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U.S. Department of Health and Human Services

Import Alert 53-19
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 53-19
Published Date: 02/11/2013
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Henna Based Skin Color"

Reason for Alert:
In April, 1997, LOS-DO examined two shipments of a hair color product, brand names Zarqa and Almas, for color additives. Neither product has directions for use. However, the labels for both products declare henna as the sole ingredient and depict designs on the hands and feet.

The color additive regulation 21 CFR 73.2190 specifically allows for the safe use of henna in coloring the hair only. The regulation does not allow for the safe use of henna to make colored designs directly on the skin, including the hands and feet.

Guidance:
Districts may detain, without physical sampling and analysis, all entries of henna based color ***products*** from the***firms identified in the attachment for this Import Alert.***

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:
Henna powder

Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears not to be a hair dye and it appears to bear or contain, for the purpose of decorating the skin, a color additive which is unsafe within the meaning of Section 721(a) [Adulteration, Section 601(e)]."

OASIS charge code - COSM COLOR

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


BANGLADESH
Zam Zam Cosmetic Industries Ltd
Date Published : 04/26/2011

218 Mitford Rdmomtaz Market , Dhaka, BANGLADESH
50 N - - 18 Henna
Date Published: 04/26/2011

Desc:Shahzadi Gold Henna
50 N - - 18 Henna
Date Published: 04/26/2011

Desc:Shahzadi Henna Paste
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/26/2011

Desc:Shahzadi Gold Henna
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 04/26/2011

Desc:Shahzadi Henna Paste

INDIA
Andri Pama Exim
Date Published : 09/18/2009

D-229 Defence Colony , New Delhi 110024 India, INDIA
53 F - - 03 Hair Rinses (Coloring) (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Bulk Henna Powder
Notes:6/2/04

Babulal Brijbhushan
Date Published : 09/18/2009

Unknown , Sojat City, INDIA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Henna (Khoja Galli)
Notes:4/28/00

Bharat Enterprises
Date Published : 08/05/2011

7 Sai Niwas Laxmi Bldg 116 Bhavani Gokha , Maharashtra, INDIA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/05/2011

Desc:Henna Oil
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 08/05/2011

Desc:Henna Cone

Crystal India
Date Published : 09/18/2009

C-316 Yojna Vhar , Delhi, INDIA
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:Henna Paste Tube Kit (all brands including Surkh and colors)
Notes:12/7/01
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:Henna Powder Kit Tattos - all brands and colors
Notes:12/7/01
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:Henna Powder Kit Tattoos all brands and colors
Notes:12/7/01
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:Henna Paste Tube Kit all brands including Surkh and colors
Notes:12/7/01
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Henna Powder Tattoo Kit all brands and colors
Notes:12/7/01
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Henna Paste Tube Kit ( all brands and colors - including Surkh)
Notes:12/7/01

Dave Mehandi Centre
Date Published : 09/27/2010

Plot No. 6 Rosy Colony , Khandwala Lane Daftary Road , Mumbai, Malad INDIA
50 N - - 18 Henna
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder
53 F - - -- Hair Coloring Prep
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder

Federal Exports International
Date Published : 09/18/2009

166 Double Storey , New Rajinder Nagar , New Delhi, INDIA
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Herbal Henna Pack
Notes:9/19/00
53 G - - -- Makeup Prep(Not For Eyes)
Date Published: 09/18/2009

Desc:Herbal Henna Pack
Notes:9/19/00

HARUMAL GANGARAM & CO.
Date Published : 09/18/2009

171 Samuel St. , Masjid Bunder , Bombay 400 009, INDIA
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Henna (Khoja Galli)
Notes:4/28/00

Hesh Pharma Mfg & Exporter Of Herbal Products
Date Published : 09/18/2009

B/3, Singh Industrial Estate No-1 Ram , Mumbai, INDIA
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Henna Powder
Notes:10/25/00
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:Henna Powder
Notes:10/25/00

Jawa Exports
Date Published : 09/18/2009

548 Udai Marg, Tilak Nagar , Jaipur, INDIA
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Henna Powder
Notes:6/26/01
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Powder
Notes:6/26/01

Lokhandwala Exports
Date Published : 09/18/2009

72 Gandhi Nagar, Dainik Shivner Road , Worli , Mumbai, INDIA
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Henna Powder
Notes:3/11/03
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Powder
Notes:3/11/03
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:Henna Powder
Notes:3/11/03

M/S KESHAV EXPORTS PVT LTD
Date Published : 09/27/2010

28/2 GOWDANA PALYA , DEVEYANI INDL COMPLEX , Bangalore, INDIA
50 N - - 18 Henna
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder
53 F - - -- Hair Coloring Prep
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/27/2010

Desc:Dulhan Mehendi Deluxe Heena Powder

Mahashian Di Hatti Ltd.
Date Published : 09/18/2009

Kirti Nagar , Industrial Area , New Delhi, In-Dl INDIA
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Henna Powder
Notes:6/21/01
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Powder
Notes:6/21/01

