Nature's Pharmacopeia: A World of Medicinal Plants

Chapter 2

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The Regulation of Drugs

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Mate de coca (coca tea) for sale at an Andean market in Humahuaca, Argentina. This product contains cocaine, which is restricted in the United States.

Wherever humans have settled, they have made plants important elements in their pursuit of physical, mental, spiritual, and community health. People have also recognized the value of toxic leaves, stems, and seeds and harnessed their poisons as weapons. To this day, medicinal plants serve mixed roles in society: they can rid patients of disease, and they can extinguish an enemy’s life. They can be used to help a man fight an infection, or they can release his psyche to communion with a vast supernatural world. Human cultures variously define wellness at individual and group levels; see physical, mental, and spiritual health differently; and have assigned many roles to people specializing in diverse aspects of plant-based medicine. Because of the diversity of medicinal plants and the many roles these plants play across many cultural settings, people have struggled to incorporate them into the context of social norms, moral standards, and law. Which uses should be considered health promoting, and which are deemed harmful? What role should a government play in easing access to herbal remedies, and which activities should it restrict?

In different eras and regional contexts, communities have had differing approaches to these complex questions. Most societies assigned specialist roles to individuals with the knowledge to administer skillfully medicinal plant products. Over time, concepts of health were redefined, and governments and religious institutions began to limit the breadth of acceptable plant medicine and establish structures for the regulation of numerous drugs. How this came to be is a story that began more than 2000 years ago.

DRUGS AS POISONS, SPIRITUAL AIDS, AND AGENTS OF SOCIAL BONDING

Plant drugs, it was long known, could have healing or harmful properties, and the preparation of remedies and poisons often fell to specialists. The Greek and Roman scholars wrote extensive treatises on the preparation of medicinal plants in various forms of soups, ointments, and powders. Pedanius Dioscorides’s inventory of materia medica was among the earliest of pharmacies, and those knowledgeable in its use served to remedy all manner of ailments.1 However, skilled hands can also employ plants to fatal ends. While extracts of hemlock (Conium maculatum) were used medicinally by ancient Greeks and Romans, the practitioner must have exercised extreme caution, as this herb contains potent nerve toxins.2 To this effect, hemlock was implemented in the dramatic execution of the Greek philosopher Socrates (469–399 B.C.E.).3 Over the years, a class of learned individuals specialized not in the healing properties of plants but in their deadly effects. During medieval and Renaissance times, several families in Italy, such as the Borgia and Baglioni, either were themselves or employed experts in poisons. They developed ingenious methods of delivery and ensured their ascent on the social ladder over the bodies of their opponents. Apothecaries, whose knowledge of medicinal plants could be applied to the preparation of both therapies and poisons, served dual roles. (“Such mortal drugs I have,” said the apothecary in Shakespeare’s Romeo and Juliet.)4 These potent preparations included mineral toxins, toad poisons, and extracts of plants such as monkshood (Aconitum spp., also known as wolfsbane and aconite) and nux vomica (Strychnos nux-vomica, also known as the strychnine tree).

Plant extracts have been used to heal and to harm. Through history, the use of medicinal plants has frequently occurred in conjunction with spiritual or religious appeals. This is because, in many parts of the world, health was characterized by inseparable spiritual and physical components. For example, a sixteenth-century drawing of an Aztec healing ritual pictures a patient in a steam bath, in the presence of medicinal plants, doctors, and an idol of the face of the goddess of medicine, Teteo Innan.5 This imagery supports a well-documented medical-religious practice in ancient Mexico in which priests served to diagnose and treat illness.6 The connection between medicine and faith is evident in Asia as well. In Tibetan herbalism, for instance, practitioners combined medicine with mantras to “energize” the herbs and promote their efficacy.7 In modern-day Suriname, along the Atlantic coast of South America, a survey of plant merchants revealed that 56 percent of medicinal plants sold at local markets were used for winti, Afro-Surinamese religious-spiritual health rituals.8 Thus the medical uses of plants have mystical elements in many cultures.

