Herbolaris Internacional

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

Refusal charges, in plain English

• NO ENGLISH11 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.

• NUTRIT LBL4 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.

• UNAPPROVED4 refused lines

  Unapproved new drug

  The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

• DIETARYING2 refused lines

  Dietary ingredients not listed

  The dietary supplement label appeared not to list each dietary ingredient and its quantity, or the total quantity of a proprietary blend.

• LABELING1 refused line

  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/C1 refused line

  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 INGRE1 refused line

  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).

• NCONTACT1 refused line

  No U.S. adverse event contact on supplement label

  The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.

Questions about Herbolaris Internacional

Is Herbolaris Internacional on an FDA import alert?

Yes. As of October 26, 2026, Herbolaris Internacional is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for cbc dietary supplement; FDA published the listing on January 24, 2018.

Has FDA refused shipments from Herbolaris Internacional?

Yes. FDA refused 15 shipment lines from Herbolaris Internacional between January 25, 2017 and October 27, 2025. The most recent, on October 27, 2025, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as NO ENGLISH (required label information not in english).

Why did FDA refuse Herbolaris Internacional's shipments?

The most frequent charges are NO ENGLISH (required label information not in english, 11 lines) and NUTRIT LBL (nutrition information missing from label, 4 lines).

When was Herbolaris Internacional last inspected by FDA?

FDA's most recent inspection of Herbolaris Internacional with a final classification is dated May 30, 2014 and was classified OAI (Official Action Indicated).

What is Herbolaris Internacional's FEI number?

Herbolaris Internacional's FDA Establishment Identifier (FEI) is 3010178058.

Can shipments from Herbolaris Internacional still enter the U.S.?

Shipments of cbc dietary supplement from Herbolaris Internacional can be detained without physical examination under Import Alert 54-16; 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).