FDA Sends Warning Letter to Pharmachem

FDA Sends Warning Letter to Pharmachem

WASHINGTONTheFood and Drug Administration (FDA) on Nov. 19, 2004, sent a warning letter to Pharmachem Laboratoriesrelating to claims made for its Phase 2® ingredient. On Nov. 1, 2004, theagency sent a number of warning letters to finished dietary supplement marketersthat had included Phase 2 in their products, singling out claims for theingredient as potentially false and misleading.

In its letter to Pharmachem, the agency singled out claims forPhase 2 including Phase 2 has been successfully clinically studied to neutralizedietary starch absorption by over 70%, with slow, steady stimulant-free weightloss and Several clinical studies of Phase 2 Starch Neutralizer havedemonstrated efficacy in weight loss and in the improvement of post-prandialglucose tolerance. After reviewing Pharmachems studies, FDA stated theclaims were not supported by competent and reliable scientific evidence, makingthe claims false and misleading and causing the product to be misbranded.

Mitch Skop, Pharmachems director of new productdevelopment, told INSIDER thecompany was working to resolve the issue. Pharmachem has been in contact with FDA regarding theletter and will be submitting a complete research report in early Februarydocumenting our clinical studies, he said. We are confident that the datapresented will demonstrate that our claims for Phase 2 are scientificallysupported. Pharmachem has invested in nine separate studies over the lastthree years that have determined the efficacy and safety of Phase 2 and noadverse side effects have been reported.