Supreme Court rules on Ephedra
2007 - Utah-based Nutraceutical Corporation lost its fight to keep ephedra over the counter. In 2007, the Supreme Court issued a "certiorari denied" without comment in the case of Nutraceutical Corp vs. Eschenbach, meaning it is refusing to consider an appeal. In 2005, a Utah judge countered and blocked FDA's action against Nutraceutical Corporation and the banned herbal. This was then overturned by the federal appeals court decision in August of the same year. Judge Tena Campbell had sided with Nutraceutical and stated that the FDA did not prove a daily dosage of 10mg or less of ephedra results in an unreasonable risk of illness or injury.
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I personally prefer the appetite suppressing effect of 5-HTP, the serotonin precursor, and hoodia is also an option although I personally do not have too much experience with it. An alternative to ephedra that is now being more commonly used is citrus aurantium.
Since Ephedra is banned, why shouldn't acetaminophen (Tylenol) be banned also?
There are hundreds of deaths from Tylenol poisoning or toxicity each year and tens of thousands of individuals who are hospitalized. Why is Tylenol available over the counter while ephedra has been banned? It does not seem to be a consistent policy.
2006 - The U.S. Court of Appeals for the Tenth Circuit in Denver upheld the Food and Drug Administration's (FDA) final rule declaring all dietary supplements containing ephedrine alkaloids adulterated, and therefore illegal for marketing in the United States, reversing a decision by the District Court of Utah. The Tenth Circuit Court of Appeals' ruling demonstrates the soundness of FDA's decision to ban dietary supplements containing ephedrine alkaloids, consistent with the Dietary Supplement Health and Education Act (DSHEA) of 1994. The Tenth Circuit Court of Appeals also found that Congress clearly required FDA to conduct a risk-benefit analysis under DSHEA. FDA evaluated the relevant scientific data evidence on ephedrine alkaloids before issuing its final rule, which became effective in 2004. The court found that the 133,000-page administrative record compiled by FDA supports the agency's findings that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure. No dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the United States is illegal and subject to FDA enforcement action.
2006 - Nutraceutical Corporation is not giving up its fight for
ephedra and has filed a petition for rehearing in front of the entire
tenth circuit of the US Court of Appeals, following a federal appeals
court decision in August.
Dr. Sahelian comments: It is not scientifically accurate to say that no dosage of ephedrine alkaloids are safe. Certainly one milligram of ephedrine alkaloids could be considered safe. It's like saying no dose of alcohol is safe. Why is ephedra banned but not aspirin or acetaminophen. There are thousands of people who die or are seriously harmed by these two over the counter drugs. Why are they not banned? Are we to ban anything that could potentially endanger our health? What about banning skydiving or skiing. There are countless people who break bones or tear ligaments by skiing. For the safety of the American public, should skiing be banned? These are all questions for you, the reader, to ponder. There is a certain amount of inconsistency, perhaps hypocrisy, when an agency goes out of their way to ban ephedra, but does little to ban acetaminophen. Should we ban alcohol use? It's a slippery slope.
2006 - A federal judge who lifted the ban on dietary
supplements containing low doses of the weight-loss aid ephedra
misunderstood the law, the Food and Drug Administration is arguing in
trying to restore the ban. An attorney for Nutraceutical
International Corporation that
successfully challenged the ban told a three-judge panel of the 10th U.S.
Circuit Court of Appeals that if the judge's decision is overturned, the
FDA could ban virtually any substance on the market it determines is
harmful in large doses, such as vitamin C tablets or peanut butter.
Dr Sahelian's opinion:
Although I believe ephedra has serious safety concerns in high doses, more than most herbs and supplements, I do not think it should be totally banned from the market. Policy makers have to be consistent in their approach. Even though aspirin and acetaminophen have caused thousands of deaths, they are still on the OTC market. Why are they still allowed to be sold while ephedra was pulled? This is not a consistent policy approach and that is what disturbs me.. And we don't even need to discuss the dangers of smoking and drinking alcohol, which any adult can purchase.
As to safe ephedra supplement doses, I would agree providing some guidelines is quite helpful, and perhaps limiting daily intake to no more than 24 mg a day would be appropriate. Strong emphasis needs to be placed that anyone with a heart condition or other medical problems should not use this thermogenic plant.
