Regulatory confusion over eyelash enhancer

By Katie Bird

- Last updated on GMT

Related tags: Pharmacology, Pharmaceutical drug, Bimatoprost

Jan Marini Skin Research (JMSR) has removed its eyelash lengthening
product from the market due to fears over the FDA's standpoint on
products that blur the line between cosmetics and drugs.

According to press reports the California-based skin care company is suspending US sales of the product to avoid conflict with the FDA and a patent battle with pharmaceutical company Allergan. This particular move is voluntary and follows the seizure by the FDA of the product's predecessor the Age Intervention Eyelash Enhancer. The original product contained the ingredient bimatoprost - an FDA-approved drug for glaucoma treatment - and the regulatory body objected calling the eyelash product an unapproved and misbranded drug. The company's reformulated product does not contain the contentious ingredient but it still may be seen as straddling the boundary between cosmetics and drugs posing problems for regulation. Company CEO Jan Marini was reported in the Wall Street Journal stating that the regulatory confusion surrounding such products was the reason for the withdrawal. Marini added that although she wasn't sure of the FDA's standpoint on products that blur the boundary between cosmetics and drugs, she felt the issue would not disappear. In addition, the withdrawal of the product from the US market will allow the company to focus its attention on the rest of its skin care range, she said. Jan Marini's is not the only eyelash enhancing product on the market and the proliferation of these and other cosmeceuticals suggests the need to address the regulatory issues of this emerging category. Shortly after the seizure of the original Marini product Athena withdrew its bimatoprost-containing product Revitalash from the market, stating that a release of a reformulation without the ingredient would soon follow. In addition, the pharmaceutical company Allergan - which is suing JMSR for alleged patent infringement - is rumoured to be testing an eyelash product called Lumilash taking inspiration from its glaucoma drug Lumigan. JMSR has been diversifying its product base over the course of 2007 with the release of its facial sun protector in June containing the active ingredient PhytoMelanin, a derivative of date palm fruit, promising to protect against both UVA and UVB rays. In addition the company has been expanding into the hair care sector, releasing its anti-aging hair care range in February 2007. The range targets age-related hair thinning and the dull, lifeless appearance often associated with aging hair.

Related topics: Market Trends, Color Cosmetics

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