FERNANDEZ Y CANIVELL SA · 99-39 · SPAIN
For FERNANDEZ Y CANIVELL SA · 99-39 · SPAIN, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is SPAIN; product is CEREGUMIL ROYAL JELLY CAPS | CEREGUMIL ORIGINAL 200ML | CEREGUMIL KIDS 250ML | CEREGUMIL LIQUID IRON 250ML | CEREGUMIL VITAMIX PLUS CAPS | Cereguimil | CEREGUMIL VITAMIX 250ML/500ML; product code is 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C; date published is 03/29/2016; address is Calle Severo Ochoa 13 , Malaga, Malaga SPAIN, verified against its source on 2026-09-16.
- Firm
- FERNANDEZ Y CANIVELL SA verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- SPAIN verified
- Address
- Calle Severo Ochoa 13 , Malaga, Malaga SPAIN verified
- Date published
- 03/29/2016 verified
- Product code
- 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. | 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. each item verified
- Product
- CEREGUMIL ROYAL JELLY CAPS | CEREGUMIL ORIGINAL 200ML | CEREGUMIL KIDS 250ML | CEREGUMIL LIQUID IRON 250ML | CEREGUMIL VITAMIX PLUS CAPS | Cereguimil | CEREGUMIL VITAMIX 250ML/500ML each item verified
- FDA notes
- The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). | The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). | The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). | The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). | The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). | The article is subject to refusal of admission pursuant to section 801(a) (3) in that the product is misbranded within the meaning of section 403 (i)(2) [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label; as required by 21 CFR 101.4(b)(2). We object to the way "syrup" is used in the ingredient statement. Syrup should not be listed in the ingredient statement unless it is actually used as an ingredient. If syrup is used as an ingredient; the manufacturer may declare syrup on the ingredient statement by either listing the component ingredients (sub-ingredients) used to make the syrup (e.g. water; honey; sugar) (21 CFR 101.4(b)(2) (ii)) or by listing syrup followed by a parenthetical declaration of each sub-ingredient (e.g. syrup (water; honey; sugar)) (21 CFR 101.4(b)(2) (i)). Under the first alternative; the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative; the component ingredients must be listed in descending order of predominance in the finished food. (21 CFR 101.4(a)) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded with the meaning of section 403(f) [21 U.S.C. 343(f)] because the product label contains information in two languages but does not repeat all the required label information in both languages. For example; the supplement facts label and ingredients list are presented in English only. In accordance with 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; 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 Published on 06/25/2015 | The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). each item verified
What the source says
FERNANDEZ Y CANIVELL SA Date Published : 03/29/2016 Calle Severo Ochoa 13 , Malaga, Malaga SPAIN 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/10/2017 Desc: CEREGUMIL ROYAL JELLY CAPS Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/10/2017 Desc: CEREGUMIL ORIGINAL 200ML Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/10/2017 Desc: CEREGUMIL KIDS 250ML Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/10/2017 Desc: CEREGUMIL LIQUID IRON 250ML Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/10/2017 Desc: CEREGUMIL VITAMIX PLUS CAPS Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a). 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 03/29/2016 Desc: Cereguimil Notes: The article is subject to refusal of admission pursuant to section 801(a) (3) in that the product is misbranded within the meaning of section 403 (i)(2) [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and each ingredient is not declared on the label; as required by 21 CFR 101.4(b)(2). We object to the way "syrup" is used in the ingredient statement. Syrup should not be listed in the ingredient statement unless it is actually used as an ingredient. If syrup is used as an ingredient; the manufacturer may declare syrup on the ingredient statement by either listing the component ingredients (sub-ingredients) used to make the syrup (e.g. water; honey; sugar) (21 CFR 101.4(b)(2) (ii)) or by listing syrup followed by a parenthetical declaration of each sub-ingredient (e.g. syrup (water; honey; sugar)) (21 CFR 101.4(b)(2) (i)). Under the first alternative; the component ingredients must be listed in descending order of predominance within the multi-component ingredient; and under the second alternative; the component ingredients must be listed in descending order of predominance in the finished food. (21 CFR 101.4(a)) The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded with the meaning of section 403(f) [21 U.S.C. 343(f)] because the product label contains information in two languages but does not repeat all the required label information in both languages. For example; the supplement facts label and ingredients list are presented in English only. In accordance with 21 CFR 101.15(c); if a product label contains any representation in a foreign language or foreign characters; 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 Published on 06/25/2015 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 08/10/2017 Desc: CEREGUMIL VITAMIX 250ML/500ML Notes: The product appears to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of the nutrition information on the labeling of the products does not comply with 21 CFR 101.36. Specifically, the Ceregumil product labels fail to declare the source of the dietary ingredient, e.g., vitamins and minerals, in the Supplement Facts panel. Ingredients that are sources of dietary ingredients may be listed either in the Supplement Facts panel (e.g., "Calcium (as calcium carbonate)" or in the ingredient statement (also called an ingredient list), or in both, in accordance with 21 CFR 101.36(d), 101.4(g), and 101.4(a).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
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