Santa Helena Industria de Alimentos S.A.

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

Refusal charges, in plain English

• ALLERGEN27 refused lines

  Major food allergen not declared

  The label appeared not to declare all major food allergens present in the product, as section 403(w) of the FD&C Act requires.

• NUTRIT LBL27 refused lines

  Nutrition information missing from label

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

• NO ENGLISH21 refused lines

  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.

• HEALTH C6 refused lines

  Unauthorized nutrient content or health claim

  The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.

• LABELING6 refused lines

  Fair Packaging and Labeling Act

  The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.

• LACKS N/C6 refused lines

  Net quantity statement missing

  The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.

• LIST INGRE4 refused lines

  Ingredients not listed

  The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

• INCONSPICU2 refused lines

  Required information not conspicuous

  Information required on the label appeared not to be placed prominently or conspicuously enough to be read and understood by an ordinary consumer.

Questions about Santa Helena Industria de Alimentos S.A.

Is Santa Helena Industria de Alimentos S.A. on an FDA import alert?

Yes. As of October 26, 2026, Santa Helena Industria de Alimentos S.A. is on the red list of FDA Import Alert 99-22, “Undeclared or mislabeled major food allergens”, for pacoquita peanut candy bar; pacoquita peanut candy bar for sugar ingestion controlled diet; FDA published the listing on January 11, 2018.

Has FDA refused shipments from Santa Helena Industria de Alimentos S.A.?

Yes. FDA refused 37 shipment lines from Santa Helena Industria de Alimentos S.A. between December 1, 2017 and August 5, 2025. The most recent, on August 5, 2025, was candy bar or pieces (not caramel or fondant), soft, with nuts or nut products (without chocolate), charged as NO ENGLISH (required label information not in english).

Why did FDA refuse Santa Helena Industria de Alimentos S.A.'s shipments?

The most frequent charges are ALLERGEN (major food allergen not declared, 27 lines) and NUTRIT LBL (nutrition information missing from label, 27 lines).

When was Santa Helena Industria de Alimentos S.A. last inspected by FDA?

FDA's most recent inspection of Santa Helena Industria de Alimentos S.A. with a final classification is dated June 12, 2017 and was classified NAI (No Action Indicated).

What is Santa Helena Industria de Alimentos S.A.'s FEI number?

Santa Helena Industria de Alimentos S.A.'s FDA Establishment Identifier (FEI) is 3009844287.

Can shipments from Santa Helena Industria de Alimentos S.A. still enter the U.S.?

Shipments of pacoquita peanut candy bar; pacoquita peanut candy bar for sugar ingestion controlled diet from Santa Helena Industria de Alimentos S.A. can be detained without physical examination under Import Alert 99-22; 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).