Dietary Supplements and Their Natural Dangers: Things to Know
The Law Offices of Christopher E. Grell is one of only a handful of law firms in the United States who represents individuals who have been harmed by herbal products, also sold as dietary supplements, nutritional products and/or nutriceuticals.
Mr. Grell's interest in these kinds of products arose out of his 37-year old wife's sudden and unexplained death in 1991. Struggling for answers, Mr. Grell was ultimately able to link his wife June's death to her use of a innocent looking, so-called all natural herbal dieter's tea. As it turned out, the diet tea contained nothing more than herbal laxatives and diuretics. Laxatives and diuretics, whether natural or man-made, are drugs, which deplete the body of essential electrolytes, particularly potassium, which keeps the heart beating regularly. When potassium levels in the body are depleted, the heart is at much greater risk of developing a cardiac arrhythmia or irregular heart beat. Cardiac arrhythmias, if sustained, can cause death since blood is cut off from the brain.
At or about the time Mr. Grell's investigation began, Congress passed the Dietary Supplement and Health Act of 1994, more commonly known as DSHEA. As a result of DSHEA, Congress set up a system that is truly the last frontier of the American free enterprise system since anyone, no matter how inexperienced or untrained, can mix up a bunch of herbs, into a product, label it as a dietary supplement, and sell it to the general public without ever testing the product for safety or without ever getting approval by the FDA or any other government agency. Under DSHEA, even if such a product is found to be dangerous, the burden of proof is now on the FDA to show that the product is unsafe. Because this is a long drawn out process which is vigorously contested by the dietary supplement industry, many products that present a risk of harm are still being sold. For example, herbal diet teas containing the herb senna, which virtually every expert in the country agrees should not be used for prolonged periods of time, are still being sold as diet teas and promoted for long-term use.
Products containing ephedrine or ma huang are another group of products which the FDA has determined to pose a health risk given the levels of ephedrine typically found in these products. Despite the FDA's findings, nothing has been done to force these manufacturers to reduce the levels of ephedrine in these products to make them safe.
Other anti-consumer protection provisions that DSHEA created is the lack of any law which requires companies who make dietary supplements to report injuries or adverse consumer reactions from their products to the FDA. (Drug companies and companies selling traditional food products are required to do.) As a result, few, if any, complaints filed with these companies are ever reported to the FDA.
In fact, as a result of several law suits filed by this office, we uncovered evidence from several different companies attesting to the fact that their company never reported any of their consumer complaints to the FDA or any other government agency. In one case, the company received and never reported over 3,500 complaints. In another case, the other company does not know how many complaints they received since their policy is to "respond to the consumer complaint and then throw away all records of it."
Another reason why injuries associated with the use of these "all natural products" are often times not reported is because the medical profession, for the most part, is unaware of the potential harm these products can cause. When was the last time a doctor asked you about your use of these products? When was the last time you volunteered this information to your doctor?
Typically, most consumers assumes that since these products are "natural," they are safe. As a result, many times consumers fail to associate any adverse effects with the use of the product. As a result, the consumer does not report the problem to their doctors. When they do report the problems to the doctors, I am aware of several situations where the doctors ignored the patient's concerns. For example, in one case involving the sudden death of a young woman, the medical examiner threw out the herbal product that the family brought in for analysis without ever analyzing it. Later, after independent evidence of the product's dangers were sent to the medical examiner, he amended the young woman's death certificate to state that her use of this product was a cause of her death.
The lack of knowledge by the medical profession was recently highlighted in a an episode of the TV show, "ER." In this episode, a hyperactive and rude young child was brought into the ER where she proceeded to drive everyone nuts. She was sent home. The following day, she was taken into the ER and died. As it turns out, she died from iron poisoning she got taking iron containing vitamins which the doctor never asked the mother or little girl about. (Iron poisoning is a leading cause of death in children under six. Look carefully, you will see this warning on children's vitamins containing iron.)
