Consumer Information

Industry Recommendation

Serving Limits, Warnings and Precautions for Taking Ephedra Products

• 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

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Consumer Information on Ephedra

Dietary supplements containing ephedrine alkaloids are formulated to enhance energy and promote weight loss. Here are some of the things you might like to know about Ephedra and Ephedra products.

Ephedra Is An Herb

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.

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.

Industry adopted these standards as a recommendation for distributors, marketers and consumers of dietary supplement products containing ephedrine alkaloids. A panel of experts from a variety of scientific and medical backgrounds endorsed the standards that the trade recommendation established. In addition, several states, including Ohio, Michigan, Nebraska, Texas, Oklahoma, Hawaii, and Washington have adopted portions of these standards as state law.


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.

Science Supports The Safety And Effectiveness Of Ephedra

Scientific studies confirm that Ephedra products are safe when used as part of an overall weight-loss program. In particular, a six-month study by researchers at Harvard and Columbia Universities on Ephedra/caffeine products concluded that the products were safe and produced significant weight loss. Nevertheless, critics of Ephedra often cite Adverse Event Reports (AERs), which are anecdotal reports compiled by the Food and Drug Administration, as cause for concern. However, even the critics agree that AERs are not reliable. The same medical and scientific experts that supported AHPA's trade recommendation have also reviewed the AERs. The panel of experts concluded that the AERs do not provide sufficient evidence to link significant adverse events to Ephedra. The General Accounting Office investigators reached the same conclusion in its report to Congress.

AERs Do Not Negate The Science Supporting Safety And Efficacy Of Ephedra

An AER is a report made to FDA by a consumer or health care professional. These reports contain information of widely varying degrees of quality concerning adverse events that may be related to the ingestion of a product. While widely reported as a basis for concern, FDA itself admits that these reports are subjective, do not represent scientific data, cannot be used as a basis for scientific regulation, and ordinarily cannot be used to determine if the adverse event was caused by the product in question.

FDA's longstanding practice is to use AERs as a signal to consult the available data on a product to determine if the reported events are consistent with the data. Without such consultation, an AER has no scientific significance. Industry's principal objection to FDA's statements and ensuing public debate is that it has been based entirely on the scientifically invalid AERs and not on scientific data.

A relatively small number of ephedra AERs have been reported when one considers how widely consumed the product is in the United States.  In spite of the proportionally small number of reports, the EEC has been a strong advocate for the U.S. Department of Health and Human Services, the National Institutes of Health and its Office of Dietary Supplements to study all the available scientific data on Ephedra in order to evaluate whether the AERs collected by FDA provide any cause for concern.

Ephedra Is Useful

The ephedrine alkaloids in Ephedra act as a mild stimulant, with effects similar to those of caffeine. Ephedra products can enhance energy and, when used in conjunction with a healthy diet, they can also lead to weight loss. 

  

Ephedra And Other Dietary Supplements Are Regulated By The Government

In 1994, the United States Congress passed the Dietary Supplement Health and Education Act (DSHEA), which amended the Federal Food, Drug, and Cosmetic Act (FDC Act). DSHEA gave the FDA substantial new policing authority to stop the distribution of unsafe dietary supplements. Widely repeated assertions that dietary supplements are unregulated are simply incorrect ‚ extensive requirements regulating product quality and product claims are in effect, and industry supports vigorous enforcement of these requirements.

Obesity – A National Epidemic

Obesity is one of our nation's foremost health problems and is directly link to numerous other diseases, including heart disease, hypertension and diabetes. In December 2001, the U.S. Surgeon General sounded the alarm, releasing a "Call to Action to Prevent and Decrease Overweight and Obesity." The Call to Action included some frightening obesity statistics:

• Nearly 40 million American adults are obese
  
• The national obesity average jumped from 12% in 1991 to 19.8% in 2000
  
• Some 300,000 Americans die from obesity-related diseases every year -- making obesity second only to smoking as a leading cause of premature death in the U.S.

Drs. Roland Sturm of Rand and Kenneth Wells of Rand also studied our national obesity epidemic and discovered that the health risks associated with obesity are greater than those associated with smoking, drinking or poverty. According to the study, the findings suggest that weight reduction should be an urgent public health priority.

By stimulating weight loss, Ephedra products can be a valuable weapon in the battle against excess weight , and as research shows, weight loss helps cut the risk of other health problems. 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.

You can determine whether or not Ephedra products can help you in your overall health program by first calculating your Body Mass Index (BMI). BMI is a tested method to determine if you should be concerned about your weight. Of course, you should contact your physician or other health care professional to obtain specific information and advice concerning your weight and health.