Reference Source

Da Cheng Vegetarian International Co., Ltd. · 99-39 · TAIWAN

For Da Cheng Vegetarian International Co., Ltd. · 99-39 · TAIWAN, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is TAIWAN; product is Vegan Ham | VEGAN CHICKEN CUBE | VEGAN CHICKEN CUBE | VEGAN CHICKEN GENG | Vegan Drum Stick | Vegan Chicken Ham | VEGAN CHICKEN CUBE | Vegan Golden Nugget | Vegan Ham | Vegan Golden Nugget | Vegan Chicken Ham | VEGAN CHICKEN CUBE | Vegan Drum Stick | Vegan Golden Nugget | Vegan Drum Stick | Vegan Drum Stick | Vegan Golden Nugget | VEGAN CODFISH STEAK | VEGAN CODFISH STEAK | Vegan Ham | Vegan Golden Nugget | VEGAN CODFISH STEAK | Vegan Drum Stick | Vegan Chicken Ham | VEGAN CHICKEN GENG | Vegan Chicken Ham | VEGAN CHICKEN GENG | Vegan Chicken Ham | Vegan Chicken Ham | Vegan Ham; product code is 18 A - - 05 Meat-Textured Vegetable Protein Product with Appearance of Red Meat Portion | 18 B - - 01 Chicken-Flavored Crumbs or Chips (Vegetable Protein) | 18 B - - 02 Chicken-Flavored Loaf (Vegetable Protein) | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. | 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. | 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. | 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. | 18 C - - 02 Poultry-Like Combinations (Vegetable Proteins) | 18 C - - 02 Poultry-Like Combinations (Vegetable Proteins) | 18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C. | 18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C. | 18 D - - 01 Fish-Textured Vegetable Protein (Products having Appearance of Fish Portions, Fillets, Etc.) | 18 E - - 03 Soybean Protein Powder (Meat Extender) | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C. | 25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C. | 37 B - - 32 Bean curd, n.e.c. (Multiple Food Specialties, Side Dishes & Desserts) | 37 K - - 17 Bean, Ground Paste | 37 K - - 17 Bean, Ground Paste; date published is 03/21/2023; address is No. 268, Wuhe St., , Qionglin Township,, Hsinchu County TAIWAN, verified against its source on 2026-09-16.

Firm
Da Cheng Vegetarian International Co., Ltd. verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
TAIWAN verified
Address
No. 268, Wuhe St., , Qionglin Township,, Hsinchu County TAIWAN verified
Date published
03/21/2023 verified
Product code
18 A - - 05 Meat-Textured Vegetable Protein Product with Appearance of Red Meat Portion | 18 B - - 01 Chicken-Flavored Crumbs or Chips (Vegetable Protein) | 18 B - - 02 Chicken-Flavored Loaf (Vegetable Protein) | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions | 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. | 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. | 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. | 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. | 18 C - - 02 Poultry-Like Combinations (Vegetable Proteins) | 18 C - - 02 Poultry-Like Combinations (Vegetable Proteins) | 18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C. | 18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C. | 18 D - - 01 Fish-Textured Vegetable Protein (Products having Appearance of Fish Portions, Fillets, Etc.) | 18 E - - 03 Soybean Protein Powder (Meat Extender) | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. | 25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C. | 25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C. | 37 B - - 32 Bean curd, n.e.c. (Multiple Food Specialties, Side Dishes & Desserts) | 37 K - - 17 Bean, Ground Paste | 37 K - - 17 Bean, Ground Paste each item verified
Product
Vegan Ham | VEGAN CHICKEN CUBE | VEGAN CHICKEN CUBE | VEGAN CHICKEN GENG | Vegan Drum Stick | Vegan Chicken Ham | VEGAN CHICKEN CUBE | Vegan Golden Nugget | Vegan Ham | Vegan Golden Nugget | Vegan Chicken Ham | VEGAN CHICKEN CUBE | Vegan Drum Stick | Vegan Golden Nugget | Vegan Drum Stick | Vegan Drum Stick | Vegan Golden Nugget | VEGAN CODFISH STEAK | VEGAN CODFISH STEAK | Vegan Ham | Vegan Golden Nugget | VEGAN CODFISH STEAK | Vegan Drum Stick | Vegan Chicken Ham | VEGAN CHICKEN GENG | Vegan Chicken Ham | VEGAN CHICKEN GENG | Vegan Chicken Ham | Vegan Chicken Ham | Vegan Ham each item verified
FDA notes
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. | 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 because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12). | 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 because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12). | 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(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act [21 U.S.C. § 343(i) (2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product(s) bear(s) or contain an artificial flavoring, coloring, or chemical preservative. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the Nutrition Facts label (NFL) is not as defined in 21 CFR 101.9. | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. | 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 because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12). | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. | 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 because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12). | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | 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) because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. | 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) because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | 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) because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. | The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. | 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(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act [21 U.S.C. § 343(i) (2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product(s) bear(s) or contain an artificial flavoring, coloring, or chemical preservative. