FDA Should not set stricter limits on Ephedrine
Than it has on Synthetic Ephedrine

Food and Drug Administration
12410 Park lawn Drive, Room 1-23
Rockville, MD 20857
Attn: Dockets Management Branch, HFA-305
(Fax: 301-594-3215 or 202-260-8957)
RE: [Docket No. 95N-0304]

Dear Gentle persons:

I respectfully request you withdraw this entire proposed rule. I am strongly opposed to FDA's June 2, 1997 proposal which would mandate an unreasonably low limit of 8 milligrams per serving, in a 6 hour period, with a total daily intake of 24 mg. of natural ephedrine. It would also mandate label statements instructing consumers NOT to use the product for more than 7 days.

FDA's Deputy Commissioner William Schultz said these limits "...would essentially prohibit any ephedrine supplement being sold as a weight loss product." (AP 5/2/97) FDA's proposed new limits for natural ephedrine dietary supplement is far below the 25 mg. per dose and maximum daily intake of 150 mg. which FDA has reasonably allowed for decades on synthetic ephedrine drug products.

BOTH the natural and synthetic sources of ephedrine are Safe When Used As Directed (SWUAD) up to the 25/150 mg. levels. However the natural herbal source is safer than the synthetic. It does not make sense to set a maximum 24 mg. daily limit for the safer herbal source of ephedrine which is more that six (6) times lower than the 150 mg. maximum daily level FDA has set for the less safe synthetic source.

The Readers Digest Family Guide to Natural Medicine says: "For thousands of years, practitioners of Chinese medicine have relied on Ma Huang tea to treat asthma, flu, and even arthritis." Two decades ago Danish investigators found it was effective in weight loss. Since then, millions of consumers have safely used Ephedra/Ma Huang to lose weight and help keep it off. Please Withdraw This Proposal or Grant a 6 Month Extension.

Sincerely Yours,

Prepared by Clinton Ray Miller, Health Freedom Legislative Advocate for the National Council For Improved Health (NCIH). Contact Miller: Box 77034, Washington, D.C. 20013; (202) 543-6441; or (704) 924-8615 (limit-1) (97-17)

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For help with a relative legislative project or consultation, Mr. Miller can be reached at:
Miller, Clinton Ray
Health Freedom Legislative Advocate
Box 77034
Washington, D.C. 20013
202-543-6441 voice
202-543-7109 fax
704-924-8615 voice
704-924-8616 fax
cmiller@calcoast.com

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