Import Alert 40-05

Import Alert # 40-05

Published Date: 05/30/2025

Type: DWPE

***”DETENTION WITHOUT PHYSICAL EXAMINATION OF ADULTERATED AND MISBRANDED INFANT FORMULA"***

Note: The revision of this Import Alert (IA) dated 05/30/2025 updates the IA name, reason for alert, guidance including the agency contacts, charge code language and PAF. Changes to the import alert are bracketed by asterisks (***).

***Since an infant formula shortage in early 2022, the U.S. Food and Drug Administration (FDA or the Agency) and U.S. government partners have been working to expand consumer access to infant formula products, while also ensuring that these products are safe and nutritionally adequate. As we emerged from the acute crisis, the agency has participated in numerous reviews, including an evaluation of the agency’s infant formula response.

FDA has taken many steps to improve the resiliency of the infant formula supply, including by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula products in the U.S. marketplace. The agency has also taken steps to enhance the safety of powdered infant formula through the development of a Cronobacter prevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate. The revision of this import alert aligns with the Agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible.

This import alert addresses infant formulas that appear to be adulterated and/or misbranded. A detention recommendation case should be forwarded to Human Food Program – Division of Produce and Imports Enforcement, Imports Enforcement Branch.***

***Divisions may detain without physical examination shipments of identified products from firms on the Red List of this Import Alert.***

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

***Recommendations for DWPE, additions to the Red List of this import alert, require documentation of FDA’s Human Food Program – Division of Produce and Import Enforcement, Imports Enforcement Branch, for concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE addition to the Red List should be forwarded to the Division of Import Operations (DIO)***

***Release of Articles Subject to Detention Without Physical Examination (DWPE) Under this Import Alert:

***In order to secure release of an individual shipment subject to DWPE under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product meets applicable requirements. Such evidence could include:
1. Private laboratory analysis of samples.

And/or

2. Documentation supplied in English which shows the product meets
the labeling requirements for infant formula.

Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.***

***Removal from DWPE (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from DWPE, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to request removal from DWPE under this Import Alert, all relevant information supporting the request should be sent via email to:
Importalerts2@fda.hhs.gov***

***Questions or issues involving import operations should be addressed to OII/DIO at (301) 796-0356 or Imports@fda.hhs.gov

Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to fdaprivatelabimportalerts@fda.hhs.gov

Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to HFP/Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov

                                                                                                                                                           ***

Infant formula

The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that the infant
formula appears to be 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 adulterated in that it does not
meet the quality factor requirements prescribed by the
Secretary under Section 412(b)(1). [Adulteration,
Section 412(a)(2)].

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 adulterated in that the
processing of such infant formula is not in compliance
with the good manufacturing practices and the quality
control procedures prescribed by the Secretary under
Section 412(b)(2). [Adulteration, Section 412(a)(3)].

OASIS charge code: INSANITARY

And/or

The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that the infant
formula appears to be adulterated in that it contains
a poisonous and deleterious substance which may render
it injurious to health. [Adulteration, Section
402(a)(1)].

OASIS charge code: POISONOUS

And/or

The article is subject to refusal of admission
pursuant to Section 801(a)(3) in that it appears to be
adulterated within the meaning of section 402(a)(4)
because the food was prepared, packed, or held under
insanitary conditions whereby it may have been
rendered injurious to health. [Adulteration, Section
402(a)(4)].

OASIS charge code: INSANITARY

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) and (j)].

