Nostalgia Foods S.A. · 99-39 · GUATEMALA
For Nostalgia Foods S.A. · 99-39 · GUATEMALA, import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is GUATEMALA; product is BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy); product code is 33 G - - 02 Caramel Candy Pieces, Soft, with Nuts or Nut Products (without Chocolate) | 34 B - - 99 Chocolate and Cocoa, N.E.C. | 34 C - - 04 Chocolate Covered Candy Pieces, with Nuts or Nut Products (not Coconut) | 34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut) | 34 D - - 99 Chocolate and Chocolate Covered Candy, with Coconut, N.E.C. | 34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit | 34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C. | 34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C. | 34 Y - - 99 Chocolate and Cocoa Products, N.E.C; date published is 12/09/2024; address is Sector 2, Lote 74 Apt B , Carretera A Los Ocotes , Guatemala City, GUATEMALA, verified against its source on 2026-09-16.
- Firm
- Nostalgia Foods S.A. verified
- Import alert
- 99-39
- Import alert name
- Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- Country
- GUATEMALA verified
- Address
- Sector 2, Lote 74 Apt B , Carretera A Los Ocotes , Guatemala City, GUATEMALA verified
- Date published
- 12/09/2024 verified
- Product code
- 33 G - - 02 Caramel Candy Pieces, Soft, with Nuts or Nut Products (without Chocolate) | 34 B - - 99 Chocolate and Cocoa, N.E.C. | 34 C - - 04 Chocolate Covered Candy Pieces, with Nuts or Nut Products (not Coconut) | 34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut) | 34 D - - 99 Chocolate and Chocolate Covered Candy, with Coconut, N.E.C. | 34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit | 34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C. | 34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C. | 34 Y - - 99 Chocolate and Cocoa Products, N.E.C. each item verified
- Product
- BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) | BOTONETAS NEGRA (Chocolate Flavor Candy) each item verified
- FDA 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). | 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). each item verified
What the source says
Nostalgia Foods S.A. Date Published : 12/09/2024 Sector 2, Lote 74 Apt B , Carretera A Los Ocotes , Guatemala City, GUATEMALA 33 G - - 02 Caramel Candy Pieces, Soft, with Nuts or Nut Products (without Chocolate) Date Published: 12/09/2024 Desc: BOTONETAS NEGRA (Chocolate Flavor Candy) 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 34 B - - 99 Chocolate and Cocoa, N.E.C. Date Published: 12/09/2024 Desc: BOTONETAS NEGRA (Chocolate Flavor Candy) 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 34 C - - 04 Chocolate Covered Candy Pieces, with Nuts or Nut Products (not Coconut) Date Published: 12/09/2024 Desc: BOTONETAS NEGRA (Chocolate Flavor Candy) 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 34 C - - 99 Chocolate and Chocolate Covered Candy, with Nuts or Nut Products, N.E.C. (not Coconut) Date Published: 12/09/2024 Desc: BOTONETAS NEGRA (Chocolate Flavor Candy) 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 34 D - - 99 Chocolate and Chocolate Covered Candy, with Coconut, N.E.C. Date Published: 12/09/2024 Desc: BOTONETAS NEGRA (Chocolate Flavor Candy) 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 34 F - - 04 Chocolate Covered Candy Pieces, without Nuts and Fruit Date Published: 12/09/2024 Desc: BOTONETAS NEGRA (Chocolate Flavor Candy) 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 34 F - - 99 Chocolate and Chocolate Covered Candy, without Nuts and Fruit, N.E.C. Date Published: 12/09/2024 Desc: BOTONETAS NEGRA (Chocolate Flavor Candy) 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 34 G - - 99 Chocolate and Chocolate Covered Candy, with Nuts and Fruit, N.E.C. Date Published: 12/09/2024 Desc: BOTONETAS NEGRA (Chocolate Flavor Candy) 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a). 34 Y - - 99 Chocolate and Cocoa Products, N.E.C. Date Published: 12/09/2024 Desc: BOTONETAS NEGRA (Chocolate Flavor Candy) 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(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language, Spanish; therefore, all required information must be in both languages (i.e., the English language as well as the foreign language). Statement of identity must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). inner unit containers are not exempt from the bilingual labeling requirements in 21 CFR 101.15(c)(2). exemptions in 21 CFR 1.24(a)(14) do not extend to the labeling requirements in 21 CFR 101.15 and section 403(w) of the Act. Section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] in that the product is fabricated from two or more ingredients and the common or usual name of each ingredient is not declared on the label, as required under 21 CFR 101.4. Missing lentils as sub-ingredients for “chocolate flavored lentils”. Vegetable shortening does not list vegetable source of the shortening. [21 CFR 101.4(b)(14)]. Product label lists the percent of the ingredient before the listing of the intended ingredient and it is not listed parenthetically. [21 CFR 101.4(e)]. English translation of outer package label shows: whey powder, carob flour, lazicar, solid green FCF, talc. e. Buttermilk is declared on the outer label, but based on the google translation, but not declared on the individual units. Section 403(e)(1) of the Act [21 U.S.C. § 343(e)(1)] in that the product labels fail to include the place of business of the manufacturer, packer, or distributor, as required by 21 CFR 101.5(a).
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_1144.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.