Pearls of Beauty
Date Published : 12/14/2011

28 Indl. Area Baddi , Distt. Solan (H.P.), INDIA
50 N - - 18 Henna
Date Published: 12/14/2011

Desc:New Extra Rich Henna
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 12/14/2011

Desc:New Extra Rich Henna
53 F - - 03 Hair Rinses (Coloring) (Hair Coloring Preparations)
Date Published: 12/14/2011

Desc:New Extra Rich Henna
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/14/2011

Desc:New Extra Rich Henna

Ram Gopal Grand Sons
Date Published : 09/18/2009

unknown , Faridabad, Haryana INDIA
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:Henna Paste Tube Kit all brands and colors including Eatle
Notes:12/7/01
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:henna Paste Tube Kit all brands and colors including Eatle
Notes:12/7/01
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Henna Paste Tube Kit; all brands and colors including Eatle
Notes:12/7/01

Raun Harman Exports (P) Ltd.
Date Published : 09/18/2009

D-252 Ashok Vihar , Phase 1 , New Delhi, INDIA
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Henna Powder and paste
Notes:8/2/01
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Powder and Paste
Notes:8/2/01

Supreme Henna Exports
Date Published : 12/13/2011

4/5, Nirmal Ashish Ind. Estate, Asangaon , (W) Shahpur , Shahpur, IN-MH INDIA
50 N - - 18 Henna
Date Published: 12/13/2011

Desc:Henna Tatoos
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 12/13/2011

Desc:Henna Tatoos
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 12/13/2011

Desc:Henna Tatoos

Topline Exim Inc.
Date Published : 10/25/2012

1002 Abhijeet-2 , Mithakhali Six Roads , Ahmedabad, INDIA
50 N - - 18 Henna
Date Published: 10/25/2012

Desc:Royal Henna Powder
53 F - - -- Hair Coloring Prep
Date Published: 10/25/2012

Desc:Royal Henna Powder
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 10/25/2012

Desc:Royal Henna Powder
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 10/25/2012

Desc:Royal Henna Powder
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 10/25/2012

Desc:Royal Henna Powder

Tulaja Exports(India) Pvt Ltd
Date Published : 09/18/2009

108, Siddhivinayak Complex , Sector No 19-c, Plot No. 1, Opp Bank Of , Navi Mumbai, INDIA
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:henna Mehendi Cone
Notes:2/5/04
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:Henna Mehendi Cone
Notes:2/5/04

Uttam Exports
Date Published : 09/18/2009

820 A , Sadar Bazar , Karnal, IN-HR INDIA
53 F - - -- Hair Coloring Prep
Date Published: 09/18/2009

Desc:Uttam Henna Herbal Mehndi Powder
Notes:8/18/06
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 09/18/2009

Desc:Uttam Henna Herbal Mehndi Powder
Notes:8/18/06
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:Uttam Henna Herbal Mehndi Powder
Notes:8/18/06
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Uttam Henna Herbal Mehndi Powder
Notes:8/18/06

pearls of beauty
Date Published : 09/18/2009

3107/29, Ranjit Nagar , New Delhi, INDIA
50 N - - 18 Henna
Date Published: 09/18/2009

Desc:Henna Shampoo
Notes:7/8/05
53 F - - 04 Hair Shampoos (Coloring) (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Shampoo
Notes:7/8/05
53 F - - 99 Other Hair Coloring Preparations, N.E.C.
Date Published: 09/18/2009

Desc:Henna Shampoo
Notes:7/8/05

MOROCCO
Ste Zineglob.sarl dba Argane Achifae
Date Published : 12/21/2012

No. 95 Ibn Khaldoun .lot 2 , Agadir, Agadir Ida Ou Tanan MOROCCO
50 N - - 18 Henna
Date Published: 12/21/2012

Desc:Henna Powder
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 12/21/2012

Desc:Henna Powder

PAKISTAN
AHMED IMPORT EXPORT HOUSE
Date Published : 09/18/2009

F-10, SECTOR C-VIII , Karachi, PAKISTAN
53 F - - 03 Hair Rinses (Coloring) (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Powder
Notes:7/11/03

FIDAI TRADING ENTERPRISE
Date Published : 09/18/2009

8/3 Arkay Square Extension , New Challi , Karachi, PK-SD PAKISTAN
53 F - - -- Hair Coloring Prep
Date Published: 09/18/2009

Desc:Dulhan Mehndi Body Color (Natural Henna Powder)
Notes:11/28/05
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Dulhan Mehndi Body Color (Natural Henna Powder)
Notes:11/28/05

Hemani International
Date Published : 02/11/2013

Plot No. 11, Sector A-IV Karachi 75150 , Karachi, Sindh PAKISTAN
50 N - - 18 Henna
Date Published: 02/11/2013

