Keep SIUU email messages separate from approved-use promotional emails

AI-verifiedwarningFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

Email messages used to share an SIUU communication should be separate from email messages used to share promotional communications about approved uses of the medical product.

Check

Check whether SIUU content and approved-use promotional content appear in the same email message. A violation is one email message carrying both.

Where this comes from

Section V, Q3, item 2, Example 3 · page 22. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ions through the clear and prominent presentation of the disclosures recommended in this guidance. FDA also recommends that firms not include direct links from web pages that host promotional communications about approved uses to web pages that host SIUU communications. Example 3: If a firm chooses to share information about both approved and unapproved uses of its medical products to HCPs through email messages, FDA recommends that email messages used to share SIUU communications be separate from email messages used to share promotional communications about approved uses of the medical product and that the email messages used to share SIUU communications clearly identify those communications through the clear and prominent presentation of the disclosures recommended in this guidance. Example 4: If a firm’s representative delivers an SIUU communication during an in-person visit with an HCP, that SIUU communication should be separate from (i.e., not attached to or intermingled with) any promotional commu…

Open the original at page 22 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

Mediumdigital

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 — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The source supports the content: the quote is a whole sentence, verbatim, from Q3 item 2, Example 3, stated in FDA's own recommending voice, and the rule does not strengthen it.
- It is not atomic. The rule bundles two independently checkable requirements: (a) SIUU emails are sent separately from approved-use promotional emails, and (b) the SIUU emails clearly identify themselves through the clear and prominent presentation of the recommended disclosures. The Check itself names two distinct violations ('combining the two in one email, or an SIUU email lacking clear disclosure'), which confirms the bundle.
- The determinism flag is wrong. Part (a) is presence/absence, but part (b) turns on whether the disclosures are 'clear and prominent' — the guidance resolves that against type size, font style, layout, contrast, graphic design, headlines and spacing, which is a prominence judgment, not a literal match. A single 'deterministic' flag cannot cover both.
- Authority 'guidance' matches the source document, applies_when (hcp, unapproved-use-scientific, digital) is justified by the email setting of Example 3, and severity 'warning' is defensible.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Example 3 in Q3 item 2 states 'FDA recommends that email messages used to share SIUU communications be separate from email messages used to share promotional communications about approved uses of the medical product'; the rule restates this as 'should' and the title is an imperative recommendation, not 'must'.
- The quote is a complete clause with its own subject and verb ('FDA recommends that ...'); it ends cleanly before the separate 'and that the email messages ... clearly identify' clause, which is a distinct (disclosure) recommendation, so the rule is atomic.
- Whether a single email carries both SIUU and approved-use promotional content is a presence check, so deterministic is defensible.
- applies_when (hcp, unapproved-use-scientific, digital) matches the example's scope (sharing to HCPs through email messages); severity warning and locator are appropriate for a non-binding recommendation.