OASIS charge code: NUTR UNIT

And/or

The article is subject to refusal of admission
pursuant to Section 801(a)(3) of the FD&C Act in that
it appears to be misbranded within the meaning of
Section 403(a)(1) of the FD&C Act in that the label or
labeling is false or 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) of the FD&C Act in that
it appears to be misbranded within the meaning of
Section 403(e)(1) of the FD&C Act in that the food is
in package form and the label fails to bear the name
and place of business of the 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) of the FD&C Act in that
it appears to be misbranded within the meaning of
Section 403(e)(2) of the FD&C Act in that the food is
in package form and the label fails to bear an
accurate statement of the quantity of the contents in
terms of weight, measure, or numerical count in
accordance with Section 403(e)(2) of the FD&C Act.
[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) of the FD&C Act in that
it appears to be misbranded within the meaning of
Section 403(i)(1) of the FD&C Act in that the label
fails to bear the common or usual name of the food, if
any there be. [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) of the FD&C Act in that
it appears to be misbranded within the meaning of
Section 403(i)(2) of the FD&C Act in that it is
fabricated from two or more ingredients and the label
fails to bear the common or usual name of each such
ingredient [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) of the FD&C Act in that
it appears the label fails to declare all major food
allergens present in the product, as required by
Section 403(w)(1). [Misbranded, Section 403(w)].***

OASIS charge code: Allergen

Desc: LittleOak Natural Goat Milk Follow-on Formula (6-12 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: LittleOak Natural Goat Milk Infant Formula 1 (0-6 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: LittleOak Natural Goat Milk Follow-on Formula (6-12 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: LittleOak Natural Goat Milk Infant Formula 1 (0-6 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: LittleOak Natural Goat Milk Infant Formula 1 (0-6 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: LittleOak Natural Goat Milk Follow-on Formula (6-12 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: LittleOak Natural Goat Milk Infant Formula 1 (0-6 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: LittleOak Natural Goat Milk Follow-on Formula (6-12 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: LittleOak Natural Goat Milk Infant Formula 1 (0-6 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: LittleOak Natural Goat Milk Follow-on Formula (6-12 months)

Notes: The LittleOak Company, Australia is the shipper of the listed products. The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that they appear to be misbranded within the meaning of Section 403(a)(1)/201(n) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(n)] in that the labels are false or misleading because the products purport to be or are represented for special dietary use but do not bear the information that FDA has determined to be necessary in order to fully inform purchasers as to their value for such uses. - The product label for the LittleOak Natural Goat Milk Infant Formula contains the statements “0-6 months” and the product label for the LittleOak Natural Goat Milk Follow-on Formula contains the statement "6-12 months"; therefore, these products appear to be an infant formula intended for infants less than 12 month old. -The products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: Holle Goat Stage Pre Organic Infant Milk Formula (Holle Bio Pre Anfangsmilch aus Ziegenmilch)

Notes:                                                                                                                                                                         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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Section 403(f) of the Act in that it fails to bear all words, statements, and other information required by or under authority of the act to appear on the label or labeling in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2).

Desc: Holle Goat Stage Pre Organic Infant Milk Formula (Holle Bio Pre Anfangsmilch aus Ziegenmilch)

Notes:                                                                                                                                                                         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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Section 403(f) of the Act in that it fails to bear all words, statements, and other information required by or under authority of the act to appear on the label or labeling in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2).

Desc: HiPP Combiotic PRE Infant Milk

Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically, (1) the translation indicates that the product label contains the statements 'Anfangsmilch' which translates to 'Infant Formula' and 'Anfangsmilch von Geburt' which translates to 'Beginning milk from birth'; (2) the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: HiPP Combiotic PRE Infant Milk

Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically, (1) the translation indicates that the product label contains the statements 'Anfangsmilch' which translates to 'Infant Formula' and 'Anfangsmilch von Geburt' which translates to 'Beginning milk from birth'; (2) the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: HiPP Combiotic PRE Infant Milk

Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically, (1) the translation indicates that the product label contains the statements 'Anfangsmilch' which translates to 'Infant Formula' and 'Anfangsmilch von Geburt' which translates to 'Beginning milk from birth'; (2) the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Notes: PRODUCT: Nestle Lactogen 2 Follow Up Infant formula; CHARGE CODE: Lacks N/C, List Ingredients 4/18/2007

Notes: PRODUCT: Nestle Lactogen 2 Follow Up Infant formula; CHARGE CODE: Lacks N/C, List Ingredients 4/18/2007

Notes: PRODUCT: Nestle Lactogen 2 Follow Up Infant formula; CHARGE CODE: Lacks N/C, List Ingredients 4/18/2007

