IA#45-06, REVISED 2/2/96, ATTACHMENT REVISED 12/19/95
SUBJECT : "AUTOMATIC DETENTION OF STEVIA LEAVES, EXTRACT OF
STEVIA LEAVES, AND FOOD CONTAINING STEVIA"
NOTE : This alert has been revised to incorporate analytical
methodology. Changes are bracketed by asterisks
(***).
TYPE OF ALERT : Automatic Detention
(Note: This import alert contains guidance to FDA
field personnel only. It does not establish any
requirements or obligations on FDA or on regulated
entities.)
PRODUCT : Stevia> leaves, stevioside (extract of stevia leaves),
foods containing stevia, unless explicitly labeled as
a dietary supplement or for use as a dietary
ingredient of a dietary supplement.
PRODUCT CODE : 45T[][]99
All food product codes where the leaves or stevioside
are present as an ingredient (except for dietary
supplements).
PROBLEM : Unsafe food additive
PAC : 09006A
COUNTRY : See attachment
MANUFACTURER/
SHIPPER : See attachment
MANUFACTURER/
SHIPPER
I.D.# : N/A
IMPORTERS
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to
contain a food additive which is unsafe within the
meaning of Section 409, namely stevia leaves or the
extract thereof (stevioside) [Adulteration, Section
402(a)(2)(c)]."
RECOMMENDING
OFFICE : DAL-DO (HFR-SW140);
CFSAN/Office of Special Nutritionals/Regulatory
Branch, (HFS-456);
CFSAN/Office of Field Programs/Import Programs Branch,
(HFS-637)
REASON FOR
ALERT : <Stevia> leaves are a native product in Brazil and
Paraguay. The extract, stevioside, has reportedly been
approved for use in foods in Brazil and Japan. The
product is used in these countries as a table-top
sweetener in virtually all food commodities and as a
flavor enhancer in such products as teas. Stevioside
is reportedly 250-300 times sweeter than sugar and
contributes no calories to the diet.
With regard to its use in foods, stevia is not an
approved food additive nor affirmed as GRAS in the
United States. Available toxicological information on
stevia is inadequate to demonstrate its safety as a
food additive or to affirm its status as GRAS.
However, with regard to its use in dietary
supplements, dietary ingredients, including stevia,
are not subject to food additive regulations.
<Stevia> leaves and stevioside have been offered for
entry both in bulk and in finished products. Examples
of products detained because of stevia include teas,
drinks, seafood, fruits, vegetables, and candies. FDA
analysis performed by Dallas district found diet teas
to consist of up to six percent of stevioside.
GUIDANCE : Districts may detain without physical examination all
products identified on the attachment to this alert.
If review of the labeling or import paperwork reveals
stevia leaves, stevioside, or products containing
stevioside, districts may detain these items without
physical examination, unless explicitly labeled as a
dietary supplement, or for use solely as a dietary
ingredient in the manufacture of a dietary supplement
product.
If stevia is to be used in a dietary supplement for a
technical effect, such as use as a sweetener or
flavoring agent, and is labeled as such, it is
considered an unsafe food additive. However, in the
absence of labeling specifying that stevia is being or
will be used for a technical effect, use of stevia as
a dietary ingredient in a dietary supplement is not
subject to the food additive provisions of the FD&C
Act.
If districts determine through analysis that a product
contains stevia leaves or stevioside, recommendations
for automatic detention should be forwarded to DIOP,
HFC-170, with the analytical package unless the
product is explicitly labeled as a dietary supplement
or for use solely as a dietary ingredient in the
manufacture of a dietary supplement product.
In FY'95, there have been several shipments of pickled
radishes from Japan detained because of presence of
stevioside. Also, in recent years stevia has been
found in many seafood products from Japan. Districts
should consider sampling these products for the
presence of stevioside if its presence cannot be
determined from the label.
<Stevia> leaves/stevioside may be under study in the
United States in research settings as a basis for
establishing toxicological information for future food
additive petitions. As stevia leaves/stevioside are
not available in the United States, imported shipments
of stevia leaves/stevioside may be considered for
release when documentation exists to demonstrate that
the pending destination and use of the product is for
research purposes.
***The Division of Field Science recommends that
district laboratories utilize the method published in
the Journal of Chromatography, 474 (1989), p. 447-451,
"Simultaneous Determination of Stevioside,
Rebaudioside A and C and Dulcoside A on Foods by
High-Performance Liquid Chromatography."
A laboratory must assure that recommended
methodologies are reliable and accurate by utilizing
appropriate validation procedures. Reference to any
commercial materials, equipment, or processes does not
in any way constitute approval, endorsement, or
recommendation by FDA.***
For questions or issues concerning science, science
policy, sample collection, analysis, preparation, or
analytical methodology, contact the Division of Field
Science at (301) 443-3320 or 3007.
PRIORITIZATION
GUIDANCE : II
FOI : No purging required.
KEYWORDS : <Stevia, stevioside, sweetener, flavor enhancer, unsafe
food additive
DATE LOADED
INTO FIARS : February 2, 1996
ATTACHMENT TO IMPORT ALERT #45-06 REVISED 12/19/95
SPECIFIC FIRMS AND PRODUCTS IDENTIFIED FOR AUTOMATIC DETENTION
JAPAN (JP, 490)
FIRM: PRODUCT: AUTO DET: PRODUCT CODE:
Kuroda Shokuhin Pickled Radish 9/18/95 25J[][]26
Co., Inc.
Kobe City, Hyogo, Japan
MID# JPKURSHO1511KOB
Nozaki Tsukemono Co., Ltd Salted Radish 12/19/95 25J[]P26
95 Takaasu-Cho 25J[]P27
Miyazaki, Japan
MID# JPNOZTSU95MIY
FEI# 1000339196
Shinshin Shokuryo Kogyo Salted Radish 12/19/95 25J[]P26
Co., Ltd. 25J[]P27
3-38 Kanda
Chiyoda-Ku, Tokyo, Japan
MID# JPSHISHO338TOK
FIE# 1000152843