Claims Classify Iren’s Natural Products As Drugs; FDA Cites CGMP Violations
This article was originally published in The Tan Sheet
Executive Summary
FDA found "significant deviations" from current good manufacturing practices at Iren Corp.'s manufacturing facility after the agency determined the firm's claims for some products indicate their intended use as drugs, according to an April 3 warning letter
|
FDA found "significant deviations" from current good manufacturing practices at Iren Corp.'s manufacturing facility after the agency determined the firm's claims for some products indicate their intended use as drugs, according to an April 3 warning letter. In the letter posted on FDA's Web site April 17, the agency said its warnings concern Iren's products including Secret Anti-Fungus Cream , intended for treatment of fingernails and toenails, Natural Weight Control Cream as well as creams intended to counteract aging, fungus, eczema, psoriasis and rosacea. Label claims such as "penetrates pores to relieve fungus and prevent the development of new fungus infections" classify the products as drugs and therefore subject them to drug regulations such as cGMPs, FDA's Philadelphia district office says in the letter. Marketing the products is in violation of the Food, Drug and Cosmetic Act because there is no evidence Iren's products "are generally recognized by qualified scientific experts as safe and effective for their labeled uses," and none of them is the subject of a new drug application, FDA says. FDA cited cGMP violations including failing to establish a written testing program to assess the stability characteristics of drug products and to test in-process materials for identity, strength, quality and purity, and failure. Furthermore, the firm has not followed through on an earlier pledge to change its conduct, the agency says. Following FDA officials' inspection of Iren's site in July and August 2006 the firm said it "temporarily discontinued the manufacture of drug products" and "would implement corrective actions before restarting the manufacturing operations." However, the firm's Web site indicated it is "still marketing various products," according to FDA's letter. According to Iren, it has developed a patented technology to manufacture products "based on natural healing oils, herbal extracts and natural active microencapsulated ingredients." FDA instructed the firm to respond within 15 working days of receiving the letter with descriptions of the corrective actions it will take. - Malcolm Spicer ([email protected]) |