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the Nutrition Facts label (NFL) is not as defined in 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. | 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(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act [21 U.S.C. § 343(i) (2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product(s) bear(s) or contain an artificial flavoring, coloring, or chemical preservative. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the Nutrition Facts label (NFL) is not as defined in 21 CFR 101.9. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. | The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. each item verified
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DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Da Cheng Vegetarian International Co., Ltd. Date Published : 03/21/2023 No. 268, Wuhe St., , Qionglin Township,, Hsinchu County TAIWAN 18 A - - 05 Meat-Textured Vegetable Protein Product with Appearance of Red Meat Portion Date Published: 06/08/2023 Desc: Vegan Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 18 B - - 01 Chicken-Flavored Crumbs or Chips (Vegetable Protein) Date Published: 08/21/2023 Desc: VEGAN CHICKEN CUBE 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 because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12). 18 B - - 02 Chicken-Flavored Loaf (Vegetable Protein) Date Published: 08/21/2023 Desc: VEGAN CHICKEN CUBE 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 because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12). 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions Date Published: 04/22/2024 Desc: VEGAN CHICKEN GENG 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(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act [21 U.S.C. § 343(i) (2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product(s) bear(s) or contain an artificial flavoring, coloring, or chemical preservative. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the Nutrition Facts label (NFL) is not as defined in 21 CFR 101.9. 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions Date Published: 03/21/2023 Desc: Vegan Drum Stick Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions Date Published: 06/08/2023 Desc: Vegan Chicken Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions Date Published: 08/21/2023 Desc: VEGAN CHICKEN CUBE 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 because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12). 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions Date Published: 03/21/2023 Desc: Vegan Golden Nugget Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 B - - 03 Vegetable Protein Product, Meat Textured, with Appearance of Poultry Portions Date Published: 06/08/2023 Desc: Vegan Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. Date Published: 03/21/2023 Desc: Vegan Golden Nugget Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. Date Published: 06/08/2023 Desc: Vegan Chicken Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. Date Published: 08/21/2023 Desc: VEGAN CHICKEN CUBE 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 because it contains information in a second language, Chinese; therefore, all required information must be in both languages. For example, the ingredient statement, net quantity of contents, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required by 21 CFR 101.4. Section 403(q) of the Act in that the nutrition information (e.g., Nutrition Facts label) is not as required by 21 CFR 101.9. Specifically, the serving size does not appear to be in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Reference Amount Customarily Consumed (RACC) of “85g cooked; 110g uncooked.” The product label declares a “Serving Size (100g)” and “30 servings per container.” Therefore, all nutrient amounts are incorrectly declared (21 CFR 101.12). 18 B - - 99 Poultry-Like Products (Vegetable Protein), N.E.C. Date Published: 03/21/2023 Desc: Vegan Drum Stick Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 C - - 02 Poultry-Like Combinations (Vegetable Proteins) Date Published: 03/21/2023 Desc: Vegan Golden Nugget Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 C - - 02 Poultry-Like Combinations (Vegetable Proteins) Date Published: 03/21/2023 Desc: Vegan Drum Stick Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C. Date Published: 03/21/2023 Desc: Vegan Drum Stick Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 C - - 99 Combination Meat-Like Vegetable Protein Products, N.E.C. Date Published: 03/21/2023 Desc: Vegan Golden Nugget Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 D - - 01 Fish-Textured Vegetable Protein (Products having Appearance of Fish Portions, Fillets, Etc.) Date Published: 06/08/2023 Desc: VEGAN CODFISH STEAK 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) because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. 