IA #21-04, 4/4/08, REVISION TO IMPORT ALERT #21-04 "DETENTION WITHOUT PHYSICAL
EXAMINATION AND INCREASED SURVEILLANCE OF DRIED FRUITS" Attachment A 9/8/08,
Attachment B - 9/12/08
***This revision provides additional guidance, updates the product codes, and
includes Alert formatting changes.***"
Alert language changes are bracketed by asterisks (***).
TYPE OF ALERT: Detention Without Physical Examination
(Note: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or products(s)
at issue. It does not create or confer any rights for or on any
person, and does not operate to bind FDA or the public).
PRODUCT: Dried Preserved Fruits
PRODUCT
CODE: ***20B[][][], 20H[][][], 20Q[][][]
21B[][][], 21H[][][]
22B[][][], 22H[][][]***
PROBLEM: Filth
Unsafe Color Additives
Labeling
Unsafe Food Additives
Cyclamates
Undeclared Saccharin
PAF: FIL (Filth)
FAD (Food Additives)
COL (Colors in Foods and Cosmetics)
LBL (Labeling)
PAC FOR
COLLECTION: 03819A, 09006A, 09006B
COUNTRY: See Attachments
MANUFACTURER/
SHIPPER
& FEI# : See Attachments
CHARGE: For Detention Without Physical Examination charge:
1. Insect and/or Rodent Filth:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to
contain insect and/or rodent filth [Adulteration,
402(a)(3)]."
2. Artificial Sweeteners
a) Undeclared Saccharin:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it fails to
declare the presence of saccharin as an added
ingredient [Misbranded 403(i)]."
3. Unsafe Food Additives
a) Cyclamates and/or Dulcin:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to
contain cyclamate and/or dulcin, an unsafe food
additive within the meaning of Section 409.
[Adulteration, 402(a)(2)(c)]"
4. Unsafe Color Additives:
"The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to
contain color additives which are unsafe within the
meaning of 721(a). [Adulteration, 402(c)]"
OASIS CHARGE
CODE: FILTHY
SACCHARLBL
CYCLAMATE
DULCIN
UNSAFE COL
RECOMMENDING
OFFICE: Division of Import Operations & Policy (HFC-170)
REASON FOR
ALERT: The history of detentions of dried preserved and/or sweetened
plums from Hong Kong between March 1 and September 1, 1986,
resulted in these products being detained without physical
examination due to the presence of insect and/or rodent filth and
non-nutritive sweeteners (saccharin and/or cyclamates).
During FY '87 ORA conducted an import targeting project for
preserved fruits. Samples of preserved, sweetened, dehydrated,
candied, dried or salted fruits from Southeast Asian countries
were collected. Analyses revealed non-permitted or undeclared
color additives and non-nutritive sweeteners, a problem that
appears to be pervasive in the industry.
Dried preserved fruits from TAIWAN were found to contain non-
nutritive sweeteners (saccharin and/or cyclamates, and one
contained dulcin) and unapproved and/or undeclared color additives
such as FD&C Yellow #5 (C.I. No. 19140 - tartrazine) FD&C Red #3
C.I. No. 45430 - Erythrosine), and Carmoisine (C.I. No. 14720 -
former ext. D&C Red #10).
Samples of dried, preserved fruit from HONG KONG and the PEOPLES
REPUBLIC OF CHINA were found to contain non-nutritive sweeteners,
insect and/or rodent filth, and/or undeclared or non-permitted
color additives.
In addition to the above, examination of data from PODS, Import
Detention System, and the import targeting project revealed
violative samples from Thailand, Japan, Korea, and the
Philippines; however, the number of violative samples was not
enough to detain these countries without physical examination.
THAILAND - Samples contained non-nutritive sweeteners
(cyclamates and/or saccharin), undeclared color additives (FD&C
Yellow #5 - Tartrazine (certifiable as FD&C Yellow No. 5), or
Sunset Yellow FCF (certifiable as FD&C Yellow No. 6), and insect
and/or rodent filth.
JAPAN - Samples contained unapproved color additives, undeclared
Tartrazine, and the non-nutritive sweetener saccharin).
KOREA - Undeclared Tartrazine and the non-nutritive sweetener
saccharin were found in one sample.
PHILIPPINES - Samples contained the unapproved color additive
Amaranth (C.I. No. 16185 - former FD&C Red #2) and undeclared
Sunset Yellow FCF.
Examples of types of dried preserved fruits which were found
violative include: papaya, kumquats, prunes, mixed fruits, sugar
palm fruit, sweet fruit, plum, mango, jujube fruit, mayom, lemon,
grapes, olives, and tamarind.