In addition to roles in spiritual health, medicinal herbs have been used to promote comfortable social interactions. These special functions in community life are evident in numerous cultures around the world, and expertise in preparing these materials sometimes became the domain of a unique class of healer. Among some indigenous American groups, for example, tobacco (Nicotiana spp.) was important in social-bonding rituals and in such settings was dispensed by elders and spiritual leaders.9 To this day, rites of passage in many regions are marked by the consumption of medicinal plants. Some medicinal plants play a more ubiquitous role in the social life of people: for example, the leaves of the tea plant (Camellia sinensis) or coffee seeds (Coffea spp.) serve to produce beverages around which people form friendships and business relationships. Thus medicinal plants can have roles in social health.10

DIVERSE PROFESSIONS SPECIALIZED IN SUPPLYING MEDICINAL PLANTS

During the Roman era, while some useful herbs fell under the auspices of physicians, people also incorporated medicinal plants in their everyday cuisine and visited spice merchants to obtain the balance of flavors and temperatures deemed healthy according to their medical beliefs. Similarly, in Asia, the maintenance of health through choice of food was a day-to-day function of the meal preparer. In China, specialized herb shops became established, where patients seeking treatment could turn in their physician’s prescription for carefully measured packets of herbs to brew into teas and soups at home. These specialist herb shops still exist in Chinese communities around the world and serve as trusted pharmacies. Today, pharmacies in China often have separate sections, one selling either herbal, animal, and mineral drugs for use in traditional medicine and the other selling prepared and synthetic biomedical drugs and antibiotics. Since medicine and cuisine have been so closely linked for so long, and in many parts of the world, food merchants and spice and herb sellers have played an important and continuing role in providing medicinal plants and perpetuating knowledge.

In Europe, the roles of plant medicines became gradually defined by the various specialists who tailored their use to heal, to poison, for cuisine, and for religious and other ends (figures 2.1 and 2.2). By the Middle Ages, a distinction developed among spiritual-medical practitioners that resulted in herbalism falling into the hands of a diverse group of specialists. Midwives and village herb gatherers provided folk medicinal materials to a great many individuals during this period, even as monasteries remained the repository of classical and religious knowledge, maintaining Greek- and Roman-inspired herb gardens for this practice. Pepperers and spicers were merchants in herbs for culinary and medicinal uses. Apothecaries and alchemists developed a trade in mixing herbs, metals, and animal parts into solid and liquid concoctions, frequently for medicinal goals.11 Meanwhile, the production of poisons by sorcerers became a lucrative trade, dependent on great insight into drug action—yet separate from the medical-chemical professions. Finally, expertise in the use of certain types of mind-altering herbs fell to the so-called witches, who developed potent cocktails for their spiritual rituals.12 Later, during the era of the Enlightenment, these divisions became further entrenched, since empirical medicine had no accommodations for spiritual or mystical healing. However, these specialist titles certainly should not imply exclusive roles. Apothecaries sold remedies and poisons. Folk herbalists had knowledge to diagnose and treat patients and probably to induce mind-altered states.

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FIGURE 2.1   Pierre Quthe, an apothecary. This portrait shows a medicine provider with his most important tool: a book of herbal medicines. [Painting by François Clouet [1562]; BIU Santé, 66442x13)

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FIGURE 2.2   Medicinal herbs are prepared in many different settings and have been largely unregulated until recent times: (left) a woman mixing an herbal recipe at home for an ill relative; (right) patients visiting a shop operated by a monk to obtain eye medicine. ([left] Illuminated manuscript, Bruges [late fifteenth century]; British Library Royal 15 D, i. fol. 18; [right] illuminated manuscript, Austria or southern Germany [ca. 1675]; Wellcome Library, London, L0042099)

As a result of the European experience, many people viewed the broad array of medicinal plant practices as composing two categories: on the one hand, the use of herbs to treat bodily ailments and, on the other, all other uses. In the latter category are many social and religious herbal practices now considered outside the realm of medicine in Europe, the United States, and elsewhere. In the European context, the ancient doctors and herbalists of the classical era gave rise to medieval apothecaries and modern physicians and pharmacists, administering treatments in response to primarily physical disorders.

