IA #99-20, 11/14/94, DETENTION WITHOUT PHYSICAL EXAMINATION OF IMPORTED FOOD
PRODUCTS DUE TO NLEA VIOLATIONS, 3/11/09
TYPE OF ALERT: DETENTION WITHOUT PHYSICAL EXAMINATION
PRODUCT: See Attachment
PRODUCT CODE: All Food Product Codes
HARMONIZED
CODES: Multiple
PROBLEM: NLEA Violations (Labeling; Nutrition Information; Health
Claims) (MLLM)
PAC FOR
COLLECTION: 21005
COUNTRY: See Attachment
MANUFACTURER/
SHIPPER: See Attachment
MANUFACTURER/
SHIPPER I.D.#: See Attachment
IMPORTER'S
I.D. #: N/A
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be misbranded within
the meaning of Section 403 in that the label or labeling
fails to bear the required nutrition information (e.g.
Nutrition Facts panel) [Misbranded, Section 403 (q)]".
OASIS Charge code "Nutrit LBL" PAF's NIS or LBL
And/Or
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be misbranded within
the meaning of Section 403 in that the label or labeling
bears an unauthorized nutrient content/health claim
(specify) [Misbranded, Section 403(r)(1)(A)/(B)]".
OASIS Charge Code "Health C" PAF's NIS or LBL
And/Or
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to be misbranded within
the meaning of Section 403 in that the label or labeling
fails to bear required information (specify, e.g. common or
usual name of each ingredient in a standardized food,
percent of juice, names of certified colors) [Misbranded,
Section 403(I)(2)]".
OASIS Charge Codes LIST INGRE or JUICE % PAF LBL
RECOMMENDING
OFFICE: CFSAN/OFP/DPPE/Import Programs Branch, HFS-637
REASON FOR
ALERT: The Nutritional Labeling and Education Act (NLEA) of 1990
provided FDA with specific authority to require nutrition
labeling of most foods regulated by the Agency, both import
and domestic, and to require that all nutrient content
claims (e.g., "high fiber", "low fat", etc.) and health
claims be made consistent with the Agency regulations.
Regulations implementing the NLEA labeling provision issued
on January 6, 1993. The regulations became effective for
health claims and ingredient declarations on May 8, 1993,
and became effective for nutrition labeling and other
provisions on May 8, 1994.
On March 21, 1994, letters were sent to the foreign
embassies advising them about the May 8, 1994 effective date
for nutrition labeling and the small business exemption
provisions.
NOTE: Effective date of the regulation was subsequently
postponed from May 8, 1994 until August 8, 1994.
In conjunction with the guidance in this import alert, the
Nutrition Labeling of Imported Foods assignment, which
instructs the field to perform label exams on imported
foods, began September 19, 1994. This alert will track
manufacturer/product/container size (net weight or fluid
measure) combinations subject to automatic detention because
of NLEA violations.
INSTRUCTIONS: The manufacturer/product/container size combinations listed
in the Attachment are subject to DWPE.
The first time a specific product from a foreign
manufacturer/shipper is found to be in violation, districts
should issue a Release Notice With Comments in accordance
with the instructions listed in the assignment. If the same
product from the same manufacturer/shipper is found to be in
violation 60 or more days after the initial Release with
Comment has been issued, a recommendation for detention
should be made in accordance with the assignment. Once a
detention has been approved, the manufacturer/shipper and
product will be added by CFSAN to the Attachment of this
import alert and will be subject to the automatic detention
guidance.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required
KEYWORDS: NLEA, labeling, nutrition, labeling violations, misbranded
PREPARED BY: Linda Wisniowski, DIOP, 301-443-6553
ATTACHMENT - FIRMS RECOMMENDED FOR DWPE DUE TO NLEA VIOLATIONS 3/11/09
BANGLADESH (BD)
FIRM PRODUCT/ VIOLATION
PRODUCT CODE
Janata Foods Date cake The label fails to
Zaman Chamber 47 03R[][]02 bear trans-fat
Dilkusha Chamber, 4th Fl. 03R[][]99 declaration as required
Dhaka, Bangladesh 22K[][]99 by Section 403(q) of the
FEI# 3004354084 10/30/07 FD&C Act and 21 CFR
3005352217 101.9(c)(2)(ii)and the
serving size/servings
Per container is
inconsistent
101.9(b)(1).
BOLIVIA (BO)
FIRM PRODUCT/PC VIOLATION
[Repacker]
Import & Export Santa Spearmint Leaves Product is misbranded
Catalina Inc. 28A[][]45 under Section 403(a)(1)
Av. Petrolera Km. 4« #1358 10/31/07 in that the amounts of
Av. Ayacucho #127 Vitamin C, calcium,
Cochabamba, Bolivia Q'uillquina and iron are less than
FEI# 3004404089 (Dried herbs 80% of declared amounts;
for tea)
31K[][]99 Product is further
10/31/07 misbranded under Section
403(q) in that the
nutrition label does not
comply with format
requirements in 21CFR
101.9 (type size and
bolding requirements are
not met; Total Fat/
Saturated Fat amounts
are not correctly
declared);
Product is further
misbranded in that the
Nutrition Facts panel
fails to base the
nutrient information on
the proper serving size
[21 CFR 101.12(b)(2)];
Product is further
misbranded in that the
Nutrition Facts panel
fails to declare the
vitamins and minerals
as specified by 21 CFR
101.9 (c)(8)(ii)
BRAZIL (BR)
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
Bauducco & Cia, Ltd Cake W/Chocolate Chips Product is misbranded
Rau Endres 191 03R[][]01 within the meaning of
Guarulhos, 03R[][]99 Section 403(a) in that
San Paulo 03/9/04 its labeling is false.