As to the possibility of rare cases of harm that occur from an ephedra product, that is a risk a free democratic society has to take in order to allow its citizens access to a variety of products. If we were to disallow anything that could potentially harm the public in the long term or short term, we would have to ban sodas, donuts, and even skiing and parachute jumping.
Understanding Ma Huang
Ephedra is a shrublike plant found in desert regions throughout the world. It is distributed from northern China to Inner Mongolia. The dried green stems of the three Asian species (Ephedra sinica, intermedia, equisetina) are used medicinally.
Ephedras main active medicinal ingredients are the alkaloids ephedrine and pseudoephedrine. The stem contains 13% total alkaloids, with ephedrine accounting for 3090% of this total, depending on the plant species. Both ephedrine and its synthetic counterparts stimulate the central nervous system, dilate the bronchial tubes, elevate blood pressure, and increase heart rate. Pseudoephedrine (the synthetic form) is a popular over-the-counter remedy for relief of nasal congestion. Little research has been done on using the whole plant (compared to its isolated alkaloids) for any condition.
The crude powdered stems of ephedra (with less than 1% ephedrine) are used at 14 grams per day in tea form. Tinctures of 13 ml three times per day can be taken. Over-the-counter drugs containing ephedrine can be used by adults at 10 mg every 8 hours. Adults should take no more than 30 mg every twenty-four hours.
Ephedra Side Effects, danger, safety, risk
Abuse of herbal ephedra (and particularly ephedrine) especially for weight loss or as a recreational drug can lead to amphetamine-like side effects, including high blood pressure, rapid heart beat, nervousness, irritability, headache, urination disturbances, insomnia, dry mouth, heart palpitations, possibly seizures, and even death due to heart failure, stroke, or irregular rhythms. One study has shown that a single dose caused mild elevation of heart rate but did not consistently affect blood pressure in otherwise healthy adults. When taken at higher levels, ephedra can cause drastic increases in blood pressure, as well as cardiac arrhythmias. Ephedrine is considered potentially habituating, though it is unclear if the whole herb ephedra is likely to do the same thing. Ephedra in high doses may increase the risk for stroke. Anyone with a medical condition (particularly hypertension, heart disease, diabetes, glaucoma, anxiety, thyroid disorders) or taking medicines or other supplements should consult their physician before taking ephedra.
The severity of toxic reactions to ephedra: comparisons to other
botanical products and national trends from 1993-2002.
Clin Toxicol. Division of General Pediatrics, Children's Hospital, Boston, Massachusetts
This study's purpose was to compare toxicity from botanical products containing ephedra to nonephedra products. The Toxic Exposure Surveillance System (TESS), a national poison center database, was utilized to determine the number and outcomes of cases involving botanical products reported from 1993-2002. There were 21,533 toxic exposures with definitive medical outcomes reported over the 10 yrs where a botanical product was the only substance involved. Of these, 4306 (19%) had moderate or major medical outcomes and there were two deaths, for an overall hazard score of 200 per 1000 exposures. The number of ephedra reports to poison centers increased 150-fold over the 10-yr period. The hazard rate for products that contained only ephedra was 250 per 1000 exposures and 267 per 1000 exposures for products that contained ephedra and additional ingredients; whereas the hazard score for only nonephedra botanical products was 96 per 1000 exposures.Yohimbe-containing products had the highest hazard score and rate ratio. Ephedra-containing botanical products accounted for a significant number of toxic exposures with severe medical outcomes reported to poison centers. Hazard rate analysis suggests poison center-reported events involving ephedra-containing botanical products were much more likely to result in severe medical outcomes than those involving nonephedra-containing botanical products.
G Ital Cardiol (Rome). 2013. Herbs and cardiotoxic effects. Accidental or deliberate ingestion of poisonous herbs has become an increasingly common phenomenon over the last years. From existing literature data and case reports from emergency room visits or poison control centers, an overview is presented of the potential cardiotoxic manifestations following intoxication by wild herbal plants of the territory. The effects of the consumption of cardiac glycoside-containing plants (e.g., digitalis) are discussed along with tachyarrhythmias induced by Aconitum napellus, Atropa belladonna, Mandragora officinarum or Ephedra distachya herbs, and hypertensive crises associated with licorice abuse.
