American Behavioral Research Institute, LLC
American Behavioral Research Institute, LLC (ABRI), the maker and sponsor of the dietary supplement Relaxium® Sleep, received an FDA Warning Letter dated April 30, 2025, for conducting a clinical investigation (Protocol ABRI-002) on human subjects to evaluate Relaxium's effects on insomnia without first submitting a required Investigational New Drug (IND) application. FDA determined that because the study was designed to assess Relaxium's efficacy in treating insomnia — a disease — the product was being used as a drug under the FD&C Act, regardless of its commercial marketing as a dietary supplement. ABRI's response, which argued Relaxium was a dietary supplement and that no future studies were planned, was deemed inadequate because it lacked a corrective and preventive action plan for IND compliance. FDA required ABRI to respond within 15 business days with actions taken to prevent future violations, warning that failure to do so may lead to regulatory action.
Flagged claims (3)
As is obvious from the formulation, labeling, marketing, and advertising of Relaxium, the article is and is intended to be a dietary supplement, and not a drug.
at no time was Relaxium intended to treat, cure, mitigate, or diagnose a disease, whether as a commercially available finished product or as a supplement, in study ABRI-002.
whether Relaxium has any effect on subjects with sleep disorders is not evidence that the article is a drug as defined by 21 USC 321(g). Subjects with sleep disorders (as with any medical condition) may also take dietary supplements – and doing so does not cause the supplements to be drugs. Even determining the effect of a dietary supplement on persons with a particular condition does not amount to an intended use of that supplement to treat that condition.
Required actions (2)
Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future.
ABRI's written response does not provide sufficient details of a corrective and preventive action plan for developing and implementing procedures to comply with IND regulations, should ABRI decide in the future to initiate another clinical investigation for which an IND is required.
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