| Comment Record |
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Commentor |
Ms. Dorena Rode |
Date/Time |
2003-03-25 14:06:23 |
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Organization |
UCDavis |
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Category |
Academic |
| Comments for FDA General |
| Questions |
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1. General Comments
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The intent of the proposed rule should be to limit consumer risk when consuming concentrated ephedrine alkaloids. I believe that products that contain crude herbs only should be exempt. Alternatively, products that fall below an action level (maybe <3 mg/daily dose) of ephedrine alkaloids should be exempt. I am particularily concerned with Sida cordifolia products that contain small amounts of the herb in conjunction with other herbs and are used to support healthy circulation (verified with clinical trials -one currently in process at Univeristy of California San Francisco for its effect on peripheral artery disease) A warning as proposed on such a product would be misleading and could harm the public by leading them away from a herbal blend which might actually be beneficial.
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