Important Updates:
April 2005: An article posted in the online version of BLV Health Watch "In A Nutshell, The Recent Ephedra Lawsuit" will bring you up to date on the controversy surrounding the ban on ephedra products and supplements. Keep in mind, the ban is actually on ephedrine alkaloids, however all natural supplements were also pulled from the market. Not because of the ban, but owing to increased insurance rates for many supplement providers that would have made such supplement costs prohibitive. Interesting, don't you agree?

Dec. 2003: Since the original draft of this article on Best Liquid Vitamins we received the word in Dec. 2003 that the FDA plans to prohibit sales of dietary supplements containing Ephedra (Ma Huang). Click here for the full story.

The FDA's concerns about dietary supplements containing ephedra arise in part from ephedra's mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the nervous system and heart.

Ephedra is a naturally occurring substance derived from the Chinese herbal Ma Huang. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. While products containing natural ephedrine alkaloids have long been used to treat certain respiratory symptoms in traditional Chinese medicine, in recent years they been extensively promoted and used with the goals of aiding weight loss, enhancing sports performance, and increasing energy.

As early as 1994 the USA Federal Government has been publishing Medical Bulletins on the adverse effects that products containing ephedra can have.

The first online article - "Adverse Events with Ephedra and Other Botanical Dietary Supplements" - went into some details regarding negative reports received resulting from use of certain products.

Quote From The FDA Medical Bulletin - September 1994: "FDA has been receiving increasing numbers of reports recently of adverse events associated with the use of certain products marketed as dietary supplements for weight loss, energy, and ergogenic (performance-enhancing) and body-building purposes. These apparently diverse categories of products often contain a number of similar ingredients, including Ma huang (Ephedra sinica or Chinese ephedra, a botanical source of ephedrine, pseudoephedrine, and norpseudoephedrine), guarana or Kola nut (caffeine sources), white willow (salicin source), and chromium."

At that time reported reactions varied from the milder adverse effects known to be associated with sympathomimetic stimulants (e.g., nervousness, dizziness, tremor, alternations in blood pressure or heart rate, headache, gastrointestinal distress) to chest pain, myocardial infarction, hepatitis, stroke, seizures, psychosis, and death. The adverse reactions were reported both in young, otherwise healthy individuals and persons with confounding or complicating conditions such as hypertension. In addition, a stimulant "overdose" syndrome has been reported in children and teenagers who used these products.

Additional Sidenote: the Sept. 1994 Medical Bulletin went on to expand on other products which could present serious side effects. "Related weight-loss products often marketed as 'dieter's or slimming teas' contain a variety of strong botanical laxatives (Cassia species (senna), Cascara sagada (botanical name Rhamnus purshiana)) and diuretics. Adverse reactions that have been reported to FDA as associated with these products are characteristic of those seen in laxative abuse syndromes, and include severe electrolyte imbalances leading to cardiac arrhythmia and death."

As recently as Feb. 28, 2003 the FDA published "HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra" in which they reported "On the basis of new evidence in the medical literature and in adverse event reports, there are reasons for heightened concern that dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury."

"We want to caution all Americans - particularly athletes and those who engage in strenuous activities - about using dietary supplements that contain ephedra," said Secretary of Health and Human Services Tommy G. Thompson. "There continue to be serious questions about the risks surrounding this particular dietary supplement."

A recent study in the Annals of Internal Medicine, found that although ephedra-products make up less than one percent of all dietary supplement sales, these products account for 64 percent of adverse events associated with dietary supplements.

Another "case-control" study, published in the journal Neurology, concluded that the rate of hemorrhagic (bleeding) strokes among ephedra users was statistically significantly higher than among non-users, for people who take doses above 32 milligrams a day. (Many ephedra dietary supplement labels recommend that users take up to approximately 100 mg of ephedra daily.)

The FDA proposed a warning label for all ephedra-containing dietary supplements. The proposed label warns about the risks of serious adverse events, including heart attack, seizure, stroke, and death; cautions that the risk can increase with the dose, with strenuous exercise, and with other stimulants such as caffeine; specifies certain groups (such as women who are pregnant or breast feeding) who should never use these products; and lists other conditions, such as diseases and the use of certain medications, that rule out the use of ephedrine alkaloids.

As recently as July 1, 2003 the FTC previously brought four enforcement actions challenging deceptive safety and "no side effects" claims for ephedra supplements marketed for body-building and energy, and as alternatives to street drugs like Ecstasy.

So, given the facts above, you decide. Wouldn't you rather be ephedrine free?

Sources:

U. S. Food and Drug Administration/FDA Medical Bulletin - September 1994
"Adverse Events with Ephedra and Other Botanical Dietary Supplements"

FDA News Release PO3-13 - February 28, 2003
"HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra"

Federal Trade Commission (FTC) News Release July 01, 2003:
"FTC Charges Direct Marketers of Ephedra Weight Loss Products With Making Deceptive Efficacy and Safety Claims"

UPDATE - Federal Trade Commission (FTC) News Release December 30, 2003:
FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra