Lotte Company, Ltd.
FDA import alert and refusal historyShinjuku, JapanFEI 1000266106
As of October 26, 2026, Lotte Company, Ltd. (Shinjuku, Japan) is on the red list of FDA Import Alert 45-02 (Foods with illegal or undeclared colors) for bubble gum (without chocolate), published by FDA on September 18, 2009, and has 5 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 45-02 · red list
- Last import refusal
- Bubble gum (without chocolate) · UNSAFE COL
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Lotte Company, Ltd.
6 records, newest first. Each line links to the FDA page it came from.
2023
- Import refusalRefused, Bubble gum (without chocolate)UNSAFE COLEntry 799-8040520-3Source
2022
- Import refusalRefused, Chocolate filled/iced cookies,biscuits and wafersNO ENGLISHEntry AJR-7407129-9Source
2018
- Import refusalRefused, Chewing gum (without chocolate)NO ENGLISHEntry UPS-8142402-1Source
2017
- Import refusalRefused, Chewing gum, n.e.c. (without chocolate)NO ENGLISHEntry UPS-2104378-2Source
- Import refusalRefused, Chewing gum, n.e.c. (without chocolate)NO ENGLISHEntry UPS-2119271-2Source
2009
- Import alert listingListed on Import Alert 45-02red listBubble Gum (without Chocolate)Source
Refusal charges, in plain English
- 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.
- UNSAFE COL1 refused line
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.
Questions about Lotte Company, Ltd.
- Is Lotte Company, Ltd. on an FDA import alert?
- Yes. As of October 26, 2026, Lotte Company, Ltd. is on the red list of FDA Import Alert 45-02, “Foods with illegal or undeclared colors”, for bubble gum (without chocolate); FDA published the listing on September 18, 2009.
- Has FDA refused shipments from Lotte Company, Ltd.?
- Yes. FDA refused 5 shipment lines from Lotte Company, Ltd. between February 13, 2017 and November 14, 2023. The most recent, on November 14, 2023, was bubble gum (without chocolate), charged as UNSAFE COL (color additive unsafe under section 721).
- Why did FDA refuse Lotte Company, Ltd.'s shipments?
- The most frequent charges are NO ENGLISH (required label information not in english, 4 lines) and UNSAFE COL (color additive unsafe under section 721, 1 line).
- What is Lotte Company, Ltd.'s FEI number?
- Lotte Company, Ltd.'s FDA Establishment Identifier (FEI) is 1000266106.
- Can shipments from Lotte Company, Ltd. still enter the U.S.?
- Shipments of bubble gum (without chocolate) from Lotte Company, Ltd. 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).
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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.