The over-the-counter (OTC) herbal remedies business is reported to be well over $1.5 billion in current sales with an estimated annual growth rate of 15%. In 1994, $813.8 million of the health food store's $4.815 billion in sales (17%) was from herbal remedies. Herbal product vendors benefit from society's romanticized view that equates "natural" with "safe." Unfortunately, the assumption that natural products are safe is false. It is precisely because herbs are a source of potent drugs that responsible people are concerned about the manner in which herbal remedies are being marketed. Consumers are being denied the most fundamental information and assurances of quality. By law, drug labels must provide essential information, but herbal remedies are being marketed as "dietary supplements" with little of the type of information needed to enable people to use these products properly. The herbal industry blames current regulatory policies for some of these problems. They say that FDA regulations prevent them from supplying drug information because their products are regulated as dietary supplements, and that herbal remedies cannot be profitably marketed if they have to meet the full requirements of drug approval. Reformers argue for herbal remedies to be given special regulatory consideration. The FDA is bound by the law to regulate products that make medical claims as drugs. NCAHF finds the present situation untenable, but believes that there is room for regulatory adaptation without sacrificing consumer protection principles. Recommendations are directed at legislators and regulators, manufacturers and marketers, physicians, and consumers.

Background Information

The fact that most drug-abuse substances are of herbal origin attests to the potential harm of natural substances. The opium poppy is the source of heroin, morphine, and codeine. Coca leaf is the source of cocaine; morning glory seed is the source of the street drug Heavenly Blue. Hemp is the source of marijuana and hashish. The peyote cactus is the source of mescaline. The ephedra plant contains ephedrine often the source of the street drug speed. Psilocybe mexicana is a hallucinogenic mushroom. Even ethanol is associated with the plant world being derived from yeast (fungi) fermentation. Guarana is a potent source of caffeine used to produce the street drug zoom. Other potent sources of caffeine include kola nut and mate. 

Many standard drugs originated from plant sources. The story of Dr. William Withering's discovery of digitalis from foxglove in an old woman's herbal concoction is established medical lore. Willow bark, a source of salicin, served as the basis for aspirin, and Indian snakeroot was the source of reserpine, a medicine used to control blood pressure. Extracts from the seeds and roots of the autumn crocus provide colchicine, a drug for gouty arthritis, and birth control pills are made from Mexican yam. Several billion dollars worth of prescription drugs are derived from plants each year. Pharmacognosist^* Norman Farnsworth says that about 10% of all plant species (25,000 to 75,000) have been used in traditional medicine, with about one percent, 250-750 species, being scientifically verified as being therapeutically valuable. Although the study of herbal medicines has led to medical discoveries, herbs are often undesirable as sources of medicine. Wild herb stocks can be quickly decimated when they become valuable to hunters. Because herbs are natural products, the amount of active substances found in the same species can vary widely. When natural medicines are discovered, pharmaceutical companies work to learn how to synthesize the active ingredient in order to provide a more reliable supply, standardize the dosages, and control the effects on the body. 

Despite a long history of the scientific study, a popular view persists that medical science has ignored herbal sources of medicine. This idea is encouraged by herbal marketers who wish to portray their products as "nature's secret remedies." Media presentations have helped romanticize herbal remedies by showing ethnopharmacologists with native healers searching the Amazon rain forest for medicines. They have created the impression that plants are wondrous sources of only good things. This is a misconception. Herbs can also be highly toxic. Plants are sources of potent chemicals because they have developed defenses against natural enemies such as viruses, bacteria, fungi, and insects as part of the natural selection process. A review of 2,222 plants reported some anti-microbial activity in 1,362 of them, but all were too toxic for human use. Herbs with anti-cancer effects are a media favorite. However, stripped of romanticism the term "anti-cancer effects" means cytotoxicity, i.e., "having a specific toxic action upon cells or special organs." In other words, such herbal substances are selective poisons that can be used against cancer cells. Although there has been considerable media attention to taxol, the breast cancer drug derived from the bark of the pacific yew tree, the knowledge that plants contain anticancer agents is not new. The National Cancer Institute has been studying natural products since 1955. By the early 1980s, its Cancer Drug Development Program had screened nearly three-quarters of a million potentially active agents, including products of fermentation and plant derivatives. Each of the agents tested was thought to have potential when review began, yet fewer than 70 made it to market. Currently, only three anti-cancer drugs from natural botanical sources (vinblastine, vincristine, and taxol) are in use. In addition to fighting cancer, natural plant substances can also cause cancer. The best known example is tobacco (chewed, snuffed or smoked), an herbal product originally promoted for its alleged health benefits, now known to be responsible for more preventable premature deaths than any other cause in the US and Canada. Many other natural substances can induce tumors. 

