HHS NEWS

U.S. Department of Health and Human Services
Food and Drug Administration

Arthur Whitmore: (202) 205-4144

Consumer Hotline: (301) 532-4440

P97-15

June 2, 1997

The Food and Drug Administration today proposed to reduce risks associated with dietary supplement products containing ephedrine alkaloids by limiting the amount of ephedrine alkaloids in products and requiring labeling and marketing measures that give adequate warning and information to consumers.

Ephedrine alkaloids are amphetamine-like compounds with potentially powerful stimulant effects on the nervous system and heart. Hundreds of consumer illnesses and injuries associated with the use of these products have been reported.

The proposal would not ban dietary supplements that contain ephedrine alkaloids.

"Consumers should be aware that just because a product is labeled 'natural' or from an herbal source it is not guaranteed to be safe," said Dr. Michael Friedman, Deputy Commissioner of Food and Drugs. "The effects of ephedrine alkaloids are potentially powerful ones. We urge people to talk to their doctors before using dietary supplements containing ephedrine alkaloids, and to always use them with caution."

Because ephedrine alkaloids are heart and nervous system stimulants, certain individuals including those with hypertension, heart conditions and neurologic disorders, should avoid their use. Pregnant women, too, should avoid the use of dietary supplements with ephedrine alkaloids.

The proposal would prohibit the marketing of dietary supplements containing 8 milligrams or more of ephedrine alkaloids per serving. Labeling that recommends or suggests conditions of use that would result in an intake of 8 mg or more in a 6-hour period or a total daily intake of 24 mg or more also would not be allowed.

In addition, the proposal would require label statements instructing consumers not to use the product for more than 7 days, and would not allow label claims for uses for which long-term intake would be necessary to achieve the purported effect. These safety measures are based on the fact that long-term intake of ephedrine alkaloids increases the likelihood of serious adverse events.

Another measure in the proposal would apply to products with claims that encourage short-term excessive intake to enhance the claimed effect, such as energy enhancement. Such products would be required to bear a labeling statement that "Taking more than the recommended serving may result in heart attack, stroke, seizure or death."

The proposal also would prohibit the use of other stimulant ingredients such as botanical sources of caffeine with ephedrine alkaloids because the combination increases the stimulant effects of ephedrine alkaloids and the chance of consumer injury.

Dietary supplement products containing ephedrine alkaloids are currently sold for a variety of purposes including weight loss, increased energy and body building.

Since 1994 the agency has received and investigated more than 800 reports of adverse events associated with the use of these products. Reported adverse events range from episodes of high blood pressure, irregularities in heart rate, insomnia, nervousness, tremors and headaches, to seizures, heart attacks, strokes and death. Most events occurred in young to middle aged, otherwise healthy adults using the products for weight control and increased energy.

Ephedrine alkaloids in dietary supplements are usually derived from one of several species of herbs of the genus Ephedra, sometimes called Ma huang, Chinese Ephedra and epitonin. Other botanical sources include Sida cordifolia.

The proposed measures were developed based on FDA's review of its adverse event reports, the scientific literature, and public comments reviewed by the agency, including comments generated by an October 1995 advisory working group public meeting and an August 1996 public meeting of FDA's Food Advisory Committee. These experts suggested a number of steps the agency might take to reduce injuries associated with use of dietary supplements containing ephedrine alkaloids.

FDA invites written comments on the proposal from the public and industry, which may be submitted to the Dockets Management Branch, HFA-305, Food and Drug Administration, 12410 Parklawn Drive, Room 1-23, Rockville, MD 20857. The closing date for comments is August 18, 1997.

Comments received to date and in response to the proposal are available for public examination in public docket No. 95N-0304 located in the Dockets Management Branch Office. All comments received will be reviewed and considered by the agency in developing the final rule.

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