The controversial ban of ephedrine by the FDA

How come that ephedrine is so efficient for weight loss, has been used for more than 5,000 years and is now so controversial?

Ephedrine miracle diet

Imagine that you want to lose weight and that all these diets you have been trying for years didn’t make you lose even one pound… Then you see this ad with a beautiful body, perfect abs and iron butt, telling you that losing 10 pounds in 1 month is easy with these miraculous diet pills called ephedrine… And all this could be yours for a mere $49.99 that is, the cost of a month supply of these magic diet pills – and not some illegal stuff but an over-the-counter product!

Does this ring a bell? Of course! We have been overwhelmed by this kind of ads since years now, and for a good reason: rich people in industrial countries are getting fatter and obesity is becoming a major health issue , especially in the United States for all population groups over the last decades. The figures presented by the « U.S. Obesity Trends » website are alarming:

  • About one-third of U.S. adults (33.8%) are obese [1]
  • Approximately 17% (or 12.5 million) of children and adolescents aged 2—19 years are obese [2]

No surprise that there is a huge market here. And fact is that Ephedrine has played a very lucrative role in this business, considering its core benefits:

  • Improve athletic performance by stimulating the central nervous system and by increasing heart rate and contraction force via activation of the beta-1 receptors
  • Suppress appetite by increasing norepinephrine release through stimulation of adrenergic pathways in the hypothalamus
  • Promote weight loss by increasing thermogenesis and resting energy expenditure via stimulation of the muscle beta-2 receptors to increase substrate metabolism [3]

So what’s the problem with earning decent money while helping people in their weight loss quest, based on natural qualities of this Chinese herb called Ephedra or Ma Huang?

Ephedrine can cause a heart attackThe problem is that « natural » doesn’t mean safe in all cases, despite the common belief: according to the Food and Drug Administration, the use of ephedrine has led to dozens of deaths and thousands of health dangers. Over 800 reports of people taking ephedrine mentioned side effects as « nervousness, dizziness, tremor, alternations in blood pressure or heart rate, headache, gastrointestinal distress, chest pain, myocardial infarctions, hepatitis, stroke, seizures, psychosis and dozens of deaths ».

Ephedrine has also been suspected as the cause for heart attacks, strokes and seizures in healthy young adults, thereof a previously healthy 23-year-old Boson college student using ephedrine for bodybuilding. « A 35-year-old woman had a heart attack after 11 days only, and a man of the same age had also a heart attack after taking just five capsules », the FDA added [4].

Ephedrine is suspected in the death of baseball playerThe death of Baltimore Orioles prospective pitcher Steve Bechler on Feb. 17, 2003 that was linked to the use of ephedrine has also contributed to the FDA’s decision in 2004 to ban all ephedrine supplement in weight loss programs. Congress became all of a sudden in favor of an ephedra ban, which Time Magazine described as a « dazzling display of hypocrisy ».[5]

Of course, companies having financial interests in ephedrine based diet programs didn’t see it this way: for instance Metabolife, distributing an over-the-counter diet pill containing ephedrine, questioned very openly this decision, repeating that their product was « safe and effective when taken as directed. These FDA reports of death are not properly investigated, they are not based on fact and hard data, but instead are based on anecdotes ».

Rob McCaleb, President of the Herb Research Foundation, said that ironically, « after over 5,000 years of human use, Ephedra herb is now controversial because of abuse in diet and energy products and the use of strong concentrates in products ».
The counterpoint made by ephedrine supporters to the ban in the US has been organized around the supposed answers to these two questions:

Is ephedrine effective in weight loss?

Yes – no doubt, many studies did confirm the effectiveness of ephedrine based products, thereof a double-blind, placebo-controlled clinical study conducted by the Harvard Medical School and Columbia University and published in the May 2002 issue of the International Journal of Obesity (IJO) [6]. Also, Cantox Health Sciences International compiled all available scientific information and concluded from 19 clinical trials that ephedra was both safe and beneficial for weight loss at the 90 mg per day dosage [7]. As a consequence of such results produced by world famous organizations, the effectiveness of ephedrine dietary supplements has rarely been questioned by opponents, FDA or others.

Is ephedrine safe?

This question is crucial because the ban decided by the FDA was based on safety issues. The above-mentioned studies proved with no doubt that ephedrine is safe when taken at the prescribed dosage.
The authors of the Harvard study, Dr. Patricia Daly and Dr. Carol Boozer, director of the New York Obesity Research Center, reported that «…herbal ephedrine/caffeine (EC stack) herbal supplements, when used as directed by healthy overweight men and women in combination with healthy diet and exercise habits, may be beneficial for weight reduction without significantly increased risk of adverse events.»
The Cantox study confirmed that «there is no association between serious adverse events and ephedra when consumed as directed».

