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FDA Proposed Ephedra Guidelines (1997)

From the friendly folks at the CSOM

The FDA has proposed safety measures for ephedrine dietary supplements. On June 2, 1997 the FDA proposed limiting the amount of ephedrine alkaloids in dietary supplements and requiring safety warnings on labels. It would also prohibit the use of ephedrine alkaloids with other botanical stimulants like caffeine. The proposal would limit marketing of dietary supplements with more then 8 milligrams of ephedrine alkaloids. It would also require labeling that would not result in doses of more then 24 mg in a day or more then 8 milligrams in one dose.

The FDA invites written comments on the proposal until august 18, 1997. It would be good for acupuncturists and acupuncture associations, to write the FDA and request that any restrictions on ephedra or Ma Huang take into consideration the fact that licensed acupuncturists use ephedra fortreating their patients and that allowances be made for this. All comments received will be reviewed and considered before developing the final rule.

You can write the FDA at
Dockets Management Branch,
HFA-305, Food and Drug Administration,
12410 Parklawn Dr.
Room 1-23
Rockville, MD 20857


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