Huychun (Thailand) · 99-39 · THAILAND
For Huychun (Thailand) · 99-39 · THAILAND, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is THAILAND; product is Falooda Basil Seed Milkshake (Mango) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Rose) | Falooda Drink with Almond (Banana Flavor) | Falooda Drink with Almond (Strawberry Flavor) | Falooda Drink with Almond (Rose Flavor) | Falooda Drink with Almond (Mango Flavor) | Falooda Drink with Almond (Mango Flavor) | Falooda Drink with Almond (Rose Flavor) | Falooda Drink with Almond (Banana Flavor) | Falooda Drink with Almond (Strawberry Flavor) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Rose) | Falooda Basil Seed Milkshake (Mango) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Mango) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Rose) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Mango) | Falooda Basil Seed Milkshake (Rose) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Rose) | Falooda Basil Seed Milkshake (Mango); product code is 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated | 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated | 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated | 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - -- Noncarb Soft Drink | 29 A - - -- Noncarb Soft Drink | 29 A - - -- Noncarb Soft Drink | 29 A - - -- Noncarb Soft Drink | 29 A - - -- Noncarb Soft Drink | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 30 A - - -- Fruit Beverage Base | 30 A - - -- Fruit Beverage Base | 30 A - - -- Fruit Beverage Base | 30 A - - -- Fruit Beverage Base | 30 A - - -- Fruit Beverage Base | 30 Y - - -- Beverage Base N.E.C. | 30 Y - - -- Beverage Base N.E.C. | 30 Y - - -- Beverage Base N.E.C. | 30 Y - - -- Beverage Base N.E.C. | 30 Y - - -- Beverage Base N.E.C; date published is 05/23/2019; address is 16/3 Moo 2 Nongpaklong A. Muang , Nakornpatom, TH-73 THAILAND, verified against its source on 2026-09-16.
- Firm
- Huychun (Thailand) verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- THAILAND verified
- Address
- 16/3 Moo 2 Nongpaklong A. Muang , Nakornpatom, TH-73 THAILAND verified
- Date published
- 05/23/2019 verified
- Product code
- 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink | 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated | 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated | 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated | 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - 99 Noncarbonated Soft Drink, N.E.C. | 29 A - - -- Noncarb Soft Drink | 29 A - - -- Noncarb Soft Drink | 29 A - - -- Noncarb Soft Drink | 29 A - - -- Noncarb Soft Drink | 29 A - - -- Noncarb Soft Drink | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 29 R - - -- Noncarbonated Water (Nonmedicinal) | 30 A - - -- Fruit Beverage Base | 30 A - - -- Fruit Beverage Base | 30 A - - -- Fruit Beverage Base | 30 A - - -- Fruit Beverage Base | 30 A - - -- Fruit Beverage Base | 30 Y - - -- Beverage Base N.E.C. | 30 Y - - -- Beverage Base N.E.C. | 30 Y - - -- Beverage Base N.E.C. | 30 Y - - -- Beverage Base N.E.C. | 30 Y - - -- Beverage Base N.E.C. each item verified
- Product
- Falooda Basil Seed Milkshake (Mango) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Rose) | Falooda Drink with Almond (Banana Flavor) | Falooda Drink with Almond (Strawberry Flavor) | Falooda Drink with Almond (Rose Flavor) | Falooda Drink with Almond (Mango Flavor) | Falooda Drink with Almond (Mango Flavor) | Falooda Drink with Almond (Rose Flavor) | Falooda Drink with Almond (Banana Flavor) | Falooda Drink with Almond (Strawberry Flavor) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Rose) | Falooda Basil Seed Milkshake (Mango) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Mango) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Rose) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Mango) | Falooda Basil Seed Milkshake (Rose) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Strawberry) | Falooda Basil Seed Milkshake (Banana) | Falooda Basil Seed Milkshake (Kulfi) | Falooda Basil Seed Milkshake (Rose) | Falooda Basil Seed Milkshake (Mango) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. | The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. | 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. each item verified
What the source says
Huychun (Thailand) Date Published : 05/23/2019 16/3 Moo 2 Nongpaklong A. Muang , Nakornpatom, TH-73 THAILAND 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Mango) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Kulfi) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Strawberry) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Banana) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 21 V - - -- Sub/Trop Fruit Juice Conc./Milk/Creme/Nectar/Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Rose) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated Date Published: 05/23/2019 Desc: Falooda Drink with Almond (Banana Flavor) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated Date Published: 05/23/2019 Desc: Falooda Drink with Almond (Strawberry Flavor) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated Date Published: 05/23/2019 Desc: Falooda Drink with Almond (Rose Flavor) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated Date Published: 05/23/2019 Desc: Falooda Drink with Almond (Mango Flavor) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. 29 A - - 99 Noncarbonated Soft Drink, N.E.C. Date Published: 05/23/2019 Desc: Falooda Drink with Almond (Mango Flavor) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. 29 A - - 99 Noncarbonated Soft Drink, N.E.C. Date Published: 05/23/2019 Desc: Falooda Drink with Almond (Rose Flavor) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. 29 A - - 99 Noncarbonated Soft Drink, N.E.C. Date Published: 05/23/2019 Desc: Falooda Drink with Almond (Banana Flavor) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. 29 A - - 99 Noncarbonated Soft Drink, N.E.C. Date Published: 05/23/2019 Desc: Falooda Drink with Almond (Strawberry Flavor) Notes: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded within the meaning of: Section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] in that they fail to bear a common or usual name of the food, as required by 21 CFR 101.3. "Falooda" appears to be a foreign language term used to describe this food. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that they are fabricated from two or more ingredients, but each ingredient is not declared on the label, as required by 21 CFR 101.4, and products which purport to contain juice due to the explicit vignette of the fruits but fail to bear a percent juice declaration in accordance with 21 CFR 101.30(b). Section 403(a)(1)) of the Act [21 U.S.C. § 343(a)(1)] in that the label is false and misleading. Based on the ingredient list, the characterizing flavor for all products are derived from "natural identical" flavors but the product labels fail to identify the identified flavor as being artificially derived. 