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Episode 86- When Supplements Become Drugs: What FDA’s BIMO Program Is Really Policing
Many wellness and nutraceutical companies believe that calling a product a dietary supplement creates a regulatory safe zone. FDA enforcement actions tell a very different story.
In Episode 86 of the Orange Pill Podcast, we break down the FDA’s Bioresearch Monitoring (BIMO) Program and analyze recent FDA Warning Letters that caught sponsors, CROs, and IRBs completely off guard.
This episode explains a hard regulatory truth:
the FDA does not regulate labels - it regulates intent.
We explore three critical lessons drawn directly from enforcement actions involving U.S.-based clinical trials:
• Why study design, not product category, determines whether something is legally a drug
• How enrolling diseased subjects instantly converts a “supplement study” into a drug trial
• Why skipping an IND isn’t a paperwork error but a serious safety and data integrity failure
• How validated clinical instruments can unintentionally trigger drug classification
• The role CROs and IRBs play and where accountability ultimately falls
If your clinical trial measures disease outcomes, targets pathology, or recruits diagnosed populations, the FDA will treat it as a drug study, regardless of what’s on the bottle.
This episode is essential listening for sponsors, CROs, regulatory teams, and anyone designing human research in the supplement space.
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By KGK ScienceMany wellness and nutraceutical companies believe that calling a product a dietary supplement creates a regulatory safe zone. FDA enforcement actions tell a very different story.
In Episode 86 of the Orange Pill Podcast, we break down the FDA’s Bioresearch Monitoring (BIMO) Program and analyze recent FDA Warning Letters that caught sponsors, CROs, and IRBs completely off guard.
This episode explains a hard regulatory truth:
the FDA does not regulate labels - it regulates intent.
We explore three critical lessons drawn directly from enforcement actions involving U.S.-based clinical trials:
• Why study design, not product category, determines whether something is legally a drug
• How enrolling diseased subjects instantly converts a “supplement study” into a drug trial
• Why skipping an IND isn’t a paperwork error but a serious safety and data integrity failure
• How validated clinical instruments can unintentionally trigger drug classification
• The role CROs and IRBs play and where accountability ultimately falls
If your clinical trial measures disease outcomes, targets pathology, or recruits diagnosed populations, the FDA will treat it as a drug study, regardless of what’s on the bottle.
This episode is essential listening for sponsors, CROs, regulatory teams, and anyone designing human research in the supplement space.