FDA Seazes Potentially Harmful Eyelash Product, Company Responds
FDA this morning said that Age Intervention Eyelash cosmetic product worth of about $2 million is sezed due to the risk that the product, made by Jan Marini Skin Research, Inc., contains drug ingredient, makes unapproved drug claims, could damage eye.
Jan Marini Skin Research, Inc., responded immediately in a press release stating that FDA's "concerns are not substantiated by any study or analysis that JMSR is aware of, and are certainly not substantiated by any study or analysis offered by the FDA. We are not aware of any instances where JMSR's eyelash product has damaged any user's vision or caused optic nerve damage, blindness, macular edema, or uveitis and the FDA has not informed JMSR of any. The FDA press release purporting to warn consumers about such risks has no factual support we know of."
In a press release FDA stated the following:
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized today 12,682 applicator tubes of Age Intervention Eyelash, a product that may, in some users, 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. The agency takes seriously its responsibility to protect Americans from unapproved drugs.
FDA 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 (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.
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.
However, Jan Marini Skin Research, Inc. continue in the release that "JMSR reformulated its eyelash product in late 2006 to eliminate the marketing claims and the ingredient questioned by the FDA. JMSR's new Age Intervention Eyelash Conditioner does not contain bimatoprost.