Jan Marini Skin Research Responds to FDA Seizure of Discontinued Eyelash Product
Posted on: Saturday, 17 November 2007, 00:00 CST
SAN JOSE, Calif., Nov. 16 /PRNewswire/ -- The Food and Drug Administration ("FDA") issued a press release today, Nov. 16, announcing the seizure of a discontinued product, Age Intervention Eyelash, which Jan Marini Skin Research,
Inc. ("JMSR") has not manufactured or marketed for more than one year.
The FDA asserts that it has safety concerns about JMSR's discontinued product, but those 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.
JMSR has conducted numerous safety tests on both its original and reformulated products, far beyond those ordinarily required for a cosmetic product, and the test results showed that both products are safe. JMSR also conducted additional safety studies at the request of the regulators and the results of those studies also showed the products are safe.
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. 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.
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. A new ingredient was substituted to confer similar benefits and JMSR released its reformulated product in February 2007. JMSR's current product has not been seized or embargoed.
JMSR has distributed Age Intervention Eyelash Conditioner to tens of thousands of satisfied customers with only a few instances of reported minor irritation and no reports of lasting adverse side effects.
Contact: Mark Marinovich Director of Marketing Communications (408) 362-0130, Ext. 325 mark.marinovich@janmarini.com
Jan Marini Skin Research, Inc.
CONTACT: Mark Marinovich, Director of Marketing Communications of JanMarini Skin Research, Inc., +1-408-362-0130, ext. 325,mark.marinovich@janmarini.com
Source: PRNewswire
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