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Judge Rules Against FDA Ban on Ephedra, Product More Food Than Drug:"A federal judge Thursday struck down the FDA ban on supplements containing ephedra, the once-popular weight-loss aid that was yanked from the market one year ago after it was linked to dozens of deaths.
The judge ruled in favor of a Utah supplement company that challenged the Food and Drug Administration's ban. Nutraceutical International Corp. claimed that ephedra has been safely consumed for hundreds of years.
A U.S. district judge struck down the federal ban on ephedra, the weight-loss aid that was removed from the market last year after it was linked to 155 deaths. Nutraceutical, a Utah company that challenged the ban, said in its lawsuit that ephedra "has been safely consumed" for hundreds of years and is a food, not a drug. Industry groups said supplements that included ephedra were once used by 12 million people. Last year's ban of ephedra was the first such outlawing of a dietary supplement." ******************************************************
Ephedra: Buyer Beware!
Ephedra-Containing Dietary Supplements Pose a Risk, Deborah Buchanan, RN, MS, CLNC:"Since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, consumers have seen a proliferation of dietary supplements available to them in supermarkets, drug stores, nutrition centers and via the Internet. (Dietary supplements include vitamins, minerals, amino acids, herbs or other botanicals, or any combination of these ingredients). Perhaps unknown to the average consumer is that the DSHEA greatly limits the FDA's regulation of these supplements and herbs. The fancy packaging and labeling of these supplements may give the consumer a false sense of security in believing that these products are safe, and that the statements made about them are true. While dietary supplements cannot claim to treat, cure, diagnose, or prevent disease (because that would be a violation of the Food, Drug, and Cosmetic Act), they often boast claims of health-maintenance such as "boosts energy," "mood enhancer" or "maintains healthy bones". While these claims may seem to be "just what you need," it is important to remember that just like prescribed and over-the counter medications, herbal remedies and formulas have medicinal qualities that may include unwanted and even dangerous side effects." ******************************************************
Ephedra, Products That Consumers Inquire About, U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition: ******************************************************
Adverse Events Associated with Ephedrine-Containing Products--Texas, US Food and Drug Administration Center for Food Safety and Applied Nutrition:"During December 1993-September 1995, the Bureau of Food and Drug Safety, Texas Department of Health (TDH), received approximately 500 reports of adverse events in persons who consumed dietary supplement products containing ephedrine and associated alkaloids (pseudoephedrine, norephedrine, and N-methylephedrine). This total included reports by individuals and reports identified by the Bureau of Epidemiology, TDH, in a review of records from the six centers of the Texas Poison Center Network. Reported adverse events ranged in severity from tremor and headache to death in eight ephedrine users and included reports of stroke, myocardial infarction, chest pain, seizures, insomnia, nausea and vomiting, fatigue, and dizziness." ******************************************************
The Ephedra Injury Page:"Ephedrine is a stimulant that is used as an ingredient in diet pills, illegal recreational drugs, and legitimate over-the-counter medications to treat congestion and asthma. Ephedrine has a molecular structure similar to amphetamine. Ephedrine can produce the following adverse reactions: heart attack, stroke, tachycardia, paranoid psychosis, depression, convulsions, coma, fever, vomiting, palpitations, hypertension, and respiratory depression." ******************************************************
Ephedra, Herbal Information Center:"Known as Ma Huang, (Ephedra) is a member of the family of herbs known as the Ephedracae. It has been used in China for more than 4000 years to treat symptoms of asthma and upper respiratory infections. Varieties of the herb are also grown in Europe, India, Australia and Afghanistan. American ephedra, native to the dry southwest, was used as tea by the early settlers, and was known as "Mormon tea" and "Squaw tea." It has also been used in the treatment of headaches, fevers, colds and hay fever. Today, compounds derived from this herb are commonly found in many over-the-counter cold and allergy medications." ******************************************************
Ephedrine, Ma Huang, and Ephedra, Monheit, Monheit, Silverman & Fodera:"The Food and Drug Administration and the National Council Against Health Fraud have identified ephedrine as the worst over-the-counter and/or mail order product. It is contained in many diet pills and food supplements. The FDA has reported in excess of 300 cases of adverse reaction to ephedrine in 1994 and 1995 alone. Dozens of deaths have been linked to these substances. The FDA has compiled 32 volumes of information on ephedrine." ******************************************************
Mahuang, Ephedra What Is It?:"The Chinese have used this herb for over 5,000 years, particularly to treat asthma and reduce upper respiratory infections. The primary active ingredient of Ma Huang is ephedra. Pseudo-ephedrine is a chemical isomer that is similar to ephedra. Both ephedrine and ephedra stimulate the sympathetic nervous system, causing vasoconstriction of the blood vessels in the lining of the nose. They also dilate the bronchial tubes and stimulates the heart. Benefits body building and endurance athletes by promoting themogenesis (the burning of fat)."
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http://www.prescriptionforviagra.com/drugs/diet.pills/ma_huang.extract.ephedra.ephedrine.pseudoephedrine.htm Created on October 19, 2000
Last updated by Andrew Lopez, RN on Wednesday, February 27, 2008 |
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