Problems Associated with OTC Herbal Products

Unreliable Labeling

An herb is "a plant or plant part valued for its medicinal (emphasis added), savory, or aromatic properties." Herbs "intended to prevent, alleviate, mitigate or cure a mental or physical condition in humans or animals, or alter the structure or function of the body" are drugs by definition of the United States Food, Drug and Cosmetic Act. Drug products are required by law to provide sufficient information on labels and/or package inserts to enable people to use them properly. Included are: (a) description and clinical pharmacology; (b) list of ingredients; (c) list of indications; (d) information on contraindications to use; (e) warnings and precautions; (f) what to do if adverse reactions occur; (g) proper dosage and administration; (h) what may constitute over dosage. OTC herbal remedies rarely provide consumers with these important items of information. 

False and Misleading Labels. Pharmacognosist Varro Tyler notes that herbal product consumers have less than a 50% chance of receiving a product that is accurately labeled. This means that one cannot be assured that the herb mentioned on the label is actually in the product at all or in appropriate amounts. In many instances it is difficult or impossible to determine the identity of the plant source because obscure herbs or folk names have been used. There are four ways to name an herb: the English common name, transliteration of the herb name, the latinized pharmaceutical name, and the scientific name. The corresponding names for ginseng, for example, are ginseng, ren-shen, radix ginseng, and Panax ginseng. Common names are not specific. For instance, the name ginseng is also applied to P ginseng (oriental ginseng), P quinquefolius (American ginseng), and Eleutherococcus senticosus (Siberian ginseng). Transliterations and pharmaceutical names have similar drawbacks, and some researchers find it difficult to trace them to the source species. Scientific names are more specific and acceptable. Several athletes have learned the hard way about the inadequate herbal supplement labeling. In 1988, Jimmy Martin, a leading American judo champion, used Sunrider's Vitalite Action Caps before the U.S. Olympic trials because he said they gave him terrific energy. He was disqualified after testing positive for ephedrine. British sprinter Solomon Wariso faced being banned from the Olympics after testing positive for ephedrine. He took Chinese herbal pills containing Ma Huang which he believed to be a "health food." 

Misleading labels can be dangerous. FDA Commissioner Kessler testified that white willow bark is marketed in products that are promoted as "aspirin-free" for use by children. White willow contains salicin which is converted in the body to salicylic acid, the same active ingredient that is in aspirin. However, unlike aspirin, white willow bark's label has no warning that children should not take aspirin for chicken pox or influenza symptoms because of an association with Reyes syndrome. FDA requires such warnings on aspirin-containing products. Because white willow bark shares many of the same chemical properties and side effects as aspirin, white willow should also be avoided by aspirin-sensitive adults. A weight loss product called Quicky, manufactured by Neways, Inc. of Salem, Utah, was recalled by the FDA in 1993. Although the product's label stated that it contained only papaya, kelp, garlic, and lactose, in fact, it contained a full medical dose (33.5 mg per capsule) of furosemide, a potent prescription-only diuretic. 

Canada's regulatory policies on herbal products are more lenient than in the USA. Its openness relies heavily upon the accuracy of label information. Despite this friendlier marketing climate, problems with herbal product labeling there appear too similar to those found here. Greater regulation of herbal products was called for there after a Canadian woman who used an herbal remedy to control irritability and mood swinging, gave birth to a child with reversible genital hirsutism suggestive of a drug effect. The mother reported increased hair growth while using the product. Her baby was born with thick black pubic hair and hair over the infant's entire forehead. Confusion over the product's identity caused this event to originally have been reported as involving Siberian ginseng. The herbal remedy turned out to be Chinese silk vine, which may have been adulterated. Canadian weight-lifter Jim Dan Corbett was stripped of three bronze medals won at the 1994 Commonwealth Games after testing positive for banned stimulants. Testing done by the Canadian Center for Drug-Free Sports backed up Corbett's claim that his positive test was due to a vitamin supplement Nature's Nutrition Formula One that contained three banned stimulants none of which were listed on the label. Corbett was reinstated as an athlete but did not get his medals back because the drugs may have helped his performance. Dr. Andrew Pipe, center chairman said that Corbett's case put the spotlight on the larger problem of the improper labeling of vitamin supplements. 

Misinformation Mongering. Tyler states that "more misinformation regarding the efficacy of herbs is currently being placed before consumers than at any previous time, including the turn-of-the century heyday of patent medicines." Labeling and advertising is classified as commercial language and does not enjoy full First Amendment protection. Misinformation is spread mainly through specious and/or outdated herbal books and pamphlets. Promoters make claims and give advice that would not withstand regulatory scrutiny if they appeared as labeling or advertising. The FDA has rules governing the proximity of publications to products to determine what can be regulated as an extension of a label. Promoters work hard at fulfilling the letter of the law that will enable them to promulgate misinformation with First Amendment protection. Many herbal hucksters not only make unsupported claims for the safety and efficacy of their products but also condemn standard drugs that have undergone scientific review processes that their own products have not withstood. The herbal industry has been supporting the naturopathic profession financially in a clear attempt to develop a guild of health care providers that will promote its products. Naturopathic herbal publications are not reliable sources of information because they are rooted in an ideology that imagines that things "natural" are inherently safe. Naturopathy has no standing in the scientific community.

