American Behavioral Research Institute, LLC – FDA Warning Letter, May 3, 2024

The FDA issued a Warning Letter to American Behavioral Research Institute, LLC (ABRI) following an inspection from April 17 to May 3, 2024. The inspection reviewed ABRI's role as the sponsor of clinical investigation Protocol ABRI-002, "A Study to Evaluate the Effects of Relaxium in Subjects with Sleep Disorder," involving the investigational drug Relaxium® Sleep.

The primary violation identified was ABRI's failure to submit an Investigational New Drug (IND) application for Protocol ABRI-002, which involved 40 human subjects, before initiating the clinical investigation. The FDA determined that Relaxium, as studied in Protocol ABRI-002, was intended for use as a drug to treat insomnia, based on the study's objective to investigate its effect on sleep parameters in subjects with insomnia and the use of efficacy endpoints like wrist actigraphy, the Leads Sleep Evaluation Questionnaire (LSEQ), and daily sleep diaries. This contradicts ABRI's assertion that Relaxium is a dietary supplement and not a drug.

ABRI's May 24, 2024, response to the Form FDA 483 was deemed inadequate because, while stating no future studies would occur, it did not provide a sufficient corrective and preventive action plan for developing and implementing procedures to comply with IND regulations if future clinical investigations requiring an IND are initiated. The FDA emphasized that failure to submit an IND raises significant