Somafaco, SA · 99-39 · MOROCCO

Product code, Product and FDA notes

03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C. Date Published: 10/12/2023 Desc: Powder Preparation for Flan - Chocolate Hazelnut Aroma Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because it contains information in a foreign language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign languages). Required label information is not consistently repeated in all these languages on the label as required by 21 CFR 101.15(c)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (NFL) is not as defined in 21 CFR 101.9. 03 N - - 99 Sweet Goods,Custard or Cream Filled, N.E.C. Date Published: 09/16/2026 Desc: Powder preparation for Flan - Chocolate Aroma 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) in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). Specifically, the labeling contains representations in foreign languages (Arabic, French, Spanish, and Dutch), but fails to repeat all mandatory words, statements, and other information required by or under authority of the Act. Section 403(e)(1) 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. Specifically, the label states "Imported by: ALIMENTARUS CORP 11103 NY USA," which omits the mandatory city name and fails to provide a complete, valid physical address in accordance with 21 CFR 101.5(d). Section 403(i)(2) because it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient as required by 21 CFR 101.4(a)(1) and 21 CFR 101.4(b). Specifically, the English ingredient list includes the unapproved category descriptor "gelling agent: carrageenan" rather than the common or usual name "carrageenan," and lists "chocolate flavoring" which is inconsistent with the "aroma" designation in the accompanying Spanish and French text. 13 B - - 01 Custard, Regular, Vanilla or Vanillin Flavored Date Published: 10/12/2023 Desc: Powder Preparation for Flan - Chocolate Hazelnut Aroma Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because it contains information in a foreign language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign languages). Required label information is not consistently repeated in all these languages on the label as required by 21 CFR 101.15(c)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (NFL) is not as defined in 21 CFR 101.9. 13 B - - 99 Custard, N.E.C. Date Published: 09/16/2026 Desc: Powder preparation for Flan - Chocolate Aroma 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) in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). Specifically, the labeling contains representations in foreign languages (Arabic, French, Spanish, and Dutch), but fails to repeat all mandatory words, statements, and other information required by or under authority of the Act. Section 403(e)(1) 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. Specifically, the label states "Imported by: ALIMENTARUS CORP 11103 NY USA," which omits the mandatory city name and fails to provide a complete, valid physical address in accordance with 21 CFR 101.5(d). Section 403(i)(2) because it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient as required by 21 CFR 101.4(a)(1) and 21 CFR 101.4(b). Specifically, the English ingredient list includes the unapproved category descriptor "gelling agent: carrageenan" rather than the common or usual name "carrageenan," and lists "chocolate flavoring" which is inconsistent with the "aroma" designation in the accompanying Spanish and French text. 35 C - - 99 Custard Pudding (Pie) Mix, N.E.C. Date Published: 10/12/2023 Desc: Powder Preparation for Flan - Chocolate Hazelnut Aroma Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act [21 U.S.C. 343(f)] because it contains information in a foreign language; therefore, all required information must be in all languages (i.e., the English language as well as the foreign languages). Required label information is not consistently repeated in all these languages on the label as required by 21 CFR 101.15(c)(2). Section 403(q) of the Act [21 U.S.C. §343(q)] in that the nutrition facts information (NFL) is not as defined in 21 CFR 101.9. 35 C - - 99 Custard Pudding (Pie) Mix, N.E.C. Date Published: 09/16/2026 Desc: Powder preparation for Flan - Chocolate Aroma 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) in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)). Specifically, the labeling contains representations in foreign languages (Arabic, French, Spanish, and Dutch), but fails to repeat all mandatory words, statements, and other information required by or under authority of the Act. Section 403(e)(1) 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. Specifically, the label states "Imported by: ALIMENTARUS CORP 11103 NY USA," which omits the mandatory city name and fails to provide a complete, valid physical address in accordance with 21 CFR 101.5(d). Section 403(i)(2) because it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient as required by 21 CFR 101.4(a)(1) and 21 CFR 101.4(b). Specifically, the English ingredient list includes the unapproved category descriptor "gelling agent: carrageenan" rather than the common or usual name "carrageenan," and lists "chocolate flavoring" which is inconsistent with the "aroma" designation in the accompanying Spanish and French text.