Disturbing, isn’t it? There is more: without studies which would support a case against Ephedrine, the FDA based a case on Adverse Event Reports (AER) collected over a three-year period, claiming to have over 800 reports showing the dangers of Ephedra – but after a closer look by the General Accounting Office (GAO) evidence has been made that the FDA was basing it’s case on only 13 reports, moreover some of these 13 were highly suspect.

Ephedrine's ban by FDA divide Congress The FDA has been severely criticized by the GAO as well as by members of Congress, for instance Senator Tom Harkin:
«The major finding of this report that the scientific basis upon which the FDA acted is clearly inadequate is quite disturbing. American consumers count on the FDA to provide them with recommendations based on careful, scientifically sound analysis. To base a recommended dosage level on 13 adverse events is highly questionable. More troubling, however, is GAO’s finding that FDA did not even determine that these adverse events were caused by the ingestion of dietary supplements containing Ephedra. In fact, GAO found that many of the adverse events were clearly not related to the taking of Ephedra supplements. For example, of the 13 reports, three contain physician reports that stated that the cause of the person’s adverse event was not related to their taking a dietary supplement. Also, three individuals reporting adverse events had experienced similar problems prior to or well after taking the supplement».

Pharmaceutical lobby protects their financial interestsAnother argument that ephedrine defenders use a lot is the suspicious constant effort of the FDA to limit sales of ephedrine based on safety reasons, when other over-the-counter products such as Non-Steroidal Anti-Inflammatory Drugs (NSAID’s) including popular products such as aspirin and ibuprofen, appear to have caused 16500 deaths in 1999, and yet the FDA has taken no action and probably never will. To the detractors’ point of vue it is obvious that the motives of the FDA in repeated attempts to limit the sales of Ephedrine based products have nothing to do with safety.

What would then be these motives? According to ephedrine supporters, it has to do with the lobbying and economical power of the pharmaceutical companies linked to private interests of medical doctors, the end goal being to protect their market share in the huge weight loss market, by eliminating a serious competitor based on a natural product which cannot be patented, and instead by establishing their own protected brands.
Of course these are only assumptions by companies having financial interests being hit by the FDA’s decision. They do not represent the views or opinions of the authors. The other common explanation has to do with drugs control, as ephedrine could be easily reduced to methamphetamine and thus justifies limitation on sold quantities per person and ID verification in the US.

What is the current status?

  • Canada: ephedrine is legally sold – over the counter – as a oral nasal decongestant in 8 mg pills.
  • USA: ephedrine is legal in many applications outside of dietary supplements: « Ban on ephedrine alkaloids that are marketed for reasons other than asthma, colds, allergies, other disease, or traditional Asian use » 4. In that case purchasing is limited and monitored, with differences from state to state. Má Huáng as herb is containing ephedrine but is still sold legally, it is only prohibited by law to sell ephedrine as dietary supplement (pills).
  • UK: ephedrine is not a Controlled Drug under the Misuse of Drugs Act, it is classified as « P medicine » meaning that it does not require a prescription but has to be sold under the supervision of a pharmacist.

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Where can you get real ephedrine?

Based on this information, many informed people are questioning the ban of ephedrine based products with regard to the benefits they could have within controlled short term dietary programs and they ask us frequently where to buy ephedrine, online or not.
Our first recommendation is to consult a doctor first, in order to have a clear statement about their health condition and then to envisage a long term weight loss program based on nutrition and exercise, which would produce durable effects (see our page about weight loss).
Then if the decision of buying ephedrine online is made, under own responsibility, it has to be an informed decision knowing the real risks and opportunities of ephedrine.
In fact the risk is quite high to buy fake products without good advice, that’s why we did a review of most online shops selling real ephedrine – you would need days if you wanted to search the web on your own and you wouldn’t know which seller is reliable and which is not – we know it because our review takes into account the feedback of our readers, in order to separate the wheat from the chaff and to provide safe hints to potential buyers only interested in legal products.

Join us now!

You will receive a detailed plan of our “Road To Success” for durable weight loss, as it worked for us and will work for you if you stick to the road-map. It is based on our own experience and you will not find it elsewhere on the web. Maybe you could have a look at the page About us where we say who we are and what are our motivations and projects. Just drop us a mail by completing the following form and we will keep you informed when there is something new, interesting about ephedrine. We have many things we would like to share with you: our selection of the best products with real ephedrine, information about ephedrine that we won’t publish for obvious reasons, “gossip news” etc.

By Mike Budd

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