At the end of the show, the doctor who neglected to take a history, was comforted by another doctor by stating that she did not violate the standard of care. How could she have known!! How could the doctor not have known, given the fact that the American Association of Poison Control Centers logs in over 12,000 adverse reports that are vitamin-related every year. Warning labels on vitamins containing iron are also required. If the little girl who died was my child, ER would be in serious trouble.
Another reason why many adverse events are not reported is because of the half truths used by this industry to promote their product. For example, many companies advertise that there are "no known side effects." What the company fails to mention is that the reason there are no known side effects is because no one from the company ever bothered to look. In fact, after Mr. Grell's wife's sudden death, he wrote to the company who made the diet tea asking about the herbs in the product. They wrote back saying that the diet tea was just a "refreshing, low calorie beverage" that could cause no harm! One can only imagine how many other people looking for answers wrote or called the manufacturer and receive similar answers.
Another example of half-truths is promotional literature claiming that the product was tested by such an such university. What is not reported is that the testing did not show anything to support the companies claims.
At the present time, it is estimated that approximately one third of all patients are taking some type of vitamin, herbal product or dietary supplement. As a result of this statistic, coupled with several adverse events, the American Society of Anesthesiologists issued a warning advising anesthesiologists to make sure that they ask their patient these questions before surgery. For example, prior to most surgeries, patients are advised not to take aspirin because aspirin is a blood thinner and can increase the risk of hemorrhages. Has anyone ever been told to stop taking ginko biloba another blood thinner?
Herbal weight loss products containing stimulant herbs, laxatives and/or diuretics like ephedrine and senna can lower a persons's electrolytes. A number of medical reports show that even low normal potassium levels can increase the risk of cardiac arrhythmias.
Another misconception held by many is that the young and middle age people are the main consumers of these "all natural" products. Not true. In fact, in an article written by Dr. Eli Ehrenpreis, he found that a number of his octogenarian patients who he found had colon abnormalities, were using the same diet tea discussed earlier. In interviewing his patients, Dr. Ehrenpreis found that, like everyone else, they assumed that this product, sold as an "all natural" product made from an ancient Chinese formula, was safe. Ironically, Mr.Grell's office learned that the formula for the Diet Tea had nothing to do with any ancient Chinese formula. We also learned that the extensive research referenced on the label consisted of one week of taste testing by two people with no formal training in herbs or any related science.
In short, regardless of our age or sex, many of us share the notion that if it is natural, it is safe. Mr. Grell did when he watched his wife drink the diet tea the night she died, a mistake he hopes no one else will ever make.
It is also important to emphasize that people taking other medications, especially heart medication, put themselves at even greater risk. For example, individuals using all natural products like the herbal diet tea, who are also taking other medications like digitalis or digoxin for their heart, risk serious injury as a result of electrolyte loss, since low levels of electrolytes make these kinds of drugs more potent and dangerous.
Americans are also told that the herb Ginkgo Biloba will improve your memory and concentration. What the companies do not tell people is that this herb acts as a blood thinner that can and does cause adverse affects, especially if it is being taken with other blood thinner medications such a Coumadin.
Athletes of all ages often turn to dietary supplements sold as all natural thermogenic energy boosters and muscle enhancers to improve their performance. What many of these athletes fail to realize is that these products are really nothing more than combinations of various herbal stimulants like ephedrine. Ephedrine is illegal in many sports. In fact, its use as a dietary supplement has caused several Olympic athletes to be banned from competition.
Cancer patients and AIDS patients often turn to herbal products and dietary supplements as a means of trying to cure or treat their illness. According to a report from the Los Angeles AIDS Project, a number of patients taking these products often times suffer adverse reactions which the doctors mistakenly attribute to the medications being prescribed. As a result, the AIDS Project in Los Angeles in conjunction with the National Institute of Health, advise doctors to take histories from their patients concerning the use of these products so that important treatments are not discontinued based on the erroneous believe that the medications are the cause of the adverse reaction.