Questions of Safety

Herbs in their natural state vary in potency and may contain multiple pharmacological substances which can cause undesirable effects. Medicines made from herbs have isolated and purified the desired active substances permitting dosages to be standardized, and have been tested and approved for safety and efficacy. Toxic reactions related to the use of herbal remedies result from problems such as improper preparation (failure to inactivate toxic ingredients), excessive quantities of a specific herb, substitution of one herb for another that is currently unavailable, the addition of unnamed pharmacological agents or heavy metals, and the effect of using herbal medications in combination with other pharmacological products. Another problem with herbal products is that no records are kept on batches of products that would enable manufacturers to identify and track them after distribution.

Failure to Track Harm. Herb industry spokespersons are fond of comparing the low number of reports of harm associated with herbal products compared to those associated with standard drugs, but this is unjustified. There is strong evidence that harms caused by herbal remedies are mostly hidden. A well-established system for reporting the adverse effects of standard drugs exists, and the FDA receives 80% of suspected adverse reactions reports from ethical pharmaceutical manufacturers. The herbal industry makes no comparable attempt to track harm caused by its products. On the contrary, NCAHF has observed that herbal manufacturers not only do not track adverse effects but often deny responsibility when harm is suspected. Some have been uncooperative with efforts to protect the public. 

Montana's public health agency asked a Utah company to take its popular E'Ola diet drops off the market after receiving reports of allergic reactions, high blood pressure, a stroke and heart attacks. A user in Washington State reportedly displayed severe psychotic reactions associated with the product. The state considers E'Ola an untested drug while the company claims it is only a food. The company acknowledged that it had problems when its brochure claimed that E'Ola had helped diabetics and other medical conditions, but that the literature had been recalled and rewritten. It said that the FDA had inspected the plant since the Montana complaint and expressed confidence that the company will be allowed to continue to sell its products. E'Ola contains the anti-depressant drug dimethylaminoethanol; guarana, a potent source of caffeine (marketed on street as zoom); white willow bark (a source of salicin which is synergistic with caffeine); Ma Huang (aka, ephedra which contains an amphetamine-like substance used to make the street drug speed), and licorice root which can cause pseudoaldosteronism (a life-threatening condition that includes high blood pressure and depleted potassium, sodium, plasma renin and aldosterone). A similar product, Nature's Nutrition Formula One, was implicated in the death of a Texas woman in 1994. The Texas Department of Health (THD) was unable to have the product withdrawn from the market due to a legal technicality. A health food industry-lobbying group, Citizens For Health, brought 150 members to a TDH hearing on April 28, 1995, and signed a petition against banning Ma Huang. An investigation by the Texas Attorney General found that the product was spiked with synthetic ephedrine and synthetic caffeine. The company was fined, ordered to stop adulterating its products, and required to recall affected products. There are numerous herbal products that contain ingredients not proven safe or effective that are on the market.

It is well established within public health that even widespread harm to the public can be difficult to ascertain in the absence of a formal reporting system. An example of how difficult it can be to uncover the harm of herbal products can be seen in the case of the unexpected death of a 37-year-old California woman who had been using Laci Le Beau Super Dieter's Tea. Her husband used his skills as a product liability attorney to trace the product's safety record. The health food chain that marketed the tea denied that any harm had been associated with its product. The FDA was minimally cooperative requiring that he submit a request through the Freedom of Information Act before it would disclose its records. Numerous complaints were uncovered including a reported death of a 17-year-old girl from severe potassium depletion. The cause of death was consistent with the pharmacology of the product which contained herbs with diuretic, stimulant, and laxative effects. It was not possible to prove potassium depletion as a cause at autopsy because cells release potassium immediately after death. The husband's attempts to get the coroner to pursue the matter as a wrongful death brought only the advice that he should put this unfortunate incident behind him and get on with his life. He has refused to do this because he is outraged that the herbal industry is able to operate so irresponsibly, and he feels a moral obligation to work at correcting this injustice. 

Questions of Efficacy

Prior to the 1906 Pure Food and Drug Act, concoctions were sold that contained addicting drugs, toxic herbs, and heavy metals without disclosing their contents on their labels. Extravagant claims were made for these "patent medicines" during what has been called America's "golden age of quackery." There has been slow but steady progress in improving the quality of OTC medicines in this century. The 1938 Food, Drug & Cosmetic Act required that drug products be proved safe prior to marketing. In 1962 federal law was amended to require premarketing proof of drug efficacy. OTC drug products already on the market were given a period of time to comply with the law. The FDA has been gradually banning ineffective ingredients in its efforts to clear America's medicine chests of products not proven to be safe and/or effective. FDA banned 223 ineffective ingredients from 19 product categories in 1990, 111 ineffective weight-control ingredients in 1991, and proposed to ban 415 ingredients from seven categories of nonprescription drugs in 1992. New OTC drugs are now mostly lower-dose versions of prescription drugs that have been approved by the FDA. The marketing of herbal remedies must be considered within this environment of consumer expectations.

