Marugen, Inc.

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

Refusal charges, in plain English

• UNSAFE COL5 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.

• COLOR LBLG1 refused line

  Artificial coloring not declared

  The product appeared to contain an artificial coloring without labeling that states that fact.

• 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.

Questions about Marugen, Inc.

Is Marugen, Inc. on an FDA import alert?

Yes. As of October 26, 2026, Marugen, Inc. is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for flavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate); lollipop (without chocolate); FDA published the listing on September 18, 2009.

Has FDA refused shipments from Marugen, Inc.?

Yes. FDA refused 5 shipment lines from Marugen, Inc. between June 5, 2018 and March 12, 2025. The most recent, on March 12, 2025, was flavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate), charged as UNSAFE COL (color additive unsafe under section 721).

Why did FDA refuse Marugen, Inc.'s shipments?

The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 5 lines) and COLOR LBLG (artificial coloring not declared, 1 line).

When was Marugen, Inc. last inspected by FDA?

FDA's most recent inspection of Marugen, Inc. with a final classification is dated February 6, 2015 and was classified VAI (Voluntary Action Indicated).

What is Marugen, Inc.'s FEI number?

Marugen, Inc.'s FDA Establishment Identifier (FEI) is 3008915847.

Can shipments from Marugen, Inc. still enter the U.S.?

Shipments of flavored candy, hard (live savers, etc.), without nuts and fruit (without chocolate); lollipop (without chocolate) from Marugen, Inc. 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).