Brazil Label declares a 70 g
FEI# 1000215702 serving contains 11 g
of fat, analysis found
14.8 g of fat per 70 g
serving
CANADA (CA)
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
Sunny Crunch Body Zone Choco Crisp Product is misbranded
Foods Ltd. Nutrition Bar within the meaning of
310 Steelcase Rd. East 41E- - 99 Section 403(a) in that
Markham, Canada 10/1/03 the labeling is false.
FEI# 3000233223 Specifically the
Calcium levels found
Were 78.4% and 76.8% of
the label declaration.
Double Berry Soy Product is misbranded
Protein Supplement within the meaning of
Bar Section 403(a) in that
41E[][]99 the labeling is false.
3/22/04 Specifically the
Potassium levels found
Were 62% of the label
declaration.
CHINA, PEOPLE'S REPUBLIC OF (CN)
FIRM PRODUCT CODE/PRODUCT VIOLATION
(MFR)
Changle Yongxin Food Co., Ltd. Peanuts in Product is misbranded
Liulin Jinfeng Shell under Section 403 (q)
Changle City 23A[][]07 in that the labeling
Fujian, China 33J[][]07 (Nutrition Facts Panel)
FEI# 3006324143 6/21/07 does not comply with
nutritional labeling
(Head Office) format requirements
Changle Yongxin Food Co., Ltd. {21 CFR 101.9(d)};
No. 150, Xindongyan, Jinfeng Zhen
Changle City, Fujian, China Product is further
FEI# 3006321558 misbranded in that
the net contents are
(SHIPPER) not stated in ounces/
Jiangmen Pengjiang Huiming Trading Company pounds {21 CFR 101.105
108 Flat 2 No. 16, Guifeng East Road, (b)(1)};
Xinhui, Jiangmen, Guangdong, China
FEI# 3005997893 Product is further
misbranded in that the
Jiangmen Pengjiang Huiming Trading Company labeling uses "Edible
Unit A, 12/F, Dongxing Ge, Donghua Bldg., Flavor" to list a
128 Gangkou Road flavor ingredient
Jiangmen, Guangdong, China {21 CFR 101.22(i)}
FEI# 3005066219
Kun Po (Kun BO) Food- Sweet Wintermelon The label fails to
stuffs I/E Corp., Ltd. 22A[][]07 bear trans-fat
Zhongshan Five Road 6/6/2007 declaration as required
Zhongshan City, Guangdong, by Section 403(q) of the
China Sweet lotus nuts FD&C Act and 21 CFR
FEI# 3004275116 23K[][]06 101.9(c)(2)(ii).
6/6/2007
Xing Hua Food Co., Ltd., Cole, dehydrated Product is misbranded
He Bin Road South, 24U[][][]; 24T[]H[] within the meaning of
Daze Town Xinhui 11/14/08 section 403(i)(2) of
District, Jiangmen City the Act because the
Guangdong Province, label fails to list
China (Mainland) each ingredient in the
FEI# 3004254245 ingredient statement
(21 CFR 101.4(a)(1)).
Undeclared sulfites.
Product is further
mislabeled in that
the label does not
identify sulfite as
a preservative
(21 CFR 101.22(j)).
Note: Cole refers to a family of vegetables, which includes kale, collard
greens, broccoli, cauliflower, brussel sprouts, and kohlrabi.
Zhuhai Economic Special Zone Salted Turnip Product is misbranded within
General Non-Staple Food Corp. 25J[][]14 the meaning of section
1092 Jiuzhou Road, Zhuhai, 4/11/08 403(i)(2) of the Act
Guangdong, China because the label fails to
FEI# 3002527849 list each ingredient in the
ingredient statement
(21 CFR 101.4(a)(1)).
Undeclared sulfites
COLOMBIA (CO)
FIRM PRODUCT CODE/PRODUCT VIOLATION
Passiflora Colombiana SA Baby compote mango Product is misbranded
aka Passicol 21R[][]05 under Section 430(a)(1)
aka Alpina 40K[][]99 in that it does not meet
Vereda El Eden 200 Mts. 40Y[][][][] the label declaration
Salida Manizal 4/17/08 for calcium the
Chinchina, Caldas, Colombia content is 5% of the
FEI# 3004283218 labeled value.
FIJI (FJ)
FIRM PRODUCT/PC VIOLATION
Manufacturer
Nestle Trading(Fiji) Ltd Maggi 2 Minute Noodle Product is misbranded
P.O BOX 3042 04C[][]07 within the meaning of
Lot 1 Wailekutu Sub Division 10/30/07 Section 403 in that the
Lami, Fiji nutrition information is
FEI # 3004308275 incomplete and does not
meet the formatting
Shipper requirements specified
Hardip Narayan & Sons Ltd. under 21 CFR 101.9
P.O Box 12407 [Misbranded, Section
Suva, 403(q)].
Fuji
FEI# 3004438919
(Manufacturer) Powdered Milk The product is misbranded in
Punja & Sons Ltd. 09C[]H[][] that the nutrition
P.O. Box 125 12/13/05 information that appears on
Lautoka, Fiji the label is not in the
FEI #3004580075 format specified by
21 CFR 101.9 [Misbranded,
(Shipper) Section 403(q)].
National Exports Ltd.
P.O. Box 3050
Lautoka, Fiji
FEI# 1000162822
GREECE (GR)
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
Franca S.A. Fat Free Garlic label bears the
P.O. Box 46010 Bagel Chips claim "fat free"
133 41A Liossia 07A--99 but the product
Athens, Greece fails to meet the
FEI# 1000559895 requirements for
the claim
HONG KONG (HK)
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
Choi Yue Trading Company Fish Abdomen with Product is misbranded
G/F 8A Shop Agaricus Blazei Soup under Sec.403(i)(2)
Beicher Court (Dried Soup Mix) in that the ingredient
2 Sai Cheung Street 38C -99 statement fails to
Western, Hong Kong identify each ingredient
FEI# 3004276914 by its common or usual
name. For example, the
Ingredient listed as
Fish Abdomen" fails
to identify the species
of fish.
