Reference Source

Nutrition Group PLC. · 99-39 · UNITED KINGDOM

For Nutrition Group PLC. · 99-39 · UNITED KINGDOM, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is UNITED KINGDOM; product is SKINADE Derma Defense A & D Boost | SKINADE Derma Defense A & D Boost | Skinade Clear CE | SKINADE Derma Defense A & D Boost | Skinade Cellulite | SKINADE Derma Defense A & D Boost | Skinade Cellulite | Skinade Clear CE | Skinade Clear CE | Skinade Cellulite | Skinade Clear CE | Skinade Cellulite | SKINADE Derma Defense A & D Boost | Skinade Clear CE | Skinade Cellulite | Skinade Cellulite | Skinade Clear CE; product code is 21 V - - 15 Mangosteen, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit | 29 C - - 99 Nonalcoholic Beverages, n.e.c. | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 46 Y - - 99 Food Additives For Human Use, N.E.C. | 46 Y - - 99 Food Additives For Human Use, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), 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. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 05/26/2020; address is Transcontinental House , Olympic Way; Lancashire , Blackpool, Bpl UNITED KINGDOM, verified against its source on 2026-09-16.

Firm
Nutrition Group PLC. verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
UNITED KINGDOM verified
Address
Transcontinental House , Olympic Way; Lancashire , Blackpool, Bpl UNITED KINGDOM verified
Date published
05/26/2020 verified
Product code
21 V - - 15 Mangosteen, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit | 29 C - - 99 Nonalcoholic Beverages, n.e.c. | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 41 Y - - 99 Dietary Conventional Foods, N.E.C. | 46 Y - - 99 Food Additives For Human Use, N.E.C. | 46 Y - - 99 Food Additives For Human Use, N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), 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. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
SKINADE Derma Defense A & D Boost | SKINADE Derma Defense A & D Boost | Skinade Clear CE | SKINADE Derma Defense A & D Boost | Skinade Cellulite | SKINADE Derma Defense A & D Boost | Skinade Cellulite | Skinade Clear CE | Skinade Clear CE | Skinade Cellulite | Skinade Clear CE | Skinade Cellulite | SKINADE Derma Defense A & D Boost | Skinade Clear CE | Skinade Cellulite | Skinade Cellulite | Skinade Clear CE each item verified
FDA 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 | 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. | The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. each item verified
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Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Nutrition Group PLC. Date Published : 05/26/2020 Transcontinental House , Olympic Way; Lancashire , Blackpool, Bpl UNITED KINGDOM 21 V - - 15 Mangosteen, Juice, Milk, Creme, Drink or Nectar, Sub/Tropical Fruit Date Published: 11/05/2020 Desc: SKINADE Derma Defense A & D Boost 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 29 C - - 99 Nonalcoholic Beverages, n.e.c. Date Published: 11/05/2020 Desc: SKINADE Derma Defense A & D Boost 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 05/26/2020 Desc: Skinade Clear CE Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 11/05/2020 Desc: SKINADE Derma Defense A & D Boost 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 41 B - - 99 Foods with Supplemental Nutrients Added, with or without Artifical Sweetners Date Published: 05/26/2020 Desc: Skinade Cellulite Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 11/05/2020 Desc: SKINADE Derma Defense A & D Boost 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 05/26/2020 Desc: Skinade Cellulite Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 05/26/2020 Desc: Skinade Clear CE Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 46 Y - - 99 Food Additives For Human Use, N.E.C. Date Published: 05/26/2020 Desc: Skinade Clear CE Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 46 Y - - 99 Food Additives For Human Use, N.E.C. Date Published: 05/26/2020 Desc: Skinade Cellulite Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 05/26/2020 Desc: Skinade Clear CE Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 05/26/2020 Desc: Skinade Cellulite Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 11/05/2020 Desc: SKINADE Derma Defense A & D Boost 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 (q) in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement," which term may be modified with the name of such an ingredient. Section 403 (e)(1) food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. Section 403 (e)(2) the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. 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 and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food. Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.; 10/29/2020 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/26/2020 Desc: Skinade Clear CE Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 05/26/2020 Desc: Skinade Cellulite Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/26/2020 Desc: Skinade Cellulite Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/26/2020 Desc: Skinade Clear CE Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act, in that it appears to be misbranded within the meaning of "Section 403 in that the label or labeling fails to bear the required nutrition information (e.g. Nutrition Facts, Supplement Facts, and serving size information). [Misbranded, Section 403 (q)]"; Specifically, the Center found the product misbranded within the meaning of Section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] because each label fails to bear the supplement facts label in accordance with 21 CFR 101.36 in that the supplements facts label of each product in not in the correct format.

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