The assumption that these products are "all natural" is also on occasion incorrect. As a result of our investigations, we uncovered evidence that some companies are spiking their so-called "all natural" products with man-made or synthesized pharmaceutical drugs like ephedrine HCl. To date, the FDA has done nothing even though they know that companies are doing this.
Another frightening finding recently made by the Food and Drug Branch of the State of California is that many herbal products being imported into the United States and sold as Chinese medicines, are contaminated with lead, mercury, arsenic, selenium, and a variety of pharmaceutical ingredients. Notwithstanding these findings, no serious effort has been made to alert the public or stop the sale of these products by the government.
In another case, a number of well-known dietary supplement manufacturers were sued because the companies' "calcium supplements" contained levels of lead that exceeded the levels allowable under California law.
Other reports in the literature have found lead in a number of other herbs and herbal products not sold as Chinese medicines. In one case, the source of the lead in the herb was traced to the fact that the company kept the herbs in large open containers in parking lots to dry out where trucks, using unleaded gas, were left running. (Leadedgas isallowed in China.)
Parents should also know about products being sold as liquid herbal products, like Dr. Chen's Ginseng, which contains 20%-30% alcohol, i.e., 40 to 60 proof which kids are buying to get high. In fact, the California Department of Alcohol Beverage Control issued a warning about the use of these products.
According to a Utah Highway Patrol news release, kava kava, an herb promoted to help you relax, has resulted in a number of arrests for driving under the influence.
In the U.S., Systematic Adverse Affect monitoring is pretty much limited to identification of adverse drug reactions. Systematic Adverse Affect monitoring for dietary supplements, herbal products, complimentary and alternative therapies is virtually non-existent.
Adverse reports in other countries, however, have been done. One group of investigators retrospectively studied 2,695 patients admitted to a Taiwan Department of Medicine during a ten-month period. Four percent of these patients were admitted because of drug-related problems; herbal remedies ranked third among the categories of medicines responsible for causing adverse affects.
In a case control study from the Philippines, herbal medicine use was identified as one of the main risk factors for nasopharyngeal carcinoma.
In another study which involved 1,701 patients admitted to general wards of a Hong Kong hospital, the researchers found that 2 percent of all patient admissions were due to adverse reactions to Chinese herbal drugs. As an aside, in China, people distributing herbal products must be licensed. No such license requirement exists in the United States. In fact, during our investigation, we learned that a well-known multi-billion dollar a year company with thousands of retail outlets throughout the U.S. provides a total of three weeks of training to people who buy franchises. Further, there is no requirement that you have any special knowledge or training to qualify.
In a recent note from the World Health Organization Collaborating Center For International Drug Monitoring 5,000 reports of suspected adverse affects of herbal preparations are on file.
The London-based National Poison Units retrospectively surveyed the period January 1983 to March 1989 and did a prospective survey in 1991. The Unit received 1,070 inquiries in relation to herbal and other traditional drugs. In the United States, the Poison Control Center Database run by the American Association of Poison Control Centers is not even set up to track adverse reactions to herbal products/dietary supplements. (As noted earlier, they do track adverse events linked to vitamins.)
In short, underreporting is a major problem for all the reasons discussed. Consequently, the next time you read an advertisement which states something along the lines of "no adverse reactions found," remember what it really means.
Indeed, Mr. Grell's firm uncovered a startling 1996 FDA report which listed herbal products/dietary supplements as the number one category of FDA consumer complaints received in that year. In this same report, consumer safety involving dietary supplements was ranked as the number one concern. To our knowledge, neither this report nor its finding were ever made public.
