Santa Helena Industria de Alimentos S.A. · 99-39 · BRAZIL

For Santa Helena Industria de Alimentos S.A. · 99-39 · BRAZIL, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is BRAZIL; product is Pacoquita Peanut Candy Bar | Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet | Pacoquita Peanut Candy Bar | Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet | Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet | Pacoquita Peanut Candy Bar | Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet | Pacoquita Peanut Candy Bar | Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet | Pacoquita Peanut Candy Bar | Pacoquita Peanut Candy Bar | Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet; product code is 23 B - - 07 Peanut, Shelled | 23 B - - 07 Peanut, Shelled | 33 A - - 05 Candy Bars or Pieces (not Caramel or Fondant), Hard, with Nuts or Nut Products (not Coconut)(without | 33 A - - 05 Candy Bars or Pieces (not Caramel or Fondant), Hard, with Nuts or Nut Products (not Coconut)(without | 33 B - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Coconut (without Chocolate) | 33 B - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Coconut (without Chocolate) | 33 B - - 07 Jellied Candies, Hard (Jelly Beans, Gum Drops, Etc.), with Coconut (without Chocolate) | 33 B - - 07 Jellied Candies, Hard (Jelly Beans, Gum Drops, Etc.), with Coconut (without Chocolate) | 33 D - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Nuts and Fruit (without Chocolate) | 33 D - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Nuts and Fruit (without Chocolate) | 33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate) | 33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate); date published is 01/10/2018; address is Rua Paraguai 1275 , Ribeirao Preto, Sao Paulo BRAZIL, verified against its source on 2026-09-16.

What the source says

Santa Helena Industria de Alimentos S.A. Date Published : 01/10/2018 Rua Paraguai 1275 , Ribeirao Preto, Sao Paulo BRAZIL 23 B - - 07 Peanut, Shelled Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar 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(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 23 B - - 07 Peanut, Shelled Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet 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 [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 A - - 05 Candy Bars or Pieces (not Caramel or Fondant), Hard, with Nuts or Nut Products (not Coconut)(without Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar 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(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 A - - 05 Candy Bars or Pieces (not Caramel or Fondant), Hard, with Nuts or Nut Products (not Coconut)(without Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet 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 [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 B - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Coconut (without Chocolate) Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet 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 [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 B - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Coconut (without Chocolate) Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar 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(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 B - - 07 Jellied Candies, Hard (Jelly Beans, Gum Drops, Etc.), with Coconut (without Chocolate) Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet 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 [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 B - - 07 Jellied Candies, Hard (Jelly Beans, Gum Drops, Etc.), with Coconut (without Chocolate) Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar 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(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 D - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Nuts and Fruit (without Chocolate) Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet 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 [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 D - - 05 Candy Bar or Pieces (not Caramel or Fondant), Hard, with Nuts and Fruit (without Chocolate) Date Published: 02/11/2020 Desc: Pacoquita Peanut Candy Bar 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(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate) Date Published: 01/10/2018 Desc: Pacoquita Peanut Candy Bar 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(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 40g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages. 33 G - - 05 Candy Bar or Pieces (not Caramel or Fondant), Soft, with Nuts or Nut Products (without Chocolate) Date Published: 01/10/2018 Desc: Pacoquita Peanut Candy Bar for Sugar Ingestion Controlled Diet 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 [21 U.S.C. §343(r)(1)(A)] labeling bears nutrient content claims, but the product fails to meet the requirement to make the claim. Carton and wrapper bears the term, "diet," [21 CFR 105.66(e)] and the carton label bears "no sugar" statements although the product does not meet the requirement for a "sugar free" claim. Product does not qualify to make the "low calorie" or "reduced calorie" claim because it contains more than 40 calories per RACC and it does not have 25% fewer calories per RACC than that regular Pacoquita Peanut Candy Bar [21 CFR 101.60(b)(2) & (4)]. Product does not qualify to make the "no sugar" or "sugar free" claim because it contains 0.6g per 44g serving, and above the allowable amount less that 0.5g of sugars per RACC to make a 21 CFR 101.60(c) claim. Label statement: "Contains fructose and sucrose naturally presents in the raw materials used" contradicts the sugar content claims because sugars are defined as the sum of all free mono- and disaccharides (such as glucose, fructose, lactose, and sucrose in 21 CFR 101.9(c)(6)(ii). Section 403(q) of the Act [21 U.S.C. § 343(q)] nutrition information (e.g. Nutrition Facts Panel) is either not provided, or is not provided in a correct format as required by 21 CFR 101.9. The serving size is not declared in accordance with the Reference Amount Customarily Consumed (RACC) in 21 CFR 101.12, Table 2. The RACC for these products is 44g, under the "Sugars and Sweets: All other candies" product category; therefore, the appropriate serving size is 2 units. All of the current nutrient information is incorrectly declared because it is based on the incorrect serving size. Section 403(f) of the Act [21 U.S.C. §343(f)] labels contain information in more than one language, but do not repeat all the required information in all languages.

— 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.