Herbal trade associations have been aggressive in their political activities to exempt themselves from federal regulations governing regular medicines. The American Botanical Council, the American Herbal Products Association, the American Herbalists Guild, and the Herb Research Foundation all fought the FDA's implementation of Nutrition Labeling and Education Act of 1990, which would have required that herbs whose only known use is for medicinal effects be regulated as drugs. NCAHF believes that it is reasonable and just that herbal substances with pharmacological effects be regulated as drugs whether or not drug claims are made on their labels. NCAHF is also uncomfortable with what it senses as a distinct tendency to play down rather than own up to the potential harm of herbal products by thought leaders in the industry.

Economic Issues

Herbal marketers argue that profits do not justify the high cost of moving an herbal remedy product through the standard FDA drug approval process. They add that it is not possible to patent herbal products which further inhibits their willingness to make large financial investments in clinical trials. Robert Temple, MD, of the FDA's Office of Drug Evaluation and Research rejects the view that trials are too expensive. He says that the drug industry uses high figures to show how expensive it is for them to stay in business. NCAHF is in no position to mediate this dispute, but believes that it may be mooted by the case for special consideration in the marketing OTC herbal products made by Tyler. He argues that the constituents of many herbal remedies are well enough understood by pharmacognosists to allow many herbal products to be marketed responsibly, and that for many products clinical trials are not needed. He states that the use of standardized herbal extracts would assure product quality, safety and efficacy.

After considering the consumer demand for herbal remedies, the need to put an end to current marketplace abuses, and its own principles of science and consumer protection, NCAHF believes that many OTC herbal remedies could be marketed without costly and lengthy clinical trials if basic principles of consumer protection are attended to. These principles are addressed in the following recommendations.

NCAHF Recommendations

To Legislators and Regulators:

Establish a special category of OTC medicines called "Traditional Herbal Remedies" (THRs) regulated as follows:

• Labels must alert consumers to the fact that herbal remedies are held to a lower standard than that applied to standard medicines. Suggested wording:
  This product is regulated as a Traditional Herbal Remedy, a special category of medicines not required to meet the full stipulations of the U.S. Food, Drug, & Cosmetic Act which are applied to standard medications.
• Limit THR products to those with properties sufficiently documented in the pharmacognosy literature to assure an acceptable measure of safety and efficacy.
• Limit herbal remedy products to those known not to have lethal or damaging side-effects when taken in overdose, or over an extended time period.
• Limit THRs to the treatment of non-serious, self-limiting ailments.
• Require THRs remedies to meet the same labeling standards for all drug products.
• Require plant sources to be identified by their scientific names.
• Require that all active ingredients (items that cause an effect) be quantitatively and qualitatively identified on the label.
• Require herbal remedy products to contain sufficient amounts of pharmacologically active substances for the product to perform as expected. Only those expectations that can be supported by science should be permitted on labels. The FDA should develop a set of acceptable claims just as it has with health claims for food products.
• Require labels to inform consumers about what effects they should expect. Suggested wording: (eg, valerian)
  The active ingredient in this product is valerian. Traditional folk medicinal uses for this substance include: as a sleep aid, and a relaxant. Valerian has been shown to depress the central nervous system at the doses indicated.
• Require a highly visible, easily accessible post-marketing surveillance system for tracking unanticipated adverse reactions. The system must enable consumers as well as health professionals to report, and regulators to gather and disseminate information on adverse effects. A good candidate for the agency to receive reports is the U.S. Pharmacopeia Practitioner Reporting System which passes reports on to the FDA and Poison Control Centers. Suggested wording:
  Adverse reactions associated with the use of this products should be reported to 1-800-638-6725.
• Require manufacturers to mark product batches for identification, testing, and tracking.
• Require warnings about dangers of self-treatment on labels and/or package inserts. Suggested wording:
  Caution: Self-treatment may delay proper health care. See a medical doctor if health problems persist.
• Require substantial representation from outside of the herbal industry to assure sufficient skepticism in herbal regulation.
• Impose strong penalties for adulterating herbal products with potentially dangerous substances.

To Herbal Remedy Product Manufacturers and Marketers.

NCAHF believes that herbal remedy producers would be wise to take a long range approach to marketing. Just as compliance with food and drug regulations has enabled the American pharmaceutical industry to establish itself as the standard of quality, by adopting high standards, herbal marketers will assure themselves a superior competitive position and longevity.

