Division of Dietary SupplementPrograms (HFS-822) Office of Nutritionat Products, l$betingand Dietary Soppfements Center for Food Safety and Applied Nutdtion Food and Drug Administration Harvey W. Wiley Federal building Room 4DO22 5100 Paint Branch Parkway College Park, MD 20740-3835
Monday, 19 September 2005
Dear Sir or Madam, Enclosed, please find our preemarketNotiication for our new Dietary Ingredient,Exfracf of Garcinia Cambogi9, (-) - Hydmxycitric Acid, specifically C&in K 5 bySabtnsa Corporation, pursuant to 21 C.F.R. $190.6. The notification-forwardsevide-riceof safety establishingthat the distal hg used under the conditions re~rne~~d in the labelling of the dietsrtys~ppl~e~t, will reasonably be expected to be safe by providing the Food and Drug Admi~~ration with information, including citation$to, and ‘ copiesof, pu~~sh~ articles, which a which the manufacturer has concludedthat the dietary supplement containi ingredient will reasonably be expected to be safe. See generally 21 USC. 9 350b(a)(2).
SHANNON MINERALS LTD.
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We would also like to point out that for commercial reasons we do not intend m-submitting an application for a synthetic ve@ionof {+HCA. We have attached an executive summary regardingour parent company a&the reasons for the application; we trust that this will provide youwith some bac~~Qu~~rnfo~~on on our market strategy. Please note our contact details below for any communicationwith your office: Mr. David fourville Shannon Minerals Inc. 26 Washington Street 3rd Floor, Monistown NJ 07960 Tel: +I 973-2679-980 Fax: +I 973-2676-981 Email: david@broderiektourvitle.com An original and two copies of the n~~~ion Yours sincerely, are submitted.
SHAFJNON MINERALS LTD.
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