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Eyelash product in regulatory minefield

By Katie Bird , 18-Jan-2008

A US company's eyelash lengthening product is currently under investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK following its removal from the US market.

Jan Marini Skin Research (JMSR) has hit the headlines in the US recently with its voluntary removal of its Age Intervention Eyelash Conditioner and Age Intervention Masses of Lashes products. Press reports cited a wish to avoid conflict with the FDA over the product's regulation and a patent battle with pharmaceutical company Allergan as the reasons behind the decision. The product has been available in the UK through Jan Marini's European distributor however the MHRA spokesman Steven Hallworth told 'the product is being looked into by the agency and appropriate regulatory action will be taken'. Due to the confidentiality of the proceedings Hallworth was unable to comment on the details of the case. However he explained that in the majority of cases when regulatory issues come to the attention of the agency, the manufacturer withdraws the product from the market until the necessary information is provided. The MHRA's concern with the product is likely to surround its active ingredients, as a previous eyelash lengthening product form JMSR contained the ingredient bimatoprost, licensed for use in a glaucoma drug in the US. The FDA asked for the original product to be removed from the market in 2006 and JMSR then released a new reformulated product that according to the company does not contain the contentious ingredient. This has subsequently been subject to an alleged patent infringement with the pharmaceutical company Allergan, prompting the removal of the products from the US market. JMSR CEO Jan Marini said: "We believe that it makes sense to suspend these products while we strategically review our option. "We are assured that the Allergan allegations are unfounded. However, the lawsuit is a major distraction." Marini added that the company would concentrate on its skin care sector with a number of new product launches planned for 2008.

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