Notes: PRODUCT: Nestle Lactogen 2 Follow Up Infant formula; CHARGE CODE: Lacks N/C, List Ingredients 4/18/2007

Notes: PRODUCT: Nestle Lactogen 2 Follow Up Infant formula; CHARGE CODE: Lacks N/C, List Ingredients 4/18/2007

Notes: PRODUCT: Nestle Lactogen 2 Follow Up Infant formula; CHARGE CODE: Lacks N/C, List Ingredients 4/18/2007

Notes: PRODUCT: Nestle Lactogen 2 Follow Up Infant formula; CHARGE CODE: Lacks N/C, List Ingredients 4/18/2007

Notes: PRODUCT: Nestle Lactogen 2 Follow Up Infant formula; CHARGE CODE: Lacks N/C, List Ingredients 4/18/2007

Desc: First Infant Milk

Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Section 403(i)(2) of the FD&C Act in that the ingredients do not appear to be declared in accordance with 21 CFR 101.4. Section 403(3)(1) of the FD&C Act in that the business association of the products is not declared as required by 21 CFR 101.5. Section 403€(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity or contents in avoirdupois pound in accordance with 21 CFR 101.7.

Notes: Materna Infant Formula

Desc: EkoBaby Zuigelingenmelk 1

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Groeimelk 3

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Opvolgmelk 2

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Zuigelingenmelk 1

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Opvolgmelk 2

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Groeimelk 3

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Zuigelingenmelk 1

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Groeimelk 3

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Opvolgmelk 2

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Opvolgmelk 2

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Groeimelk 3

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: EkoBaby Zuigelingenmelk 1

Notes: The products appear to be misbranded within the meaning of Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107. Specifically (but not limited to), (1) the translated product labeling contain the statements "...When breast milk is absent or not enough, Ekobaby is a good choice..." and "According to different nutritional needs of different ages, Ekobaby infant formula products have different assortments. Ekobaby 1 is infant formula for newborn baby from 0 month, Ekobaby 2 follow on formula is for baby from 6 months old, and Ekobaby 3 growing-up formula is for baby above 10 months old"; therefore, the products appear to be infant formulas intended for infants less than 12 months old; and (2) the products do not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: Loulouka Goat Follow-On Formula

Notes: 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(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Label states “6 + months”; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: Loulouka Goat Follow-On Formula

Notes: 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(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Label states “6 + months”; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: Holle Organic Infant Follow-On Formula 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. DWPE date: 04/14/2017

Desc: Holle Organic Infant Follow-On Formula 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. DWPE date: 04/14/2017

Desc: Holle Organic Infant Follow-On Formula 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. DWPE date: 04/14/2017

Desc: Holle Organic Infant Follow-On Formula 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. DWPE date: 04/14/2017

Desc: Holle Organic Infant Follow-On Formula 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. DWPE date: 04/14/2017

Desc: Holle Organic Infant Follow-On Formula 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107.

Desc: Holle Organic Infant Follow-On Formula 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. DWPE date: 04/14/2017

Desc: Holle Organic Infant Follow-On Formula 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. DWPE date: 04/14/2017

Desc: Holle Organic Infant Formula Bio-Folgemilch 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a). DWPE date: 02/13/2017

Desc: Holle Organic Infant Powder Formula Bio 1

Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, the product label contains the statements "since birth"; therefore, it appears to be an infant formula intended for infants less than 12 month old and the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a), and Section 403(f) of the Act in that all required labeling declarations are not provided in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2). DWPE date: 03/17/2020

Desc: Holle Organic Infant Formula Bio-Folgemilch 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a). DWPE date: 02/13/2017

Desc: Holle Organic Infant Powder Formula Bio 1

Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, the product label contains the statements "since birth"; therefore, it appears to be an infant formula intended for infants less than 12 month old and the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a), and Section 403(f) of the Act in that all required labeling declarations are not provided in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2).

