# Silvana Natalia Galvan Ponce De Leon · 99-39 · MEXICO — FDA import alert red lists: firms subject to detention without physical examination

For Silvana Natalia Galvan Ponce De Leon · 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 COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO | COCKTAIL PREPARATION MIX- MICHELADA MIX CUBANA | COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO; product code is 30 N - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors | 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid | 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid; date published is 07/31/2019; address is Roque Estrade #26 Planta , Deleg.Tlaplpan Mexico D, MEXICO, verified against its source on 2026-09-16.

- **Firm:** Silvana Natalia Galvan Ponce De Leon _(verified: appears in the quote below)_
- **Import alert:** 99-39
- **Import alert name:** Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- **Country:** MEXICO _(verified: appears in the quote below)_
- **Address:** Roque Estrade #26 Planta , Deleg.Tlaplpan Mexico D, MEXICO _(verified: appears in the quote below)_
- **Date published:** 07/31/2019 _(verified: appears in the quote below)_
- **Product code:** 30 N - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors | 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid | 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid _(verified: each item appears in the quote below)_
- **Product:** COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO | COCKTAIL PREPARATION MIX- MICHELADA MIX CUBANA | COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO _(verified: each item appears in the quote below)_
- **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(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 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling. | 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(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. The ingredient statement fails to declare "sorbate" and "benzoate"; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages. The statement of identity, ingredients, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). | 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(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 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling. _(verified: each item appears in the quote below)_

## What the source says

> Silvana Natalia Galvan Ponce De Leon Date Published : 07/31/2019 Roque Estrade #26 Planta , Deleg.Tlaplpan Mexico D, MEXICO 30 N - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors Date Published: 08/01/2019 Desc: COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO 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(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 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling. 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid Date Published: 07/31/2019 Desc: COCKTAIL PREPARATION MIX- MICHELADA MIX CUBANA 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(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. The ingredient statement fails to declare "sorbate" and "benzoate"; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages. The statement of identity, ingredients, and Nutrition Facts label must be declared in both the foreign language and English as required by 21 CFR 101.15(c)(2). 30 P - - 01 Cocktail Base, Combined True Fruit and Imitation Fruit Flavors, Liquid Date Published: 08/01/2019 Desc: COCKTAIL PREPARATION MIX- MICHELADA MIX MANGO HABANERO 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(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 The ingredient statement fails to list habanero or habanero flavor , as well as Potassium Sorbate and lists the inappropriate common or usual name "Fruit puree" as an ingredient; Section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the net quantity of contents does not appear to be declared accurately on the outer carton for the entire contents of the package, as required by 21 CFR 101.7; Section 403(f) of the Act [21 U.S.C. §343(f)] because it contains information in a second language; therefore, all required information must be in both languages; Section 403(i)(1) of the Act [21 U.S.C. §343(i)(1)] because the product does not include an appropriate statement of identity as required by 21 CFR 101.3(b). The foreign term "michelada" is listed on the product labeling.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).