1. Adopt the most scientific standards as are practical in your manufacturing and promotions, including the rejection of pseudoscientific herbal products such as homeopathic concoctions. (Also see the NCAHF Position Paper on Homeopathy)

2. Conduct ongoing consumer education warning consumers that:

A. Information found in traditional herbal books is not necessarily reliable as a guide to self-treatment.

B. The designations "herbologist," "herbalist," "Master Herbalist," and similar terms, have no legal or scientific meaning, and may be indicative of quackery.

C. Likewise, sources issuing credentials in "herbology," "herbalism," and the like, are usually "diploma mills."

To Physicians:

1. Routinely ask patients about their use of herbal products.

2. Report adverse effects utilizing either the U.S. Pharmacopeia Practitioner Reporting System or FDA's MedWatch Form 3500, or fax to 1-800-FDA-0178.

3. Write up and submit for publication case reports in which patients have experienced adverse effects from herbal product use. Include information on how the patient learned of the product and how its use was discovered.

Physicians may obtain information on herbal drugs and drug interactions from Registered Pharmacists at hospital pharmacies or from Poison Control Centers. Information on some herbal drugs, interactions, or synergistic effects may be obscure or unavailable. These are among the additional risks that those who choose to use medicinal herbal products currently face.

To Consumers:

1. Do not assume that herbal remedies are safe simply because they are natural. Herbal remedies contain substances that can have powerful effects upon the mind and/or body. Use even greater cautions than when taking standard medications.

2. Be cautious about taking medicinal herbs if you are pregnant or attempting to become pregnant.

3. Be cautious about taking medicinal herbs if you are breast feeding a baby; herbal drugs in the body may be transferred to breast milk.

4. Do not give herbs to infants or children.

5. Do not take large quantities of any herbal preparation.

6. Do not take any medicinal herb on a prolonged daily basis.

7. Buy only preparations that identify plants on the label and state contraindications for use.

8. Become familiar with the names of potentially dangerous herbs and be cautious about their use.

9. If you are taking medications, do not use medicinal herbs without checking with your doctor.

10. Do not trust your health to unqualified practitioners who use unregulated titles such as "herbalist," "herb doctor," "Master Herbalist," "herbologist," "Natural Health Counselor," or the like.

11. Beware of exaggerated claims for the benefits of herbal remedies.

12. Insist that herbal marketers meet basic consumer protection standards of labeling, safety and efficacy.

Citations

The National Council Against Health Fraud, Inc.

NCAHF is a private nonprofit, voluntary health agency that focuses upon health fraud, misinformation, and quackery as public health problems. Its funding is derived from membership dues, newsletter subscriptions, and consumer information services. NCAHF unites consumers with health professionals, educators, researchers, attorneys, and others who believe that everyone has a stake in the quality of the health marketplace. NCAHF's officers and board members serve without compensation. NCAHF's positions on consumer health issues are based upon principles of science that underlie consumer protection law which require: (1) complete information on the content of products and design of medical devices; (2) adequate information on health product labels and package brochures to enable consumers to make informed choices; (3) premarketing proof of both the safety and efficacy for products and devices that claim to aid in the diagnosis, prevention, alleviation, or cure any physical or mental disorder in humans; (4) full disclosure of the risks, and evidence for the potential benefits, of health service procedures; (5) accountability for individuals and companies that violate consumer protection laws. For more information, write: NCAHF, P.O. Box 1276, Loma Linda, CA 92354-1276; Fax: 909-824-4838. Donations to NCAHF are tax deductible under IRS tax code 501(c)(3).

Enhancing Freedom of Choice Through Reliable Information

Appendix: Reports of Harm

Research Reports

Hong Kong. At least 7,000 species of medicinal plants are used in China. Of the 150 species most commonly used, 10 are toxic. In Hong Kong, most cases of serious poisoning are related to caowu, the root of Aconitum kusnezoffii, and chuanwa, the main root of Aconitum carmichaeli, which are used to treat rheumatism, arthritis, bruises and fractures. These contain variable amounts of highly toxic alkaloids including aconitine. Signs and symptoms include neurological (paraesthesia and numbness, muscle weakness), cardiovascular (hypotension, ventricular ectopic beats, arrhythmias), or gastrointestinal (nausea, vomiting, diarrhea). Main causes of death related to aconitine are cardiovascular collapse and ventricular arrhythmias. Anticholinergic poisoning is common and mostly due to yangjinhua or naoyanghua (flowers of Datura metel L and Flos rhododendri mollis respectively) used to treat asthma, chronic bronchitis, pain from injury, epigastric pain, and toothache. These may contain scopolamine, hyoscyamine, and atropine. Infants are at greater risk than adults due to lower body weight and inadequate hepatic drug biotransformation and detoxification enzymes. one survey showed that 28-51% of Hong Kong Chinese infants were given chuenlin by their mothers which contains the alkaloid berberine. Berberine can displace bilirubin causing a rise in free bilirubin and increasing the risk of brain damage. Stephania tetrandra and Magnolia officinalis found in a slimming regimen has been associated with rapidly progressing fibrosing interstitial nephritis. Licorice is commonly used in confectionery and can cause hypokalemia and sodium and water retention. Misidentification by similar appearance or confusion of nomenclature causes poisonings by mistake. Adulteration (with cheaper, more toxic substances); inclusion in proprietary medicines of western drugs without warnings of possible side-effects; and, the fact that some contain toxic heavy metals (cadmium, lead, arsenic, mercury). ["Chinese herbal medicines revisited: a Hong Kong perspective," The Lancet, 1993;342:1532-4]