Dried fruit that has not been treated with preserving material
(i.e., sweeteners, salt) are not subject to detention under this
alert. These products should be treated in accordance with normal
import procedures.
Between August 1990 and January 1991, New York District collected
31 samples of various dried, preserved fruit products from two
manufacturers/shippers in Singapore. 7 of the 16 samples from Meng
Chong Foodstuffs PTE.LTD were found to contain cyclamates while 12
of the 15 samples from Kee Wee Hup Kee Manufacture PTE. LTD were
found to contain cyclamates. Additionally, nine of the samplesfrom
Kee Wee Hup Kee were found to contain undeclared saccharin.
GUIDANCE: ***Products other than dried and dried and preserved fruits should
be covered under the guidance of Import Alert 45-07 for undeclared
and/or non-permitted sweeteners.***
This alert is intended to apply only to fruits that are dried and
dried and preserved by adding sweeteners or salt.
Fruit that is treated by drying alone is not subject to detention
without physical examination under this alert and should be
handled in accordance with normal import procedures.
Districts may detain without physical examination shipments of
dried preserved fruits from HONG KONG, PEOPLES REPUBLIC OF CHINA
and TAIWAN except products from those ***manufacturers/***shippers
identified in Attachment B of this alert.
Districts may detain without physical examination shipments of
dried preserved fruits from the manufacturers/shippers identified
in Attachment A of this alert.
Intensified coverage of dried fruits from other
manufacturers/shippers for cyclamates, saccharin, insect/rodent
filth, and color additives is indicated.
If products are detained under this import alert and the importer
or other responsible party submits documentation to demonstrate
that the goods are not preserved by means other than drying, the
products may be released.
Continued coverage of dried fruits from Thailand, Japan, Korea,
and the Philippines as well as other countries for insect/rodent
filth, cyclamates, undeclared saccharin, and non-permitted color
additives is indicated. Surveillance of other preserved and/or
sweetened fruits from these and other countries is indicated.
For questions or issues concerning science, science policy, sample
collection, analysis, preparation, or analytical methodology,
contact the Division of Field Science at (301) 827-7605.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required
KEYWORDS: filth, saccharin, dulcin, cyclamate, color additives
PREPARED BY: Sammi L. Hadden, DIOP, (301)443-6553
DATE LOADED
INTO FIARS: April 4, 2008
ATTACHMENT A TO IMPORT ALERT #21-04 - REVISED 9/9/08
Manufacturers/shippers meeting the criteria for *** Detention Without Physical
Examination: ***
*** PEOPLES REPUBLIC OF CHINA (CN)
FIRM PRODUCT CHARGE
All All dried fruits 1,2,3,4
HONG KONG (HK)
FIRM PRODUCT CHARGE
All All dried fruits 1,2,3,4 ***
Fruitair SA de CV Mangoes, dried Cyclamates
Av Del Tercer Mundo 21S[][]05 21T[][]05
San Francisco, Nayarit 21U[][]05 21X[][]05
Mexico 01/13/03
FEI #3004670125
SINGAPORE (SG)
FIRM PRODUCT CHARGE
Kee Wee Hup Kee Manufacture All dried fruits Cyclamate
PTE.LTD
17 Chin Bee Crescent
Singapore 2261
FEI# 12879
Meng Chong Foodstuffs All dried fruits Cyclamate
PTE.LTD Undeclared
18 Senoko Way Singapore 2775 Saccharin
FEI# 12880
*** TAIWAN (TW)
FIRM PRODUCT CHARGE
All All dried fruits 2,3,4
THAILAND (TH)
FIRM PRODUCT CHARGE
A S World Trading Ltd. Preserved Mango Sweet Undeclared
Partnership and Sour w/Chilli Saccharin
69/21-22 Moo 6 21T[][]05 21X[][]05