Among many non-European cultures, the separation of physical, mental, and spiritual health is not recognized. In such societies, the role of treating illness, protecting the spirit, and expanding the mind frequently falls to the same priest, shaman, sage, or medicine man.

THE AMERICAN HERBAL MEDICAL TRADITIONS

It is a mixture of many traditions that characterized the American people of the eighteenth and nineteenth centuries: a blend of European, indigenous American, Asian, and African beliefs, an amalgam that enriches and complicates the modern-day American sense of health. Importantly, many of the divergent health beliefs of America’s peoples developed in the absence of formal government regulation. Indeed, the practices of herb collecting, medicine preparation, and spiritual healing evolved without state edicts or legislation controlling how the health trades could be practiced.13

Among the many schools of medical practice that coexisted in the nineteenth-century United States were those based on theories drawn from Europe (including humoral notions of health) and a growing cadre of physicians who embraced the biochemical and anatomical advances of early biomedicine. America’s pioneering culture and expansive, still largely wild natural environment gave rise also to domestic herbal practices that gained large numbers of adherents. One such school was founded by Samuel Thomson (1769–1843), a self-taught herbalist who rejected many of the techniques, such as bloodletting and mineral purges, still practiced at that time by formally trained European doctors.14 Instead, Thompson proposed that herbs alone could restore balance to an ill body, and his firsthand experience tasting North American plants convinced him that local herbs were better suited to treat local ailments than imported plants. He especially valued Indian tobacco (Lobelia inflata) for its capacity to induce a therapeutic bout of vomiting.15As an author, businessman (he sold proprietary herbal pills), and promoter of an American herbal medical practice, his influence persisted through much of the nineteenth century among his followers and the general public.

After Thomson, another school of American herbal medicine developed on the notion that plant-derived treatments were safer and more effective than many of the harsh methods of European medicine. Its practitioners called themselves the eclectics, on the belief that useful herbs could be found in a variety of settings, whether from North American Indian expertise or from the traditional medicines of other continents. (The eclectics most vigorously advocated the use of American medicinal herbs.) Early advocates, some of them former Thomsonians, sought also to formalize the American herbal medical tradition by establishing colleges for physician training, in which students learned physiology and chemistry in a curriculum emphasizing the use of herbs. Eclectic medical colleges trained physicians in the United States from the 1820s into the early part of the twentieth century.16 Among their legacy were numerous pharmaceutical companies grounded in the eclectic tradition, whose technicians prepared and sold a wide variety of herbal medicines and extracts in pharmacies and by catalog. By the late nineteenth century, Americans obtained medicines from a diverse assortment of medical practitioners and herb sellers, in addition to those they grew themselves.

At the turn of the twentieth century, the U.S. government—and those of most nations—had very few regulations on the manufacture and consumption of drugs. Medications of all varieties could essentially be harvested or produced by anyone, sold without a formal prescription, and marketed by specialist shops or general salesmen. The use of medicinal plants in food and drink or as drugs was considered to be an individual’s decision.17 The use of alcohol, in contrast, was much criticized during the nineteenth century, condemned by women’s groups, on the one hand, which warned of the dangers of inebriated and violent husbands, and by industrialists, on the other, who sought to sober up and increase the productivity of the workforce. Yet, particularly in the United States, individuals and interest groups had little power to effect change, as conservative forces maintained that the cultivation and harvesting of plants and the formulation of medicines was not governed by the Constitution and that any restriction in these activities would represent an affront to personal liberties.18