The list of herbal ingredients used either singularly or in combination with other products and their potential adverse affects is extensive. The following is a list of controversial herbs, vitamins and amino acids discussed by a group of people who promote herbal products and what Rob McCaleb, President of the Herb Research Foundation, a strong supporter of the dietary supplements, had to say:
- Comfrey - contains liver toxins called pyrrolizidine alkaloids. Some feel it's safe for most people, others see no point in taking any risk if other herbs can offer similar benefits. Roots have more alkaloidthan leaves, and young leaves more than older leaves.
- Chaparral - also implicated as a liver toxin, but without strong evidence. Reported cases of human toxicity are complicated and rare, no liver toxic compounds have been identified, and the FDA, which has done some feeble testing with cultured liver cells but no classic toxicology testing, has been unable to come up with compelling evidence of harm.
- Stevia - the embattled sweet herb, banned for 4 years based on a "trade complaint" (ie from a company, not a toxicologist), is now available as a dietary supplement. Looks safe.
- Ephedra - after over 5,000 years of human use, the herb is controversial because of abuse in diet and energy products and the use of strong concentrates in products. Some products contain synthetic ephedrine, just like asthma drugs.
- Laxative diet teas - can be habit-forming and produce unhealthful side-effects. Weight loss from such products may be mostly by dehydration, hence not lasting.
- Stimulant diet teas - mostly ephedra, caffeine sources and sometimes willow or aspirin. They probably are appetite suppressants, and may stimulate fat burning. Some individuals should not touch them, for others there are questions about safety and healthfulness.
- Cleansing programs - many are based on stimulant laxatives, which can be habit-forming. The concept that we need to use laxatives to "clean out" is controversial.
- Hemp - more products are appearing using the seed oil, which lacks the intoxicating components of the plant, also known as marijuana. No toxicity concerns, but the plant is controversial for obvious reasons.
- Kombucha "mushroom" products - evidence of benefits is weak. Concerns have been raised about safety of growing your own. The "brew" produced by this complex of microorganisms contains mostly vinegar, sugar, a bit of alcohol and caffeine.
- Kava kava - becoming popular as a sleep aid and anti-anxiety agent. Concerns are about potential regulatory issues (no problems so far) and possible abuse.
- Grape seed extract / Pine bark extract / "Pycnogenol" - are confusing to consumers. What are the differences? Is one better? Grape seed extract predominates in the European market, while pine bark extract is stronger in the USA, probably because of better marketing.
- Evening Primrose Oil / Black Currant Oil - are sources of the fatty acid gamma linoleic acid or GLA, beneficial to the cardiovascular system and reportedly effective for PMS and inflammatory conditions. FDA tried to claim that they were "unsafe food additives" but never had a shred of evidence of harm. The Agency lost (badly and repeatedly) in court.
- Melatonin - synthetic hormone to induce sleep. Long term safety is uncertain, but it is produced naturally in our bodies.
- Tryptophan - still off the market because of a quality problem with one manufacturer which led to illness and some reported fatalities. No one expects it to return to the market, but under the Dietary Supplement Health and Education Act of 1994 it would apparently be considered a safe and legal supplement unless FDA could prove otherwise.
- Chromium picolinate - widely sold in diet and muscle-building products. Does it work? It's an "insulin potentiator" which may improve some metabolic factors, but needs more research.
- Beta carotene - the recent report by NIH that it doesn't help and may increase cancer risk (in smokers) is raising questions among consumers. The weight of evidence seems to support this antioxidant, and there are serious questions about the study, which combined beta carotene with vitamin A (retinol) at toxic levels, then gave it to smokers who are already at risk. Nature provides vitamin A (in fruits and vegetables) in the form of 90% beta carotene, and at lower doses than those used in the study.
- Single amino acids - including tryptophan, phenylalanine, aspartic acid and others, are controversial because they are isolated and taken in high doses. Safety may be a concern.
- Germanium - rose to popularity, then declined as cases of toxicity were reported. Germanium is only healthful in very low doses.
- Selenium - same issue as germanium, complicated by the fact that areas with high selenium levels in the soil produce selenium-rich vegetables. In those areas supplementation is not necessary and could be hazardous.