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The makers of a weight-loss product implicated in the death of a Baltimore Orioles pitcher will pay New Jersey nearly $1 million to settle claims that it exaggerated the benefits and understated the risks of some products. The settlement announced involves Nutraquest Inc. and three related companies that have agreed not to make unsubstantiated claims in advertising. Nutraquest is a successor of Cytodyne Technologies, which made Xenadrine RFA-1, an ephedra-based product found to have contributed to the February 2003 spring training death of Orioles pitcher Steve Bechler.
Ephedra in the News
Some of the weight-loss aids that have quickly emerged to replace the now-banned substance ephedra may carry risks of their own. Researchers at the University of California, San Francisco found that two ephedra -free diet supplements increased the heart rates of 10 healthy volunteers, and one also raised their blood pressures. The supplements, sold as Advantra Z and Xenadrine EFX, both contain extracts of bitter orange, known scientifically as Citrus aurantium. The botanical, which has long been used in traditional Chinese medicine for digestive problems, has emerged as one of the major replacements for ephedra in over-the-counter weight-loss products. Citrus aurantium contains a compound called synephrine that, like ephedra, stimulates the central nervous system and may boost metabolism.
Dutch food group Numico NV has reached a tentative settlement in 36 cases concerning the food supplement ephedra, sold by its former GNC unit. Numico, Europe's largest maker of baby formula, said that a group of defendants in the cases had agreed to pay $19.7 million and that its own portion of those costs was covered by product liability insurance. Ephedra is derived from the Chinese herb ma huang and has long been used as a treatment for asthma. Numico said the agreement was part of a global settlement involving claims against some 20 defendants, including health food product chain GNC and other retailers. It is related to the sale of ephedra-containing products manufactured by Twin Labs. The settlement is subject to definitive documentation and ultimate approval by the Bankruptcy Court as part of Twin Labs' reorganisation plan, Numico said. If approved by the Court, it will result in the dismissal of 77 active cases, including 36 in which GNC is named as a defendant. Numico sold GNC in October 2003. It now is a specialised nutrition company with leading positions in baby food and clinical nutrition with brand names such as Nutricia, Milupa and Cow & Gate.
Supplements that contain ephedra and caffeine-rich
guarana, used for weight loss, result in significant cardiovascular and
metabolic changes. These changes could be harmful in people with high blood
pressure, atherosclerosis (clogged arteries), or glucose intolerance, a
precursor to diabetes marked by elevated blood sugar. Guarana is an herb
containing caffeine. Researchers at the University of California, San Francisco
tested the effects of Xenadrine RFA (a supplement containing 25.4 mg ephedra
alkaloids and 185 mg caffeine) and ephedra extract (23.2 mg total ephedra
alkaloids) plus guarana (167 mg caffeine), compared with placebo, in 16 healthy
adults. Repeated dosing of ephedra and guarana produced elevated ephedrine blood
concentrations, increased heart rate and blood pressure, and had unfavorable
effects on glucose and potassium homeostasis. These effects could exacerbate
obesity-related conditions such as insulin resistance and metabolic syndrome.
SOURCE: Clinical Pharmacology and Therapeutics June 2005.
Short-term metabolic and hemodynamic effects of ephedra and guarana combinations.
Clin Pharmacol Ther. 2005.
Department of Medicine, Division of Clinical Pharmacology, University of California, San Francisco
Serious adverse health events have been reported with the use of dietary supplements containing ephedra and guarana. In this study, 16 healthy adults (8 women) took 2 doses each of ephedra-guarana alone, Xenadrine RFA, a multicomponent dietary supplement containing 25 mg ephedra alkaloids and 200 mg caffeine, or placebo 5 hours apart in a randomized, double-blind, 3-arm crossover study. CONCLUSIONS: Consumption of 2 doses of ephedra and guarana supplements, per supplement label recommendations, results in persistent increases in heart rate and blood pressure and unfavorable actions on glucose and potassium homeostasis. Such effects could be detrimental in persons with hypertension, atherosclerosis, or glucose intolerance, conditions that are strongly associated with obesity.
People have reported numerous incidents of serious psychiatric problems -- including hallucinations, mania and severe depression -- that may have resulted from taking ephedra, new study findings report. Nearly one-half of those ephedra incidents involved hospitalization. Some of these of patients also harmed themselves or others, and were brought up on criminal charges for their behavior. Two-thirds of the people reporting psychiatric problems from ephedra, also known as ma huang, had pre-existing psychiatric conditions, or were using other medications or illegal drugs, according to the researchers, led by study author Margaret Maglione of the RAND Corporation, headquartered in Santa Monica, California.
