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FDA Seizes 'Age Intervention' Cosmetics

Eyelash treatment could cause optic nerve damage

November 18, 2007    Spanish
At the request of the U.S. Food and Drug Administration, U.S. Marshals have seized 12,682 applicator tubes of Age Intervention Eyelash, a product the FDA says could lead to decreased vision. Authorities said the sales value of the seized tubes is approximately $2 million.

Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.

The FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA.

FDA said it also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure, or elevated pressure inside the eye.

For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness.

Damage to the optic nerve may lead to decreased vision and possibly blindness.

In addition, the agency warns use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema - swelling of the retina- and uveitis, which is an inflammation in the eye. Both may lead to decreased vision.

The U.S. Attorney's Office for the Northern District of California filed the complaint requesting the seizure, and coordinated with the FDA. The California Department of Public Health‘s Food and Drug Branch had previously embargoed the seized products at the San Jose facility.

Jan Marini Skin Research has notified FDA that the company ceased manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost last year.

The FDA recommends that consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product. FDA also recommends that consumers consult their health care provider if they have experienced any adverse events that they suspect are related to the product's use.

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