HOPS

DANGER! UNREGULATED SUPPLEMENTS AHEAD!












  In 1941, Walter Campbell of the FDA wrote: "Our experience of more than 30 years in the enforcement of the Food and Drugs Act has demonstrated that testimonials may be obtained for practically any item labeled as a treatment for practically any disease."

Partial list of public warnings issued by the FDA about dietary supplement ingredients:

 * Chaparral - liver disease, possibly irreversible.

 * Comfrey - obstruction of blood flow to liver, possible death.

 * Ephedra - high blood pressure, irregular heartbeat, seizures, heart attack, stroke and death.

 * Dieter's teas - nausea, diarrhea, vomiting, fainting, possible death.

 * Germander - liver disease, possible death.

 * Ma Huang - overuse of this ephedrine-containing herb can cause rapid formation of kidney stones that have been found in some patients to be nearly pure ephedrine.

 * Lobelia - breathing problems, rapid heartbeat, low blood pressure, coma and death.

 * Magnolia-Stephania preparation - kidney disease, possible kidney failure, death.

 * Herbal Fen-Phen - high blood pressure, irregular heart rate, seizures, heart attack, stroke and death.

 * L-tryptophan - (an amino acid) eosinophilia myalgia syndrome, which is a potentially fatal blood disorder that can cause high fever, muscle and joint pain, weakness and swelling of the arms and legs.

 * 5-hydroxy-L-tryptophan - A precusor to L-tryptophan. Only recently gaining widespread use. Although no recent illnesses have been reported, the FDA said extra precaution is warranted because of problems with L-tryptophan. FDA studies still in progress.

 * Sleepy Buddha - Product of China. Imported and distributed by Treasure Box Products Inc. of Canada. Contains prescription-strength drug ingredient "estazolam," sedative of benzodiazapine family. Serious side effects, including drowziness, slowed motor reflexes and dependency. Can cause fetal damage in pregnant women. * Gamma butyrolactone (abbreviated as GBL) - brand names include: Blue Nitro, Revivarant Gamma G and Remforce. GBL related products have been associated with reports of at least 55 adverse health effects, including one death. In 19 of the cases, consumers became unconscious or comatose.

 * Serenity - has caused comas. Victims require breathing tubes to be revived when they become unconscious. Sold under names of Serenity, Genesis, Weight Belt Cleaner and others. Most common chemical names are tetramethylene glycol and butane-1, 4-diol.

 * Products containing "plaintain," which could actually be digitalis that has been mislabeled. Digitalis is a potent heart stimulant that can cause cardiac arrest.

 * Vitamin A - in doses of 25,000 or more International Units a day: Birth defects, bone abnormalities and severe liver disease.

 * Vitamin B-6 - in doses above 100 milligrams a day: Balance difficulties and nerve injury.

 * Selenium - in doses of 800 to 1,000 micrograms a day: Tissue damage.

     Source: FDA

WHAT IS AN ACCEPTABLE RISK?


 By Paul A. Kimpel

 University of Florida pharmacy professor Paul Doering said many people assume that products sold as dietary supplements have been checked for safety and effectiveness by some branch of the federal government.  But Doering said that although many of these products - particulary concentrated herbal medicines - should be approved by the Food and Drug Administration before being marketed, they are not.  However, there is a certain percentage of the 30,000 dietary supplements on the market - mostly vitamins and minerals that have been more rigorously tested - along with cetain "whole-food herbals" that have long-been in the food supply (garlic, etc.), that are generally regarded as safe by health professionals.

 But Congress issued this statement about the safety of dietary supplements in the Dietary Supplement Health and Education Act of 1994 (DSHEA): "The apparent safety of many dietary supplements actually increases the need for safety provisions in the law because consumers may believe that all dietary supplements are safe." 

 However, Doering said safety is a relative term. "Nothing is 100 percent safe," he said."  "Every time a person uses a health remedy or dietary supplement, they have to balance the risks against the possible benefits."  For instance, Doering said a substance that appears to be safe for short-term use may not be safe over longer periods of time.