DRUG REGULATION IN THE UNITED STATES

By the late nineteenth century, public concern about medicinal plants mounted in two areas. First, people became sensitive to the possible risks of widely distributed home-remedy elixirs and other such popular medicines. Through the nineteenth century, numerous physicians, pharmacists, and entrepreneurs claiming medical authority produced and marketed concoctions advertised to treat all manner of ailments. Such medicines often contained medicinal plant substances, but their contents were unlabeled, as manufacturers were not required to disclose this information. Furthermore, producers could make any type of claim they wished on labels or in advertising, promising to cure the most debilitating conditions and to be free of any harmful substances, without the expectation that these assertions would be tested for truthfulness (figure 2.3). These nostrums went by the name of patent medicine.

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FIGURE 2.3   An advertisement for Brown’s Vegetable Cure for Female Weakness, a patent medicine, from Sears, Roebuck and Company, 1897. The contents of these purported cures were known to only the manufacturers until the Pure Food and Drug Act (1906) required labeling.

During the second half of the nineteenth century, patent medicines were increasingly under scrutiny, especially for their unlabeled contents. Some of them, it was found, had very few medicinal ingredients but high levels of alcohol; others packed potentially dangerous doses of drugs such as cocaine (from coca [Erythroxylum coca]) and morphine (from the opium poppy [Papaver somniferum]). The public and lawmakers sought to control this burgeoning industry of cure-all patent medicines (figure 2.4).19 Beginning with the Pure Food and Drug Act of 1906, which required the food and medicine industries to label the contents of their products, the government’s role in protecting public health took root.20

A second factor that influenced the course of medicinal plant regulation in the United States was the sensitivity of some Americans to the changing face of their society. As immigration advanced in the nineteenth century and domestic racial minorities pursued their lives alongside whites, the largely white media and government institutions targeted the (real and imagined) drug-taking customs of certain groups and developed laws to restrict particular types of medicinal plant use. For example, many were troubled by the Chinese custom of opium smoking (which grew stylish among Americans of all races) and the supposed nefarious connection between drug use and crime in immigrant communities.21 Racial motives in the regulation of medicinal plants are evident in the public discourse and in legislation surrounding poppy, coca, and marihuana (Cannabis sativa), among others. In short, from an era in which medical regulation was essentially absent, widespread concern over the potentially dangerous contents of unlabeled patent medicines, coupled with a desire to target certain practices among America’s ethnic groups, led to the development of a framework in which drug control became conscionable.

While the Pure Food and Drug Act required manufacturers to label their products, it did not restrict the producers’ choice of ingredients. (Manufacturers facing scrutiny of post-1906 labeled contents often chose to eliminate dangerous ingredients voluntarily.) Policies advanced during the twentieth century sought to restrict the production, distribution, or consumption of particular drugs based on the government’s growing responsibility to protect Americans from the potential dangers of medicines. Using legislative powers and executive privileges, the government had enormous latitude in curbing a range of practices across the spectrum of American life, from traditional spiritual rituals, to destructive narcotic abuse, to the consumption of home-remedy elixirs.

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FIGURE 2.4   “Death’s Laboratory”: a magazine cover critical of unlabeled, dangerous patent medicines. (Illustration by E. W. Kemble [1906])

THE FOOD AND DRUG ADMINISTRATION

Before the twentieth century, the production and sale of drugs was left to the free market, and the consumption of medicines was largely considered a matter of personal choice in the United States. The regulatory landscape changed in 1906 when the government passed the Pure Food and Drug Act, which required the labeling and enforced the testing of food, drinks, and medicine in interstate commerce. Products became subject to rigorous government testing for strength and purity, and from 1912 on, the law prohibited the sale of medicines under fraudulent claims of effectiveness. Originally monitored by the Department of Agriculture, such products came under the management of the Food and Drug Administration (FDA) in 1930.

