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Do not overmedicate with ephedra

Ephedra, the main ingredient in several weight-loss, bodybuilding and decongestant products has been the subject of much debate recently. Recently the Canadian Health regulatory agency, Health Canada requested a voluntary recall of a wide range of products containing the herb ephedra or its chemical derivative ephedrine, saying large amounts "pose serious risk to health".

Ephedra or ma huang contains two alkaloids that are powerful stimulants, ephedrine and pseudoephedrine. Ephedrine causes blood vessels to constrict and the heart to beat faster and stronger, and pseudoephedrine opens up air passages in the lungs and decreases nasal congestion. Health Canada said it had written to many distributors and importers to request they recall products that do not meet federal guidelines. Products such as nasal decongestants are mainly unaffected and will continue to be available provided they do not contain caffeine and that the ephedrine content does not exceed eight milligrams per single dose or 32 mg per day.

The US Food and Drug Administration also approved some uses of ephedra in over-the-counter drugs. However, in 1997 after recording reports of adverse events, the FDA proposed to limit ephedra's use in weight management products. The FDA withdrew the proposed limit after the industry and congressional investigators challenged it, saying the FDA did not have sound scientific evidence to support their position.

The National Nutritional Foods Association (NNFA) was one of many organisations that also protested, saying that adverse event reports lacked identification of the product or product ingredients, insufficient or no information on dosage amounts, duration or frequency, or medical records.

The insufficient reports raised valid questions about whether reactions were caused by abuse of the products, or interaction with other products, or pre-existing medical conditions. The NNFA believed that reports which formed the basis of the FDA's attempt to restrict ephedra could not be used as scientific conclusions. Instead, they requested the FDA commission a properly designed clinical study to assess the safety. The NNFA also requested that the FDA endorse the reasonable safe dose per day levels already being applied by the industry, Ohio and other states.

Ephedra has been in use for over 5000 years. According to Dr. Roger W. Wicke, Ph.D of The Rocky Mountain Herbal Institute, ephedra is a useful herb if used as indicated, but can be dangerous if used to excess or for a condition for which it may only mask symptoms.

"Many of the current popular uses for ephedra would be considered inappropriate from the perspective of the Traditional Chinese Medicine (TCM) pharmacopoeia," writes Dr. Wicke in the Institute's newsletter 2000. In TCM ephedra is often used to relieve coughs and asthma, promote urination and relieve edema.

"To use ephedra for weight loss or as a stimulant, two popular uses, risks exhausting the chi, resulting in adrenal exhaustion," writes Dr. Wicke. He noted that many Americans already have some type of exhaustion due to stress, overwork, and poor diet and any use of ephedra, especially without counteraction by other herbs, may risk aggravating their condition.

According to the Ephedra Education Council more than 3 billion doses of ephedra were consumed in 1999. If those doses were consumed by 1 million people (300 doses or approximately three to five months of use) then approximately 0.0075% of those people(75) have appeared in the FDA's adverse event report for the year.

This number is modest in relation to the widespread use of the product and in relative terms is no greater than the number of adverse events associated with many other products. Also millions of people safely consume over-the-counter cold and asthma remedies containing synthetically produced versions of the same alkaloids present in ephedra.

The FDA and the American Medical Association support the regulation of dietary supplements (the term dietary supplement refers to all herbal, vitamin and mineral supplements) in the same way as pharmaceutical drugs. This would require products to demonstrate absolute proof of efficacy and safety before they could be marketed. Of course FDA approval doesn't necessarily mean a product is safe - many drugs have been recalled due to health risks after receiving FDA approval.

However, other groups including the Council for Responsible Nutrition, the American Preventative Medical Association, the American Botanical Council and consumer groups such as Citizens for Health predict that this type of regulation would eliminate a huge portion of the dietary supplement industry. If this plan was implemented all dietary supplements would be removed from the market place until having passed through an approval process.

The FDA approval for drugs costs hundreds of millions of dollars, usually takes eight to ten years and requires an enormous amount of documentation. The only companies that can afford this are large multinational pharmaceutical giants. This is also part of the reason drugs cost so much - the other is greed. Since a plant cannot be patented there is no incentive for private companies to invest in herbal products. Many herbs could vanish from the marketplace permanently depriving us of valuable choices for health care.

There are a lot of products that we can purchase off the shelf that can pose a risk to our health if not used as directed. The consumer needs more information; not their freedom of choice eliminated. A society without freedom of choice is a threat to our well being. It has been said that very few things in nature are toxic if used in the correct dose, after all, ephedra has been used for thousands of years by many different cultures without problems.

A better solution would be to provide more information on ephedra to the public by more labelling. Also the industry could introduce its own independent testing organisation such as other industries faced with the same problems have done. Finally, it is important to use medicinal herbs responsibly by consulting a qualified health care professional.