Import Alert 53-15

"Detention Without Physical Examination of Eye Area Cosmetics Containing Kohl, Kajal, or Surma"

This alert was first initiated in response to a report from the State of California, Department of Health Services, Food and Drug Branch, concerning the use of eye area cosmetic (e.g., pencils and eyeliners) containing Kohl and/or Kajal. These cosmetics were reportedly being imported from Germany and are labeled as having "FDA approval."

A subsequent report received from the New York State Department of Health indicated that Surma, a powdered eye area product manufactured and used in Pakistan, India, and other Middle Eastern countries, was believed to be the source of lead poisoning in a young child. Available reference materials indicate that the Indian colorant "Surma" is also known in Arab countries as Kohl.

The products generally bear limited English language labeling. They are frequently imported in personal baggage and are being sold in stores that specialize in Middle Eastern commodities.

There are no color additive regulations allowing for the use of these substances in cosmetics. Furthermore, the use of these colors may present a hazard to health because of their heavy metal content (i.e., they may contain more than acceptable trace levels of lead).

Districts may detain, without physical examination, eye a cosmetics which contain Kohl, Kajal, Surma or lack ingredient declaration.

For eye area cosmetics that bear ingredient declarations, automatically detain only those products that list colors not specifically permitted by color additive regulation for use in the area of the eye.

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.

Any eye area cosmetic containing Kohl, Kajal, or Surma

"The article is subject to refusal of admission pursuant to on 801 (a)(3) in that it is not a hair dye and it appears to r to bear or contain, a color additive which is unsafe within eaning of Section 721(a) [Adulteration, Section 601(e)]."

OASIS charge code - COSM COLOR

If the product labeling states or suggests "FDA Approved," add a second charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that its labeling appears to be false or misleading [Misleading, section 403(a)]."

If the outer carton labeling (or immediate container labeling in cases where no outer carton exists) fails to bear an ingredient declaration, the following charge should be added:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the label fails to bear an ingredient declaration in accordance with the requirements of Section 1454(c)(3)(B) of the Fair Packaging and Labeling Act and 21 CFR 701.3."