Embotelladora Nacional S.A.

3 records, newest first. Each line links to the FDA page it came from.

Refusal charges, in plain English

• UNSAFE COL2 refused lines

  Color additive unsafe under section 721

  The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.

• NO ENGLISH1 refused line

  Required label information not in English

  Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

• NUTRIT LBL1 refused line

  Nutrition information missing from label

  The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

Questions about Embotelladora Nacional S.A.

Is Embotelladora Nacional S.A. on an FDA import alert?

Yes. As of October 26, 2026, Embotelladora Nacional S.A. is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for orange flavored soda mirinda brand; FDA published the listing on September 18, 2009.

Has FDA refused shipments from Embotelladora Nacional S.A.?

Yes. FDA refused 2 shipment lines from Embotelladora Nacional S.A. between February 8, 2019 and February 9, 2024. The most recent, on February 9, 2024, was soft drink, subtropical or tropical fruit flavored, carbonated, charged as UNSAFE COL (color additive unsafe under section 721).

Why did FDA refuse Embotelladora Nacional S.A.'s shipments?

The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 2 lines) and NO ENGLISH (required label information not in english, 1 line).

What is Embotelladora Nacional S.A.'s FEI number?

Embotelladora Nacional S.A.'s FDA Establishment Identifier (FEI) is 3010120277.

Can shipments from Embotelladora Nacional S.A. still enter the U.S.?

Shipments of orange flavored soda mirinda brand from Embotelladora Nacional S.A. can be detained without physical examination under Import Alert 45-02; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).