GRAS Notice (GRN) No. 658 11111111111111111111 · PDF file GR 11111111111111111111 . ORIGINAL SUBMISSION ., ... which is Citrus X Paradisi

GRAS Notice (GRN) No. 658 http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/default.htm
GR 11111111111111111111
ORIGINAL SUBMISSION

.,
Notice to the US Food and Drug Administration that the use of Vancitrix, a glycerin Citrus
Extract, is Generally Recognized as Safe
GRN ODDb58 Submitted and Prepared by the Notifier: r----------,
(Pa~(C~~~~[)) Chemie Research & Manufacturing, Co., Inc. JUL 1 2016
OFFICE OF FOOI3> ADDITIVE SAFETY18 March 2015 (Original subm ission)
07 June 2016 (Revised submission)
THOMAS WRIGHT

Table of Contents
GRAS Exemption Claim 2
Name and Address of Notifier 2
Common or Usual Name 2
Conditions of Use 2
Basis for GRAS Determination 3
Data I Information Availability Statement 3
Characterization 3
Chemical Composition 4
Organic Certification 4
Manufacturing and Production 5
Company Overview 5
Raw Materials 5
Manufacturing 5
Specifications and Batch Analysis 7
Specifications and Quality Control 7
Ascorbic acid, Citric acid, Naringin and other Flavonoids 8
Screening for Pesticides I Bactericides 9
Heavy Metal Analysis 9
Minimum Inhibitory Concentration (MIC) 10
Microbial Assay (USP-51) 11
History of Consumption 12
Production 12
Safety Assessment 13
Toxicological Studies 13
Drug Interactions 13
Current Regulatory Status 14
Regulatory Status of Citrus Fruit 14
Regulatory Status of Additional Vancitrix
Components 14
Intended Use 14
Estimated Daily Intake (EDI) 15
General Recognition I Basis for GRAS Determination 16
References 17
1

..
GRAS Exemption Claim
Chemie Research & Manufacturing, Co., Inc. (the notifier) has determined that Vancitrix grapefruit
extract, hereafter referred to as Vancitrix, is Generally Recognized as Safe (GRAS) for its intended use,
consistent with section 201 (s) of the Federal Food, Drug and Cosmetic Act. The determination has been
made based on experience of common use in food as well as scientific procedures, and therefore the
use of Vancitrix grapefruit extract, for its intended purpose is exempt from the requirement of pre
(b) (6):f- JvN. - zotk
Thomas R. Wright Date
Chemist, Chemie Research & Manufacturing. Co., Inc.
Name and Address of Notifier
Thomas R. Wright
Chemie Research & Manufacturing. Co., Inc.
160 Concord Drive
Casselberry, FL. 32707
USA
Common or Usual Name
Vancitrix is an organic glycerin extract from organic Citrus X paradisi.
Conditions of Use
Vancitrix is intended for use as an ingredient at a concentration of up to 125mls I L (V/V) I serving in all food categories including beverages and dietary supplements, where standards of identity allow,
except that it is not intended for use in infant formula or in food products that are regulated by the
United States Department of Agriculture (USDA). Vancitrix is intended to be used as a supplemental I additive source for ascorbic acid and citric acid primarily, with additional antimicrobial I antioxidant benefits in some food products (see microbial assay, page 11). As a food additive, Vancitrix would fall
under two types of ingredient classifications. The first being as a preservative where ingredients include;
ascorbic acid and citric acid. Additional preservative qualities are derived from antioxidant benefits from
ascorbic acid, citric acid, naringin and other bioflavonoids. The second type of ingredient is as a nutrient
based on the additional vitamin C. The purpose of adding Vancitrix to food would be:
1. To Maintain or improve safety and freshness- one example of preservatives are antioxidants.
2. To improve or maintain nutritional value- this would be an example of how ascorbic acid and
citric acid could be used as a nutritional supplement.
2