Case Reports

Nonpermanent Injury (*near-death episodes that required emergency medical intervention)

1. A 53-yr-old man suffered shortness of breath, ankle edema, increasing abdominal girth, weight gain, headache, and weakness for one week. Physical exam revealed moderate respiratory distress, distended neck veins, and many other reported abnormalities (diagnosis: pseudoaldosteronism and heart failure). Cause was determined to be poisoning from licorice candy. JAMA, 1970;213:1343.

2. *A 58-yr-old woman suffered cardiac arrest due to hypokalemia caused by licorice ingestion. British Medical J., 1977;(9/17):738.

3. A 26-yr-old female came to an emergency department complaining of blurred vision, inability to void, dry mouth, and a history of bizarre behavior. It was believed that the patient was demonstrating the effects of an atropine-like steroid from having ingested burdock root tea purchased from a local health food store, an outlet of a national chain. JAMA, 1978;239:2157.

4. A 6-month-old Hispanic girl experienced liver poisoning from a tea prepared from gordolobo yerba (Senecio longilobus) which contains pyrrolizidine alkaloids. MMWR, 1977;26:(32):257.

5. A 59-yr-old woman suffered lead poisoning from Chinese herbal medications prescribed by an herbalist-acupuncturist. JAMA, 1977;238:1539. 

6. *A 24-year-old female was hospitalized as the result of ingesting one-quarter ounce of pennyroyal oil she had taken to induce an abortion. She was a student of "Herbal Science and Acupuncture" at a local college in Colorado. MMWR, 1978;27:(51):511. 

7. *An 22-year-old female experienced an acute episode of toxicity as the result of ingesting pennyroyal oil she had taken to induce an abortion. JAMA, 1979;242:2873-4. (Also reported in MMWR, 1978;27:(51):511.)

8. A 49-yr-old woman presented with nausea, general malaise, and pain. A test revealed liver dysfunction produced by mistletoe poisoning. Brit Medical J. 1981; (1/17):186-7.

9. *A 65-year-old female experienced an anaphylactic reaction to bee pollen supplements. Pieroni RE, et al. J. Medical Assoc. Alabama, 1982;51:(12):11-16.

10. A 25-yr-old woman consulted her gynecologist because of excessive uterine bleeding. Cause was determined to be from drinking large amounts of a "seasonal tonic" herbal tea for approximately 2 months. JAMA, 1983;249:2679-80.

11. *A 20-yr-old female experienced near-fatal hypokalemia caused by excessive licorice ingestion (100-200 g/day). (Neilsen I, Pedersen RS. "Life-threatening hypokalemia caused by licorice ingestion," Lancet, 1984; [June 9]:1305)

12. A number victims are described as having complained of nausea, indigestion, vomiting and diarrhea caused by Nature's Sunshine's LBS-II capsules which contained Lobelia inflata. FDA Consumer, May, 1985, p.41. 

13. A 64-year-old female experienced insomnia, tremor and headache from a ginseng product (Natrol High). Three years later she experienced similar symptoms from a ginseng tonic prescribed by an acupuncturist. (J Clin Psychopharmacology, 1988;8:235) 

14. Two cases (42-yr-old male & 41-yr-old female) of acute toxic hepatitis induced by chaparral (creosote bush Larrea tridentata) supplements. MMWR, 1992;41:(43):812-13. 

15. Two cases of idiopathic liver toxicity associated with the use of Chinese herbal remedies (a 28-yr-old woman, and a 9-yr-old girl) are reported by the National Poisons Unit, London (UK). The Lancet, 1992;340:674.

16. 7 cases of hepatitis after germander (Teucrium chamaderys) use. (Dominique, et al. Annals of Internal Med, 1992;117:129-320)

17. Two cases of heavy metal poisoning (arsenic and mercury) due to Indian ethnic remedies. A 35-yr-old, and a 32-yr-old Asian man treated by a hakim for atopic eczema. Kew, et al. "Arsenic and mercury intoxication due to Indian ethnic remedies," Brit Med J., 1993;306:506-7).