Product is further
misbranded in that the
label does not bear
nutrition information
in the proper format.
INDIA (IN)
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
Britannia Industries, Ltd. Jacob's Thin Arrowroot Product is misbranded
5/1A Hungerford Street Biscuits(Britannia Brand) under Sec.
Kolkata 700017 03F[][]99 03H[][]08 403(i)(2)labeling
India 03H[][]01 03H[][]99 fails to bear an
FEI# 3004323793 05/24/04 ingredient statement
that lists the common
SHIPPER
or usual name of all
Tastel ingredients, i.e.
2, Veena Vihar milk and milk
Dayal Das Road products, dough
Vile-parle East conditioner, permitted
Mumbai 400057 antioxidant, edible
India color, vegetable
FEI# 3004257599 oils and edible
starches are not
listed by their common
or usual names and the
sub-ingredients are
not listed; product is
further misbranded
because label does not
bear nutrition
information in the
proper format.
Vita Maria Gold Biscuits Product is misbranded
(Britannia Brand) under Sec. 403(i)(2)
03F[][]99 03H[][]08 labeling fails to
03H[][]01 03H[][]99 bear an ingredient
05/24/04 statement that lists
the common or usual
name of all ingredients,
i.e. milk and milk
products, dough condit-
ioner, permitted color,
antioxidant and edible
vegetable oils are not
listed by their common
or usual names and the
sub ingredients are not
listed;
50-50 Biscuits Product is misbranded
03H--99 under Sec.403(i)(2) in
7/3/06 that the ingredient
statement fails to
identify each ingredient
by its common or usual
name. For example,
edible vegetable oils,
raising agent, dough
conditioner (E223),
acidity regulator
(E330), improvers
(E1100, 1101),
antioxidant (INS319),
and synthetic Food
colours (E102, 124) are
not listed by their
common or usual names.
Product is further
misbranded in that the
nutrition label does not
provide all of the
information required by
21CFR101.9, and is not
in the required format.
Marie Gold Biscuits Product is
03H -99 misbranded under Sec.
7/3/06 403(i)(2) in that the
ingredient Statement
fails to identify each
ingredient by its common
or usual name. For
example, edible
vegetable oils, raising
agent, emulsifier
(E471), dough
conditioner (E223),
antioxidant (INS319),
and natural & synthetic
food colours (E102, 124,
150) are not listed by
their common or usual
names.
Product is further
misbranded in that the
nutrition label does not
provide all of the
information required by
21CFR101.9, and is not
in the required format.
Good Day Cashew Product is misbranded
Biscuits under Sec.403(i)(2) in
03H--05 that the ingredient
statement fails to
Good Day identify each ingredient
Choco-nut by its common or usual
Biscuits name. For example,
03H--05 edible vegetable oils/
03H--02 hydrogenated vegetable
oils, raising agents
[E 500(ii), 503(ii),
Nice Time Sugar 450(i)], emulsifiers
Showered Coconut (E322,471), antioxidant
Biscuits (INS319), and synthetic
03H--05 food colours (E102,124)
8/28/06 are not listed by their
common or usual names.
Product is further
misbranded in that the
nutrition label does not
provide all of the
information required
by 21CFR101.9, and is
not in the required
format.
MANUFACTURER:
Indo Nissin Foods Limited Top Ramen Product is misbranded
Centenary Building, Curry Noodles within the meaning of
28 M.G. Road 04C[][]07 Section 403(i)(2) in that
Bangalore, India 2/9/09 the label fails to
FEI# 3007351175 bear required information
as required in 21 CFR
MANUFACTURER/SHIPPER: 101.4(a)(1), e.g. common or
P J Exports, PJ House Z3 usual name of each
Shree Arihant Compound, Reti Bunder Road ingredient; label fails to
Kalher Village, In-Mh, India declare sodium as required
FEI# 3004348364 in 21 CFR 101.9(g) in that
the nutrient content is
greater than 20% in excess
of the declared value on the
label. Product fails to
declare iron are required by
CFR 101.9(g)(4)(ii).
Ruchi Soya Industries Ltd. Nutrela High Protein Product is misbranded
408, Tulsiani Chambers Soya Chunks under 403(q)in that the
Nariman Point, 02Y[][]99 format of the nutrition
Mumbai, India 400021 37C[][]99 label does not comply
FEI# 3004120038 5/31/07 with 21CFR101.9.
Nutrela High Protein Product is misbranded
Soya Granules under 403(q)in that the
02Y[][]99 format of the nutrition
37C[][]99 label does not comply
5/31/07 with 21CFR101.9.
Tropicana World Kerala Fish Curry Sauce Product is subject to
Trade Pvt. Ltd. 16Y[][]03 refusal of admission
16/453 Thoppumpady 16Y[][]09 pursuant to Section 801
Cochin, India 16Y[][]17 (a)(3) in that it
FEI# 3002971130 16Y[][]99 appears to be
37J[][]05 misbranded in that the
37J[][]23 declared value for
37J[][]99 sodium in the Nutrition
37J[][]05 Facts label does not
3/31/04 meet the compliance
requirements of 21 CFR 101.9)g)(5). Label
declares a 65 g serving
contains 240 mg of
sodium, analysis found
145% of the declared
amount of sodium on
original analysis and
155% on check analysis.
INDONESIA (ID)
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
PT. Ultrajaya Milk Industry Mango Slice Product is misbranded within
& Trading Company Tbk (Manisan Mangga) the meaning of section 403(q)
JL. Raya Cimareme 21T[][]05 of the Act for failing to
131 Padalarang 01/28/08 declare sodium as required by
P O Box 1230, Bandung 21 CFR 101.9(c)(4) and
Indonesia trans fat as required by 21
FEI# 3004404337 CFR 101.9(c)(2)(ii).
FEI# 2000013884 Also Vitamin A, Calcium and
Iron are incorrectly declared
as 0.1%, 0.2% or 1%
respectively.
