Rules/misleading presentation/US-MIS-048

Vocalize, visualize, or place concurrent SUPERs for required claim qualifiers

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

Rule

When a claim needs a qualifier to avoid misleading, FDA recommends the qualifier be vocalized, shown visually, or placed as a prominent SUPER running concurrently with the claim.

Check

For each claim requiring qualification, confirm the qualifier is delivered by voice, visual, or a concurrent on-screen SUPER rather than omitted or delayed.

Escalate when

When a qualifier is present but its timing/medium relative to the claim is ambiguous.

Where this comes from

Section III.C.2, Non-Print Promotion, Textual Elements · page 22. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…tion “[q]ualifying disclosures…be legible and understandable,” recognizes that, “in many circumstances reasonable consumers do not read the entirety of an ad or are directed away from the importance of the qualifying phrase by acts or statements of the seller.” FDA has similar concerns. FDA assesses the temporal location of SUPERs within a broadcast ad or video when evaluating whether it is false or misleading. If claims must be qualified to avoid misleading the audience, we recommend that the qualifier be vocalized, presented through visual images, or placed in a prominent SUPER that runs concurrently with the claim. If SUPERs do not appear close enough to the claim or risk information requiring qualification, a misleading impression of the product may result. In addition, if qualifying information is complex and requires more than one line of text, we recommend that manufacturers use other means to convey this information. Other issues FDA considers important that manufacturers should keep in mind include the following: — …

Open the original at page 22 on fda.gov ↗Read our full copy →

Document: FDA guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion (see document)
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: f5654ab082f6cd4408143f16…

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

Applies when

Naturepromotional

Mediumbroadcast

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
- Supported: the quoted sentence is the operative recommendation in Section III.C.2 under 'Textual Elements', introduced by 'FDA assesses the temporal location of SUPERs within a broadcast ad or video when evaluating whether it is false or misleading'. The rule statement is a faithful restatement.
- Not overstated: the rule explicitly says 'FDA recommends', preserving the non-binding character of the guidance, and reproduces all three acceptable delivery options rather than mandating one.
- Atomic: a single requirement (the qualifier reaches the audience with the claim) with three permitted means. The disjunction is the source's own, not a bundling of independently checkable obligations.
- 'judgment' is correct: whether a claim 'must be qualified to avoid misleading', and whether a SUPER is 'prominent' and runs concurrently, turn on impression and prominence rather than a literal match.
- Authority 'guidance' matches the source document. The applies_when limit to non-print/broadcast is justified — the surrounding text is Section III.C.2 'Non-Print Promotion' and concerns SUPERs in broadcast ads and videos — and 'broadcast' is the available scoping term for that medium, so the scope is neither invented nor missing an expressible limit.
- Category, severity 'warning' and the locator (Section III.C.2, Non-Print Promotion, Textual Elements) are correct; the quote is a complete sentence.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence ('If claims must be qualified ... we recommend that the qualifier be vocalized, presented through visual images, or placed in a prominent SUPER that runs concurrently with the claim'); the 'must' inside it is the source's conditional about when qualification is needed, and the rule correctly keeps 'FDA recommends'.
- The three delivery options are alternatives of a single recommendation, so the rule is atomic.
- Whether a SUPER is prominent and concurrent is a judgment; warning severity, broadcast medium scope, and locator are defensible.

Nearby rules

US-MIS-049 US-MIS-050 US-MIS-051 US-MIS-052 US-MIS-053 US-MIS-054