The FDA just called out another non-IND clinical trial with a supplement claiming medical benefits. An FDA inspection revealed that the sponsor of a Relaxium® Sleep study bypassed critical regulatory steps, raising serious concerns about participant safety and data integrity in unapproved clinical trials.
In a Warning Letter to the American Behavioral Research Institute (ABRI), sponsor of a clinical study on Relaxium® Sleep, FDA cited improper conduct of a clinical trial without submitting an Investigational New Drug (IND) application, a required regulatory step for studying drugs in human subjects. During an inspection of the sites participating in a clinical trial sponsored by ABRI, FDA inspectors found that the study enrolled 40 participants to assess the impact of Relaxium on insomnia-related sleep parameters, using wrist actigraphy, sleep quality questionnaires, and sleep diaries. Although the study was clearly looking at therapeutic endpoints, the sponsor did not file an IND application with the FDA and got approval to proceed with this trial. While it is possible to conduct certain clinical trials without an IND, such trials must meet specific well-defined criteria or be formally exempted by the FDA from IND requirements. None of that was applicable to the study in question.
FDA regulations are clear: any sponsor studying a product intended to treat, cure, or mitigate disease must submit an IND before launching a clinical trial. Under the Food, Drug, and Cosmetic Act (FD&C Act), a “drug” is defined as any article intended for the diagnosis, cure, mitigation, treatment, or prevention of disease. The FDA concluded that Relaxium, as used in the ABRI-002 protocol, was clearly being investigated as a treatment for insomnia—a medical condition. Therefore, it met the definition of a drug under federal law and triggered the IND requirement.
ABRI, however, argued that Relaxium is marketed and intended solely as a dietary supplement, not as a drug. In its May 24, 2024 response, the sponsor claimed that testing a supplement in individuals with a sleep disorder does not necessarily change the legal classification of the product. They contended that Relaxium was never promoted as a treatment for insomnia and denied any drug-like intent in the study design.
The FDA disagreed, pointing to the protocol’s explicit focus on treating sleep disorders and using medical-grade tools to assess changes in sleep quality and insomnia severity. These elements confirmed that the study’s goal was to treat a condition—thus categorizing Relaxium as a drug in this context.
Although the issue was not initially flagged on the inspection’s Form FDA 483, it was addressed in the final Warning Letter. The agency emphasized that ABRI failed not only to follow mandatory IND procedures but also to propose a credible corrective and preventive action plan. The company stated it had no future plans for clinical research, but FDA found this response insufficient, particularly if ABRI later reenters the clinical trial space.
The FDA’s action serves as a clear warning: supplement makers must tread carefully when testing their products in clinical settings. If a study crosses into “drug-like” intent—especially by targeting medical conditions—regulatory compliance with IND requirements becomes mandatory. Skipping these steps risks subject safety and can invalidate all collected data, putting sponsors at odds with federal law and public trust.
