WASHINGTON (Reuters) - U.S. marshals on Friday seized 12,682 applicator tubes of a discontinued cosmetic called Age Intervention Eyelash, which the Food and Drug Administration said could harm some users' vision.
By Jim Wolf
WASHINGTON (Reuters) - U.S. marshals on Friday seized 12,682 applicator tubes of a discontinued cosmetic called Age Intervention Eyelash, which the Food and Drug Administration said could harm some users' vision.
The product -- once promoted as increasing eyelash growth -- had been sold and distributed by San Jose, California-based Jan Marini Skin Research, Inc, which accused the FDA of unfairly singling it out.
The FDA said it considered Age Intervention Eyelash "adulterated" and potentially dangerous, notably for users with elevated pressure inside the eye.
!ADVERTISEMENT!The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat this condition.
For patients on the prescription drug, using Age Intervention Eyelash may boost the risk of optic nerve damage "because the extra dose of bimatoprost may decrease the prescription drug's effectiveness," the FDA said.
Jan Marini, the company's president and chief executive, said the product at issue had been in its warehouse since September 2006, when California public health authorities "embargoed" it at FDA request.
The company added in a statement it had offered to destroy the product, "but the FDA recently informed JMSR that it preferred to seize the product so that it could issue a press release announcing the seizure."
"We have been unfairly singled out," Marini said in a telephone interview. "Other companies use the same ingredient and we're not aware of any action that has been taken against them."
FDA spokesman Brad Swezey said in response, "As a matter of policy, we can't acknowledge whether any company is or is not the subject of an ongoing investigation."
The company said it had reformulated its eyelash product a year ago to eliminate the ingredient questioned by the FDA and had scrapped its marketing claims.
In its statement, the FDA said the sales value of the seized tubes was about $2 million and the marshals acted at the FDA's request.
Consumers, dermatologists and beauticians who may still have Age Intervention Eyelash should discontinue using it and discard it, FDA said.
It recommended consumers consult health-care providers if they have experienced any problems they suspect are related to the product's use.
"The agency takes seriously its responsibility to protect Americans from unapproved drugs," the statement said.
(Reporting by Jim Wolf; Editing by Peter Cooney)
