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

For INDUSTRIAS LACTEAS TONI S.A. · 99-39 · ECUADOR, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is ECUADOR; product is VANILLA MILK DRINK | Chocolate Milk Drink (Reduced Fat Chocolate Milk) | VANILLA MILK DRINK | Chocolate Milk Drink (Reduced Fat Chocolate Milk) | Chocolate Milk Drink (Reduced Fat Chocolate Milk) | Chocolate Milk Drink (Reduced Fat Chocolate Milk) | Chocolate Milk Drink (Reduced Fat Chocolate Milk) | VANILLA MILK DRINK; product code is 09 D - - 11 Milk With Multivitamins Added,Low Fat | 09 D - - 11 Milk With Multivitamins Added,Low Fat | 09 H - - 06 Cultured or Acidified and Flavored Fluid Milk, Grade A | 14 Y - - 99 Filled or Imitation Milk or Milk Type Products Not Elsewhere Mentioned, N.E.C. | 21 V - - 99 Sutropical and Tropical Fruit, Juice, Milk, Creme, Drink or Nectar, N.E.C. | 29 A - - 09 Soft Drink, Other Fruit Flavored, Noncarbonated | 29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated | 29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated; date published is 06/13/2019; address is Av. Francisco de Orellana km. 17,5, Coop. San Nicolas , Mz. 429 Solar 1 , Guayaquil, Guayas ECUADOR, verified against its source on 2026-09-16.

What the source says

INDUSTRIAS LACTEAS TONI S.A. Date Published : 06/13/2019 Av. Francisco de Orellana km. 17,5, Coop. San Nicolas , Mz. 429 Solar 1 , Guayaquil, Guayas ECUADOR 09 D - - 11 Milk With Multivitamins Added,Low Fat Date Published: 07/27/2020 Desc: VANILLA MILK DRINK 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(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard. 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. 09 H - - 06 Cultured or Acidified and Flavored Fluid Milk, Grade A Date Published: 07/27/2020 Desc: VANILLA MILK DRINK 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(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard. 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. 29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated Date Published: 07/27/2020 Desc: VANILLA MILK DRINK 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(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard.

— accessdata.fda.gov, retrieved 2026-09-15

The same source also states

Industrias Lacteas Toni S.A. Date Published : 06/13/2019 Km 7 1/2 via a Daule , Guayaquil, Guayas ECUADOR 09 D - - 11 Milk With Multivitamins Added,Low Fat Date Published: 07/27/2020 Desc: VANILLA MILK DRINK 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(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard. 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. 09 H - - 06 Cultured or Acidified and Flavored Fluid Milk, Grade A Date Published: 07/27/2020 Desc: VANILLA MILK DRINK 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(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard. 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. 29 A - - 70 Soft Drink, Milk Based (Chocolate Flavored, Etc.), Noncarbonated Date Published: 07/27/2020 Desc: VANILLA MILK DRINK 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(r)(1)(A) of the Act in that the labeling bears a "reduced fat" and a "38% less fat than whole milk" nutrient content claim but fails to comply with the requirements for a relative claim under 21 CFR 101.13(j)(2) and 101.62(b)(4)(ii). Section 403(f) of the Act because the product label contains information in two languages but does not repeat all the required information in both languages in accordance with 21 CFR 101.15(c). Section 403(i)(2) of the Act in that each ingredient is not declared by its common or usual name in accordance with 21 CFR 101.4. Emulsifier E471, vitamin B1, and vitamin B3 are not the common or usual names of ingredients. Vitamins B1 and B3 are not the common or usual names for thiamin and niacin, respectively. Section 403(g)(1) of the Act because they purport to be a food for which a definition and standard of identity has been prescribed by regulations but fails to conform. The milk is subject to the standard of identity in 21 CFR 131.110. The products are labeled to contain vitamins and minerals that are not permitted under this standard.

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.