HERB S ,,nI;(,I”‘ r.. --; -, .*I’ (’ -i J *-Mblufacturers 1 2
of Fresh Botanical Extracts
Division of Compliance and Enforcement/ONPLDS Center for Food Safety and Applied Nutrition Food and Drug Administration HFS-810 200 C Street, SW Washington, DC 20204 Dear Sir:
February 11,2002
This letter is to provide notification, within the prescribed 30 days of marketing, of a name change that Gaia Herbs is making to one product in our line that contains a structure function claim This product is a Liquid Phyto-Cap that is an herbal dietary supplement. I have attached a copy of the old and new label that contains the structure function claim as well as other information. The original name of the product, which was submitted with a group of 34 products in a letter dated February 6,2001, was as follows:
l
Ginkgo Gotu Kola ( Ultimate Support to Improve Memory)
It is being changed to:
l
Mental Alertness ( Ultimate Support to Improve Memory)
Please call at 828-883-5938 if you need addition information or if you have any questions.
‘ --/James A. Grant Regulatory Compliance Officer
ISudement
Facts
Ultimate
Support
to
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Improve Memory*
100% VEGEIARIAN
60 lIQlJIO-fIllED CAPIlJLfI
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1
I 40 mpt 40 mpt
26 mgt
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22 mot
Ultimate
1
Support
to
I
Improve Memory*
100% VEGEIARIAN 60 LIQUID-CILlfD CAPIUlfI