TESTING DIETARY SUPPLEMENTS FOR SIBUTRAMINE (MERIDIA)

Recently, FRL has received numerous calls regarding the testing of dietary supplements for the presence of a pharmaceutical drug called sibutramine.   This drug is available in the United States by prescription only.   A recent publication in a peer-reviewed journal discusses a case of adulteration in a dietary supplement resulting in an adverse event in Europe (overdosage).   Because this drug is used in weight management, the likely dietary supplement ingredients/products that could be adulterated would be those used in weight management.   Recently, a sibutramine analogue was also discovered and the FDA just issued an advisory on a dietary supplement found to contain sibutramine in the US.

Currently, we are offering qualitative screening for sibutramine using a variety of methods.   The methodology may include HPLC-DAD, HPLC-MS/MS, HRGC-MS and/or HRGC-MS/MS as well as other or orthogonal techniques depending on the matrix.   We have obtained an authentic sample of this drug material for comparison and spiking studies.   Because it is a controlled substance, all US based laboratories must be registered with the US Drug Enforcement Agency to handle this material in their facility (with only certain very limited solution forms exempt).   Flora Research Laboratories is fully registered to handle all schedules of controlled substances in our research and testing and has been audited by the DEA for compliance with controlled substance handling requirements.