In 1938, the Food, Drug, and Cosmetic Act (FD&C)1 required drug manufacturers to demonstrate to the FDA that a drug was safe (by relatively loose standards) before it could be sold.2 An amendment in 1951 established a system whereby certain drugs became labeled for sale by prescription only. Despite these regulations, most drug companies performed perfunctory drug trials that fell short of scientific credibility; in short, many medicines had not been demonstrated safe and effective by properly controlled study. To resolve this deficiency, Congress passed amendments to the FD&C in 1962 establishing rules by which drug manufacturers tested their products. The FDA served to approve or disapprove the marketing of these drugs based on a number of scientific criteria demonstrating their safety and efficacy.3

The Fair Packaging and Labeling Act of 1966 gave the FDA purview over the honest and informative labeling of products. In 1970, the FDA required that paper inserts accompany medicines to inform patients of the risks and benefits of medications, and in 1972 the FDA began to evaluate the claims of safety and effectiveness of over-the-counter medications.

In the modern era, drug companies seeking to market new drugs must apply to the FDA after performing substantial animal testing and propose their methodology for conducting human trials. Only after approval of this investigational new drug application can pharmaceutical firms commence human clinical trials.4

Along with oversight of prescription and over-the-counter drugs, the FDA regulates the labeling and sale of foods and dietary supplements, many of which have traditionally been regarded as medicinal. A 1958 amendment to the FD&C established that a large number of food additives and food colors (following certain guidelines) could be regulated under a framework of Generally Recognized as Safe (GRAS). GRAS products required a “reasonable certainty” of safety as demonstrated by “recognized experts,” the burden of proof held by the product’s manufacturer.5

Grandfathered into the GRAS standard were products in common use in food before 1958, provided an expert consensus existed that they were safe for human consumption. Thus most herbal preparations that were not explicitly sold as drugs came under regulation as food additives and therefore were required to meet the GRAS standard. While the GRAS standard provided a mechanism whereby manufacturers demonstrated the safety of their herbal products, the FDA found itself examining the health-related claims on the labels of such products and preventing their sale as unlawful, unapproved drugs. While such actions ensured (in the FDA’s view) public protection from potentially unsafe dietary additives and unsupported drug claims, the public’s perspective was of poor access to nutritional health supplements in a climate of burdensome regulation.

The response of Congress was to enact the Dietary Supplement Health and Education Act (DSHEA) of 1994,6 which loosened the FDA’s regulation of such supplements in several ways. First, DSHEA explicitly defined dietary supplements and ingredients as foods, preventing the FDA from treating them as drugs or GRAS additives. Second, DSHEA allowed manufacturers to assume the safety of their dietary ingredients, placing the burden to demonstrate lack of safety on the FDA. Third, dietary supplements are subject to a “reasonable expectation” of safety, in contrast to the “reasonable certainty” of safety for GRAS, a substantially less emphatic standard. Any dietary supplements in common use before October 15, 1994, are not considered new and are therefore exempt from any review process under DSHEA. Thus herbal supplements commonly used during the twentieth century can be marketed as dietary supplements without demonstrating safety, as long as they are labeled as dietary supplements, provide recommended dosage on the label, and do not make declarations of effectiveness to treat or prevent illness (or other drug claims).

An illustration of how DSHEA changed the regulatory environment for herbal products is in the marketing of the sweet-tasting compound stevioside from the South American sweetleaf (Stevia rebaudiana) plant (figure B.1).7 The plant has a long history of use by indigenous South Americans, particularly the Guaraní of Brazil, Paraguay, and Argentina. Under the GRAS standard, the burden of proof for the safety of food additives is on the manufacturers. For stevioside, the FDA warned that so little toxicology data had been accrued in scientific studies that producers had failed to demonstrate its safety adequately. Thus the FDA considered stevioside a food additive incompliant with the required “reasonable certainty” for safety. As a dietary supplement, however, manufacturers were mandated to notify the FDA only of stevioside’s impending release onto the market, and the FDA presented no objection based on the “reasonable expectation” of safety in the statute. Therefore, marketing of stevioside was banned under food-additive standards but permitted under dietary-supplement standards, where it currently enjoys commercial success as a diabetic-friendly alternative sweetener with about 200 times the sweetness of table sugar (sucrose).