Desc: Holle Organic Infant Formula Bio-Folgemilch 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a). DWPE date: 02/13/2017

Desc: Holle Organic Infant Powder Formula Bio 1

Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, the product label contains the statements "since birth"; therefore, it appears to be an infant formula intended for infants less than 12 month old and the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a), and Section 403(f) of the Act in that all required labeling declarations are not provided in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2).

Desc: Holle Organic Infant Formula Bio-Folgemilch 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a). DWPE date: 02/13/2017

Desc: Holle Organic Infant Powder Formula Bio 1

Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, the product label contains the statements "since birth"; therefore, it appears to be an infant formula intended for infants less than 12 month old and the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a), and Section 403(f) of the Act in that all required labeling declarations are not provided in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2). DWPE date: 03/17/2020

Desc: Holle Organic Infant Formula Bio-Folgemilch 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a).

Desc: Holle Organic Infant Powder Formula Bio 1

Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, the product label contains the statements "since birth"; therefore, it appears to be an infant formula intended for infants less than 12 month old and the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a), and Section 403(f) of the Act in that all required labeling declarations are not provided in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2).

Desc: Holle Organic Infant Powder Formula Bio 1

Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, the product label contains the statements "since birth"; therefore, it appears to be an infant formula intended for infants less than 12 month old and the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a), and Section 403(f) of the Act in that all required labeling declarations are not provided in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2). DWPE date: 03/17/2020

Desc: Holle Organic Infant Formula Bio-Folgemilch 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a). DWPE date: 02/13/2017

Desc: Holle Organic Infant Powder Formula Bio 1

Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, the product label contains the statements "since birth"; therefore, it appears to be an infant formula intended for infants less than 12 month old and the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a), and Section 403(f) of the Act in that all required labeling declarations are not provided in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2).

Desc: Holle Organic Infant Formula Bio-Folgemilch 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a). DWPE date: 02/13/2017

Desc: Holle Organic Infant Powder Formula Bio 1

Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, the product label contains the statements "since birth"; therefore, it appears to be an infant formula intended for infants less than 12 month old and the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a), and Section 403(f) of the Act in that all required labeling declarations are not provided in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2).

Desc: Holle Organic Infant Formula Bio-Folgemilch 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a). DWPE date: 02/13/2017

Desc: Holle Organic Infant Powder Formula Bio 1

Notes: The product appears to be misbranded within the meaning of: Section 403(a)(1)/201(z) of the Act [21 U.S.C. §343(a)(1)/[21 U.S.C. § 321(z)] in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, the product label contains the statements "since birth"; therefore, it appears to be an infant formula intended for infants less than 12 month old and the product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a), and Section 403(f) of the Act in that all required labeling declarations are not provided in English as required by 21 CFR 101.15(c)(1). In addition, if the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label must appear in the foreign language as required by 21 CFR 101.15(c)(2).

Desc: Holle Organic Infant Formula Bio-Folgemilch 2

Notes: 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(a)(1)/201(z) of the Act in that the label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however, the product is not labeled as required by 21 CFR 107. Specifically, according to the English translation, this product is intended for infants after 6 months of age; therefore, it appears to be an infant formula intended for infants less than 12 month old. The product does not appear to declare nutrients in accordance with the requirements in 21 CFR 107.10(a). DWPE date: 02/13/2017

Desc: HiPP Organic Good Night Milk

Notes:                                                                                                                                                                                                                 

Desc: HiPP Organic Combiotic Anti-Reflux Milk Powder

Notes:                                                                                                                                                                                                                 

Desc: HiPP Organic Combiotic anti-reflux milk powder

Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however; the product is not labeled as required by 21 CFR 107.

Desc: HiPP Organic Good Night milk

Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however; the product is not labeled as required by 21 CFR 107.; Section 403(e)(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity or contents in avoirdupois pound in accordance with 21 CFR 101.7.

Desc: Combiotic First Infant Milk

Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old; however; the product is not labeled as required by 21 CFR 107. Section 403(e)(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity or contents in avoirdupois pound in accordance with 21 CFR 101.7.