Basis for GRAS Determination
Experience based on common use in food of all ingredients that compose Vancitrix, as well as
scientific procedures are the basis for this GRAS determination. Please see current regulatory status on
page 14 for more details.
Data /Information Availability Statement
The data and the information that serve as the basis for this GRAS determination will be available for
review and copying at reasonable times at the office of Chemie Research & Manufacturing, Co., Inc. 160 Concord Drive, Casselberry, FL. 32707 or will be sent to FDA upon request.
Characterization
Vancitrix is formulated based on a glycerin extract of organic grapefruit which is Chemie Research and
Manufacturing, Co., Inc.'s certified organic proprietary glycerin grapefruit extract. The grapefruit extract
is prepared from organic grapefruit grown and harvested in Florida, USA. One GRAS citrus species is
used in the manufacturing of Vancitrix, which is Citrus X Paradisi.
21 CFR 101.44 states that grapefruit is among the 20 most frequently consumed raw fruits. Grapefruit,
specifically Citrus Paradisi Macf is listed in both: 21 CFR 182.20 Essential oils, oleoresins (solvent-free),
and natural extractives (including distillates) that are Generally Recognized As Safe for their intended
use, within the meaning of section 409 of the Act. 21 CFR 582.20 Essential oils, oleoresins (solvent-free),
and natural extractives (including distillates) that are generally recognized as safe for their intended use,
within the meaning of section 409 of the Act.
As will be further discussed, Vancitrix consists of organic certified vegetable sourced glycerin (palm
free), grapefruit extract (glycerin extract using organic certified vegetable sourced glycerin and organic
certified grapefruit, Citrus X Paradisi), non-organic ascorbic acid, non-organic lactic acid, non-organic
naringin and non-organic citric acid.
The organic grapefruit are harvested and juiced at a local organic certified grower in Central Florida. The
peel, rind, rag and seeds are then moved to another facility, which is also organic certified, for drying.
These dried remnants are then added to organic vegetable glycerin as heat and pressure are applied to
create the extract. The resulting extract is added to more organic vegetable glycerin along with ascorbic
acid, lactic acid, naringin and citric acid. All of these ingredients are food grade and non-GMO. The
product is tested on a per batch basis through a well-established quality control program to confirm the
product's physical and chemical characterization. Certificates of analysis are available upon request
detailing instrumentation used as well as value ranges.
Consumption of citrus fruits is known to be beneficial to human health (Baghurst 2003; Mclndoo, 2012).
The polyphenolic components of citrus fruits have been linked to various health promoting properties.
Citrus fruits are high in antioxidants, such as vitamin C and flavonoids, which provide protection against
harmful free radical species and oxidative stress (Jayaprakasha et al. 2008). 1
3

Chemical Composition
Vancitrix is a water soluble, proprietary glycerin grapefruit extract prepared from locally grown
organic grapefruit. The product is a non-volatile, non-flammable, non-toxic transparent liquid with a
Gardner color range of 8 -12. The specific gravity range is 1.10-1.35 g/ml, and a pH range of 1.5- 3.5.
Approximately 2.65% ascorbic acid is added to the final product. Additional ascorbic acid that is
determined via Metro Ohm Easy Ox DPI titration is attributed to ascorbic acid added as per the
formulation and in the grapefruit extract itself. Active bioflavonoids that are prevalent in the grapefruit
extract are naringin and narirutin.
Organic Certification
The extract used to make Vancitrix is certified through Quality Certification Services under the US
National Organic Program 7 CFR Part 205. QCS Entity ID: 1783P. All ingredients used to include those
that are not certified organic are non-GMO and food grade. GMP is adhered to in all stages of production.
Certified Products
Organic
Product 10 Mark Date Added Compliance DF-100 Organic Grapefruit Extract-Liquid
Chemie Research & Manufacturing Co., Inc.
3/10/14 NOP
DF-100 Organic Grapefruit Extract-Liquid
3/10/14 Japan Export Arrangement
3/10/14 Taiwan Export Arrangement
3/10/14 US-Canada Equivalency
3/10/14 US-EU Equivalency
P-50 Organic Grapefruit Extract-Liquid
3/10/14 NOP
3/10/14 Japan Export Arrangement
3/10/14 Taiwan Export Arrangement
P-50 Organic Grapefruit Extract -Liquid
3/10/14 US-Canada Equivalency
Chemi

Documents

GRAS Notice (GRN) No. 658 11111111111111111111 · PDF file GR 11111111111111111111 . ORIGINAL SUBMISSION ., ... which is Citrus X Paradisi