Unapproved Eyelash Drug, Age Intervention Eyelash, Seized by FDANov 19, 2007 | Parker Waichman LLP
Thousands of tubes of Age Intervention Eyelash, a cosmetic product promoted as an eyelash lengthener, have been seized by the Food & Drug Administration (FDA). In announcing the Age Intervention Eyelash seizure, the FDA alleged that the eyelash drug was an unapproved medication, and that some ingredients in the cosmetic were dangerous and could lead to decreased vision. In all, the FDA seized more than 12,000 tubes of this defective drug, worth more than $2 million.
Age Intervention Eyelash is made and sold by Jan Marini Skin Research, Inc., of San Jose, California. The defective eyelash drug looks like a tube of mascara and has a brush for applying the product along the base of the lashes. Age Intervention Eye lash typically sells for about $140 online and in spas and doctors' offices.
The seizure of the eyelash drug was prompted by a complaint filed by the US Attorneys Office for the Northern District of California. Prior to the seizure, the California Department of Public Health's Food and Drug Branch had embargoed tubes of Age Intervention Eyelash at the San Jose facility. The FDA said it had recommended the Age Intervention Eyelash seizure to show that the agency takes seriously its mission to protect Americans from unapproved drugs.
According to the FDA, Age Intervention Eyelash is an unapproved drug because it was marketed as an eyelash lengthener. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA.
But even more disturbing, the FDA said that Age Intervention Eyelash was considered an adulterated drug because it contained bimatoprost, an active ingredient in an FDA-approved drug to treat elevated pressure inside the eye. According to the Wall Street Journal, doctors and patients alike have noticed that eyelash growth is a side effect of a bimatoprost. That discovery has prompted cosmetics companies to create new eyelash treatments that contain bimatoprost.
According to the FDA, however, bimatoprost can cause problems for some people. If patients using a drug that contained bimatoprost also use Age Intervention Eyelash, there is a risk that their optic nerve could be damaged. This could lead to decreased vision, and even blindness. The FDA also said that use of the defective eyelash drug 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 FDA has warned anyone who purchased Age Intervention Eyelash who still has it to 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 this dangerous eyelash drug.