Violation Code: 198

FDA Violation

Charge Code: COLOR LBLG

881

Total Refusals

361

Affected Firms

12/30/2025

Latest Case

1/3/2002

First Case

Violation Details

Violation Code (ASC ID): 198
Charge Code: COLOR LBLG
Description: The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Legal Section: 602(e), 801(a)(3); MISBRANDING

Most Affected Firms

#	Firm Name	Location	Cases
1	Castle World Wide Taiwaw	Taipei, TAIWAN	67
2	Logona Naturkosmetik Und Heilmittel Hans Hansel Gmbh	Salzhemmendorf, GERMANY	42
3	Jianing Cosmetics Co Ltd	Zhanzhou, CHINA	16
4	Unilever Mexico S de R.L. de C.V.	Jiutepec, MEXICO	15
5	Jinhua Mingmei Cosmetics Co Ltd	Jinhua, CHINA	14
6	Hemani International	Karachi, PAKISTAN	14
7	Ni Hau Industrial Co Ltd	Tainan City, TAIWAN	13
8	Purebeau New Cosmetics Gmbh	Berlin, GERMANY	13
9	PATANJALI AYURVED LIMITED	Haridwar, INDIA	12
10	Pinnacle Cosmetics	Etobicoke, CANADA	12
11	Unilever Lever Faberge Deutschland	Mannheim, GERMANY	12
12	Faipa Cosmetics S R L	Pomezia, ITALY	11
13	Zhejiang Ushas Cosmetics Co., Ltd.	Jinhua, CHINA	10
14	ZHEJIANG IRMA COSMETICS COLTD	Zhou, CHINA	10
15	Zhejiang Yasili Cosmetics Co., Ltd.	Jinhua, CHINA	8
16	Nouvelle Parfumeria Gandour	Abidjan 01, IVORY COAS	8
17	Yiwu Zhuoyun Import & Export Co., Ltd.	Jinhua, CHINA	8
18	Taylor Of Old Bond Street	London, UNITED KIN	7
19	Naturelle LLC	Ras Al Khaimah, UNITED ARA	7
20	Laboratories De Productos Naturales Azeteca S.A. De. C.V.	Ciudad De Mexico, MEXICO	7

Recent Import Refusals

Date	Product	Firm
12/30/2025	EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CH03	Guangzhou Bause Cosmetics Co., Ltd.CHINA
11/13/2025	BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JD01	Beiersdorf AGGERMANY
11/4/2025	SAUCES, N.E.C. 37JCE99	Nutri-Asia, Incorporated dba UFC PhilippinesPHILIPPINE
10/29/2025	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	PATANJALI AYURVED LIMITEDINDIA
10/7/2025	BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI01	Karnataka Soap & Detergents LimitedINDIA
9/30/2025	OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. 53ED99	Emami Limited "Epip ComplexINDIA
9/30/2025	OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. 53ED99	Emami Limited "Epip ComplexINDIA
9/30/2025	OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. 53ED99	Emami Limited "Epip ComplexINDIA
9/30/2025	BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JI01	HINDUSTAN UNILEVERINDIA
9/15/2025	BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JY01	Hemani InternationalPAKISTAN
9/12/2025	SYRUPS AND MOLASSES, N.E.C. 36BHT99	MOTUMAL TANUMAL SHARBATWALA'S SONSINDIA
9/12/2025	BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) 53GH01	GUANGZHOU MEIKUANG COSMETICS COLTDCHINA
9/12/2025	BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) 53GH01	GUANGZHOU MEIKUANG COSMETICS COLTDCHINA
9/12/2025	BLUSHERS (ALL TYPES) (MAKEUP PREPARATIONS, NOT FOR EYES) 53GH01	GUANGZHOU MEIKUANG COSMETICS COLTDCHINA
8/29/2025	NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS) 53HD05	Zhejiang Enchant Cosmetic Co., Ltd.CHINA

Frequently Asked Questions

What is FDA violation code 198?

198 is an FDA violation code that indicates: "The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.". This violation is based on 602(e), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 198?

According to FDA Import Refusal data, there have been 881 import refusals issued for violation code 198, affecting 361 unique firms.

When was the most recent refusal for violation 198?

The most recent import refusal for violation 198 was on December 30, 2025.

What products are commonly refused for violation 198?

Products commonly refused under violation 198 include: EYE SHADOW (EYE MAKEUP PREPARATIONS), BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS), SAUCES, N.E.C., SHAMPOOS (HAIR PREPARATIONS, NON-COLORING). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 198?

Violation code 198 is based on 602(e), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.