18. *Three cases of poisoning in children (13 month-old boy, 2.5 yr-old girl, and 23 month-old girl) from ingesting Jin Bu Huan tablets, a Chinese herbal medicine used for relieving pain. Symptoms were life-threatening bradycardia with rapid onset and central nervous system depression. The products were obtained through health food stores in Denver, Colorado. Active ingredient was found to be the alkaloid levo-tetrahydroplamatine (L-THP). (Horowitz RS, et al. "Jin Bu Huan toxicity in children--Colorado, 1993," MMWR, 1993;42:[33]:633-6)

19. Eight persons, including six teenagers, were treated in emergency departments for palpitations and anxiety attacks related to the use of the herb product Formula One. The product combines ephedra and caffeine. (Emergency Medicine News, 8/94, p.8)

Permanent Injury

1. A 60-year-old woman who took chaparral for 10 months developed severe toxic hepatitis for which no other cause could be found. The patient required orthotopic liver transplantation. (Gordon, et al. JAMA, 1995;273:589-90)

2. A 51-yr-old woman experienced kidney failure due to ingestion of a Chinese herbal medicine (Tung Shueh pills produced by Ta Ang Pharmaceutical Co, Taiwan, and illegally imported) contaminated with mefenamic acid (not on label). Kidney function improved following a short course of hemodialysis. Some permanent damage is likely. (Abt. "Chinese herbal medicine induced acute renal failure," Arch Intern Med 1995;155:211-12.

Death

1. A 2-month-old Hispanic boy experienced fatal liver poisoning from a tea prepared from gordolobo yerba (Senecio longilobus) which contains pyrrolizidine alkaloids. MMWR, 1977;26:(32):257.

2. An elderly couple both died following ingestion of a tea made from foxglove (mistaken for comfrey); they had learned of the home remedy for arthritis from a health spa. MMWR, 1977;26:(32):257-8.

3. An 18-year-old female died as the result of ingesting pennyroyal oil she had taken to induce an abortion. JAMA, 1979;242:2873-4. (Also reported in MMWR, 1978;27:(51):511-12.)

4. A Longview, Washington, woman died as a result of taking Chinese herbal pills for her arthritis. The pills were determined to contain high doses of phenylbutazone. The Oregonian (Portland, OR). 6/5/83.

5. Mentions three cases of serious illness and one death resulting from Chinese herbal pills containing aminopyrine and phenylbutazone. Zamula E. "Of pills that pack too much punch," FDA Consumer, February, 1984, pp.38-40.

6. Fatal hepatitis occurred in a 68-yr-old woman who had been using Tealine, an herbal medicine sold for losing weight. Wild germander (Teucrium chamaedrys) was the likely cause. Mostefa-Kara, et al. The Lancet, 1992;340:674.

7. A 23-yr-old man died and his 39-yr-old brother was made ill from ingesting the root of water hemlock. They were foraging for wild ginseng in the Maine woods. (MMWR, 1994;43:229-30)

8. An Austin, TX woman taking the herb product Formula One collapsed and died of cardiac arrest on a tennis court. The product combines ephedra and caffeine. (Emergency Medicine News, August, 1994, p.8)

9. A 24 yr-old female (Kristina Humphrey) collapsed and died (8/14/94) after ingesting an extract of pennyroyal. A lawsuit against the manufacturer, Gaia Herbs (Massachusetts) and the Bread of Life health food store (Campbell, CA) that sold it did not warn that pennyroyal should not be taken by pregnant women. (San Jose Mercury News, 8/20/94)

Multiple Reports/Reviews

1. Numerous cases of poisoning (injury and death) cited. (Huxtable RJ. Annals Intern Med, 1992;117:165-6)
2. Larkin T. "Herbs are often more toxic than magical," FDA Consumer, October, 1983, pp.5-11.
3. Patient Counseling. "Many herbal teas are toxic," American Pharmacy, 1988;NS28:(4):230-1.
4. Marderosian AD, Liberti L. Natural Product Medicine, Philadelphia: Geo F. Stickley Co. 1988.
5. Toxicants Occurring Naturally in Foods. National Academy of Sciences, 1973.

The Rest of the Story

The harm that results from herbal remedies often involves the interplay of many factors. Misinformation, ideological wishful thinking, alienation from mainstream society, desperation, and other human weaknesses may be involved. The following reports will provide insight into the humanistic aspects of how tragedies can happen when many factors come together. 

