Import Alert 40-05

"Detention Without Physical Examination of Infant Formula Due to Failure to Meet Nutrient and Labeling Requirements"

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 Red List 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.

Districts may detain without physical examination the infant formula(s) from the identified manufacturers on the attachment for this import alert.

For questions or issues concerning science, science policy, or analytical methodology, contact the Division of Field Science at 301 796-6600.

Refer to the Infant Formula Compliance Program (7321.006) for guidance on product coverage, sample collection, sample preparation, and sample analysis.

Infant formula

"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)]".

OASIS 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)]."

OASIS 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)]."

OASIS 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)]."

OASIS 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)]."

OASIS 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)]."

OASIS 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)]."

OASIS 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)]."

OASIS CHARGE CODE: Allergen