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
"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
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
Rockville, MD 20857
For more information,
Federal Register: June 4, 1997 (Volume 62, Number 107)
Dietary Supplements Containing Ephedrine Alkaloids