ISRAEL (IL)
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
Materna Laboratorios Infant cereal The label fails to
Ltd. 40B[][][][] bear nutritional
Kibutz Maatarot 2/5/07 information as required
Maatarot, Israel by Section 403(q) of the
FEI# 3005336410 FD&C Act and 21 CFR
101.9; The label fails
SHIPPER: to bear an ingredient
Maabarot Products, Ltd. statement that lists
Kibutz Maabarot the common or usual name
Maatarot, Israel of all ingredients, i.e.
FEI# 3004328244 minerals, dietary fiber,
and vitamins 403(i)(2).
Cheong Jung Naru Food Salted Clams, Product is misbranded
316-1 Songdae-Ri, Frozen within the meaning of
Ochang-Myeon, 16X[][]30 Section 403 in that
Chungcheongbukdo City 16E[][]02 the labeling (Nutrition
Cheongwon-Gun Chungbuk 3/4/08 Facts panel) does not
Province, comply with format
Korea, Republic of requirements of
FEI# 3004310532 21 CFR 101.9(d).
Salted Seasoned Product is misbranded
Oyster, Frozen within the meaning of
16X[][]32 Section 403 in that
16E[][]02 the labeling (Nutrition
3/4/08 Facts panel) does not
comply with format
requirements of
21 CFR 101.9(d);
NOTE: The oyster product is also indicated for detention in that the
ingredient statement declares ingredients not found in the product per the
manufacturing process statement [Section 403(a)(1)]. The label declares Millet
Jelly, Garlic, and Ginger, but Salt and Red Pepper Powder are the only
ingredients added in the manufacturing statement.
MALAYSIA
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
Thomyam Food Industries Dragonfly Brand Product is misbranded
Lot 76, No.10 Semambu Assorted Pudding under 403(i)(2) in
Industrial Estate 35D--99 that the listing of
Kuantan, Malaysia 25350 5/4/07 sodium caseinate as a
FEI# 3004274327 sub-ingredient of the
non-dairy creamer
does not include a
parenthetical term
such as "a milk
derivative" as required
by 21CFR101.4(d)
Also, Product is
misbranded under 403(q)
in that the label does
not comply with the
labeling requirements in
21CFR101.9.
Specifically, the label
does not list trans fat
and the format of the
nutrition information is
incorrect. Product is
further misbranded under
403(q)in that there is
no French translation on
the nutrition label as
required by
21CFR101.15(b)(3).
Dragonfly Brand Product is misbranded
Pandan Flavor under 403(i)(2) in
Pudding that the label fails to
35D 99 declare all ingredients
5/5/07 in the ingredient
statement by their
common of usual names
required by 21CFR101.4.
Specifically, sodium
caseinate.
Also, product is
misbranded under 403(q)
in that the label does
not comply with the
labeling requirements in
21CFR101.9.
Specifically, the label
does not list trans fat
and the format of the
nutrition information is
incorrect. Product is
further misbranded under
403(q)in that there is
no French translation on
the nutrition label as
required by
21CFR101.15(b)(3)
Dragonfly Brand Product is misbranded
Mini Pudding under 403(i)(2) in
Tropical Fruit that the label fails to
35D--99 declare all ingredients
5/4/07 in the ingredient
statement as required by
21CFR101.4.
Specifically, sodium
caseinate.
Also, the product is
misbranded under 403(q)
in that the format for
the nutrition facts
label does not comply
with 21CFR101.9. Product
is further misbranded
under 403(q) in that
there is no French
translation on the
nutrition label as
required by
21CFR101.15(b)(3)
Dragonfly Brand Product is misbranded
Mango Pudding under 403(i)(2) in
35D--99 that the label fails to
5/4/07 declare all ingredients
in the ingredient
statement by their
common or usual name as
required by 21CFR101.4.
Specifically, sodium
caseinate.
Also, Product is
misbranded under 403(q)
in that the label does
not comply with the
labeling requirements in
21CFR101.9.
Specifically, the label
does not list trans fat
and the format of the
nutrition information is
incorrect. Product is
further misbranded under
403(q)in that there is
no French translation on
the nutrition label as
required by
21CFR101.15(b)(3).
MEXICO (MX)
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
Agroindustrias Deander Jalapeno Peppers, The product's label
de Delicias, S.A. de C.V. sliced in #10 cans fails to bear nutrition
RFC AID-891 221-HT4 (102 oz.) information as required
Carretera Delicias- 24F-E08 by Section 403 (q) of
Naica Km.6 24F-I08 the FD&C Act and 21 CFR
Cd. Delicias 5/5/03 101.9 and is not exempt
Chihuahua, Mexico CP 33000 under 403(q)(5) of the
FEI# 1000269734 Act.
API-Royal SA de CV Ultra Pina Linzaa The nutritional
Calle 7a, #237 Altos (powder drink mix) information is not
Col. San Luis 30J[][][][] in the format specified
San Luis Potosi, Mexico 30Y[][][][] by 21 CFR 101.36
FEI# 2000006774 54I[][]99 [Misbranded, Section
54Y[][]99 403 (q)]; The product
9/5/06 contains less than 7%
of the declared amountof
riboflavin [Misbranded,
Section
403(r)(1)(A)/(B)].
Linzaa powder The nutritional
(powder drink mix) information is not
30J[][][][] in the format specified
30Y[][][][] by 21 CFR 101.36
54I[][]99 [Misbranded, Section
54Y[][]99 403(q)]; The product
9/5/06 contains less than 3%
of the declared amount
of riboflavin
[Misbranded, Section
403(r)(1)(A)/(B)].
Ultra Manzana The nutritional
Lax powder information is not
powder drink mix) in the format specified
30J[][][][] by 21 CFR 101.36
30Y[][][][] [Misbranded, Section
54I[][]99 403(q)]; The product
54Y[][]99 contains less than 6%
9/5/06 of the declared amount
of riboflavin
[Misbranded, Section
403(r)(1)(A)/(B)].