 A good example of this is provided by Dr. Susan Percival, a UF professor of human nutrition who performs research on dietary supplements. The popular herbal product echinacea has been shown in well-designed studies to stimulate the immune system.  However, Percival, who recently completed a study on echinacea, said when people read that echinacea boosts the immune system, they often believe it should be consumed all the time.

 But Percival said an over-stimulated immune system produces a lot of free radicals, and that is not good.  "If a flu virus overcomes an already boosted immune system, a person will get a worse case of the flu," she said.  "Overuse of echinacea actually weakens the immune system."  Percival said echinacea should only be taken at the first onset of flu or cold symptoms, and that more well-designed clinical trials need to be done on the herb.

Self-Medication and Your Doctor

 Many people who self-medicate with dietary supplements fear traditional doctors will not be open to alternative treatments, and therefore hide the fact that they take supplements. One recent afternoon at Mother Earth Market in Gainesville, three out of five shoppers would not disclose their last names for this article, worried that their doctors would be upset if they discovered the patients were self-medicating.

 Bruce Silverstein, a Gainesville cardiologist, said patients should not be afraid to tell their doctors what supplements they (patients) want to try. He added that doctors need to become more open-minded regarding alternative medicine, but said most doctors are trained to be conservative about products until they have been tested for safety and effectiveness.

 Moreover, health professionals who advise people with medical conditions caution patients to be especially careful with ceratin dietary supplements.  Jerald Foote and Bev Cohen, registered dietitians who have practices in Colorado, said chronically ill patients who experiment with herbals must be particularly attentive to side effects.  One of the examples they cite is the use of laxative herbs in patients with kidney diseases.

 Foote said laxative or cathartic herbs, especially those with the ingredients senna, cascara, buckthorn or rhubarb, should not be used by people with kidney disease. Foote said these herbs accumulate in kidney tissue and can cause electrolyte and fluid imbalance.

 In 1999, Health" magazine reported that a 37-year-old San Francisco woman died after drinking "dieter's tea" over a period of several months. The tea contained senna, a laxative, and uva ursi, a diuretic, both of which can deplete potassium, which is needed to regulate heartbeat. Reportedly, none of the standard warnings about taking laxatives and diuretics for more than a week appeared on the label, nor did the label state any tolerable upper intake limits for the product.

 Dr. Elaine Turner, UF assistant professor of human nutrition, said tolerable upper-intake limits, which is defined as the largest amount of a substance a person should take in a single day, have not been set for many supplements. She said the Food and Nutrition Board of the National Academy of Sciences began in 1997 to set upper limits for vitamins and minerals. But upper levels for substances that many people assume are safe, such as vitamin C, have not been determined.

 In addition, Turner said caution must be used because the upper limit is generally not much higher than the recommended daily intake.  For example, with folic acid, a B-vitamin important for women of child-bearing age, the recommended daily intake is 4/10 of a milligram, but the upper limit is only 1 milligram, Turner said. She said people can easily reach upper limits by taking supplements because intake of folic acid is also provided by food.

 A milligram is so small that a level teaspoon holds about 5,000 milligrams of a ground substance, such as salt.  Interestingly, there are vitamins, such as B-12, and other dietary supplement ingredients that are potent at the microgram level, which is 1/1,000 of a milligram.

A Lack of Consistency in Herbals

 The Good Housekeeping Institute this year compared six widely available St. John's wort supplement capsules and four liquid extracts.  The laboratory reported a "startling lack of consistency in the quantity of hypericin." Hypericin is advertised as the active ingredient in St. John's wort, but many scientists now dispute its properties, saying there are many other substances in St. John's wort that act upon the brain and central nervous system.

 The Institute found the amount of hypericin in St. John's wort products varied greatly, with the largest concentration 17 times the smallest amount.  Moreover, due to the lax selling atmosphere under DSHEA, St. John's wort is popping up in stores everywhere. In June, the Lil' Champ chain of convenience stores started selling St. John's wort manufactured by TrimFast Holdings of Tampa, Fla.

