FAQ / Is Ephedra bad?

Ephedra sinica, also known as ma huang, is the plant most commonly used as a source of Ephedra products. Ma huang is a popular dietary supplement in the United States and has been used for thousands of years in Chinese medicine. Ephedra includes "ephedrine alkaloids," which are naturally occurring compounds that are found in plants.

Ephedra dietary supplements generally contain standardized extracts that have 6 to 8 percent ephedrine alkaloids. Manufacturers are required by law to declare the amount of ephedrine alkaloids in each serving.

There is a difference between ephedrine alkaloids and synthetic ephedrine. Ephedrine is only one of the naturally occurring alkaloids present in Ephedra extracts. Other alkaloids include pseudoephedrine (which is less potent than ephedrine) and alkaloids that slow the absorption of ephedrine from the digestive tract and/or counteract the stimulant effects of the ephedrine in the extracts. However, synthetic ephedrine, which is used in a number of common cold remedies, is not a naturally occurring substance. Synthetic ephedrine can be easily identified on the label of these cold products as "ephedrine hydrocloride."

The majority of Ephedra products contain naturally occurring ephedrine alkaloids. Industry standards and some state laws prohibit the use of synthetic ephedrine in Ephedra dietary supplement products. If a product contains synthetic ephedrine, the EEC recommends that you not purchase the product.

Industry Recommendations

Ephedra Is Safe When Taken As Directed

Experts who have reviewed all of the available historical and clinical data agree: You can take Ephedra safely if you stick to the serving limits and follow the warnings and precautions adopted by the Industry.

Do not take more than 25 mg ephedrine alkaloids per serving and not more than 100 mg per day. Consult a health care professional before consuming an Ephedra-containing dietary supplement if you have heart disease, thyroid disease, diabetes, high blood pressure, depression or other psychiatric condition, glaucoma, difficulty in urinating, prostate enlargement, or seizure disorder, if you are using a monoamine oxidase inhibitor (MAoI) or any other prescription drug, or you are using an over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine (ingredients found in certain allergy, asthma, cough/cold and weight control products).

Do not use Ephedra products if you are under the age of 18. Do not use Ephedra products if you are pregnant or nursing. Discontinue use and call a health care professional immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of breath, or other similar symptoms. Exceeding recommended serving will not improve results and may result in serious adverse health effects.

Although many Ephedra product manufacturers follow the industry recommendation, not all do, so check the label of your Ephedra product to make sure it bears the recommended serving limits and warnings. If information and warnings comparable to those listed in the trade recommendation are not included on the label, then the EEC recommends that you do not purchase the product. It is very important that you read products labels, warnings and cautions, and follow the directions. Ephedra is not for everyone and must be used responsibly.

WASHINGTON (October 10, 2002) - On October 8, 2002, the U.S. Department of Health and Human Services (HHS) requested the strongest possible warning labels and good manufacturing practices regulations for Ephedra dietary supplement products. In response, Wes Siegner, general counsel to the Ephedra Education Council, today issued the following statement:

"The HHS announcement on warning labels and good manufacturing practices regulations (GMPs) is welcomed. Responsible industry members recognize and agree that these measures, and in particular GMPs, are long overdue. We are one of the few industries that has urged the federal government for stronger regulations and enforcement of existing requirements. Consumer safety is a top priority for us, and having appropriate regulations, and enforcement of those regulations, will promote consumer confidence in the safety and benefits of Ephedra dietary supplements and other natural supplements as well.

"For many years, the responsible manufacturers and distributors of Ephedra dietary supplements have fought for uniformity within the industry. However, in the absence of federal government action, those industry members adopted national standards for warning labels and serving limits, supported state laws codifying these standards and worked hard to implement industry-wide GMPs.

"The industry also welcomes FDA's aggressive enforcement of the 1994 Dietary Supplement Health and Education Act (DSHEA) against rogue Ephedra products that are marketed for improper or illicit purposes and that target minors, such as Yellow Jackets. Our industry's national standards prohibit such activity and also warn against use of Ephedra products to minors."

There are several problem areas in the way ephedra "reactions" are reported to the FDA. No. 1, causality not established. There is no analysis of possible causal relationships between products and adverse reactions for dietary supplements. The FDA does not followup to make sure that an adverse event is actually caused by a dietary supplement.

Ironically, this is done for veterinary drugs. For instance, if a dog takes a medicine and a dog has a heart attack and dies, the FDA evaluates this report to see if the death was related to the drug or not. Because they followed up on the veterinary reports, the FDA was able to determine that in 1997, of 3,000 adverse event reports to the center for veterinary medicine, only 1 percent were definitely associated with a product, 31 percent were probably associated, 45 percent possibly were associated, 12 percent were definitely not related to the product, and 11 percent lacked adequate information to determine association.

With people and dietary supplements events, the FDA has not done this analysis. They cannot provide this type of information. If the FDA does this for animals, why not for people? On the FDA website, two deaths are attributed to ephedra, 15 to ephedrine, and 12 to ma huang.

I have further information on two such cases. This case states that one death attributed to ephedra was actually attributable to hypothermia, the other is the death of a woman who had been using an ephedra supplement. She died after driving her automobile the wrong way on a one-way street and struck a pole going 90 miles an hour. Her blood alcohol limit was .212, more than twice the legally intoxicated limit in most States. Are these two cases really ephedra deaths?

No. 2, no classification of seriousness of event. The website lists over 2,000 adverse events, but there is no evaluation of whether these are mild events, moderate events, or serious events. The impression the FDA gives, especially in the press, is that all of these events are serious events.

According to information provided to the committee by the FDA, of 600 events received, 60 percent were not serious events. Additionally, it is unclear on the website what actually should be reported.

The Ephedra Education Council (EEC) is supported primarily by members of the Ephedra Committee of the American Herbal Products Association, a recognized leader in promoting the safe and responsible marketing of dietary supplements. The Council provides factual information to the media and public about dietary supplements containing Ephedra. For more information, logon to www.EphedraFacts.com.

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