29 A - - -- Noncarb Soft Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Strawberry) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages 29 A - - -- Noncarb Soft Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Rose) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 29 A - - -- Noncarb Soft Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Mango) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 29 A - - -- Noncarb Soft Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Banana) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 29 A - - -- Noncarb Soft Drink Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Kulfi) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 29 R - - -- Noncarbonated Water (Nonmedicinal) Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Mango) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 29 R - - -- Noncarbonated Water (Nonmedicinal) Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Kulfi) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 29 R - - -- Noncarbonated Water (Nonmedicinal) Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Strawberry) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages 29 R - - -- Noncarbonated Water (Nonmedicinal) Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Banana) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 29 R - - -- Noncarbonated Water (Nonmedicinal) Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Rose) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 30 A - - -- Fruit Beverage Base Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Banana) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 30 A - - -- Fruit Beverage Base Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Strawberry) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages 30 A - - -- Fruit Beverage Base Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Mango) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 30 A - - -- Fruit Beverage Base Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Rose) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 30 A - - -- Fruit Beverage Base Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Kulfi) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 30 Y - - -- Beverage Base N.E.C. Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Strawberry) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that "Natural identical flavor" is not a natural flavor. Label shows "artificially flavored" on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). "Label declares "milkshake"; but product does not contain milk. The ingredient 'non-dairy creamer' with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a). Color additives subject to certification must be declared (21 CFR 101.22(k)(1)). In accordance with the regulation for colors subject to certification, manufacturers may parenthetically declare an appropriate alternative name of the certified color additive following its common or usual name as specified in part 74 or part 82 of this chapter. While Allura Red appears to be an appropriate alternative name, it must be provided in parentheses following the FD&C common or usual name. There is no provision for the use of "Veg Source" nor the E numbers (E473; E129; E127). Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for "UK/EU" and "AUSTRALIA" is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages 30 Y - - -- Beverage Base N.E.C. Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Banana) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on the lower third of the principal display panel (PDP), this is not included in SOI (21 CFR 101.22(i)(2)). “Label declares “milkshake”; but product does not contain milk. The ingredient ‘non-dairy creamer’ with casein as a sub-ingredient, which is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not an appropriate common or usual name for this product. Label states the product is non-dairy. Section 403(i)(2) of the Act. 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). Ingredient names do not appear to be the appropriate common or usual names in accordance with 21 CFR 101.4(a); ‘E’ numbers are not part of the common or usual name of any ingredient and colors and flavors (21 CFR 101.22). “Emulsifier (E473) [Veg Source]”, “(Natural Identical Flavor)”, and “Natural Color [Alpha, Beta, & Gamma Carotene] (E160a).” Appropriate alternative names must be provided in parentheses following the FD&C common or usual name. The ingredient list declares “natural identical flavor;” however, natural identical flavor is not a natural flavor. There is no provision for the use of “Veg Source.” Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 30 Y - - -- Beverage Base N.E.C. Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Kulfi) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 30 Y - - -- Beverage Base N.E.C. Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Rose) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages. 30 Y - - -- Beverage Base N.E.C. Date Published: 03/17/2025 Desc: Falooda Basil Seed Milkshake (Mango) 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(a)(1)/201(n) of the Act. Statement of Identity (SOI) for the products do not meet requirements in 21 CFR 101.22(i)(2); SOI fails to reveal the material fact that “Natural identical flavor” is not a natural flavor. Label shows “artificially flavored” on principal display panel (PDP); this is not included in SOI (21 CFR 101.22(i)(2)). “Labeled as “milkshake”; but product does not contain milk. Casein is a milk derivative, not milk (21 CFR 101.4(d)). Milkshake is not appropriate common or usual name for this non-dairy product. Section 403(i)(2) of the Act. Product fabricated from two or more ingredients and the common or usual name of each ingredient not declared (21 CFR 101.4). Veg Source or the E numbers not permitted (21 CFR 101.22). “Nata de Coco” is not an appropriate common or usual name. “Noodles” and “Nata De Coco” are multi-component foods, but sub ingredients not declared (21 CFR 101.4(b)(2). Noodle products are standardized foods in 21 CFR 139.150; this ingredient does not meet standards for ‘noodles’. Caseinate must be followed by parenthetical statement identifying its source (21 CFR 101.4(d)) and shall include a parenthetical term such as “a milk derivative” after sodium caseinate. Color additives not subject to certification must be declared in accordance with 21 CFR 101.22(k)(2). There is no provision for the use of the term “natural color.” Alternative names must be provided in parentheses following FD&C common or usual name. No provision for use of Gamma-carotene. Section 403(q) of Act. Nutrition Facts information not formatted per 21 CFR 101.9. Additional panes of nutrition information formatted for “UK/EU” and “AUSTRALIA” is prohibited. Section 403(f) of the Act. Label contains information in a third foreign language; therefore, all required information must be in all languages.
— accessdata.fda.gov, retrieved 2026-09-16
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html