SOI Kingkaew 54 21T[][]99
Kingkaew Road 21S[][]05
Rachathwea, Bangplee 21S[][]99
Samutprakarn, Thailand 3/15/04
FEI# 3004248958
# 3003967217 Preserved Jujube Undeclared
Sweet & Sour Saccharin
w/Chili Cyclamates
21G[][]05
21H[][]05
21J[][]05
21G[][]16
21H[][]16
21J[][]16
3/15/04
Preserved Thai Olive Undeclared
Sweet & Sour Saccharin
21G[][]09 21G[][]10
21G[][]11 21G[][]99
21H[][]09 21H[][]11
21H[][]99 21J[][]09
21J[][]99 22J[][]99
22H[][]99
1/30/04
Pa-Siam Intertrade Co. Ltd. Preserve Plum/21G[][]14
619 621 623 Rama 3 Road Salted Mango/21T[][]05
Bangkok, Thailand 3/27/02
FEI# 13365
Wang Derm Exporters, Ltd. Dehydrated Mango Non-permitted
Partnerships 21T[][]05 Tartrazine &
10/78 Moo Thakam 10/23/98 Sunset Yellow
Phraram 2 Road Bangkok, FCF
Thailand
FEI# 1000355679 ***
ATTACHMENT B TO IMPORT ALERT #21-04 - REVISED 9/12/08
Manufacturers/shippers in Hong Kong, PROC and Taiwan exempt from *** Detention
Without Physical Examination ***:
PEOPLES REPUBLIC OF CHINA (CN)
FIRM PRODUCT
Chenghai Native Produce I/E Co. Salted Prune
Zhong Shan Road 21G[][]15
Chenghai, Guangdong 21H[][]15
China 03/10/05
FEI# 3004669979
Dong Bou Foodstuff Dried Salted Prunes
Industrial Co., Ltd. 21G--15
No. 1 Huangan Development Area 21H--15
Xinxing, China 2/5/02
FEI# 3002872593
Shenzhen Ao Xin Tai Imp. & Exp Plum
4005 Donxiao Road Building 6, Suite 606 21G[]B14
Luohu District 21G[]C14
Shenzhen 1/12/07
China
FEI #3004278320
Shoei Foods Qingdao Co., Ltd. Prepared dried strawberries
Yuhuangling Industry Park, infused with sugar
Chengyang, Qingdao, China 20BGH14
FEI# 2000008676 9/9/08
Xing Hua Food Co. Ltd. Dried Persimmon
He Bin Road South, Da Ze Town, 22H[][]02
Xin Hui District, Jiang Men City, 07/30/08
Guangdong, China
FEI# 3004260967
3004254245 Dried Dates
3004255553 21H[][]05
9/3/08
Dried Persimmons
22H[][]02
9/3/08
HONG KONG (HK)
FIRM PRODUCT
Manuf: Mee Chun Canning Co., Ltd Kumcho Tim Mui
D.D 127 Ping Shaw (sweet & Sour Plums or
Yuen Long, Hong Kong Preserved Plums)
FEI# 3002482636 Preserved Lemons
Tang Hoi Moom Kee Co., Ltd. Preserved Plum
175 Wing Lok Street, G/F. 21G[][]14
Sheung Wan, Hong Kong 21H[][]14
FEI# 3003526449 6/2/05
Shipper: Wing Coffee Co. (HK) Ltd. 8/16/94
156-164 Des Voeux Road, C.
505 Gen Comme Bldg.
Hong Kong
FEI# 12881
TAIWAN (TW)
FIRM PRODUCT
Chuun Huung Int'l Trading Co. Dried Prunes
4 No. 108-1, Sec. 1, Hsin Sheng S. 21G[][]15, *** 21H[][]15
Taipei, Taiwan, Republic of China 1/14/00
FEI# 1000274944 Name Change
Fu Cheng Foods Industrial Co. Plums
522 San Teiaaao St. (preserved, dried,
Yuanlin Hsssien, Taiwan cured, salted)/21H[][H]14
FEI# 100010945 7/16/92
Goang Yuan Bio-Tech Co., Ltd. Dry Plum
#23-1, Mai Pu Li 21J--15
Tai Bao 21GG-14
Chia-Yi, Taiwan 7/28/06
FEI# 3004061018
Lian Kok Food Industrial Co., Ltd Preserved Prunes/Plums
No. 100 Shan Chiao Road and Shredded Mango
Chen H sing Li Yuanlin, Ghang Hwa,
Taiwan
FEI# 12640
Ming Jang Enterprise Co.
P.O Box 57
Taiwan
FEI# 12639
Pongshin Corp Dried Salted Prunes
No. 60 12/6/91
Taipei, Taiwan
FEI# 12398
Prince Ginger & Foods Corp. Dried Salted
No. 480 Sec. 2, Chung Shang Road Prunes/21G[][]15
Yuan Lin, Chang Hua Taiwan 12/21/99 *** 21H[][]15 ***
FEI# 3001687521
Sanh Yuan Enterprises Co., Ltd Dried Prunes
4th Floor, 108-1, Sec. 1 *** 21G[][]15 ***,
Hsin Sheng Rd. 21H[][]15
Taipei, Taiwan 12/12/00
FEI# 1000292648
Yi Chering Lii Co., Ltd *** Prunes, *** dried and
No.7 Pusi Strret salted
Changhua City, Taiwan 21H[][]15
FEI# 3005094192 5/1/98
Plums, dried and salted
21H[][H]14
5/1/98
Name and address change
9/12/08
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