Desc:Henna
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 02/11/2013

Desc:Henna
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 02/11/2013

Desc:Henna

M Manzoor & Co Pak (Pvt) Ltd
Date Published : 09/18/2009

13 Sind Mkt M A , Jinnah Rd , Karachi, PAKISTAN
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Henna Powder
Notes:8/14/01
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Powder
Notes:8/14/01

M.I.A.G. (Muhammad Ismail Abdul Ghani)
Date Published : 09/18/2009

M.A. Jinnah Road , Molvi Musalir Khana , Karachi, PAKISTAN
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Henna Powder
Notes:8/14/01
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Powder
Notes:8/14/01

Mehran Spice Industries
Date Published : 09/18/2009

P.O. Box 3226 , Shersha, PAKISTAN
53 F - - 01 Hair Dyes and Colors (all Types Require Caution Statements and Patch Tests) (Hair Coloring Preparati
Date Published: 09/18/2009

Desc:Henna Powder
Notes:8/14/01
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:henna powder
Notes:8/14/01

NAAJO & CO.,
Date Published : 09/18/2009

86 VAZIR MANSION, AIWAN-E-TIJARAT , ROAD, , KARACHI- 74000, PAKISTAN
53 F - - -- Hair Coloring Prep
Date Published: 09/18/2009

Notes:Henna Powder

NAVAID CO
Date Published : 09/18/2009

C 302 BLACK-6 F.B. AREA , KARACHI, PAKISTAN
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 09/18/2009

Desc:Henna Paste
Notes:6/14/01
53 P - - 99 Other Cosmetic Raw Materials, N.E.C.
Date Published: 09/18/2009

Desc:Henna Paste
Notes:6/14/01
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 09/18/2009

Desc:Henna Paste
Notes:6/14/01

Nasil
Date Published : 09/18/2009

F.-124, S.I.T.E. , Sialkot, PAKISTAN
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Rani Kone Henna Paste
Notes:1/29/01
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 09/18/2009

Desc:Rani Kone Henna Paste
Notes:1/29/01

Zaiqa Food Industries
Date Published : 09/18/2009

Apt No. 2 Musmillah Bldg 13-C Comm , 51-9 Sector 15 , Karachi, PAKISTAN
53 F - - 02 Hair Tints (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Powder
Notes:9/28/00
53 F - - 03 Hair Rinses (Coloring) (Hair Coloring Preparations)
Date Published: 09/18/2009

Desc:Henna Powder
Notes:9/28/08

SAUDI ARABIA
Rafea Cosmetics Industry
Date Published : 03/21/2012

Warehouse City Alkhumrahpo Box 1697 , Jeddah, SAUDI ARABIA
50 N - - 18 Henna
Date Published: 03/21/2012

Desc:Henna Nail Paste
50 N - - 18 Henna
Date Published: 03/21/2012

Desc:Henna Paste
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 03/21/2012

Desc:Henna Paste
53 H - - 05 Nail Polish and Enamel (Manicuring Preparations)
Date Published: 03/21/2012

Desc:Henna Nail Paste
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 03/21/2012

Desc:Henna Paste

Rani Cosmetics
Date Published : 05/13/2010

Industrial Areariyadh , Riyadh, SAUDI ARABIA
50 N - - 18 Henna
Date Published: 03/21/2012

Desc:Henna Paste
50 N - - 18 Henna
Date Published: 03/21/2012

Desc:Henna Nail Paste
53 F - - -- Hair Coloring Prep
Date Published: 05/13/2010

Desc:Rani Kone Henna Paste
53 G - - 04 Leg and Body Paints (Makeup Preparations, not for Eyes)
Date Published: 03/21/2012

Desc:Henna Paste
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 05/13/2010

Desc:Rani Kone Henna Paste
53 H - - 05 Nail Polish and Enamel (Manicuring Preparations)
Date Published: 03/21/2012

Desc:Henna Nail Paste
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/13/2010

Desc:Rani Kone Henna Paste
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/13/2010

Desc:Rani Kone Henna Paste

Saleh Ahmed Bin Afif Cosmetics Factory
Date Published : 05/13/2010

Unknown , Unknown, SAUDI ARABIA
53 F - - -- Hair Coloring Prep
Date Published: 05/13/2010

Desc:Rani Kone Henna Paste
53 G - - 99 Other Makeup Preparation, not for the Eyes, N.E.C.
Date Published: 05/13/2010

Desc:Rani Kone Henna Paste
53 L - - 99 Other Skin Care Preparations, N.E.C.
Date Published: 05/13/2010

Desc:Rani Kone Henna Paste
53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C.
Date Published: 05/13/2010

Desc:Rani Kone Henna Paste

UNITED ARAB EMIRATES
Abbeshaikh Trading
Date Published : 12/18/2012

Behind Gold Souo , Dubai, UNITED ARAB EMIRATES
53 E - - 99 Other Hair Preparations, Non-coloring), N.E.C.
Date Published: 12/18/2012

Desc:Royal Henna Powder

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