U.S.
Department of Health and Human Services
James T.
Tanner, Ph.D.
Executive
Vice President of Science
Food Research,
Inc.
328 N. College Street
Harrodsburg, KY 40330
Dear Dr.
Tanner:
This responds
to your inquiry of November 8, 2000, requesting our comments on the
product CitroBio. In the letter, you indicate that your client, CitroBio,
Inc (bearing the same name as the product) has authorized you to reformulate
and resubmit the information concerning this product to FDA. You describe
the manufacturing process of CitroBio and its intended use. You state
that because all of the ingredients in CitroBio are generally recognized
as safe (GRAS), the product itself is GRAS.
Based
on the information you provided, CitroBio is a diluted aqueous solution
of the filtrate of a homogeneous mixture deriving from whole oranges,
glycerin, citric acid and alpha-tocopherol. During the manufacturing
of CitroBio, only low heat is applied to the mechanically compressed
oranges, which is then followed by addition of the other three ingredients
under a specific order and specific conditions. CitroBio is intended
for use as an antimicrobial for washing fruits, vegetables and seafood.
GRAS status
in general refers to food ingredients, rather than to food products.
A food product is considered legal if all of its ingredients are GRAS
or approved food additives. Because all of the ingredients that make
up CitroBio are GRAS, the product CitroBio made in the manner as described
in your letter would be legal under the current FDA regulations for
its intended use, provided that the product is effective as an antimicrobial
for such use.
If you
have any further questions concerning this matter, please do not hesitate
to contact us.
Sincerely,
/LJL/Lawrence
J. Lin, Ph.D.
Division of Petition Control, HFS-215
200 C Street, S.W.
Center
for Food Safety and Applied Nutrition
|
CitroBio, Inc.
7614-15th Street East Sarasota FL 34243
1.800.332.1647
Citribio uses FDA/GRAS approved ingredients! |
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