# Lotte Confectionery Co., Ltd. · 99-39 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Lotte Confectionery Co., Ltd. · 99-39 · KOREA (THE REPUBLIC OF), import alert is 99-39; import alert name is Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded; country is KOREA (THE REPUBLIC OF); product is Lotte European Waffles | The Lotte European Waffles | The Lotte European Waffles; product code is 03 R - - 60 Waffles Without Custard or Cream Filling | 03 S - - 60 Waffles Prepared Dry Mix Without Custard or Cream Filling | 03 T - - 60 Waffle Dough or Batter Without Custard or Cream Filling; date published is 04/06/2015; address is 25 Yangpyung-Lo 21-Gil , Seoul, Youngdeungpo-Gu KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Lotte Confectionery Co., Ltd. _(verified: appears in the quote below)_
- **Import alert:** 99-39
- **Import alert name:** Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
- **Country:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 25 Yangpyung-Lo 21-Gil , Seoul, Youngdeungpo-Gu KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 04/06/2015 _(verified: appears in the quote below)_
- **Product code:** 03 R - - 60 Waffles Without Custard or Cream Filling | 03 S - - 60 Waffles Prepared Dry Mix Without Custard or Cream Filling | 03 T - - 60 Waffle Dough or Batter Without Custard or Cream Filling _(verified: each item appears in the quote below)_
- **Product:** Lotte European Waffles | The Lotte European Waffles | The Lotte European Waffles _(verified: each item appears in the quote below)_
- **FDA notes:** Charge: 403(i)(1) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because there is no accurate statement of identity on the Principal Display Panel, as required under 21 CFR 101.3. We question the name of the product "Lotte Waffle" being an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food within the meaning of sections 21 CFR 101.3(b) and 21 CFR 102.5(a). The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. It appears that this product is not generally recognized by American consumers as a waffle, but may be similar to a snack cracker or cookie product. We also note that the statement of identity must be consistent wherever it appears on the label. Charge: 403(i)(2) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i) (2)] because they are fabricated from two or more ingredients but the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, Charge: 403(f) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) are misbranded with the meaning of section 403(f) because the product labels contain information in two languages but do not repeat all the required label information in both languages. It appears a second language (possibly Korean) is declared on the label; therefore all words, statements, and other information required by or under authority of the act to appear on the label must also be represented in the foreign language in accordance with 21 CFR 101.15(c)(2). | The products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 04/06/2015 | The products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 04/06/2015 _(verified: each item appears in the quote below)_

## What the source says

> Lotte Confectionery Co., Ltd. Date Published : 04/06/2015 25 Yangpyung-Lo 21-Gil , Seoul, Youngdeungpo-Gu KOREA (THE REPUBLIC OF) 03 R - - 60 Waffles Without Custard or Cream Filling Date Published: 04/06/2015 Desc: Lotte European Waffles Notes: Charge: 403(i)(1) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) sold to individual customers are misbranded within the meaning of Section 403(i)(1) of the Act [21 U.S.C. 343(i)(1)] because there is no accurate statement of identity on the Principal Display Panel, as required under 21 CFR 101.3. We question the name of the product "Lotte Waffle" being an appropriately descriptive term or when the nature of the food is obvious, a fanciful name commonly used by the public for such food within the meaning of sections 21 CFR 101.3(b) and 21 CFR 102.5(a). The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. It appears that this product is not generally recognized by American consumers as a waffle, but may be similar to a snack cracker or cookie product. We also note that the statement of identity must be consistent wherever it appears on the label. Charge: 403(i)(2) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343(i) (2)] because they are fabricated from two or more ingredients but the labels fail to declare the common or usual name of each ingredient, as required under 21 CFR 101.4. Specifically, Charge: 403(f) • The Lotte European Waffles (1.41 oz. and 5.64 oz.) are misbranded with the meaning of section 403(f) because the product labels contain information in two languages but do not repeat all the required label information in both languages. It appears a second language (possibly Korean) is declared on the label; therefore all words, statements, and other information required by or under authority of the act to appear on the label must also be represented in the foreign language in accordance with 21 CFR 101.15(c)(2). 03 S - - 60 Waffles Prepared Dry Mix Without Custard or Cream Filling Date Published: 10/07/2015 Desc: The Lotte European Waffles Notes: The products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 04/06/2015 03 T - - 60 Waffle Dough or Batter Without Custard or Cream Filling Date Published: 10/07/2015 Desc: The Lotte European Waffles Notes: The products are misbranded within the meaning of Section 403(q) of the Act [21 U.S.C. 343(q)] in that the nutrition facts information is not in an appropriate format as defined in 21 CFR 101.9. Published on 04/06/2015

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_1144.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).