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HERBCLIP ™ FILE: • Herb Market DATE: January 15, 200000 Post Office Box 144345 Austin, Texas 78714-4345 Phone 512/926-4900 Fax 512/926-2345 Email: [email protected] www.herbalgram.org Mark Blumenthal Editor Wayne Silverman, PhD Underwriting Coordinator Leela Devi, MSN, RN Marian Garner-Wizard Betsy Levy Heather Oliff, PhD Risa Schulman, PhD Densie Webb, PhD Summary Writers Karen Newton Database Manager Karen Robin Susan McFarland Coordinators Dawnelle Malone Research Assistant The American Botanical Council provides this summary and the enclosed article as an educational service. By providing this article, ABC does not warrant that the data is accurate and correct, nor does distribution of the enclosed article constitute any endorsement of the information contained or of the views of the authors. ABC does not authorize the copying or use of the original articles. Reproduction of the summaries is allowed on a limited basis for students, colleagues, employees and/or customers. Other uses and distribution require prior approval. HC 111196 RE: Botanical Bloopers: Fads, Fallacies & Frauds in the Herb Marketplace Blumenthal, M. Botanical Bloopers. Whole Foods. July, 1999, pp. 78 - 80; August, 1999, pp. 67 - 70. Everybody makes mistakes, and some of those made over the past 20 years by herbal manufacturers and distributors, and by the Food and Drug Administration (FDA), are reviewed in Mark Blumenthal's two-part article. Some "bloopers" in the herbal industry may be attributed to its youth and sometimes inadequate knowledge on the part of some of its members, while others border on fraud. One example, predating the rest, exhibits both factors and left thousands of people with neurological damage in the 1930s. During Alcohol Prohibition, a popular Jamaican ginger extract containing 70% alcohol featured a new, inexpensive additive, which turned out to be toxic. While the neurotoxicity of tri-ortho-cresyl phosphate was not well known at the time, accompanying claims that the drink was a "headache remedy" were clearly intended as a cover for the alcohol. The "Ginger Jake" episode, which produced permanent limping in some consumers called “Jake Leg,” and a spate of blues songs on this topic, is a warning to manufacturers and regulators alike to ensure that good manufacturing practices and proper checking of all ingredients are given due diligence. Another example is the sale of canaigre (Rumex hymenosepalus) as "wild red desert ginseng", an energy tonic, when in fact canaigre is traditionally used for sore throat, and bears no chemical or botanical relationship to Asian or North American ginseng (Panax spp). Internal industry education and a policy statement by the Herb Trade Association, forerunner of the American Herbal Products Association (AHPA), ended its popularity. Caffeine presents a persistent labeling disclosure problem. Present in seven plant species: coffee, tea, chocolate, yerba maté, guarana, cola, and yaupon (Ilex vomitoria), most "authoritative references consider the compounds identical in chemical structure and pharmacological activity", caffeine in tea may be called theine; that from guarana, guaranine; that from maté, mateine, etc. Marketers of weight-loss products, energy supplements, and "natural stimulants" have claimed that they are "caffeine free" when in fact they contain caf- feine, but from species other than coffee. Not only is this misleading, but, for some caffeine sensitive people, it is a potential health hazard. Selling herbs by common names, especially before the publication of the AHPA Herbs of Commerce directory in 1992, has led to several herbal bloopers. "Missouri snakeroot," for instance, refers to both purple coneflower (Echinacea purpurea) and prairie dock or wild quinine (Parthenium integrifolium). Unfortunately, German researchers announced the isolation of two new sesquiterpene lactones from E. purpurea in the mid-1980s, only to find that they had been working with supplies of Parthenium instead. Confusion in names has also led to importation of misidentified herbs. Examples of outright fraudulent marketing include questionable herbal alternatives to illegal drugs; a tea implied to treat, and possibly prevent, cancer (with the unspecified ingredient "herbaline"); and bodybuilding formulas containing sarsaparilla, which claimed to contain testosterone, which no scientific evidence supports and no analytic test has found. On the other hand, bloopers committed by the FDA, can be seen in several examples of policies and statements seemingly fueled by anti-herb sentiment. A 1977 list of "Unsafe Herbs," including the now popular and relatively safe herbs St. John's wort (Hypericum perforatum) and horse chestnut (Aesculus hippocastanum). The Dietary Supplement Health and Education Act of 1994 (DSHEA) did away with this list. At the time, however, the 27 herbs on this list were banned from commerce in the U.S. Another 1977 FDA list, "Herbs of Undefined Safety", included arrowroot (Maranta arundinacea), a widely used cooking starch, and many other herbs whose safety was well known (at least as far as knowledgeable herbalists were concerned). One, slippery elm (Ulmus rubra), was even approved by the FDA as a safe and effective over-thecounter drug when this policy guide was released. Also in 1977, the FDA issued an import alert on all ginseng products, unless labeled as “tea.” In the FDA's view, ginseng (Panax ginseng) in any form other than as a beverage (i.e., capsule, extract) was an unsafe food additive, based on the policy that food additives are deemed unsafe until proven safe. Manufacturers responded by labeling capsules, tablets and even bulk ginseng root powder as "tea." In 1988, the FDA issued import detentions on both black currant oil (Ribes nigra) and evening primrose oil (Oenothera biennis), saying that they were unsafe food additives. However, the FDA had no evidence of adverse reactions or even a shred of data to show them unsafe. In court, the FDA admitted that black currant oil was safe taken by the spoonful, but became unsafe if added to a gelatin capsule. Partly because of these incidents, in 1994 DSHEA specifically stipulated that herbs are not food additives. Passage of DSHEA has not changed all of the FDA's illogical herbal policies. Stevia (Stevia rebaudiana), a non-caloric natural sweetener, still can be imported only as a dietary supplement, and not as a sweetener. "The irony of this is. . .self-evident: consumers ingest larger quantities of stevia in a dietary supplement than they would if it were an ingredient in an herbal tea," Blumenthal writes. An FDA report issued during the DSHEA debates recommended stricter herb regulations without justification, attributed specific supplement claims to the wrong manufacturers, and was issued without appropriate review, as required by Federal procedures. This contributed to an agency reputation for bias against the herbal and dietary supplement industry. In a post-DSHEA example, the FDA recently tried to limit importation of Chinese red yeast rice (Monascus purpurea) because it contains a naturally occurring compound chemically similar to the prescription drug ingredient, lovastatin. A federal court ruled that the product in question is a dietary supplement, not a drug. This case is on appeal. Blumenthal stresses that all of these bloopers, both industry and agency, are the exception and not the rule, and reminds readers that the issue of accuracy in dealing with herbs is the responsibility of everyone involved. —Mariann Garner-Wizard Enclosure: Bin #168 Copyright © 1999, by Whole Foods. Reprinted with permission.