Hemani International

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

Refusal charges, in plain English

• UNAPPROVED13 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.

• LABELING12 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.

• 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).

• NO ENGLISH4 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.

• DIETARYLBL3 refused lines

  Not identified as a dietary supplement

  The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).

• COLORLABEL1 refused line

  Required information not prominent

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

• FILTHY1 refused line

  Filthy, putrid or decomposed substance

  The product appeared to consist in whole or in part of a filthy, putrid, or decomposed substance, or to be otherwise unfit for food.

• HEALTH C1 refused line

  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 Hemani International

Is Hemani International on an FDA import alert?

Yes. As of October 26, 2026, Hemani International is on the red list of FDA Import Alert 99-19, “Food products: Salmonella”, for whole black pepper; FDA published the listing on May 19, 2014.

Has FDA refused shipments from Hemani International?

Yes. FDA refused 25 shipment lines from Hemani International between July 17, 2017 and August 28, 2026. The most recent, on August 28, 2026, was herbals & botanicals (not teas), n.e.c., charged as LIST INGRE (ingredients not listed).

Why did FDA refuse Hemani International's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 13 lines) and LABELING (fair packaging and labeling act, 12 lines).

What is Hemani International's FEI number?

Hemani International's FDA Establishment Identifier (FEI) is 3008985479.

Can shipments from Hemani International still enter the U.S.?

Shipments of whole black pepper from Hemani International can be detained without physical examination under Import Alert 99-19; 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).