Do not host SIUU communications on platforms too limited to carry the required disclosures

AI-verifiedwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

Character-space-limited or otherwise presentationally limited platforms that cannot accommodate all recommended disclosures should not be used to host an SIUU communication directly; they may instead be used to direct HCPs to an SIUU communication hosted elsewhere.

Check

Determine whether the platform's format allows all recommended Q2 disclosures to be included; if not, check whether SIUU content is being hosted there directly (violation) versus merely linked to (acceptable).

Escalate when

Whether a platform's space constraints genuinely preclude the required disclosures is a judgment call.

Where this comes from

Section V, Q3, item 3 · page 23. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… variety of media types and platforms, and each medium and platform may prompt unique presentational challenges and considerations. For example, certain online platforms may impose character-space limitations or other presentational limitations that would not enable a firm to include within their communications on that platform all of the disclosures that are recommended for an SIUU communication. To be consistent with the recommendations in this guidance, such platforms should not be used to host SIUU communications but could be used to direct HCPs to an SIUU communication. For example, it would be consistent with the recommendations in this guidance for a communication on a character-space limited platform to direct HCPs to an SIUU communication through a statement that does not mention the name of any specific medical product, such as “New publication for Health Care Providers—phase 3 trial results for an investigational treatment for [disease X],” followed by a link to a website whe…

Open the original at page 23 on fda.gov ↗Read our full copy →

Document: FDA guidance: Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (final)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: a36a07e1efd950b7a2a8f6b3…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Audiencehcp

Basisunapproved-use-scientific

Mediumsocialdigital

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a whole sentence, verbatim, from Q3 item 3. Its subject is anaphoric ('such platforms'), and the rule resolves the antecedent correctly from the immediately preceding sentences — platforms whose character-space or other presentational limitations would not enable a firm to include all of the recommended disclosures. Nothing is invented and no unrelated sentence is run into.
- Not overstated: the rule keeps 'should not be used to host' and preserves the source's express carve-out that such platforms may still be used to direct HCPs to an SIUU communication hosted elsewhere. Omitting that carve-out would have made the rule broader than the source.
- Atomic: one prohibition with its own carve-out, not two independent requirements.
- Determinism 'judgment' is right: the trigger is whether the platform's constraints genuinely preclude all the recommended disclosures, which turns on adequacy rather than a literal match. The escalation note states this correctly.
- Authority 'guidance' matches the source document.
- applies_when (hcp, unapproved-use-scientific, social/digital) is justified by the source's reference to 'certain online platforms' with character-space limitations.
- Severity 'warning' is defensible and consistent with the other Q3 presentational rules.
- Violable and checkable: a reviewer can find an SIUU communication hosted directly on a platform that cannot carry the Q2 disclosures.