Eyelash product ingredient focus of FDA seizure, Allergan lawsuit

San Jose, CA-U.S. marshals seized more than 12,000 applicator tubes of an eyelash product (Age Intervention Eyelash, Jan Marini Skin Research Inc. [JMSR]) valued at a total of $2 million at the request of the FDA because of agency concerns that it might cause optic nerve damage, macular edema, or uveitis.

The FDA described the product as “an unapproved and misbranded drug” because it said the manufacturer claimed that it could increase eyelash growth and as “an adulterated cosmetic” because it contains bimatoprost, which is approved to treat elevated IOP. Use of the eyelash product by patients taking glaucoma medication also containing the prostaglandin analogue could lead to serious side effects, according to the agency.

The eyelash product’s manufacturer, however, issued a statement that it has not made the formulation for more than a year and is unaware of any safety issues related to its use. A new version of the product (Age Intervention Eyelash Conditioner) does not contain bimatoprost and has not been embargoed, according to the statement, issued Nov. 16, the same day as the seizure.

“The discontinued product was stored in JMSR’s warehouse since September 2006, when it was embargoed by the California Department of Health Services’ Food and Drug Branch at the FDA’s request,” according to the company. “JMSR offered to destroy the product voluntarily, but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizure.”

The seizure followed the Nov. 7 filing of a lawsuit by Allergan Inc. in U.S. District Court in Santa Ana, CA, against seven companies it said sell products containing prostaglandin analogues such as bimatoprost and promote them to grow eyelashes. Allergan makes a glaucoma medication (Lumigan) that contains bimatoprost and maintains that the other companies are infringing on a patent related to the prostaglandin analogue’s ability to help eyelashes grow. Allergan does not make a product specifically for eyelash growth.

The lawsuit names JMSR as well as Athena Cosmetics Inc., Cayman Chemical Co., Civic Center Pharmacy, DermaQuest Inc., Intuit Beauty Inc., and PhotoMedex Inc.