IA #40-05, 4/18/07 IMPORT ALERT #40-05, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF INFANT FORMULA DUE TO FAILURE TO MEET NUTRIENT AND LABELING
REQUIREMENTS" ATTACHMENT REVISED 9/20/07
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 product(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: Infant formula
PRODUCT
CODE: 40 C [][][][]
PROBLEM: Nutrient deficiency
Labeling violations
PAC: 21006
PAF: NIS - Nutrition
LBL - Labeling
COUNTRY: All countries
MANUFACTURER/
SHIPPER: See attachments
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a)(3)in that the infant formula appears to
adulterated in that it does not provide the nutrients
required by 21 CFR 107.100 [Adulteration, Section
412(a)(1)]".
CHARGE CODE: NUTR DEF
and/or
"The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that the infant formula appears to be
misbranded within the meaning of Section 403 in that the
labeling fails to use the proper units to declare the
nutrients as specified in 21 CFR 107.10 [Misbranded, Section
403(f)]."
CHARGE CODE: NUTR UNIT
and/or
"The article is subject to refusal of admission pursuant to
Section 801(a)(3)in that the infant formula appears to be
misbranded within the meaning of Section 403 in that the
label or labeling is false and misleading in any particular
[Misbranded, Section 403(a)(1)]."
CHARGE CODE: FALSE
and/or
"The article is subject to refusal of admission pursuant to
Section 801(a)(3)in that the infant formula appears to be
misbranded within the meaning of Section 403 in that the
label or labeling fails to declare the name and place of
business of manufacturer, packer, or distributor
[Misbranded, Section 403(e)(1)]."
CHARGE CODE: Lacks Firm
and/or
"The article is subject to refusal of admission pursuant to
Section 801(a)(3)in that the infant formula appears to be
misbranded within the meaning of Section 403 in that the
label or labeling fails to declare accurate statement of
quantity of contents [Misbranded, Section 403(e)(2)]."
CHARGE CODE: Lacks N/C
and/or
"The article is subject to refusal of admission pursuant to
Section 801(a)(3)in that the infant formula appears to be
misbranded within the meaning of Section 403 in that the
label does not declare the common or usual name [Misbranded,
Section 403(i)(1)]."
CHARGE CODE: Usual Name
and/or
"The article is subject to refusal of admission pursuant to
Section 801(a)(3)in that the infant formula appears to be
misbranded within the meaning of Section 403 in that the
label or labeling fails to list ingredients by common or
usual name [Misbranded, Section 403(i)(2)]."
CHARGE CODE: List Ingre
and/or
"The article is subject to refusal of admission pursuant to
Section 801(a)(3)in that the infant formula appears to be
misbranded within the meaning of Section 403 in that the
label or labeling fails to declare allergens [Misbranded,
Section 403(w)]."
CHARGE CODE: Allergen
RECOMMENDING
OFFICE: CFSAN/Division of Enforcement, Imports Branch (HFS-606)
CFSAN/Office of Nutritional Products, Labeling and Dietary
Supplements (HFS-800)
CFSAN/Division of Field Programs, Compliance Programs Branch
(HFS-636)
REASON FOR
ALERT: In June 2004, infant formula manufactured in China was found
on the store shelves of an Asian retail store in the
Chinatown section of Manhattan New York. On July 9, 2004,
FDA warned consumers not to feed their infants infant
formula from China because the safety and nutritional
adequacy of infant formula from China is unknown.
In September 2005, CFSAN issued the "Unregistered Infant
Formula at Ethnic Retail Establishments" field assignment.
As a result of this assignment, samples of unregistered
infant formulas from India and Israel were collected and
based on the analyses, certain nutrients were inadequately
declared on the label and there were also significant
labeling violations found on the product labels.
Domestic and foreign manufacturers of infant formula who
intend to introduce new infant formula into interstate
commerce must first provide CFSAN's Office of Nutritional
Products, Labeling and Dietary Supplements (ONPLDS) written
notification at least 90 days prior to marketing the
formula. The notification must contain the name of such
person, the place of business of such person, and all
establishments at which such person intends to manufacture
such new infant formula. (Refer to Section 412 of the FD&C
Act for other provisions applicable to infant formula).
Districts should not detain infant formula products solely
on the basis that the manufacturer has not provided this
notification to FDA. The products listed on the attachment
for this alert have either been analyzed by FDA and they do
not meet the nutrient requirements applicable to infant
formula as specified in 21 CFR 107.100 or were found to be
misbranded due to labeling violations.
GUIDANCE: Districts may detain without physical examination the infant
formula(s) from the identified manufacturers on the
attachment to this import alert.
For questions or issues concerning science, science policy,
or analytical methodology, contact the Division of Field
Science at (301) 827-7605.
Refer to the Infant Formula Compliance Program (7321.006)
for guidance on product coverage, sample collection, sample
preparation, and sample analysis.
PRIORITIZATION
GUIDANCE: I
FOI: No purging required.
KEYWORDS: Infant Formula, Nutrient deficiency, Labeling
PREPARED BY: Ted Poplawski, DIOP (HFC-170)
Rosemary Gary, CFSAN/Division of Enforcement, Imports
Branch, HFS-606
DATE LOADED
INTO FIARS: April 18, 2007
ATTACHMENT TO IMPORT ALERT #40-05 9/20/07
Foreign Manufacturers of Adulterated and/or misbranded Infant Formula
INDIA (IN)
MANUFACTURER PRODUCT CHARGE CODE
Nestle India Limited Nestle Lactogen 2 Lacks N/C,
M-5A, Connaught Circus Follow Up Infant formula List Ingre
New Delhi, India 110001
FEI# 3004494164
ISRAEL (IL)
MANUFACTURER PRODUCT CHARGE CODE
Materna Laboratories Ltd. Materna Infant NUTR DEF, 412(a)(1)
Kibutz Maabarot 40230 Formula NUTR UNIT, 403(f)
Post Maabarot, Israel 40C[][][][] LIST INGRE, 403(i)(2)
FEI# 3005336410 9/20/07
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