Canas Y Piloncillos
Bagerhat Seafood Industries Raw Black Product is misbranded under
Town Nowapara Tiger Shrimp Section 403(q) in that trans
Bagerhat, Bangladesh 16X[][]21 fat is not listed; hairline
FEI# 3004284950 16J[][]05 is incorrect; bolding
12/5/07 is not used; serving size
and servings/container are
not consistent [21 CFR 101.9];
Product is further misbranded
under Section 403(i)(1)in that
the label does not list each
ingredient by its common or
usual name [21 CFR 101.4];
Product is further misbranded
under Section 403(e)(1) in
that the label fails to bear
the ingredient statement and
the name and address of the
manufacturer without other
intervening material [21 CFR
101.2(e)]
Chuy's Crunchie Charal Fried Charal Product is misbranded
Cheston de Mazatlan #209 with Chili within the meaning of
Hoga Del Pescador 16A[][]33 Section 403 in that
Mazatlan, Sinaloa, MX 9/24/08 the amount of sodium
FEI# 3004345667 exceeds the declared
amount [239%];
Product is further
misbranded within the
meaning of Section 403
in that the labeling
[Nutrition Facts panel]
does not comply with format
requirements of 21 CFR
101.9 (d) [Required hairlines
are missing, "Calories from
fat" is missing; Vitamin A,
Vitamin C, iron and calcium
are not declared; the format
is improperly split; saturated
and trans fat are not declared
in proper increments; the
nutrients required to be
highlighted are not bolded;
the nutrients are not indented
as required; the required bars
are missing];
Product is further misbranded
in that the vegetable oil
ingredient is not declared in
accordance with 21 CFR
101.4(b)(14).
NOTE: this product is also indicated for detention because its labeling
fails to declare the presence of the major food allergen "wheat" as required
by section 403(w)(1) of the Act. The products lists flour in the ingredients
statement (flour is the name for wheat flour, and wheat is a major food
allergen). [Misbranded, section 403(w); use OASIS charge code ALLERGEN]
Brown Sugar The product is
De Nayarit SPR de RL 36A[][]02 misbranded in that the
Camino Uzeta-Amatian 36A[][]03 label or labeling fails
De Canas Km 1.5 36A[][]99 to bear the required
Uzeta municipio de 3/7/07 nutrition information
Ahuacetian as required by 403(q)
Mexico of the FD&C Act and
FEI# 3005281156 21 101.9.
FEI# 2000009423
Cereales y Semillas Brown Sugar Cane Product is misbranded
Hernandez 36A[][]02 under Section 403(a)(1)
Chicalote #2622 36A[][]03 in that it does meet
Mercado de Abastos 3/12/07 the label declaration
Guadalajara, MX for calcium;
FEI# 3004389480
Product is further
misbranded in that the
nutrition label does
not comply with format
requirements in 21 CFR
101.9 (nutrition
information is not set
in a box by use of
hairlines, nutrient
order incorrect,
incorrect increments,
serving size not
declared, serving per
container not declared)
Comercializadora BA-CAL Refreshing Natural Product is misbranded
Calle Sebastian Beverage with Maguey under 403(a)(1)in that
Vizcaino 412 Extract the declared value for
Garita de Otay 30A[][]06 carbohydrates is false
Tijuana, B.C. 30N[][]99 & misleading;
Mexico 22500 29C[][]99
FEI# 3004283103 4/20/07 Product is further
misbranded under 403(q)
in that the nutrition
label does not comply
with format
requirements
in 21 CFR 101.9;
The statement of
identity in English
does not describe the
food appropriately (21
CFR 101.3(b)
Dulces Mexicanos Coconut Candy Rolls Total and Sat. Fat
Revolucion #14 Sta. 33H[][]99 Labeled as 0%
Cruz de las Huertas 4/4/00 Product assayed
Tonala, Jalisco, Mexico 7.45 and 6.35gms
FEI #3000260709 respectively per
Serving
Dulces Yely SA de CV Salt-Lemon Product is misbranded under
Av. De Los Astros #550-7 Seasoning Section 403(a)(1)in that the
Barrio Estrella (Checo Lim) sodium content is greater
Monterey, Mexico 28K[][]99 than 20% of the value
FEI# 3006520611 33Y[][]99 declared on the label
33S[][]06 {21 CFR 101.9(g)(5)};
33E[][]06
33C[][]99 Product is further misbranded
6/6/07 in that product fails to
declare trans fat on outer
and individual packages
{21 CFR 101.9(c)(2)(ii)};
Product is further misbranded
in that product label does not
include the metric
equivalent{21 CFR
101.9(b)(7)};
Product is further misbranded
in that the format for the
Spanish and English nutrition
labels do not comply with the
requirements in 21 CFR
101.9(d)
Mango and Chili Product is misbranded under
Flavored Section 403(a) in that the
Seasoning sodium content is greater
[Checo Lim Mango] than 20% of the value
28K[][]99 declared on the label
33Y[][]99 [21 CFR 101.9(g)(5);
33S[][]06
33E[][]06 Product is further misbranded
33C[][]99 under Section 403(q) for
12/16/08 failure to declare trans fat
[21 CFR 101.9(c)(2)(ii)];
Product is further misbranded
under Section 403(q) in that
the nutritional labeling does
not comply with the
requirements of 21 CFR 101.9
(d) [lacks proper hairlines;
calories/amount per
serving/daily values are not
properly bolded; inadequate
width of nutrition facts;
Percent Daily Values declared
for fats and sugars in the
Facts panel)
Effem Mexico Inc Y Compania Cucumber The article is misbranded
S. EN N.C. de C.V. Flavored within the meaning of
Km 4.5 Carretera a Powder section 403(a)(1) of the
Chichimequillas, El Marques 28K[][]99 Act [21 U.S.C 343 (a)(1)]
Queretaro 76260, Mexico 33S[][]99 for failing to declare
FEI# 3004401979 7/9/08 sodium as required by 21
CFR 101.9(g)(5)in that the
nutrient content of the
composite is greater than
20 percent in excess of
the value for the nutrient
declared on the label.
