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FDA GRAS for birch and sarsaparilla needed


jessicajlemmon

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Evening,

 

I've got a fun one going on this formula. I have a formula that uses birch and sarsaparilla in a syrup that I submitted to blend with a vodka. We also make a 100% cane spirit and I wanted to get the same formula approved for use with that spirit, to allow flexibility. Well, they approved formula #1 after some tweaks. I copied that formula, and resubmitted it with the spirit types switched out. Now they want the GRAS for the birch and sars.... which I cannot find for love or money. I've emailed the FDA for help as well as the herbal suppliers but as of yet haven't had any success.

Does anyone have a stash of the paperwork for either of those ingredients or advice as how to skin the cat? I don't want to get my other recipe revoked by pointing out they already approved it once...

 

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Did you submit with the latin name? Always submit with the latin name. If you did, at least for Sarsaparilla (Smilax aristolochiaefolia Mill.) it's on the FDA Gras list. If you give the common name, they don't really know what it is or what part of the plant or species. 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=172.510

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  • 1 year later...
On 7/26/2017 at 9:36 AM, jessicajlemmon said:

Aha! I did not use latin, so that makes sense, and that's the database I've been looking for and can never find! Thank you!

Hi Jessica, did you ever get a GRAS reference for Birch?  I had an approved formula that included Birch revoked when I filed a cola for the formula.

I see Birch Tar Oil (yikes) is listed as GRAS on the FDA site, but I can't find regular old birch.

Any help would be much appreciated. Thanks!

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That's great to hear!  If you could provide any insight on what you needed to show, that would be great.  I have a call with the examiner scheduled for Monday, and having a few extra arrows in my quiver would be very helpful.

I did used the common name.  Which latin name did you use; Betula Pendula?  Betula Lenta?

Thanks ever so much!

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Well, I try to source botanicals that include the latin name on them because there can be differences in varieties that would change the flavor of the recipes (not to mention products not being legit). Monterey Bay or Mountain Rose Herbs tend to have pretty good background to what they provide. I usually start there because I know it's a source I can buy from easily. I just pull up what I'm looking for on their site and go from there. 

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