Reference Source

Funksjonell Mat AS · 99-39 · DENMARK

For Funksjonell Mat AS · 99-39 · DENMARK, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is DENMARK; product is Fruit Spread Forest Fruits | Fruit Spread Forest Fruits | Fruit Spread Forest Fruits | Marzipan | Sesam-mel Sesame Flour | Peanottmel Peanut Flour | Sesam-mel Sesame Flour | Sugarfree chocolate | Sugarfree chocolate | Sugarfree chocolate | Sugarfree chocolate | Sukrin Syrup With Artificial Sweetener | Sesam-mel Sesame Flour | Sukrin Plus | Fiber Syrup Clear Liquid Sweetener | Sukrin Syrup With Artificial Sweetener | Sukrin Plus | Sukrin Syrup With Artificial Sweetener | Fiber Syrup Clear Liquid Sweetener | Sukrin Plus | Sukrin Syrup With Artificial Sweetener; product code is 20 C - - 99 Berries, Jam, Jelly, Preserves, Marmalade, Butter and Candied, N.E.C. | 21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C. | 22 C - - 99 Vine Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C. | 23 D - - 01 Almond, Paste | 23 M - - 99 Edible Seed Products, N.E.C. | 23 O - - 07 Peanut, Nut Flour/Meal | 23 R - - 02 Sesame Seed (Edible Seed Paste) | 34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut) | 34 D - - 99 Chocolate and Chocolate Covered Candy, with Coconut, N.E.C. | 34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C. | 34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C. | 36 A - - 99 Sugar Products, N.E.C. | 36 A - - 99 Sugar Products, N.E.C. | 36 A - - 99 Sugar Products, N.E.C. | 36 B - - 99 Syrups and Molasses, N.E.C. | 36 B - - 99 Syrups and Molasses, N.E.C. | 36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C. | 36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C. | 36 Y - - 99 Food Sweetners (Nutritive) N.E.C. | 36 Y - - 99 Food Sweetners (Nutritive) N.E.C. | 36 Y - - 99 Food Sweetners (Nutritive) N.E.C; date published is 05/14/2019; address is Emil Neckelmanns Vej 20 , So , Odense So, Syddanmark DENMARK, verified against its source on 2026-09-16.