El Azteca SA DE CV Coconut Candy Rolls The product is misbranded in
Calzada Independencia 33H[][]05 that the individual retail
Norte 445 33H[][]99 units fail to bear a nutrition
Guadalajara, Sonora 33S[][]05 label as required by 403(q)
Mexico 33S[][]99 of the FD&C Act and 21 CFR
FEI# 3004203298 8/16/05 101.9 and fails to bear a net
quantity of contents statement
as required by Section 403 (e)
SHIPPER (2)of the FD&C Act and 21 CFR
101.105.
Dulceria La Tapatio
Mayoreo
C. Privada Benton No. 15228
Tijuana B.C. 22240
Mexico
FEI# 3003369184
El Azteca de Mexico Lemon flavored Product is misbranded
Las Flores No 113 salt powder within the meaning of
Col. l13 Victor Hugo [Limoncito] Section 403(q) in that
Zapopan, Jalisco 33S[][]99 labeling does not comply
Mexico 28K[][] with nutrition labeling
FEI# 3005677448 33Y[][]99 format requirements
33E[][]06 [incorrect hairlines,
33C[][]99 bolding, indenting],
10/17/08 21 CFR 101.9;
Product is further misbranded
under Section 403(q)in that
the nutrition facts panel
in Spanish does not comply
with nutrition labeling
requirements, 21 CFR 101.9;
Product is further misbranded
under Section 403(a) in that
the sodium content is greater
than 20% in excess of the
declared value, 21 CFR 101.9
(g)(5);
Product is further misbranded
under Section 403(a) in that
the net quantity of contents
does not comply with the
requirements of 21 CFR
101.105(s), if the
product is sold as a multi-
unit package.
(Manufacturer)
Fabrica de Chocolates Chocolate Popular The product appears to be
La Popular Para Mesa misbranded within the meaning
Aramberri Ote.112 34B[][]99 of Section 403(q) in that
Apdo 343 34B[][]05 there are two different
Monterrey, Mexico 34H[][]99 declarations for calories on
FEI# 3000172674 34Y[][]99 the Nutrition Facts
10/11/07 information. The English
label declares 70 calories and
the Spanish label declares
80 calories.
(Shipper) And
Cobos Gonzalez Asociados The product appears to be
SA de CV misbranded within the meaning
Cebolla 74 Central de Abastos of Section of 404(i)(2) in
Reynosa, Mexico that the label fails to
FEI# 3002697832 accurately declare the common
or usual name of each
ingredient. Specifically, the
English and Spanish ingredient
statements each declare
different ingredients. In
English, the ingredients
declared are "Cane Sugar,
Chocolate Liquor" but in
Spanish the ingredients are
declared as toasted ground
cacao, sugar, and cinnamon.
Grupo Jumex Jugomex Pau Pau Cherry Juice Analysis determined
SA de CV Drink that the product does
Km 12.5 Antigua 21K[][]03, 21D[][]99, not contain 10% of the
Carretera Mex-Pachuca 40E[][]40 RDI for Vitamin C as
Xalostec, Mexico 12/20/05 declared on the label.
FEI # 1000110589 Therefore the product
is misbranded under
Section 403(r)(1) of
the FFD&C Act because
it bears the nutrient
content claim
"enriched with Vitamins
A, C, B1, B2," however
the label declaration
for vitamins A (4%),
B1(6%), and B2(6%) are
less than 10% of the
RDI for Vitamins A, B1,
and B2.
Jumex Blends Exotic Analysis determined
Medley Juice Drink that the product does
21D[][]99, 40E[][]40 not contain 10% of the
22K[][]99 RDI for Vitamin A & C
6/26/07 as declared on the
label. Therefore the
product is misbranded
under Section
[403(r)(1)(A)] of the
FFD&C Act. In addition
the product appears to
contain only a small
percentage of the label-
declared amount of iron
[Misbranding,403(a)(1)]
Importadora Y Chocolate Fiber Product appears to be
Comercializadora misbranded with-
De Uncaria Powder for Kids in the meaning of
Tormentos 34B[][]06 34B[][]99 Section 403(r)(1)(B)
Avenida Patria 34H[][]02 34H[][]99 of the Act (21 USC
1357 Co. Miradora 34Y[][]99 54Y[][]99 343(r)(1)(B) in that
Zapopan, Jalisco 5/17/07 the label or labeling is
Mexico unqualified to
FEI# 2000035101 bear fiber-related
health claims specified
under 21 CFR 101.76 and
101.77. Del SolThe label
declares the following
claims:
"Fiber...help move food
through the digestive
system...protecting...ag
ainst...cancers and
constipation." and
"Fiber May also
lower...cholesterol and
...beneficial...diabetes
...heart disease."
Neither statement meets
the requirements
of their referenced
health claims because
This product is neither
a grain product,
fruit, nor vegetable.
Pastas Alimenticias Stars Pasta Product's label fails to bear
Laziali SA de CV (Faraon Brand) required nutrition information
Calle 4 Norte 04C--99/04C--02 in the format required by
No. 301 Lote 17 7/20/05 21CFR 101.9, specifically:
Toluca, Edo. De Mexico label print too small;
Mexico incorrect bolding; no
FEI# 3004053819 indentation. Serving size
visual unit of measure not
listed first, calories not
expressed in 10 cal increment.
