Import Alert 53-04

(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 # 53-04
Published Date: 08/09/2018
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Eyelash and Eyebrow Dyes Containing Coal-Tar"

Reason for Alert:

This alert was initiated in 1982 when it was noted that, upon chemical analysis, a number of eyelash and eyebrow dyes manufactured in Austria, Germany and England, shipped to the U.S., primarily through the mail, contained coal-tar dyes which are unsafe within the meaning of Section 721(a) of the FD&C Act.



The Center for Food Safety and Applied Nutrition, Health Hazard evaluation Board, evaluated the medical evidence related to a consumer injury along with scientific literature for coal-tar dyes. Based on the review, the products listed in the attachment represented an acute, severe hazard to health with the possibility of permanent injury; i.e., impaired sight, including blindness.



The products are believed to be widely distributed in the United states, although they probably are not sold for direct use by consumers, but rather sold to and used in beauty salons. Before use, the products are mixed with hydrogen peroxide and applied by a beautician to the eyelashes with a cotton swab. The primary distributors in the U.S. are likely to be firms that supply goods to beauty salons; however, products may also be shipped directly

to beauty salons by the manufacturer.



Review of FY 91-92 detention data indicated detentions of eyelash and eyebrow dyes continue to be made for Dr. Olbrich's Combinal dye, Vienna, Austria; Refecto Cil, Vienna, Austria, and Henna, Berlin, Germany. All entries were mail entries through DET-DO and BUF-DO.

Guidance:

Districts may detain,without physical examination, eyelash and eyebrow dyes identified in the Red List.



Alert U.S. Customs agents of the possible entry of the eyelash and eyebrow dyes at mail facilities. Continue surveillance for coal-tar dyes in eyebrow and eyelash dyes. Notify DIOP if any product not on the attachment is found to contain coal-tar dye.

Product Description:

Eyelash and Eyebrow Dyes

Charge:

"The article is subject to refusal of admission in accordance with Section 801 (a)(3) in that it appears to bear or contain, for the purpose of coloring only, 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)


AUSTRIA


Andora-Cosmetic
Date Published : 09/18/2009
Unknown Street , Vienna, AUSTRIA
53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Andora -Augenbrauen und Wimpernfarbe all shades
Notes: coal tar dyes
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES);

Gschwenter-Haar Kosmetic Products
Date Published : 09/18/2009
unknown , Vienna, AUSTRIA
53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Refecto Cil - Augenbrauen und Wimperfarbe graphite; black; brown and blue-black shades
Notes: mfr; coal tar dyes
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES);

W. Pauli
Date Published : 09/18/2009
A-1160 , Vienna, AUSTRIA
53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Pialan Hair Dye
Notes: mfr.; coal tar dyes
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES);

53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Dr Olbrich's Combinal Augenbrauen und Wimperfarbe black; brown; blue; grey shades
Notes: mfr.; coal tar dyes
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES);


CANADA


National Beauty Supply
Date Published : 09/18/2009
unknown , Mississagi, Ontario CANADA
53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Dr Olbrich's combinal Augenbrauen und Wimperfarbe black; brown; blue and grey shades
Notes: Known Shipper for W Pauli FEI 3003888792; coal tar dyes
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES);


GERMANY


Else Sperlich Chem. Kosm.
Date Published : 09/18/2009
Fabrick , Berlin, GERMANY
53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Henna Gora Augenbrauen und Wimpernfarbe (black; brown; blue-black shades)
Notes: mfr; coal tar dyes
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES);


SWITZERLAND


Anifa SA
Date Published : 09/18/2009
unknown , Baar, SWITZERLAND
53 C - - 07 Eyelash and Eyebrow Dye (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Belmacil color
Notes: coal tar dyes
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES);


UNITED KINGDOM


Zena Cosmetic Co.
Date Published : 09/18/2009
Unknown Street , London, England UNITED KINGDOM
53 C - - 04 Eye Lotion (Eye Makeup Preparations)
Date Published: 09/18/2009

Desc: Permalash black and brown shades
Notes: mfr coal-tar dyes
Problems: COLOR NOT CONTAINED IN TABLE (ENTER NAME IN NOTES);