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FDA and Ephedra Battle

Most of us know that in Asia medicine, Ephedra (known in Chinese as “Ma Huang”) is the primary herbal drug for the treatment of asthma and bronchitis. This herb has been employed for thousands of years. Presently, Ephedra is official in the national pharmacopeias of China, Germany and Japan, while the isolated or synthesized alkaloid from the plant, primarily ephedrine and pseudopehdrine, are official in most countries.

Dietary supplements containing Ephedra have become very popular in the past two decades to help promote weight loss ad athletic performance. The safety and efficacy of Ephedra began to be called into question in the U.S. during the 1990’s when the herb began to be used as a major ingredient in herbal dietary supplements intended to aid in weight loss and exercise. In 1997 the FDA issued proposed regulations on Ephedra-containing dietary supplements that would limit the level of the total ephedrine alkaloids in herbal products to no more than 8mg per a dose, with no more than 24mg per a day. The proposal would have banned the combination of Ephedra with other stimulants, like caffeine or caffeine-containing herbs (including Kola Nut, Guarana, Mate), in herbal products. The proposal would have also prohibited the sale of Ephedra products for use in weight loss or for athletic performance and have required warning labels on all products containing Ephedra. Industry, scientific and medical experts, and many consumers criticized the proposed rule, often noting that the AER’s (Adverse Event Reports) were not valid scientific basis for rule making, as established by the FDA’s own policies.

Congress then requested the US General Accounting Office to conduct and audit of the scientific basis for the FDA’s propesed rule. In Aug.1999. the GAO issued a 68 page report. The report revealed deficiencies in the FDA’s rule on Ephedra. GAO questioned the reliability of many of the AER’s and criticized the apparent lack of science employed in formulating the proposed dosage limits of alkaloids, the proposed duration limits, and ban on weight loss and exercise claims. GAO recommended that the FDA not finalize the proposed rule, unless it could develop a valid scientific basis and meet other requirements applicable to federal rule making. In March 2000, the FDA responded to the GAO by withdrawing the majority of the proposed rule.

Safety – Overview

According to a survey by AHPA of 14 companies that manufactured and marketed Ephedra-containing supplements, there was a 700% increase in sales from 1995 to 1999, representing 425 million “servings” sold in 1995, rising to an estimated 3 billion servings in 1999, with total estimated sales of Ephedra supplements equaling 6.8 billion servings (McGuffin, 2000).

An independent Canadian research organization (Cantox Health Sciences International) concluded that on the basis of quantitative method that 90mg per a day is a safe upper limit for the ingestion of Ephedra alkaloids in normal, healthy individuals and the lowest observed adverse effect level is 150mg per day.

Greenway Zool Study published that recent clinical research suggests that Ephedra, in combination with other herbs, produces significant weight loss with no clinically significant adverse effects in the study participants, and with small impact on blood pressure or heart rate (Boozer et. Al 2002; de Jonge et al 2001).

The Ephedra Conspiracy

The FDA approved ephedrine and pseudoepherdine as safe and effective for the pharmaceutical industry, but they say the Ephedra as a dietary supplement is harmful in any dosage level? Many manufacturing dietary supplement industries feel the FDA favors the pharmaceutical industry.

So many now wonder why the FDA is no adamant in banning Ephedra to be used as an effective diet aid. They say ephedrine and pseudoephedrine as o.t.c. drugs are safe and effective for their intended uses such as asthma and as a decongestant. Both have been labeled safe for over 50 years. Yet Ephedra used as a dietary weight loss aid is classified as unsafe and can not be used at any dosage. This leaves many asking why the same compound can be safe as a drug and allowed to be sold, and the same compound as a dietary supplement be banned? This leaves many to believe that the FDA and Pharmaceutical companies are very close.

Many have thought that the FDA would attempt to make an ephedrine+caffeine synthetic drug combination and sell it over the counter. However a recent announcement of the launch of Alli® by GlaxoSmithKline has left a lot of people wondering now. Alli is an o.t.c. reduce dose of 60mg version of Xenical®, it is being brought to the market without a prescription. GlaxoSmithKline and Roche came together to promote Xenical in the U.S. in in July of 2004 a $100 million agreement came allowing Glaxo to acquire the nonprescription marketing riths from Roche. So many feel that the FDA’s motive for banning Ephedra was to create a open market for Alli to come onto the market.

Conclusion

Once again the FDA and Nutracuetical Corp. are back in the courts fighting over Ephedra. Nutraceutical needs to be greatly thanked for the time and investment they put forth to keep and and hopefully finalize the legality of Ephedra sales in dietary supplements. Nutraceutical says low-dose ephedrine alkaloids if sold in a gel capsule are dangerous and illegal, but higher doses of the same substance sold in tea bags are perfectly legal?

The Dietary Supplement Health and Education Act (DSHEA) -- part of the Food and Cosmetics Act -- ensures that ingredients marketed in the United States prior to October 1994 do not need to be approved by the FDA before they can be used in consumer products. The company's appeal calls such analysis subjective, and says it sets a precedent for the FDA to preside over the entire herbal supplements industry.

Nutracuetical will be asking the U.S. Supreme Court to hear the case. Let’s hope that the system works for the consumers and finalizes the use and sale of Ephedra once and for all.

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Scottsdale Nutrition Suppy is an online retailer for discount supplemtents in weight loss, sports nutrition and healthcare. We have been in business since early 2004 and currently specialize in the most complete selection online of Ephedra Weight Loss Pills (www.snsupply.com/ephedra-diet-pills.html). SNS continues to grow and adds high qaulity products to our site on a weekly basis. Please feel free to visit our store at www.snsupply.com or www.scottsdalenutrition.com

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