Death of a salesman. BL, 36, who had just retired from the National Football League, was seeking a new career and decided to become an HerbaLife distributor. The company's product line contained herbal laxatives, diuretics, stimulants, and other pharmacological constituents. These had been hastily put together with little attention to safety or effectiveness. BL was told by his sales trainer that in order to be a successful salesman, he would have to become an HerbaLife user. Among the literature he was given was a monograph entitled: "What to symptoms expect when you improve your diet" written by a Stanley Bass, ND (Doctor of Naturopathy), DC (Doctor of Chiropractic), PhC (Philosopher of Chiropractic). Bass stated that users should expect adverse reactions such as nausea, weakness, diarrhea, chills, fever, headaches, and more. These symptoms were alleged to be poisons coming out of the body that had been accumulating there as a result of eating modern foods with preservatives, pesticide residues, and the like. Bass claimed that unexpelled these poisons would become serious diseases in the future. He urged readers to rejoice when the symptoms were bad because the worse the symptoms were, the worse were the diseases of the future being avoided. BL began taking the herbs and soon began experiencing adverse symptoms. He faithfully persisted not even confiding in his wife that he was experiencing some very serious problems. After about two weeks of suffering, he blacked out. His wife became alarmed and questioned him on what had been happening. The next day, Friday, she made an appointment for BL to see a physician on Monday. Sadly, BL never fulfilled the appointment. On Monday morning he collapsed and died in the presence of his stunned family, including his 7-yr-old daughter. The cause of death was determined to be cardiomyopathy. A physical examination for a life insurance policy 6 months prior to his death had found him to be in excellent physical health. BL's widow sued HerbaLife for the wrongful death of her husband. A pathologist was ready to testify that the HerbaLife products could have caused the condition, but the company had experts ready to testify that cardiomyopathy was often idiopathic (of unknown origin). However, BL's wife did not contend that the herbal products were responsible for BL's death, but that BL would have seen a physician much sooner if he had not been exposed to the information that had been provided by a company representative which had caused him to ignore adverse symptoms. The HerbaLife company settled out of court for an undisclosed amount and sealed the records on the case. [Civil District Court Parish of Orleans, State of Louisiana, Cynthia Lee, et al v HerbaLife International, Inc., CDC #85-16512.]

The Herb "Doctor." GH owned and operated the "House of Herbs," and referred to himself as an "herbalist." GH had no formal training in the health sciences, but based his herbal knowledge on folk practices learned in his native Germany. Self-confident and authoritarian, GH had strong opinions and shared them readily. GH wrote books and presented courses on "natural" medicine. GH translated into English the 16th Century writings of Paracelsus and used these as his main authority. To feign expertise he displayed a mail-order "Doctor of Naturopathy" degree from Bernadean University a diploma mill. GH taught that we should not kill animals; we should not eat animal products (an example of his reasoning was that eating eggs deprived hens of fulfilling themselves as mothers); we should use environmentally friendly soap; we should not poison the earth or our bodies with the unnatural products of modern living; true health is to be found in herbs. Herbs for food. Herbs for medicine. This is God's way. Immunization is putting poison into your body. Doctor's medicines are poisons. Choose who you will believe, GH or the doctors. You can't have it both ways. In addition to selling products, GH also saw patients in the back room of his store. He had developed a practice that included literally hundreds of people with diseases as serious as cancer, heart disease, diabetes, arthritis, asthma, and more. SA, an emigre from Lebanon, sought GH's advice on a sore knee for which he provided remedies. The pain eventually faded from her knee instilling confidence in GH's expertise. Her interest continued and she took a number of seminars conducted by him. In 1986, SA gave birth to her third child, Baby L, a healthy 8 lb, 3 oz. girl. When Baby L was 2 months old, SA brought her to a pediatrician and was found to be a healthy with no problems. A few weeks later, SA phoned the doctor and informed him that she did not wish to have Baby L immunized. The doctor responded that he could not properly treat the baby without immunization. SA discontinued his services and found another MD who was willing to see the baby despite the lack of immunization. Several months later, the second MD received a postcard stating that the family was moving to California and would no longer be using his services. This was a lie suggested by GH, who was now advising SA on Baby L's health care, to break off medical services without arousing concern. GH had convinced SA that by avoiding modern medicine and conventional foods Baby L would become a "superbaby." GH advised SA that Baby L be raised on a strict, organically-grown, vegetarian diet, "best eaten uncooked." GH suggested that SA avoid wheat, beans, milk products, and meat. At 11 mos. Baby L was removed from her only source of animal food (mother's milk). Fed only fruits, vegetables and rice, she eventually stopped growing, slept more and more, and suffered from more and more infections. As the Baby L went downhill GH assured the parents that this was merely "the poisons coming out of her body" and that if they remained faithful to the program, she would eventually become the super baby they desired. GH zapped the failing tyke with his violet ray machine to "energize her Life Force," which was part of his mystical, naturalism. At age 17-months, Baby L died of bronchial pneumonia complicated by severe malnutrition. At death, Baby L weighed 11.25 lbs. The parents were tried three times for failing to provide the necessities of life. Their defense was that they sincerely believed that they had been providing the best health care possible for Baby L, that they had simply trusted the wrong man. They were convicted in 1990 but the verdict was overturned on a technicality; a 1991 retrial resulted in a hung jury; in 1992 their 3rd trial was terminated by the judge because the prosecution had withheld evidence attesting to their defense. [Toronto Star (1st trial coverage began May 10, 1990; 2nd trial June 13, 1991; 3rd trial Sept. 27, 1991); Her Majesty the Queen and Sonia Atikian and Khachdour Atikian, 1992; Ash R. Coroner's Inquest Into The Death of Lorie Atikian, December, 1992.]