Reference Source

Marco Aurelio Gamino Franco · 99-39 · MEXICO

For Marco Aurelio Gamino Franco · 99-39 · MEXICO, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is MEXICO; product is Rollo De Coco Soft Candy (1-lb package) | Rollo De Coco Soft Candy (1.76 oz package) | Rollo De Coco Soft Candy(7.05 oz package) | Rollo De Coco Soft Candy (5.29 oz package) | Rollo De Coco Soft Candy (5.29 oz package) | Rollo De Coco Soft Candy (1-lb package) | Rollo De Coco Soft Candy (1.76 oz package) | Rollo De Coco Soft Candy(7.05 oz package) | Rollo De Coco Soft Candy(7.05 oz package) | Rollo De Coco Soft Candy (1-lb package) | Rollo De Coco Soft Candy (5.29 oz package) | Rollo De Coco Soft Candy (1.76 oz package) | Rollo De Coco Soft Candy (1-lb package) | Rollo De Coco Soft Candy(7.05 oz package) | Rollo De Coco Soft Candy (5.29 oz package) | Rollo De Coco Soft Candy (1.76 oz package); product code is 33 H - - -- Soft Candy W/Coconut | 33 H - - -- Soft Candy W/Coconut | 33 H - - -- Soft Candy W/Coconut | 33 H - - -- Soft Candy W/Coconut | 33 L - - -- Soft Candy W/O Nut/Fruit | 33 L - - -- Soft Candy W/O Nut/Fruit | 33 L - - -- Soft Candy W/O Nut/Fruit | 33 L - - -- Soft Candy W/O Nut/Fruit | 33 S - - -- Candy Specialties | 33 S - - -- Candy Specialties | 33 S - - -- Candy Specialties | 33 S - - -- Candy Specialties | 33 Y - - -- Candy Wo/Choc N.E.C. | 33 Y - - -- Candy Wo/Choc N.E.C. | 33 Y - - -- Candy Wo/Choc N.E.C. | 33 Y - - -- Candy Wo/Choc N.E.C; date published is 10/02/2015; address is Calle Milan No. 2595 , Fracc. PROVIDENCIA 2A. SECCION , Guadalajara, Jalisco MEXICO, verified against its source on 2026-09-16.