[Misbranded, Section 403 (q)]
NOTE: this product is also indicated for detention in that it does not meet
the 21 CFR 139.115(a)(1) requirement for enriched macaroni products;
laboratory analysis revealed the product contained less than 1.7mg/lb of
riboflavin; 21 CFR 139.115(a)(1) requires between 1.7mg/lb and 2.2mg/lb of
riboflavin for enriched macaroni products [Misbranded, section 403(g); use
OASIS charge code STD IDENT]
Alphabet Pasta Product's label fails to bear
(Faraon Brand) required nutrition information
04C--99/04C--02 in the format required by
7/20/05 21CFR 101.9, specifically:
label print too small;
incorrect bolding; no
indentation. Serving size
visual unit of measure
not listed first, calories not
expressed in 10 cal increment.
[Misbranded, Section 403 (q)]
Pastas y Galletas de Pagasa Brand Macaroni Product's label fails to
Tijuana, SA de CV Products bear required nutrition
Calle Jose Gallego L. "Tricolore Enriched" information in the
# 13250 "Penne Enriched" format required by 21CFR
Col. 20 De Noviembre, 04A[][]01 101.9, specifically:
La Mesa 12/20/07 the label does not list
Tijuana, Mexico trans fat as required in
FEI# 3004277449 21 CFR 101.9(c)(2)(ii)
[Misbranded, Section 403
(q)]
NOTE: these products are also indicated for detention because their labeling
fails to declare the presence of the major food allergen "wheat" as required
by section 403(w)(1) of the Act. The products list semolina in the ingredient
statement (semolina is wheat and wheat is a major food allergen). [Misbranded,
section 403(w); use OASIS charge code ALLERGEN]
(Manufacturer)
Plantas Medicinales Su-K rofitina syrup The nutritional
Anahuac SA de CV 54F[][]99 information is not
Oriente 255 #57 54Y[][]99 in the format specified
Col. Agricola Oriental 6/30/06 by 21 CFR 101.9
Mexico City, Mexico [Misbranded, Section
FEI# 1000599639 403(q)]
Corn Silk Blend Capsules Product is misbranded
(Cabellos de Elote Enebro) under 403(q)(5)(F) in
54Y[][]99 that the nutrition
41B[][]99 label does not include
8/13/07 adequate information;
Product is further
misbranded under
(Shipper) 403(a)(1)in that the
Manuel Gonzalez Blanco declared value for
Ahuehuete No.53 Vitamin E is false &
Fraccionamiento Floresta misleading;
Veracruz, MX
FEI# 3004679342 Product is further
misbranded under
403(i)(2) in that the
label does not declare
the capsule ingredient;
and under 403(s)(2)(C)in
that the label does not
declare the plant parts
used {21CFR 101.36,
101.3(g), and 101.4(h)}
Productos Avila S.A. de C.V. Tarritos de Chilito Product is misbranded
Puerto Melaque 1379, Liquid under Section 403(a)(1)
Col. Santa Maria [Liquid Chili Snack/ in that it does not
Guadalajara Barril con Chili] meet the label
Mexico 44350 33J[][]05 declaration for
FEI# 3003809190 33Y[][]99 iron;
33L[][]05
3/14/07
Product is further
misbranded under Section
403(q) in that
the nutrition label
does not comply with
format requirements in
21CFR 101.9 (nutrition
information is not
separated by hairlines,
bolding is incorrect,
incorrect increments,
serving size is not in
common household
measure, serving per
container is not
declared).
Productos Cihuapilla Coconut Candy Rolls Product is misbranded in that
Luis Cabera No 562 33H[][]05 retail units fail to bear a
Colinas De La Normal 33H[][]12 net quantity of contents
Guadalajara, Sonora 33H[][]99 statement as required by Sec.
Mexico 33S[][]05 403(e)(2) of the Act and 21
FEI# 3004892515 33S[][]99 CFR 101.105. Product is
8/24/05 further misbranded in that
retail units fail to bear a
SHIPPER nutritional label as required
by 403(q) of the Act and 21
Dulceria La Tapatio CFR 101.9.
Mayoreo
C. Privada Benton No. 15228
Tijuana B.C. 22240
Mexico
FEI# 3003369184
Productos de Trigo Sa De CV Rancheritas Product is misbranded under
Quetzal No. 1108/1132 Cookies Section 403(r)(1)(A) due to
Col. Morelos 03M[][]99 claim "vitamins added" where
Guadalajara, Jalisco 03H[][]99 product does not meet
Mexico 5/1/06 requirements in 21 CFR
FEI# 3004269606 101.54(c);
Product is further misbranded
in that the label does not
bear nutritional information
or the serving size in the
proper format. [21 CFR 101.9
& 101.9 (b)]
Cookies Product is misbranded within
(Marietta's Brand) the meaning of Section 403(a)
Lemon CrŠme in that its labeling is
03J[][]06 false, specifically: Analysis
03J[][]09 indicates Vitamin C is
Vanilla CrŠme present at less than 1% of
03J[][]01 the declared amount
3/31/08
Peanut Butter The level of Vitamin C
CrŠme Cookies detected in the product
03M[][]10, is below the declared
03J[][]10, amount of Vitamin C on
03M[][]99 the label and is not
02/13/09 within the compliance
criteria in 21 CFR
101.9(g).
Strawberry CrŠme The level of Vitamin C
Cookies detected in the product
03M[][]99, 03M[][]10, is below the declared
03J[][]10, 03H[][]10, amount of Vitamin C on
03M[][]09 the label & is not
3/11/09 within the compliance
criteria in 21 CFR
101.9 (g).
