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FDA Proposes Limits on Ephedrine Dietary Supplements (1997)

From Natural Healthline
By Michael Evers

The Food and Drug Administration on June 2 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.

According to the FDA, ephedrine alkaloids are amphetamine-like compounds with potentially powerful stimulant effects on the nervous system and heart. FDA claims more than 800 cases 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."

Rep. Henry Waxman (D-CA), the ranking Democrat on the House Government Reform and Oversight Committee, said he approved of the FDA's efforts to control ephedrine. "I think the [Dietary Supplement Health and Education Act] has hampered the FDA's ability to deal with dietary supplements, inadvertently placing a heavy burden on the agency to come up with research. When we first heard about the adverse reactions from ephedrine three years ago, FDA should have been able to act immediately." Waxman and his chief aide, Bill Schultz, led the opposition to DSHEA in the 103rd Congress. Schultz is now FDA Deputy Commissioner for Policy.

The FDA 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.

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.

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 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. The closing date for comments is August 18, 1997.

Comments should be submitted to:

Dockets Management Branch, HFA-305
Food and Drug Administration
2410 Parklawn Drive
Room 1-23
Rockville, MD 20857

For more information,

Federal Register: June 4, 1997 (Volume 62, Number 107)
Dietary Supplements Containing Ephedrine Alkaloids

 


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