18 E - - 03 Soybean Protein Powder (Meat Extender) Date Published: 06/08/2023 Desc: VEGAN CODFISH STEAK 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) because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. Date Published: 06/08/2023 Desc: Vegan Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. Date Published: 03/21/2023 Desc: Vegan Golden Nugget Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. Date Published: 06/08/2023 Desc: VEGAN CODFISH STEAK 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) because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. Date Published: 03/21/2023 Desc: Vegan Drum Stick Notes: The articles are subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that they appear to be misbranded within the meaning of: Section 403(e)(2) of the Act and section 1453(a)(2) and (3) of the Fair Packaging and Labeling Act (FPLA). [21 U.S.C. § 343(e)(2) and 15 U.S.C. § 1453(a)(2) and (3)], because they fail to bear an accurate statement of the net quantity of contents in terms of pounds, with any remainder in terms of ounces or common or decimal fractions of the pound, followed by the metric statement. Section 403(f) of the Act [21 U.S.C. §343(f)], because it contains information in a second language, Chinese; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)], in that the products are fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(q) of the Act [21 U.S.C. § 343(q)], in that the nutrition information (e.g. NFP) is not as required by 21 CFR 101.9. 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. Date Published: 06/08/2023 Desc: Vegan Chicken Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 18 Y - - 99 Vegetable Protein Products Not Elsewhere Mentioned, N.E.C. Date Published: 04/22/2024 Desc: VEGAN CHICKEN GENG 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(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act [21 U.S.C. § 343(i) (2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product(s) bear(s) or contain an artificial flavoring, coloring, or chemical preservative. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the Nutrition Facts label (NFL) is not as defined in 21 CFR 101.9. 25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C. Date Published: 06/08/2023 Desc: Vegan Chicken Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 25 Y - - 99 Vegetable & Vegetable Products Not Mentioned Elsewhere, N.E.C. Date Published: 04/22/2024 Desc: VEGAN CHICKEN GENG 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(a)(1) of the Act [21 U.S.C. §343(a)(1)] in that the label is false or misleading. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the product label contains information in two languages but does not repeat all the required information in both languages. Section 403(i)(2) of the Act [21 U.S.C. § 343(i) (2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Section 403(k) of the Act [21 U.S.C. § 343(k)] because the product(s) bear(s) or contain an artificial flavoring, coloring, or chemical preservative. Section 403(q) of the Act [21 U.S.C. § 343(q)] in that the Nutrition Facts label (NFL) is not as defined in 21 CFR 101.9. 37 B - - 32 Bean curd, n.e.c. (Multiple Food Specialties, Side Dishes & Desserts) Date Published: 06/08/2023 Desc: Vegan Chicken Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 37 K - - 17 Bean, Ground Paste Date Published: 06/08/2023 Desc: Vegan Chicken Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label. “Vegan seasoning” and “Vegan Binder” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient; “[V]egan binder”, “Non-GMO Textured Soybean Protein” are not declared by an appropriate common or usual name (21 CFR 101.4). Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)]. 37 K - - 17 Bean, Ground Paste Date Published: 06/08/2023 Desc: Vegan Ham Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to be misbranded within the meaning of: Section 403(f) of the Act because it contains information in multiple languages; therefore, all required information must be in all represented languages (i.e., English language and foreign language). Nutrition Facts label, and the ingredient statement must be declared in both the foreign language and English (21 CFR 101.15(c)(2)). Section 403(q) of the Act in that the nutrition information (e.g. Nutrition Facts Panel) is not as required by 21 CFR 101.9. Serving size does is not in accordance with 21 CFR 101.12(b), Table 2, for the “Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Entrees without sauce” product category with a Referenced Amount Customarily Consumed of “85 g cooked; 110 g uncooked.” The product label declares a “Serving Size 1/10 pieces (100 g)” and “10 Servings per container.” Quantitative amount of calcium must use the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8) (III) and (iv). Section 403(i)(2) of the Act in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label (21 CFR 101.4). “Vegan seasoning” and “soya sauce” appear to be a multicomponent food and the sub-ingredients are not declared (21 CFR 101.4(b)(2)). “Non-GMO” is not part of the common or usual name of any ingredient. Component ingredients (or “sub-ingredients”) may parenthetically list component ingredients after the common or usual name of main ingredient [21 CFR 101.4(b)(2)(i)], or by listing component ingredients without listing the ingredient itself [21 CFR 101.4(b)(2)(ii)].

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