 Since there is no detectable difference in milk from treated and untreated cows, the FDA does not require that products from treated cows be labeled. In 2004, the National Academy of Sciences16 published extensive guidelines for continuing to monitor safety but noted no adverse health effects attributed to genetic engineering had been documented in humans. Food irradiation and genetic engineering have been unfairly attacked by the health-food industry, the “or- ganic” food lobby, food faddists, and several “consumer” groups (Figure 25-2). The Foundation for Economic Trends, for example, which refers to genetically engi- neered foods as “Frankenfoods,” erroneously claims that milk produced with BST will contain “artificial hormones” that “could be hazardous to our health and our children.” A few restrictive state laws have been en- acted, and boycott threats by radical consumer activists have made some manufacturers and retailers reluctant to market foods produced with these technologies. Drug provisions for humans. The FD&C Act pro- hibits misbranding and adulteration of any drug. Drugs are categorized as new, investigational, prescription, or nonprescription: neW DruGS are any drugs that (a) contain a newly developed chemical, (b) contain a chemical or substance not previously used in medicine, (c) have previously been used in medicine but not in the dosages or conditions for which the sponsor now recommends use, or (d) have not been recognized by experts as safe and effective for their intended use. It is illegal to introduce a new drug into interstate commerce without FDA approval. Approval is sought by filing a new drug appli

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