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FIGURE B.1   Sweetleaf plant, source of a nonsugar sweetener.

FDA oversight of herbal products sold as dietary supplements allows three types of claims: health claims, structure-function claims, and nutrient-content claims. Health claims (such as “Scientific evidence suggests that X may reduce the risk of Y”) must be vetted by the FDA and supported with scientific authority. They rarely appear on dietary-supplement labels.

Structure-function claims (“Promotes mental acuity”) are allowable only if they make a general health statement and do not purport to treat a disease. Indeed, dietary-supplement labels must also clarify: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Manufacturers are not permitted to make a disease claim (“Protects against heart disease”), as this is seen to mislead the consumer into viewing a dietary supplement as a drug.

Nutrient content claims (“High in vitamin C”) are acceptable for many supplements for which the FDA has established recommended daily intake values; for others, a relative claim (“20 percent omega-3 fatty acids”) can appear.

Most herbal-supplement manufacturers assert structure-function claims on their products’ labels, and while they do not explicitly purport to treat disease, some members of the medical community are increasingly concerned by the off-label use of dietary supplements against specific illnesses.8 Yet some practitioners and the public feel empowered to be able to access plants and plant extracts for health-related purposes, drawn by stories of traditional uses and a growing body of investigational science (figure B.2). In the current regulatory environment, the FDA certifies neither the safety nor the effectiveness of herbal remedies when sold as dietary supplements.9

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FIGURE B.2   Dietary supplements for sale at a pharmacy in the United States.

1. Food, Drug, and Cosmetic Act of 1938, P.L. 75–717, 52 Stat. 1040, effective June 25, 1938.

2. Philip J. Hilts, Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation (New York: Knopf, 2003), 93.

3. Hilts, Protecting America’s Health, 160–161.

4. Hilts, Protecting America’s Health, 229–230.

5. George Burdock, “Dietary Supplements and Lessons to Be Learned from GRAS,” Regulatory Toxicology and Pharmacology 31 (2000): 69.

6. Dietary Supplement Health and Education Act of 1994, P.L. 103–417, 108 Stat. 4325, effective October 25, 1994.

7. Burdock, “Dietary Supplements,” 68–76.

8. Institute of Medicine, Complementary and Alternative Medicine in the United States (Washington, D.C.: National Academies Press, 2005).

9. The FDA is responsible for monitoring adverse reactions to dietary supplements after they are released in the market and reviews health-related claims and labeling “as its resources permit” (Food and Drug Administration, FDA 101: Dietary Supplements, August 4, 2008, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm). The dietary supplement industry largely self-regulates with regard to the safety of its products. The medical community is also expected to report adverse events related to dietary-supplement use to the FDA.

SCHEDULES OF CONTROLLED SUBSTANCES (CONTROLLED SUBSTANCES ACT, 1970)

Schedule I

(A)  The drug or other substance has a high potential for abuse.

(B)  The drug or other substance has no currently accepted medical use in treatment in the United States.

(C)  There is a lack of accepted safety for use of the drug or other substance under medical supervision.

Schedule II

(A)  The drug or other substance has a high potential for abuse.

(B)  The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.

(C)  Abuse of the drug or other substances may lead to severe psychological or physical dependence.

Schedule III

(A)  The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.

(B)  The drug or other substance has a currently accepted medical use in treatment in the United States.

(C)  Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.

Schedule IV

(A)  The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.

(B)  The drug or other substance has a currently accepted medical use in treatment in the United States.

(C)  Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.

Schedule V

(A)  The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.

(B)  The drug or other substance has a currently accepted medical use in treatment in the United States.

