INDUSTRIAS LACTEAS TONI S.A. · 99-39 · ECUADOR

Product code, Product and FDA notes

09 D - - 11 Milk With Multivitamins Added,Low Fat Date Published: 04/30/2021 Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled. 14 Y - - 99 Filled or Imitation Milk or Milk Type Products Not Elsewhere Mentioned, N.E.C. Date Published: 10/18/2019 Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled. 21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C. Date Published: 10/18/2019 Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled. 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated Date Published: 10/18/2019 Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled. 29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated Date Published: 10/18/2019 Desc: Chocolate Milk Drink (Reduced Fat Chocolate Milk) Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.

Product code

09 D - - 11 Milk With Multivitamins Added,Low Fat Date Published: 06/13/2019 Desc: Milk Drink Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled. 14 Y - - 99 Filled or Imitation Milk or Milk Type Products Not Elsewhere Mentioned, N.E.C. Date Published: 06/13/2019 Desc: Milk Drink Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled. 21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C. Date Published: 06/13/2019 Desc: Milk Drink Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled. 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated Date Published: 06/13/2019 Desc: Milk Drink Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled. 29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated Date Published: 06/13/2019 Desc: Milk Drink Notes: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of: Section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labels are false or misleading. Specifically, the Calcium and Iron content are not equal to the amount declared on the labels [21 CFR 101.9(g)(4)(i)]. Section 403(f) of the Act [21 U.S.C. §343(f)] in that the labels contain information in a foreign language, but all of the required labeling statements are not in both languages [ 21 CFR 101.15(c)]. Section 403(i)(2) of the Act [21 U.S.C. §343(i)(2)], in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. The terms "emulsifier", "stabilizer", "E500ii" and E234" are not the common or usual names of ingredients (21 CFR 101.4). These terms are deemed intervening material under 21 CFR 101.2 Section 403(g)(1) of the Act [21 U.S.C. §343(g)] because it purports to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. Product is being marketed as a standardized food product under 21 CFR 131.110 for flavored milk; however, the regulation does not provide for the use of sodium bicarbonate or other preservatives as optional ingredients. Product also contains other optional vitamins and minerals that are not permitted for this product as currently labeled.