Firm
Marco Aurelio Gamino Franco verified
Import alert
99-39
Import alert name
Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
Country
MEXICO verified
Address
Calle Milan No. 2595 , Fracc. PROVIDENCIA 2A. SECCION , Guadalajara, Jalisco MEXICO verified
Date published
10/02/2015 verified
Product code
33 H - - -- Soft Candy W/Coconut | 33 H - - -- Soft Candy W/Coconut | 33 H - - -- Soft Candy W/Coconut | 33 H - - -- Soft Candy W/Coconut | 33 L - - -- Soft Candy W/O Nut/Fruit | 33 L - - -- Soft Candy W/O Nut/Fruit | 33 L - - -- Soft Candy W/O Nut/Fruit | 33 L - - -- Soft Candy W/O Nut/Fruit | 33 S - - -- Candy Specialties | 33 S - - -- Candy Specialties | 33 S - - -- Candy Specialties | 33 S - - -- Candy Specialties | 33 Y - - -- Candy Wo/Choc N.E.C. | 33 Y - - -- Candy Wo/Choc N.E.C. | 33 Y - - -- Candy Wo/Choc N.E.C. | 33 Y - - -- Candy Wo/Choc N.E.C. each item verified
Product
Rollo De Coco Soft Candy (1-lb package) | Rollo De Coco Soft Candy (1.76 oz package) | Rollo De Coco Soft Candy(7.05 oz package) | Rollo De Coco Soft Candy (5.29 oz package) | Rollo De Coco Soft Candy (5.29 oz package) | Rollo De Coco Soft Candy (1-lb package) | Rollo De Coco Soft Candy (1.76 oz package) | Rollo De Coco Soft Candy(7.05 oz package) | Rollo De Coco Soft Candy(7.05 oz package) | Rollo De Coco Soft Candy (1-lb package) | Rollo De Coco Soft Candy (5.29 oz package) | Rollo De Coco Soft Candy (1.76 oz package) | Rollo De Coco Soft Candy (1-lb package) | Rollo De Coco Soft Candy(7.05 oz package) | Rollo De Coco Soft Candy (5.29 oz package) | Rollo De Coco Soft Candy (1.76 oz package) each item verified
FDA notes
The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) | 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)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table). | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4) | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4) | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) | 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)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table). | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4) | 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)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table). | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) | The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4) | 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)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table). each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Marco Aurelio Gamino Franco Date Published : 10/02/2015 Calle Milan No. 2595 , Fracc. PROVIDENCIA 2A. SECCION , Guadalajara, Jalisco MEXICO 33 H - - -- Soft Candy W/Coconut Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (1-lb package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) 33 H - - -- Soft Candy W/Coconut Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (1.76 oz package) 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)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table). 33 H - - -- Soft Candy W/Coconut Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy(7.05 oz package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) 33 H - - -- Soft Candy W/Coconut Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (5.29 oz package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4) 33 L - - -- Soft Candy W/O Nut/Fruit Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (5.29 oz package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4) 33 L - - -- Soft Candy W/O Nut/Fruit Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (1-lb package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) 33 L - - -- Soft Candy W/O Nut/Fruit Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (1.76 oz package) 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)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table). 33 L - - -- Soft Candy W/O Nut/Fruit Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy(7.05 oz package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) 33 S - - -- Candy Specialties Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy(7.05 oz package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) 33 S - - -- Candy Specialties Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (1-lb package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) 33 S - - -- Candy Specialties Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (5.29 oz package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4) 33 S - - -- Candy Specialties Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (1.76 oz package) 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)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table). 33 Y - - -- Candy Wo/Choc N.E.C. Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (1-lb package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) 33 Y - - -- Candy Wo/Choc N.E.C. Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy(7.05 oz package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that: • The nutrition facts label does not include the correct footnote required by 21 CFR 101.9(j)(13)(ii)(C). The asterisk and abbreviation "(DV)" is missing. • For the 7.05 oz label, amount per serving, calories from fat, trans fat is not permitted to be bolded. Also for the 1 lb label, amount per serving, calories from fat, saturated fat, trans fat, dietary fiber, and sugar must not be bolded. 21 CFR 101.9(j)(13)(ii)(A)(2) • The amounts and percentages for calories, calories from fat, calcium and iron are not rounded correctly. 21 CFR 101.9(c) • The units for cholesterol must be provided in mg not g. 21 CFR 101.9(c)(3) • For the 7.05 oz label, the English trans fat declaration follows the foreign language declaration. This is not in accordance with 21 CFR 101.9(d)(14). The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)], because the product bears or contains artificial coloring or chemical preservative but does not bear labeling stating that fact. Specifically, the products contain chemical preservatives, potassium sorbate and sodium propionate, however they fail to bear labeling stating that fact in accordance with 21 CFR 101.22(j). "Conservative" does not describe a function. • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • The serving size is not declared in common household measure. 21 CFR 101.9(b)(5) 33 Y - - -- Candy Wo/Choc N.E.C. Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (5.29 oz package) Notes: The articles are subject to refusal of admission pursuant to section 801(a)(3) in that they appear to be misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that the nutrition facts label is not as defined by 21 CFR 101.9. Specifically: • The labels declare the serving size as "100 g"; however, the serving size must be determined based on the reference amount customarily consumed (RACC) at 21 CFR 101.12(b) [21 CFR 101.9(b)(2)]. The RACC for All other candies is 30 g. The serving size is not correctly determined from the RACC; therefore, all of the nutrient information is incorrectly declared. • For the 1.76 oz and 5.29 oz labels, the serving size "1 ct/pza (50 g)" is not an appropriate common household measure. 21 CFR 101.9(b)(5) • For the 7.05 oz and 1 lb labels, the serving size is not declared in common household measure. 21 CFR 101.9(b)(5) • For the 5.29 oz label, the p and s in "Amount Per Serving" must not be capitalized. 21 CFR 101.9(d)(4) 33 Y - - -- Candy Wo/Choc N.E.C. Date Published: 08/21/2018 Desc: Rollo De Coco Soft Candy (1.76 oz package) 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)] in that the nutrition facts label is not in accordance with 21 CFR 101.9(d)(1). Specifically: • "Amount per serv.," "Diet. Fiber" and "Serv." are not authorized abbreviations for Amount per serving, dietary fiber, and servings per container in 21 CFR 101.9. • "1 ct" is not an appropriate common household measure in accordance with 21 CFR 101.9(b)(5)(iv). A description of the individual container or package must be used for single serving containers and for individually packaged products within multiserving containers (e.g., can, box, package). A description of the individual unit shall be used for other products in discrete units (e.g., piece, slice, cracker, bar). • The amounts of calcium and potassium are not rounded to the nearest 10 mg increment. Under 21 CFR 101.9(c)(8)(iii), the quantitative amounts of vitamins and minerals, excluding sodium, must be the amount of the vitamin or mineral included in a serving of the product using the units of measurement and the levels of significance given in 21 CFR 101.9(c)(8)(iv) (which refers to the Reference Daily Intakes (RDI) table).

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