FDA: Eyelash product seized after health concerns raised

U.S. Marshals have seized more than 12,600 applicator tubes of Age Intervention Eyelash, a product made by a San Jose, California company that may, in some users, lead to decreased vision.

The U.S. Food and Drug Administration requested the seizure.

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.

FDA officials said the Age Intervention Eyelash product is an unapproved and misbranded drug because Jan Marini Skin Research has promoted it as something that increases eyelash growth.

FDA officials said that claim had not been approved and that the eyelash lengthener may in fact damage eyes.

Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA, officials said.

The FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic.

Company CEO Jan Marini admits the company has received complaints about the product but maintains it?s safe and well received.

"Maybe 12 complaints of irritation. We have never had any lasting adverse side effects. We have over 5,000 physicians in the U.S. that carry this product, love this product," said Marini

The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (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, 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 (inflammation in the eye), which may lead to decreased vision, FDA officials said.

The U.S. attorney's office for the Northern District of California filed the complaint requesting the seizure and coordinated with the FDA, officials said.

FDA officials said they recommended the seizure as a way of showing they take seriously their responsibility to protect Americans from unapproved drugs.

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 aestheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product.

The 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.