Safety of ephedra: lessons learned.
Toxicol Lett. 2004.
Soni MG, Carabin IG, Griffiths JC, Burdock GA. Burdock Group, Vero Beach, FL
Commercially used ephedra and its products is prepared from Ephedra spp. and as such is subject to a variety of influences (including differences in species and strain; growth, harvest and storage conditions) all of which may influence the content of constituents (which may, in turn, affect the absorption, distribution, and metabolism of active constituents) and taken together, influences the net pharmacological effect. Further, as a natural substance with an easily perceived and desirable (i.e. weight-loss) pharmacological effect, ephedra is also susceptible to a variety of adulterants, both economic and efficacious. All of the foregoing represent potential for misadventure before ephedra even reaches the consumer. The consumer introduces a constellation of variables as well, including, but not limited to, acute and chronic diseases, inborn errors in metabolism, simultaneous use of prescription and over-the-counter drugs, dietary supplements, alcohol, illicit substances and certain foods (e.g. chocolate, caffeinated drinks), all or some of which may exert synergistic, additive or even antagonistic influences on the desired physiologic outcome. The foregoing not withstanding, the majority of the published nonclinical and clinical studies, and history of use, support the safety of ephedra at the proposed use levels. However, the reports of adverse events submitted to FDA raise concern about the risk associated with ephedra without establishing a direct causal relationship. Given the foregoing, how best can a decision on safety be made? Should the question actually be "can ephedra be as toxic as reported?"
A study in dogs confirms that ephedrine weight loss diet pill supplements can kill, supporting the U.S. Food and Drug Administration's action to ban them. The supplements containing ephedrine -- originally a herbal extract taken from a shrub and also used as a decongestant -- had little effect on healthy dogs, the study found. But in dogs that had their arteries artificially blocked, ephedrine had dangerous effects, said Dr. Philip Adamson of the University of Oklahoma. "For our experiment, we went to the local health food store, bought ephedrine supplements and gave our animals the dose recommended on the label," Adamson told a briefing sponsored by the American Medical Association. "In past experiments on obese, otherwise healthy individuals, ephedrine did not raise their heart rates when they were either at rest or exercising," Adamson added. "When we gave healthy animals ephedrine, we found exactly the same thing. But the moment they developed a blockage in their heart artery, which we are able to cause reversibly, their heart rates went through the roof." These fast heart rates, called fibrillation, can kill.
Q. I have a different viewpoint regarding your comments about ephedra and ephedrine products being along the same lines of concern as those of aspirin or Tylenol. Have you ever seen a family fall apart from the use of the latter medications?
A. Have you ever seen a family fall apart from the use of alcohol? Would you like to ban alcohol? If not, why not? One should be consistent in their approach to banning things. It's a slipper slope... can we entrust those in government to make such decisions? Who draws the line as to what is safe and what is not? Governments can easily go to extremes in banning things when power goes to the wrong people or to fanatics. If you wish to ban ephedra herb because it has risks, what about banning skiers and snowboarders from doing high leaps or summersaults? The number of skiers and snowboarders suffering head and spinal cord injuries is on the rise internationally, the result of greater risk-taking on the slopes. The rates of brain and spinal cord injuries among skiers and snowboarders is increasing. These injuries can be devastating or even fatal.
Q. Would I ban alcohol and have I seen its effects on families? You bet!
A. Banning of alcohol was attempted in the US in the 1920s and the results were not impressive. Different people have different opinions on a variety of topics.
I am a health food store owner and I believe ephedra
should be legal since aspirin and Tylenol are much more dangerous and they are
available over the counter. Here are some of my current ephedra best-sellers:
Black Asia, Methyldrene, Stimerex-ES, Lipodrene, Hydroxyslim, ECA Extreme Stack
by Hi-Tech Pharmaceuticals
Yellow Power, Diabloby Innovative Bio Labs, Klller Bee's by Hyper Genetic Labs have ephdra extract.
I am surprised since I thought ephedra was not allowed over the counter.
Clear Heat (herbs like Gardenia fruit - Zhi Zi), Extinguish Internal Wind (Uncaria
stem - Gou Teng, or Gastrodia rhizome - Tian Ma)