 The label claims reads: "Effectively relieves stress and nervous tension while making you more alert. You've seen the positive reports on national TV news."  However, Varro Tyler, a Purdue University professor emeritus of pharmacognosy - which is the study of medicines from plants - said St. John's wort acts like a sedative, which would not make a person more alert, but rather, more drowsy.

 In addition to questions about the consistency of so-called "standardized herbal products," which can be affected by conditions such as state of plant maturity at time of harvest and storage practices after cutting, health advocacy groups are questioning basic claims about many supplements.  The Center for Science in the Public Interest (CSPI), a Washington-based consumer advocacy group, had its scientists evaluate studies conducted on Ginseng over the past 20 years and have found that "ginseng offers no significant health benefits."

 The Center cited among others, Centrum's brand of ginseng, Ginsana, as not living up to its claim that it "enhances physical endurance or improves oxygen utilization."  The Center has requested that the FDA and the Federal Trade Commission stop these claims from appearing on labels and in advertisements unless the claims are substantiated through proven scientific methods.

 Stephen Barrett, M.D., a board member of the National Council Against Health Fraud, said terms such as "enhances, purifies or energizes," are pseudomedical jargon that are vague and hard to measure.  "These terms make it easier for companies to claim success even though nothing has been accomplished," Barrett said. He cautioned consumers about products that claim to have no side effects. "Any product strong enough to do some good is strong enough to have side effects."

Can You Believe in Brand Names?

 Many people believe they can trust well-known companies to make quality products. Turner said that although consumers may be able to take more comfort that advertised ingredients are present in brand-name products, they should not assume that a product is effective simply because it is sold by a well-known company.  "Bigger companies simply have more to lose if they make a product that doesn't contain the advertised ingredients," Turner said.

 Another problem is the lack of standards  for herbal products.  Tyler said, "Because government standards for herbal quality are nonexistent in the United States, the buyer is dependent upon the reputation of the seller. Many herbs sold today are collected in the wild in developing nations by persons not necessarily knowledgeable about plant taxonomy," Tyler said. "In addition," he said, "many organizations sell the herbs under their common names instead of the recognized Latin name. This causes confusion because of the lack of uniformity of common names."

 For example, a recent study of the herb feverfew, showed that none of the samples analyzed contained the minimal recommended content of "0.2 percent parthenolide" required for effectiveness.  Other problems with potency or mislabeling of raw herbs can have serious consequences.

 Tyler said several national organizations are in the process of developing botanical encyclopedias, also known as compendiums, that will present well-referenced information on the major botanicals in use today and hopefully prevent current problems such as the mislabeling of bulk herbs. See: FUTURE

General guidelines for using dietary supplements

* Do not take if pregnant, lactating or attempting to conceive. Kids and Supplements

* Do not give to young children.

* Do not use for treatment of serious diseases without consulting a doctor.

* These products are not miraculous cure-alls; have realistic expectations.

* Purchase products from reliable producers. Look for ingredients that have U.S.P. notation, which indicates the manufacturer followed standards established by the U.S. Pharmacopeia.

* Make sure the product shows the scientific name and quantity of any botanical, the batch and lot number, the date of manufacture and the expiration date.

* Be wary of articles using "medicalese," which is pseudo-medical language designed to read like legitimate science.

* Be wary of studies unless they are peer-reviewed, which means other health professionals have affirmed that the study is well designed and the conclusions are valid.

* Be wary of recommendations that are made to sell a product.

* If you read or hear of a product that you would like to try, search for at least two additional studies on that product that have been peer-reviewed.

* Before using herbal remedies, it is recommended that consumers read the books, "Herbs of Choice, The Therapeutic Use of Phytomedicinals," or "the Honest Herbal, a Sensible Guide to the Use of Herbs and Related Remedies," both by author Varro Tyler.

Tyler is a former Dean of Purdue University's School of Pharmacy, and is senior author of "Pharmacognosy, 9th Edition," which is the standard U.S. textbook in the field of drugs from plant sources (pharmacognosy).

Sources: University of Montana, University of Florida, Institute of Food Technologists, Varro Tyler and the FDA.

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