Holle Baby Food GmbH · 99-39 · SWITZERLAND

Product code, Product and FDA notes

40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula Date Published: 10/31/2016 Desc: Anfangs-milch 1 (infant 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(f) of the Act in that the label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1). Also; the labels appear to not comply with the requirements of 21 CFR 101.5; in part; because it appears that the business address lacks the name of the country. We further note that a statement of the country of manufacturer has little bearing on the requirements of 21 CFR 101.5. The labels appear to not comply with the requirements of 21 CFR 101.105. The net quantity of contents is not on the PDP or in the U.S. customary units. In addition; the firm should be advised that for products represented for use as an infant formula; Section 412 of the Federal Food; Drug; and Cosmetic Act requires persons responsible for the manufacture or distribution of infant formula to register and submit certain information to FDA. Failure to comply with these provisions is a prohibited act under section 301(s) of the FD&C Act. Products represented for use as an infant formula must comply with the labeling provisions of 21 CFR Part 107. Failure to comply with these regulations causes the products to be misbranded under section 403(a)/201(z) of the FD&C Act. Section 412 (a) of the Act stipulates that an infant formula is deemed adulterated if the processing of such infant formula is not in compliance with the good manufacturing practices and quality control procedures found in Title 21 of the Code of Federal Regulations Part 106. 40 P - - 01 Milk Base Infant Formula Product (0-12 months), Powder Formula Date Published: 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(e)(1) of the Act in that the business association to the product is not declared as required in 21 CFR 101.5(c). Specifically, the business addresses provided lack the name of the country. Section 403(e)(2) of the Act in that the label appears to lack the net quantity of contents statement in avoirdupois pound and ounces on the principal display panel in accordance with 21 CFR 101.105. The ingredient list appears to include the intervening material, "Germany" (21 CFR 101.2(e)). Section 403(i)(2) of the Act in that the product label fails to declare the common or usual names of each ingredient used as required by 21 CFR 101.4. For example, it appears that the foreign spelling of the words "zinc sulphate," "copper sulphate," "manganese sulphate," and "demineralised." is used. Additionally, the label appears to refer to this infant formula product as "milk" in several places. This infant formula product should not be referred to as "milk."