ISI: placement and duration in practice
What actually determines whether Important Safety Information is placed and timed correctly across formats.
Important Safety Information has a clear purpose: tell the audience what could go wrong before they act on what the asset just told them could go right. Where the rule gets complicated isn't the content of the ISI, it's how long it has to stay visible and how it has to sit relative to the benefit claim, and that changes by format.
What it is
ISI covers contraindications, warnings, precautions, and common adverse reactions tied to a promotional claim about a prescription product. The requirement isn't just that this information exists somewhere in the asset. It's that it appears with enough prominence and for long enough that an average member of the audience would actually absorb it, not just technically encounter it.
That last distinction, absorb versus encounter, is what separates ISI from a generic disclaimer. A disclaimer that exists but scrolls past in half a second, or that's legible only if paused and zoomed, doesn't meet the bar even if it's technically present in the file.
Why it matters
Placement and duration issues are a recurring reason promotional assets get sent back in review, and they're distinct from fair balance issues even though the two overlap. Fair balance is about proportion between benefit and risk information. ISI placement and duration is about whether the safety information itself is deliverable and comprehensible in the format it's running in, independent of how much benefit language surrounds it.
An asset can technically satisfy a proportion requirement and still fail on ISI duration, if the safety segment is short enough that it's proportionate to a short benefit segment, but still too short for an average viewer to read or hear it.
How it actually works
Placement and duration requirements differ meaningfully by format:
- Broadcast (audio and video): the ISI, and the related major statement, generally needs to run long enough and at a pace slow enough to be understood in real time, with no ability for the viewer to pause and re-read.
- Print: font size, contrast, and placement of the ISI need to be legible without requiring the reader to search for it, typically adjacent to or immediately following the claim it qualifies.
- Digital and interactive: if the benefit claim is visible without any extra action, the ISI generally needs to be similarly accessible, not hidden behind an additional click, scroll, or hover that the benefit claim doesn't require.
Exact thresholds (how many seconds, what point size) vary by jurisdiction and by the specific regulatory guidance a brand's own legal and regulatory team is applying, so these are the general shape of the requirement rather than a fixed formula.
Related reading
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