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    Ephedra: Is the FDA telling the truth?

    Posted by .(JavaScript must be enabled to view this email address)
    Tuesday, November 25, 2003 6:10 am Email this article
    A history of deception about other supplements casts doubts about the FDA's honesty about ephedra.

    Lawmakers are deciding whether to ban the sale of ephedra. They say it's an issue of safety, but is it? What else could it be?

    The truth may be that these products compete directly with FDA-approved drugs. The most recent issue of HerbalGram (No. 41) contained an excellent editorial titled “When Will There Come a Savior…?” about the FDA’s bias against herbal products. It was written by the distinguished Varro E. Tyler, Ph.D., Sc.D., Dean and Distinguished Professor Emeritus at Purdue University and author of numerous books including The Honest Herbal. I am not aware that Dr. Tyler supports the use of Ma Huang for weight loss and suspect that he does not. However, his article is still relevant. (For a copy of the entire editorial see ordering information at the end of the reference.)

    Passages below are from an editorial by Varro Tyler published in a past issue of HerbalGram.

    Many past and present actions of the United States Food and Drug Administration with respect to herbal products should be a matter of concern to every thinking citizen. These began long before the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and have continued ever since…

    St. John’s Wort unsafe? Nearly 20 years ago the FDA compiled and published a list of “Unsafe Herbs.”’ Included… were some that certainly did not merit inclusion [including]... Horse chestnut, a widely used treatment for varicose veins in Europe… bloodroot, a popular ingredient in toothpaste and mouthwash. But perhaps the crowning insult to herbal medicine was the categorization of St. John’s wort as unsafe. [St. John’s wort] is currently the best selling prescription drug in Germany for mild to moderate depression…

    Black currant oil unapproved food additive? In November 1988 the FDA instructed a U.S. marshal to seize two barrels of black currant oil on the grounds that because it was to be placed in gelatin capsules, it was a “component” of food and therefore an unapproved food additive. The case was summarily dismissed… but in 1992, the FDA appealed… In finding for the defendant, Judge Cudahy of [the U.S. seventh Circuit Court of Appeals] noted that under the FDA’s definition, any food to which water was added could become a food additive. He called their contention an “Alice-in-Wonderland approach” that would allow the FDA to make “an end-run around the statutory scheme.”

    Stevia non-calorie sweetener unapproved food additive? During the early 1990’s there was considerable interest… in obtaining [GRAS?generally recognized as safe] status for stevia. [It is] widely used in Asian nations as [a] non-caloric sweetener. [Its] safety… is unquestioned there. Years of use in multi-ton quantities have not resulted in any significant toxicity being reported. Nevertheless, in May 1991, the FDA embargoed the importation of stevia leaves, stevioside, and food containing them on the grounds that the herb was an unapproved food additive…

    Ginseng unsafe? In 1977 FDA questioned the inherent safety of ginseng… This action… [suggested] that ginseng was only safe as a water infusion (i.e., as an herbal tea) and that ginseng in any other form was considered unsafe a priori… The inherent absurdity of this policy was patently obvious to most observers of the scene during that time and appears to be all the more ludicrous and irrational in retrospect 20 years later…

    Previous import ban on evening primrose, and restrictions on ginseng and ephedra. Passage of DSHEA also caused the agency to lift a number of previously imposed import alerts and import bulletins affecting herbal products. These included an import ban imposed on evening primrose in 1990, as well as long-standing restrictions on ginseng and ephedra.

    DSHEA resulted from a public and legislative revolt against the agency’s proposed restriction on the availability of herbs and other dietary products… Nevertheless, the desire of the agency to exert restrictive control over herbs continues. In 1997, they adopted a new approach.

    Marketers making seemingly reasonable structure/function claims for their products began to receive letters from the FDA noting that these statements?permitted under DSHEA?were really drug (therapeutic) claims which are not allowed. That menopause is a natural process often accompanied by some unpleasant symptoms is a universal truth. Menstruation is also a well-recognized condition to which all healthy females of appropriate age are subject. Some degree of prostatic enlargement is experienced by almost all males over 40 years of age. Cholesterol is a normal component of all human blood. Claims to modify these conditions are obviously structure/function claims to everyone except FDA officials. They have apparently begun to consider as drug claims any recommendations for the alleviation of conditions that also may be treated by approved drugs.

    Red yeast consumed for 2,000 years now unsafe? Most recent in the long series of inappropriate actions by the agency was the temporary import detention on June 11, 1997, of a 5,450 pound shipment of red yeast because it “appears to be an unapproved new drug.” This product serves as the basis of Cholestin, a popular proprietary product that reduces serum cholesterol levels. Red yeast is a traditional Chinese health food, widely consumed in that country for more than 2,000 years. It has been used in the United States for at least 60 years. The detention order was subsequently withdrawn.

    The safety and efficacy of red yeast have been repeatedly confirmed by numerous clinical trials. The nature of its active principles?mevinolin and several chemically, related HMG-CoA reductase inhibitors is well-known. It obviously qualifies as a legal dietary supplement, but because it has a cholesterol-reducing effect?a condition often treated by approved drugs?the FDA has seen fit to consider it a drug.

    Prune juice unsafe? The illogical nature of the FDA’s position in this entire field is evident. Those of us who work daily with herbal medicine tend to become cynical about the agency’s actions. But how else can one interpret the activities of an organization that has found (by default) prune juice to be an unsafe and/or ineffective laxative and peppermint an unsafe and/or ineffective digestive aid?

    I have personal knowledge of attorneys… many of whom have… [worked] for the FDA, who openly characterize the agency’s position on herbs as, “If it’s green and comes from abroad, the FDA is against it.”...


    ? Tyler VE. When will there come a savior…? HerbalGram, 1997, 41:27-8, 56.

    HerbalGram is published quarterly by the American Botanical Council and Herb Research Foundation. American Botanical Council, PO Box 201660, Austin, TX 78720. (800) 373-7105, (512) 331-8868, (512) 331-1924 fax. www.herbalgram.org., email: .(JavaScript must be enabled to view this email address)

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