(C)  Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.

Source: 21 USC Sec. 812. The section of the Comprehensive Drug Abuse Prevention and Control Act of 1970 dealing with control and enforcement is known as the Controlled Substances Act.

In 1909, the federal government banned the importation of opium for smoking under the Smoking Opium Exclusion Act, and the Harrison Narcotics Tax Act of 1914 regulated all forms of opium and cocaine.22A number of further restrictions, such as controls on marihuana, hallucinogens, and synthetic drugs, accumulated in a patchwork fashion during the next half-century until comprehensive reform in 1970.23 In that year, Congress passed the Comprehensive Drug Abuse Prevention and Control Act,24 which, with amendments, presently governs American drug policy. Under one of its sections, the Controlled Substances Act, the federal government generates listings of chemicals and chemical analogs that have potential for abuse and establishes who can legally access them.

According to this system, schedule I drugs, such as heroin and marihuana, are considered under federal law to have no accepted medical use and are banned. Schedule II drugs, such as cocaine and morphine, have some restricted medical use and are allowed by a physician’s prescription under strict regulations. Schedule III drugs and schedule IV drugs include those that are regularly prescribed by physicians. Finally, schedule V drugs have a relatively low abuse potential and are available without a prescription. More recent state laws, such as those in California, Colorado, Washington, and other jurisdictions allowing prescribed marihuana or eliminating some penalties for recreational use, directly challenge federal drug policy by preventing local prosecutions for marihuana possession under certain circumstances. (Growers, sellers, and users remain subject to federal prosecution.) The consequences of this mixed legal status are playing out in the courts.25

Major laws regulating medicinal plants in the United States

1906

Pure Food and Drug Act

1909

Smoking Opium Exclusion Act

1914

Harrison Narcotics Tax Act

1937

Marihuana Tax Act

1938

Food, Drug, and Cosmetic Act

1970

Controlled Substances Act

1994

Dietary Supplement Health and Education Act

Notable plant-derived controlled substances

Schedule I

Marihuana, peyote, heroin

Schedule II

Opium, codeine, morphine, cocaine

Schedule III

Weak preparations of opium and opiates

Schedules IV and V

Mild opiates

Recent government policies on drug control have generally maintained strict punishments for the production, sale, possession, and use of scheduled substances. During the Ronald Reagan presidency (1981–1989), legislation mandating minimum sentences for drug offenses took effect, requiring judges to adhere to stringent prison terms for those convicted of such crimes, regardless of individual circumstances. This framework increased average prison time for drug-related convicts nearly threefold. It also took particular aim at the use of cocaine, imposing a five- to forty-year mandatory sentence for possession of 500 grams of powder cocaine or five grams of crack cocaine. Since black, urban users were thought more likely to possess cocaine in its crack form and white users were more closely associated with the powder form, this hundred-fold disparity in the threshold for mandatory prison sentences was long criticized for harsh treatment of America’s black cocaine users.26 In 2007, the Supreme Court ruled the sentencing inequality unconstitutional.27 This case demonstrates the subtle ways that racial notions of drug use can influence legislation.

In many parts of the world, diverse specialists have come to harvest and administer medicinal plants for spiritual, culinary, therapeutic, social, and sometimes sinister purposes. In the United States, an atmosphere of unregulated access to medicinal plants by the public gave way to one of increasing state involvement. The result of 100 years of American drug policy is an evolving framework of prohibitions, constructed first of pieced-together controls for various particular aims—some of them steeped in contemporary political culture—and later by more comprehensive policies. Yet even this unified legislative arsenal has been confronted by state and local laws and legal challenges that render this field ever changing. Interesting questions abound in the choice of drugs scheduled (for example, marihuana but not tobacco) and the effectiveness and fairness of domestic drug policies. At their core, the policies seek to protect individuals and society from the risk of drugs of abuse, drugs that can have profound effects on the human body.