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Sales of Seized Jan Marini Skin Research Eyelash Product Suspended

Jan 7, 2008 | Parker Waichman Alonso LLP

Jan Marini Skin Research, a small California company that sells a popular cosmetic product—the Age Intervention Eyelash Condition—to make eyelashes appear longer, is suspending U.S. sales of their eyelash product.  The suspension was initiated in order to avoid further conflict with the Food and Drug Administration (FDA) as well as a costly patent battle with drug maker Allergan Inc.  Jan Marini, chief executive of the closely held San Jose, California firm said her representatives started notifying customers late last week that it would no longer sell the eyelash conditioner in the U.S.  Marini and several other companies sell eyelash products that contain ingredients similar to those in prescription drugs used in the treatment of glaucoma.  Glaucoma is a series of diseases that share the common feature of damage to the optic nerve, usually accompanied by an abnormally high pressure inside thee eyeball.

In November, the FDA dispatched agents to seize several thousand tubes of a similar, discontinued Jan Marini product that the agency called a misbranded drug.  The FDA hasn't acted against the reformulated version of the product that the Marini firm is now withdrawing from the U.S. market and Marini says she isn't aware of any safety complaints related to either the original formulation that was seized or the new one being suspended.  Marini said the decision will allow her to focus her attention on the rest of her skin-care products business, adding that she doesn't know if the FDA will allow sales of eyelash conditioners like hers that blur the line between cosmetics and drugs, but "I don't think this issue is going away."

Another concern for Marini’s company was a growing conflict with Allergan Inc. over patents. Allergan, which is believed to be testing an eyelash product called Lumilash, modeled on its glaucoma drug Lumigan, sued seven eyelash-product companies alleging patent infringement this November.  "It's unfortunate that this product is no longer available from Jan Marini because it truly does grow the eyelashes and has a quantifiable benefit," unlike many so-called cosmeceuticals, said Joel Schlessinger, an Omaha, Nebraska, dermatologist who sells the product in his office and on his LovelySkin.com Web site.  Confusion over its regulatory status shows the need for a third regulatory track for cosmeceuticals, separate from those for drugs and cosmetics, he added.  Cosmeceuticals—a morph of “cosmetics” and “pharmaceutical”—are cosmetic products such as anti-aging creams and moisturizers that are claimed, primarily by those within the cosmetic industry, to have drug-like benefits.

Last week, Allergan Inc. said it has dropped one of the lawsuit defendants upon assurance that its product uses a different mechanism that doesn't violate Allergan patents.  Underscoring its intention to aggressively defend "the fruits of our scientists and other hard work," Allergan said it has "no intention of settling any case in a manner that would empower a defendant to continue to infringe our intellectual property portfolio."  Jan Marini Skin Research doesn't disclose financial results, but Marini said the eyelash conditioner product has been its top seller and accounted for roughly 30% of sales with tubes retailing for about $160 in physician offices, spas, and online.