Desc: HiPP Organic Combiotic Hungry Infant Milk

Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107; (2) Section 403 (e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared as required by 21CFR101.5(c); (3)Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label as required by 21CFR101.4 (specifically, (1)'LCP oils (fish…)' is declared on the product label, which is not in accordance with 21CFR101.4, as 'LCP' is not an appropriate common or usual name of an ingredient; (2)the ingredient declaration fails to name the common or usual name of the marine fat source(s) as required by 21CFR101.4 – note: if the fish oil is not highly refined, then the product would be required to declare the species of the fish in accordance with FALCPA).

Desc: HiPP Organic Combiotic First Infant Milk

Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107; (2) Section 403 (e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared as required by 21CFR101.5(c); (3)Section 403(w) of the Act in that the product label fails to declare all major food allergens present in the product as required by 403(w)(1) of the Act (specifically, the product contains an ingredient that is derived from fish but the species of the fish is not declared as required by FALCPA).

Desc: HiPP Organic Combiotic First Infant Milk

Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107; (2) Section 403 (e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared as required by 21CFR101.5(c); (3)Section 403(w) of the Act in that the product label fails to declare all major food allergens present in the product as required by 403(w)(1) of the Act (specifically, the product contains an ingredient that is derived from fish but the species of the fish is not declared as required by FALCPA).

Desc: HiPP Organic Combiotic Hungry Infant Milk

Notes: The product appears to be misbranded within the meaning of: (1)Section 403(a)(1)/201(z) of the FD&C Act in that the product label is false or misleading because the product purports to be an infant formula intended to be used as the sole source of nutrition by infants less than 12 months old but the product is not labeled as required by 21CFR107; (2) Section 403 (e)(1) of the Act in that the business associated to the product (address provided on product label is located in U.K. but product label also states the product is from Germany) is not declared as required by 21CFR101.5(c); (3)Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label as required by 21CFR101.4 (specifically, (1)'LCP oils (fish…)' is declared on the product label, which is not in accordance with 21CFR101.4, as 'LCP' is not an appropriate common or usual name of an ingredient; (2)the ingredient declaration fails to name the common or usual name of the marine fat source(s) as required by 21CFR101.4 – note: if the fish oil is not highly refined, then the product would be required to declare the species of the fish in accordance with FALCPA).

Desc: Combiotic Follow On Milk

Desc: First Infant Milk

Notes: As per the FDA’s Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies, dated 1/9/2023, the following products manufactured by Kendal Nutricare Ltd., Mint Bridge Road, CUMBRIA, Kendal, Cumbria GB have granted enforcement discretion by the FDA and are not subject to DWPE through 10/18/2025: Kendamil Classic First Infant Milk Stage 1; Kendamil Organic First Infant Milk Stage 1; Kendamil Goat First Infant Milk Stage 1

Desc: Follow on Milk

Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular; Section 403(e)(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity of contents; Section 403(i)(1) of the FD&C Act in that the label does not declare the common or usual name; Section 403(i)(2) of the FD&C Act in that the label or labeling fails to list ingredients by common or usual name.

Desc: Follow on Milk

Notes: Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular; Section 403(e)(2) of the FD&C Act in that the label or labeling fails to declare accurate statement of quantity of contents; Section 403(i)(1) of the FD&C Act in that the label does not declare the common or usual name; Section 403(i)(2) of the FD&C Act in that the label or labeling fails to list ingredients by common or usual name.

Desc: Aptamil Breast Milk Substitute

Notes: 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(a)(1) of the Act in that the label is false or misleading because the product is marketed specifically for children under two years of age and the label bears the claim ?Now with increased levels of LCPs (Omega 3 & Omega 6)?. This claim is not specifically permitted for use on products intended for children under two years of age. Nutrient content claims may only be made on food intended for use by infants and children less than 2 years of age if the claim is specifically provided for in Parts 101; 105; or 107 of the regulations [21 CFR 101.13(b)(3)]. 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(e)(2) of the Act because the label fails to declare accurate statement of quantity of contents statement as required in 21 CFR 101.105