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E-cigarette detainees light up ombudsman's list

This article was originally published in The Tan Sheet

Executive Summary

FDA's Center for Drug Evaluation and Research's Ombudsman's Office's report says e-cigarette companies' import and export issues related to detained products and seizures were among the most common topics it was contacted about in 2009. FDA in July stopped the products from entering the U.S. after testing lots that yielded toxic materials (1"The Tan Sheet" Jan. 18, 2010, In Brief). Other issues industry contacted CDER about include delays in generic drug applications related to citizen petitions and delayed reviews by the Office of New Drugs. Common consumer complaints included adverse events, issues with accessing information on FDA's Web site and misleading product Web sites, the report says. The Ombudsman's Office said its contacts included 9 percent FDA employees, 30 percent from the pharmaceutical industry, law firms and researchers, and 61 percent from consumers, advocacy groups and health care professionals
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