- Organic Sugar - is this just a way to "sugar-coat" something that really isn't healthful? Is the "green marketing" aspect exploitive? See above for details
(Lists of other popular herbs and their potential toxological effects taken alone or in combination with other medication will be listed shortly.)
What is even more frightening is that in several recent medical articles, researchers found that chronic use of stimulant laxatives such as senna caused a statistically significant increased risk of colon cancer if used for prolonged periods of time. The FDA, aware of these reports, responded by proposing a rule which would downgrade the use of senna as a "safe drug" to a "drug" that is in need of further research." To date, nothing has been finalized. Apparently, the concern is with prolonged use. Since commercial over-the-counter laxatives, like senna, specifically warn against prolonged use, the FDA is not that concerned with the cancer risks. After reviewing these reports, this office wrote to the FDA and pointed out that, unlike commercial laxatives, herbal products containing senna such as herbal diet teas, encourage long term use and should contain similar warning against prolonged use. The FDA has yet to respond. Frankly, we are not surprised by the lack of a response given this firm's experience. In fact, based on our experience, it appears that the FDA and other government agencies do not consider a product to be a drug unless the labeling of the product makes a drug claim! If the label makes no drug claim, the product can be sold as food or a dietary supplement. For example, during a deposition of an official from the California Food and Drug Branch, the person being deposed testified that if Sennokot, an over-the counter laxative which is sold and labeled as a drug with the appropriate drug warnings against prolonged use, was relabeled and sold with no drug claims on the packaging, it could be sold as a food. Since counsel could not believe his answer, he asked the following question: If morphine was put in a bottle and sold as a refreshing beverage with no drug claims on the label, would you consider this product to be a food? Again, his answer was "yes," as he understood the law, "such a product would also be considered to be a food!!" One example that proves this point that in the U.S., products are judged by their cover, and not their content, is the diet tea. In the United States, this product is sold s a food. When the company started selling the same product in Canada, Health Canada, the Canadian equivalent to the FDA decided to evaluate the product after receiving a number of complaints. As a result of their evaluation, Health Canada concluded that this product was not a food but a drug and must be sold as a drug and labeled with the appropriate warnings, regardless of what the label said. As will be discussed in future articles, herbs such as senna, legally sold in the United States in foods/dietary supplements, are either limited or banned from use in a number of countries.
Ephedrine, is another example of the drug versus food insanity. Recently, the FDA determined that ephedrine is unsafe if sold in certain over-the-counter drug products. Notwithstanding the reclassification of ephedrine as unsafe for use inmany drug products, dietary supplements containing ephedrine, whether natural or man-made, continue to be sold in the United States without any government interference!
So that there is no misunderstanding, we are not anti-herb. Many herbs can and do provide important benefits. In fact, many modern medicines are derived from plants. Where people make mistakes is in assuming that there is something magical about the way these products work. There is not. What these products contain are natural drugs, which can and do cause the same adverse affects as any other drug. If the companies made this point clear to the consumer, this article would not be necessary.
For those wondering how all this can this be true, it is important to know that industry sales are estimated to be around 21 billion dollars a year. All this money buys a strong lobby with the financial ability to muster a lot of slick P.R. not to mention grass root support by scaring the consumer into thinking that if the government is given more power to regulate, the consumer will lose their freedom of choice. Again, this is not true. In fact, if you look at what legal action the FDA has taken over the years, you will find few, if any cases, of abuse of power or loss of freedom of choice because of government interference.
Another form of deception that has been used by the industry for many years is the creation of the notion that the AMA and drug companies have conspired to keep these products out of the hands of the consumer. Nonsense. In fact, the next time you hear some supporter of this theory spew this rhetoric, ask for proof. After eight years of investigation, our office has found nothing to support these claims. In fact, what we did find is that many large drug companies sell vitamins, and herbal/dietary supplements and more are joining the group everyday. If you are interested in learning more about the dark side of this industry read "The Vitamin Pushers" by Stephen Barrett, M.D. and Victor Herbert, M.D.
