FDA Seizes $2 Million Of Cosmetic Eye Product Which Contains Drug Ingredient And Makes Unapproved Drug Claims

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Main Category: Eye Health / Blindness
Also Included In: Dermatology;  Litigation / Medical Malpractice;  Regulatory Affairs / Drug Approvals
Article Date: 18 Nov 2007 - 11:00 PDT

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US marshals seized 12,682 applicator tubes of Age Intervention Eyelash, the use of which can damage some users' eyesight. The US Food and Drug Administration (FDA) asked the marshals to seize the cosmetic eye products, which have a market value of over $2 million.

According to the makers, Jan Marini Skin Research, Age Intervention Eyelash promotes the growth of eyelashes - a claim that is not proven. For a new drug product to be marketed legally, its safety and effectiveness has to be proved, and then approved by the FDA. In a press release, the FDA says it takes its responsibility of protecting Americans from unapproved drugs seriously.

The FDA says it considers said products to be an adulterated cosmetic - it contains bimatoprost, an active ingredient found in an FDA-approved drug for patients with high pressure inside the eye. Those using the FDA-approved prescription drug as well as the Age Intervention Eyelash run an elevated risk of optic nerve damage because the extra bimatoprost dose can raise the prescription drug's impact on the eye - this can lead to poorer vision, and even blindness.

The bimatoprost found in Age Intervention Eyelash can cause other adverse side effects, including swelling of the retina (macular edema) and inflammation of the eye (uveitis), which can also lead to decreased vision.

The complaint and request for seizure was filed by the US Attorney's Office for the Northern District of California, and coordinated with the FDA. The California Department of Public Health's Food and Drug Branch had previously embargoed and seized the products at the San Jose facility. The manufacturers had told the FDA that they had ceased manufacturing and shipping Age Intervention Eyelash products containing bimatoprost in 2006.

If any consumer, dermatologist or esthetician still has Age Intervention Eyelash products, they should discard them, says the FDA. If you are a consumer, have used the said product, and feel you are experiencing any of the described side-effects you should see your health care provider immediately.

-- Jan Marini Skin Research
-- Jan Marini Skin Research response regarding recent FDA action

Written by׃ Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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