Disease Population + Disease Endpoints = Drug Intent

Clinical study parameters can turn a dietary supplement study into a drug study in FDA’s view, triggering Investigational New Drug (IND) requirements. In one FDA Bioresearch Monitoring investigation, a study on a product containing multiple dietary supplement ingredients was treated as a drug because it was studied for dementia outcomes. Even if an ingredient is commonly sold as a dietary supplement, an IND may still be required if the study is designed to evaluate it for diagnosing, curing, mitigating, treating, or preventing disease.

From warning letter. “Whether an investigational article is a drug depends on the intent of the investigation. Based on the study design … the investigational product … as used in the clinical investigation, was a drug … was studied for use in the treatment of mild to moderate dementia.

Asa Comments: Studying a dietary supplement for use in dementia shows intended disease use, and although some supplements do study diseased populations, this company was likely scrutinized becuase dementia is a serious disease and because a finished product, not just a single ingredient, was studied. This shows the intended product use. I am all for companies investing in science, but even if a company had great clinical data on dementia, it would not be able to use it under FDA dietary supplement marketing rules.

The key takeaway here is that studying disease populations and disease endpoints can equal drug intent. If you enroll people with a disease and measure disease status, FDA is likely going to view the intent as treatment or mitigation.

Read the warning letter here.