Salud Natural ActiKrol brand Glutamic Label does not bear
Mexicano SA de CV Acid Syrup for Children nutrition labeling
Av. Inglaterra 3109 54C- - 07 (i.e. supplement facts
Col. Arcos Sur Dinamax Jr., a liquid labels) as required
Guadalajara, Mexico vitamin supplement under Section
FEI # 3002616922 54A- -99 403(q)(5)(F)
54Y- -99 of the Act and
3/27/03 1CFR101.36
Salud Natural Caltron 600 + D Product is misbranded
Mexicano SA de CV calcium supplement because it is not
Av. Inglaterra 3109 54B- - 01 labeled as required
Col. Arcos Sur 4/16/03 under Section
Guadalajara, Mexico 403(q)(5)(F) and 21 CFR
FEI # 3002616922 101.36
Toma Products, S.A. de C.V. Agua Fruta Melon Product is misbranded
Carretera Los Pinos Km 1.5 (Cantaloupe) Fruit within the meaning of
Ramos Arizpe, Mexico Drink Section 403(a) in that
FEI # 3004294724 22D[][]01 it's labeling is false.
2/9/06 Label declares a 20%
Vitamin C per serving
analysis found <5% per
serving.
PHILIPPINES (PH)
FIRM PRODUCT/PC VIOLATION
Edlou Enterprises Dried Shrimp Fry Product is misbranded
341 Cristobal Street 16J[]H05 within the meaning of
Samapaloc, Manila, 16X[]H21 Section 403(q) in that
Philippines 9/24/08 the label fails to bear
FEI# 3004656883 required nutritional
information [trans fat,
saturated fat, cholesterol,
vitamins & minerals are not
declared], 21 CFR 101.9(c),(d)
RUSSIA (RU)
FIRM NAME PRODUCT/ VIOLATION
AND ADDRESS PRODUCT CODE
Galan Oao Chocolate Egg with Product is misbranded with in
158 Kommunisticheskaya Toy inside the meaning of section 403(f)
Street, Kurganinsk, 34F[][]07 of the Federal Food, Drug, and
Russia 34F[][]08 Cosmetic Act because the
FEI # 3004894155 3/10/05 following required label
information is not presented
in English as required by
Title 21 Code of Federal
Regulations 101.15(c) (1):
Statement of identity (21 CFR
101.3), Net quantity of contents
statement (21 CFR 101.105), List
of ingredients (21 CFR 101.4),
Name and address of the
manufacturer, packer, or distributor
(21 CFR 101.5) Nutrition
information (21 CFR 101.9)
SOUTH AFRICA (ZA)
FIRM PRODUCT CODE/PRODUCT VIOLATION
Tiger Food Brands Ltd. Baby cereal, mix, 101.9(j)(5) foods
3 Bayete Road, Maitland w/strawberries other than infant
Capetown, South Africa 40B[][]20 formula for infants
FEI# 3004299724 322227 DET-DO and children shall
7/20/05 not include calories
from fat or saturated
fat.
Tiger Food Brands Ltd. 7/20/05
54 Oxford Street, Oxford Gate
Durbanville, South Africa
FEI# 3003346630
Tiger Food Brands Ltd. Baby cereal, wheat, 101.9(j)(5) foods
3 Bayete Road, Maitland with bananas other than infant
Capetown, South Africa 40B[][]06 formula for infants
FEI# 3004299724 322395 DET-DO and children shall
7/20/05 not include calories
from fat or saturated
fat.
Tiger Food Brands Ltd. 7/20/05
54 Oxford Street, Oxford Gate
Durbanville, South Africa
FEI# 3003346630
TAIWAN (TW)
FIRM PRODUCT/PC VIOLATION
Taiwan Wachine Co. Bamboo Shoots, Product is misbranded within
4F. No 20, Nanhai Rd. Cooked the meaning of Section 403(i)
Chungcheng District 24T[][]03 (2)in that the label fails to
Taipei City 100 1/12/09 list each ingredient in the
Taiwan R.O.C. ingredient statement
FEI# 3006400613 (21 CFR 101.4(a)(1),
Undeclared Sulfites
NOTE: This bamboo product is also indicated for detention in that a chemical
preservative (sulfite) is an ingredient in the product and is not identified
as a preservative [FFD&CA Section 403(k); 21 CFR 101.22(j)].
UNITED KINGDOM (UK)
MANUFACTURER PRODUCT/PRODUCT CODE VIOLATION
Panesar Foods Ltd. Harissa Hot Chile The level of Vitamin C
Black Lake House Paste detected in the product
West Bromwich, 37K[][]99 is below the declared
United Kingdom 11/29/06 amount of Vitamin C on
FEI# 3004309147 the label and is not
within the compliance
criteria in 21 CFR
101.9(g).
Walkers Chocolates Chocolate Mint Thins Product is misbranded
Walker House Brickfield Road 34F[][]05 within the meaning of
Coventry, Birmingham 1/12/07 Section 403 (i)(2) in
United Kingdom that the product label
FEI# 3003434349 or labeling fails to
bear the required
information (e.g.
common or usual name of
each ingredient i.e
case in)
VIETNAM (VN)
MANUFACTURER PRODUCT/PRODUCT CODE VIOLATION
South Kinh Do Corporation Round Crackers Product is misbranded
6/134 13th National Road 03F[][]02 under Sec 403(r)(l)(B)
Thu Duc District 03F[][]99 in that the claim
Ho Chi Minh 5/24/05 "prevents heart attacks"
Sai Gon, Vietnam is not an authorized
FEI# 3004759430 health claim and is not
the subject of a
qualified health claim.
Mini Round Crackers Product is misbranded
03F[][]02 under Sec 403(r)(l)(B)
03F[][]99 in that the claim
5/24/05 "prevents heart attacks"
is not an authorized
health claim and is not
the subject of a
qualified health claim.
Creatures of the Sea Product is misbranded
Crackers under Sec 403(r)(l)(B)
03F[][]02 in that the claim
03F[][]99 "prevents heart attacks"
5/24/05 is not an authorized
health claim and is not
the subject of a
qualified health claim.
Mini Butter-Cheese Product is misbranded
Crackers under Sec 403(r)(l)(B)
03F[][]02 in that the claim
03F[][]99 "prevents heart attacks"
5/24/05 is not an authorized
health claim and is not
the subject of a
qualified health claim.
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