IA #53-19, 8/5/97 -IMPORT ALERT #53-19, "DETENTION WITHOUT PHYSICAL
EXAMINATION OF HENNA BASED SKIN COLOR" Attachment Revised 6/2/04
TYPE OF ALERT: Detention Without Physical Examination
(Note: This import alert represents the agency's
current guidance to FDA field personnel regarding
the manufacturer or product at issue. It does not
create or confer any rights for or on any
individual and does not operate to bind FDA or the
public.)
PRODUCT: Henna powder
PRODUCT CODE: 53F[][]02
PROBLEM: ***Unsafe color additive
[OASIS CHARGE CODE= COSM COLOR - ADULTERATION]***
PAC FOR
COLLECTION: 29002
PAF: COL (Colors in foods & cosmetics)
COUNTRY: Pakistan (PK,)
MANUFACTURER: ***SEE ATTACHMENT***
FEI: ***SEE ATTACHMENT***
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)]."
RECOMMENDING
OFFICE: Los Angeles district, IOB (HFR-PA200)
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 listed in the attachment of 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) 443-3320 or 3007.
PRIORITIZATION
GUIDANCE: II
FOI: No purging required.
KEYWORDS: Henna, hair dye, color, hair color, Almas, Zarqa
PREPARED BY: Jack Geltman, DIOP, (301) 443-6553.
DATE LOADED
INTO FIARS: February 2, 2000 ***ATTACHMENT TO IA 53-19 6/2/04
Ahmed Import Export House Henna Powder
Karachi, Pakistan 53FH03
FEI# 3003851347 7/11/03
Andri Pama Exim Bulk Henna Powder 53F[][]03 6/2/04
D-229 Defence Colony
New Dehli, India
FEI #3004503353
Crystal India Henna Paste Tube Kit 53G[][]04/ 12/7/01
C-316, Yojna Vihar (all brands [including 53G[][]99/
Delhi - 110092 India Surkh] & colors) 53Y[][]99
FEI #3003438219 AND
Henna Powder Kit 53G[][]04/
Tattoos (all brands 53G[][]99/
& colors) 53Y[][]99
Harumal Gangaram & Co. Henna 53Y[][]99 4/28/00
171 Samuel Street (Khoja Galli)
Masjid Bunder, Bombay -400 009
India
FEI #3002926979
And
Babulal Brijbhushan
Unknown Address, Sojat City
India
FEI #3002983470
Federal Exports International Herbal Henna Pack 53F--01 9/19/00
166 Double Storey 53G---
New Rajinder Nagar
New Delhi, IN
FEI# 3003065710
Hesh Pharma Henna Powder 53F--01 10/25/00
B/3, Singh, Industrial Estate No. 1 53G--99
Ram Handir Road, Goregaon (W)
Mumbai, 400 014, India
FEI #3003110600
Jawa Exports Henna Powder, "Reshma" brand 6/26/01
548 Udai Marg, Tilak Nagar 53F[][]01/53F[][]02
Jaipur, India
FEI# 3003341111
Lokhandwala Exports Henna Powder 53F -01 3/11/03
72 Gandhi Nagar 53F--02
Dainik Shivner Road 53G--99
Mumbai, India 40018
FEI #3002925733
Mahasahian Di Hatti Ltd. Henna Powder 53F--01 6/21/01
9/44 MDH House 53F--02
Ind. Area. Kirti Nagar
New Delhi, IN
FEI# 1000293488
M.I.A.G. (Muhammad Ismail Abdul Ghani) Henna Powder
M.A. Jinnah Road 53F[][]01/53F[][]02
Molvi Musalir Khana 8/14/01
Karachi, Pakistan
FEI# 3003407168
M. Manzoor & Co.
13 Sind Market Ma Jinnah Rd.
Karachi, Pakistan
FEI #1000192695
***Mehran Spice Industries***
P.O. Box 3226
Shersha, Pakistan
FEI #3002903207***
Navaid Co. Henna Paste/53L--99 6/14/01
C 302 Black-6 F.B. Area 53P--99
Karachi, Pakistan 53Y--99
FEI #3003265453
Nasil Rani Kone Henna Paste
F. -124 S.I.T.E. 53F[][]02
Karachi, Pakistan 53G[][]99
FEI #3003218667 1/29/01
Ram Gopal Grand Sons Henna Paste Tube Kit 53G[][]04/ 12/7/01
Faridabad-121 002 (all brands [including 53G[][]99/
India Eatle] & colors) 53Y[][]99
FEI #3003510980
Raun Harman Exports Pvt. Ltd. Henna Powder and paste 8/2/01
D-252 Ashok Vihar, Phase 1 53F[][]01/53F[][]02
New Delhi, India
FEI# 3002796106
Tulaja Exports (India) Pvt. Ltd Henna Mehendi 53G[][]04 2/5/04
108 Siddhivinayak Complex Cone 53G[][]99
Plot No. 1., Off. Bank of Saurashtra
Vashi, Navi Mumbai, 400 705
India
FEI #3004117679
Zaiqua Food Industries Henna Powder 53F--02 9/28/00
51/9 Sector 15 53F--03
Korangi Industrial Zone
Karachi, Pakistan
FEI #3002480175