Firm
Funksjonell Mat AS verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
DENMARK verified
Address
Emil Neckelmanns Vej 20 , So , Odense So, Syddanmark DENMARK verified
Date published
05/14/2019 verified
Product code
20 C - - 99 Berries, Jam, Jelly, Preserves, Marmalade, Butter and Candied, N.E.C. | 21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C. | 22 C - - 99 Vine Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C. | 23 D - - 01 Almond, Paste | 23 M - - 99 Edible Seed Products, N.E.C. | 23 O - - 07 Peanut, Nut Flour/Meal | 23 R - - 02 Sesame Seed (Edible Seed Paste) | 34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut) | 34 D - - 99 Chocolate and Chocolate Covered Candy, with Coconut, N.E.C. | 34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C. | 34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C. | 36 A - - 99 Sugar Products, N.E.C. | 36 A - - 99 Sugar Products, N.E.C. | 36 A - - 99 Sugar Products, N.E.C. | 36 B - - 99 Syrups and Molasses, N.E.C. | 36 B - - 99 Syrups and Molasses, N.E.C. | 36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C. | 36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C. | 36 Y - - 99 Food Sweetners (Nutritive) N.E.C. | 36 Y - - 99 Food Sweetners (Nutritive) N.E.C. | 36 Y - - 99 Food Sweetners (Nutritive) N.E.C. each item verified
Product
Fruit Spread Forest Fruits | Fruit Spread Forest Fruits | Fruit Spread Forest Fruits | Marzipan | Sesam-mel Sesame Flour | Peanottmel Peanut Flour | Sesam-mel Sesame Flour | Sugarfree chocolate | Sugarfree chocolate | Sugarfree chocolate | Sugarfree chocolate | Sukrin Syrup With Artificial Sweetener | Sesam-mel Sesame Flour | Sukrin Plus | Fiber Syrup Clear Liquid Sweetener | Sukrin Syrup With Artificial Sweetener | Sukrin Plus | Sukrin Syrup With Artificial Sweetener | Fiber Syrup Clear Liquid Sweetener | Sukrin Plus | Sukrin Syrup With Artificial Sweetener each item verified
FDA notes
The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2). | 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(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2). | 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(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2). | 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(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2). | 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(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim. | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Lower in calories than syrup'; website: 'Low calories', 'Low carb alternative'), but the product does not meet the requirements to make such a claim; 403(i)(1) because the product label fails to bear the common or usual name of the food as required by 21 CFR 101.3 (product label implies syrup is derived from fiber, but FDA questions source of fiber based on ingredient statement); 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim. | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim. | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Lower in calories than syrup'; website: 'Low calories', 'Low carb alternative'), but the product does not meet the requirements to make such a claim; 403(i)(1) because the product label fails to bear the common or usual name of the food as required by 21 CFR 101.3 (product label implies syrup is derived from fiber, but FDA questions source of fiber based on ingredient statement); 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim. each item verified
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DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Funksjonell Mat AS Date Published : 05/14/2019 Emil Neckelmanns Vej 20 , So , Odense So, Syddanmark DENMARK 20 C - - 99 Berries, Jam, Jelly, Preserves, Marmalade, Butter and Candied, N.E.C. Date Published: 06/26/2019 Desc: Fruit Spread Forest Fruits Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 21 C - - 99 Mixed Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C. Date Published: 06/26/2019 Desc: Fruit Spread Forest Fruits Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 22 C - - 99 Vine Fruit, Jam, Jelly, Preserves, Marmalade, Butter or Candied, N.E.C. Date Published: 06/26/2019 Desc: Fruit Spread Forest Fruits Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'No Added Sugar'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 23 D - - 01 Almond, Paste Date Published: 06/26/2019 Desc: Marzipan Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 23 M - - 99 Edible Seed Products, N.E.C. Date Published: 06/26/2019 Desc: Sesam-mel Sesame Flour Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 23 O - - 07 Peanut, Nut Flour/Meal Date Published: 06/26/2019 Desc: Peanottmel Peanut Flour Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 23 R - - 02 Sesame Seed (Edible Seed Paste) Date Published: 06/26/2019 Desc: Sesam-mel Sesame Flour Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut) Date Published: 05/14/2019 Desc: Sugarfree chocolate Notes: 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(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2). 34 D - - 99 Chocolate and Chocolate Covered Candy, with Coconut, N.E.C. Date Published: 05/14/2019 Desc: Sugarfree chocolate Notes: 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(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2). 34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C. Date Published: 05/14/2019 Desc: Sugarfree chocolate Notes: 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(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2). 34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C. Date Published: 05/14/2019 Desc: Sugarfree chocolate Notes: 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(q) of the Act [21 U.S.C. §343(q)] in that the nutrition information (e.g. Nutrition Facts label) does not conform to the US format as required by 21 CFR 101.9. Section 403(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)], label bears a nutrient content claim but fails to meet the requirements to bear such claims for "No added sugar", 21 CFR 101.60(c)(2)(v), Section 21 CFR 101.60(b)(2), and Section (21 CFR 101.60(b)(4). Products contain erythritol which appears to be a sugar alcohol, and is not declared on Nutrition Facts, section 21 CFR 101.9(c)(6)(iv). Section 403(e)(2) of the Act [21 U.S.C. §343(e)(2)], label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7. The term "net weight" shall be used when stating the net quantity of contents in terms of weight, 21 CFR 101.7(j)(3). Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that the ingredients do not appear to be listed in descending order of predominance by weight, in accordance with 21 CFR 101.4(a)(1). "Cocoa mass", "cocoa solids" and "milk solids" do not appear to be an appropriate common or usual name for these ingredients. 21 CFR 101.4 Section 403(f) of the Act [21 U.S.C. §343(f)], product labels contain information in more than one language, but does not repeat all the required information in all languages, 21 CFR 101.5(c), 21 CFR 101.15(c)(2). 36 A - - 99 Sugar Products, N.E.C. Date Published: 05/14/2019 Desc: Sukrin Syrup With Artificial Sweetener 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(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim. 36 A - - 99 Sugar Products, N.E.C. Date Published: 06/26/2019 Desc: Sesam-mel Sesame Flour Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(f) because all required statements are not written in English as required by 21 CFR 101.15(c)(1); 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Rich In Protein'), but the product does not meet the requirements to make such a claim; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 36 A - - 99 Sugar Products, N.E.C. Date Published: 02/12/2020 Desc: Sukrin Plus Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 36 B - - 99 Syrups and Molasses, N.E.C. Date Published: 06/26/2019 Desc: Fiber Syrup Clear Liquid Sweetener Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Lower in calories than syrup'; website: 'Low calories', 'Low carb alternative'), but the product does not meet the requirements to make such a claim; 403(i)(1) because the product label fails to bear the common or usual name of the food as required by 21 CFR 101.3 (product label implies syrup is derived from fiber, but FDA questions source of fiber based on ingredient statement); 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 36 B - - 99 Syrups and Molasses, N.E.C. Date Published: 05/14/2019 Desc: Sukrin Syrup With Artificial Sweetener 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(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim. 36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C. Date Published: 02/12/2020 Desc: Sukrin Plus Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 36 D - - 99 Imitation Syrups, Molasses and Honey, N.E.C. Date Published: 05/14/2019 Desc: Sukrin Syrup With Artificial Sweetener 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(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim. 36 Y - - 99 Food Sweetners (Nutritive) N.E.C. Date Published: 06/26/2019 Desc: Fiber Syrup Clear Liquid Sweetener Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(r)(1)(A) because the product label bears a nutrient content claim (i.e. 'Lower in calories than syrup'; website: 'Low calories', 'Low carb alternative'), but the product does not meet the requirements to make such a claim; 403(i)(1) because the product label fails to bear the common or usual name of the food as required by 21 CFR 101.3 (product label implies syrup is derived from fiber, but FDA questions source of fiber based on ingredient statement); 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 36 Y - - 99 Food Sweetners (Nutritive) N.E.C. Date Published: 02/12/2020 Desc: Sukrin Plus Notes: The article appears to be misbranded within the meaning of the following section of the FD&C Act: 403(q) because the Nutrition Facts information is not in an appropriate format as defined in 21 CFR 101.9; 403(e)(1) because the product label fails to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 36 Y - - 99 Food Sweetners (Nutritive) N.E.C. Date Published: 05/14/2019 Desc: Sukrin Syrup With Artificial Sweetener 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(r)(1)(A) the Act [21 U.S.C. §343(R)(1)(a)] because the product labeling bears nutrient content claims but fails to meet the requirements to bear such claim.

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