In short, when taking an herbal product/dietary supplement, as with any drug or medication, know exactly what you are taking before taking it, how much to take and when not to take it. Report symptoms to your doctor and to the FDA. If you need help, contact us.
Since it is difficult to find credible information that answers many of these questions, (stores selling these products usually want to emphasize only the good), the following are several books which we found to be good, credible references.
1)Adverse Effects of Herbal Drugs
P.A.G.M. De Smet (Managing Editor)
K. Keller R. Hansel R. F. Chandler
G. Abel; R. Bos; I.H. Bowen; R.F. Chandler; D. Corrigan; I.J. Cubbin; P.A.G.M. De Smet; N. Pras; J.J.C. Schefffer; T.A. Van Beek; W.Van Uden; H.J. Woerdenbag
In collaboration with the Pharmaceuticals Programme of the World Health Organization, Regional Office for Europe
2)The Honest Herbal
A Sensible Guide to the Use of Herbs and Related Remedies
Varro E. Tyler, PhD
Lilly Distinguished Professor of Pharmacognosy
Purdue University School of Pharmacy and Pharmacal Sciences
3)Chinese Herbal Medicine
Daniel P. Reid
4)Handbook of Medicinal Herbs
James A. Duke
5)The Complete German Commission E Monographs
Therapeutic Guide to Herbal Medicines
Developed by a Special Expert Committee of the German
Federal Institute for Drugs and Medical Devices
Senior Editor, MarkBlumenthal, Founder and Executive Director, American Botanical Council
Associate Editors, Werner R. Busse, Ph.D., Alicia Goldberg, Joerg Gruenwald, Ph.D., Tara Hall, Chance W. Riggins, Robert S. Rister
Primary Translator, Sigrid Klein, Ph.D.
Associate Translator, Robert S. Rister
6)Encyclopedia of Common Natural Ingredients Used in Food, Drugs, And Cosmetics
Albert Y. Leung
7)The American Pharmaceutical Association Practical Guide to Natural Medicines
The First Authoritative Home Reference for Herbs and Natural Remedies, from the Nation's Largest and Most Respected Organization of Pharmacists
Introduction by Andrew T. Weil, M.D.
8)Botanical Safety Guide
Edited by Michael McGuffin, Managing Editor
Christopher Hobb, L.Ac.
Roy Upton, Herbalist
Prepared for the Standards Committee of the
American Herbal Products Association
The message in this article is the same message that Christopher Grell has tried to take to the American public ever since he first realized that these products are not what they appear to be. The information and story of his wife's death has been featured on Prime Time Live, American Journal, The Ophra Show, Maury Povich Show, Hard Copy, Day and Date, not to mention and numerous network new stations both local and national. Dozens of articles have also appeared in magazines and newspapers like Good Housekeeping, Consumer Reports, Glamour, The Washington Post, Prevention not to mention numerous health letters.
As a result of Mr. Grell's Office's efforts and the efforts of others who shared his concern, the State of California became the first state in the nation to pass an emergency regulation requiring a warning notice to the consumer about the potential dangers of using products containing herbal laxatives. As a result of Mr. Grell's efforts, The FDA Consumer magazine, the official magazine of the FDA, did an article entitled "Dieter's Brews Make Tea Time a Dangerous Affair."
Mr. Grell has appeared before the FDA and the California Food and Drug Branch to argue the need for greater consumer protection. He has written hundreds of letters to medical groups, industry and consumer groups in an effort to make these groups aware of these issues.
In addition to representing clients who have been harmed, Christopher Grell has provided information to numerous individuals who just want to know more about the products they are taking. He does this without charge so that no one has to go through what he went through after his wife's death.
If you have been harmed or if you are taking an herbal product and would like more information, please feel free to contact us.