IA #99-20, 11/14/94, DETENTION WITHOUT PHYSICAL EXAMINATION OF IMPORTED FOOD PRODUCTS DUE TO NLEA VIOLATIONS,
5/24/04
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 : 21007
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)]".
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)]".
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)]".
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 : David Egelhofer, Import Programs Branch, HFS-637,
202-205-4606; and Linda Wisniowski, DIOP,
301-443-6553
ATTACHMENT - FIRMS ON DWPE DUE TO NLEA VIOLATIONS 5/24/04
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)
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.
GREECE, GR
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
INDIA (IN)
FIRM NAME PRODUCT/PRODUCT CODE VIOLATION
Britannia Industries, Ltd. Jacob's Thin Arrowroot Product is misbranded under
5/1A Hungerford Street Biscuits(Britannia Brand) Sec. 403(i)(2)labeling fails
Kolkata 700017 03F[][]99 03H[][]08 to bear an ingredient statement
India 03H[][]01 03H[][]99 that lists the common or usual
FEI# 3004323793 05/24/04 name of all ingredients, i.e.
milk and milk products, dough
SHIPPER conditioner, permitted color,
antioxidant, edible vegetable
Tastel oils and edible starches are
2, Veena Vihar not listed by their common or
Dayal Das Road usual names and the sub-ingre-
Vile-parle East dients are not listed; product
Mumbai 400057 is further misbranded because
India label does not bear nutrition
FEI# 3004257599 information in the proper format.
Vita Maria Gold Biscuits Product is misbranded under
(Britannia Brand) Sec. 403(i)(2) labeling fails to
03F[][]99 03H[][]08 bear an ingredient statement 03H[][]01
03H[][]99 that lists the common or usual
05/24/04 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 subingredients are not liste
d;
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.
MEXICO, MX
FIRM: PRODUCT/ DATE OF
PRODUCT CODE DWPE 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.
Dulces Mexicanos Coconut Candy Rolls 4/4/00 Total and Sat. Fat
Revolucion #14 Sta. 33H[][]99 Labeled as 0%
Cruz de las Huertas Product assayed
Tonala, Jalisco, Mexico 7.45 and 6.35gms
FEI #3000260709 respectively per
Serving
Salud Natural ActiKrol brand Glutamic 3/27/03 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 1CFR101.36
Salud Natural Caltron 600 + D 4/16/03 Product is misbranded
Mexicano SA de CV calcium supplement because it is not
Av. Inglaterra 3109 54B- - 01 labeled as required under
Col. Arcos Sur Section 403(q)(5)(F)
Guadalajara, Mexico and 21 CFR 101.36
FEI # 3002616922
THAILAND, TH
Thai Agri Foods Public Guava drink/21V--04 07/25/01 Misdeclaration of
Company, Ltd. Tamarind drink/21V--14 iron and
155/1 Moo 1 Theparak Rd. failure to declare
Bangsaothong, Samutprakarn total percentage
10540 Thailand of fruit juice
FEI # 3002809249 contained in the product