Plantas Medicinales de Mexico

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

Refusal charges, in plain English

• UNAPPROVED156 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.

• NO ENGLISH42 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 LBL26 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.

• NCONTACT19 refused lines

  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.

• INCONSPICU11 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.

• UNSAFE ADD7 refused lines

  Food additive unsafe under section 409

  The product appeared to contain a food additive that is unsafe within the meaning of section 409 of the FD&C Act, the section that governs which food additives may be used and under what conditions.

• 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.

• HEALTH C5 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.

Questions about Plantas Medicinales de Mexico

Is Plantas Medicinales de Mexico on an FDA import alert?

Yes. As of October 26, 2026, Plantas Medicinales de Mexico is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for vitamins/minerals (human/animal); proteins/unconv dietary supp (human); pharm necess & ctnr for drug/bio; antibiotics (human/animal); human and animal therapeutic biologic and biosimilar drugs; human and animal drugs; FDA published the listing on June 8, 2022.

Has FDA refused shipments from Plantas Medicinales de Mexico?

Yes. FDA refused 174 shipment lines from Plantas Medicinales de Mexico between April 10, 2019 and August 13, 2026. The most recent, on August 13, 2026, was omega-3 (fats and lipid substances), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Plantas Medicinales de Mexico's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 156 lines) and NO ENGLISH (required label information not in english, 42 lines).

What is Plantas Medicinales de Mexico's FEI number?

Plantas Medicinales de Mexico's FDA Establishment Identifier (FEI) is 3014611081.

Can shipments from Plantas Medicinales de Mexico still enter the U.S.?

Shipments of vitamins/minerals (human/animal); proteins/unconv dietary supp (human); pharm necess & ctnr for drug/bio; antibiotics (human/animal); human and animal therapeutic biologic and biosimilar drugs; human and animal drugs from Plantas Medicinales de Mexico 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).