Rules/misleading presentation/US-MIS-049

Qualifying SUPERs should appear close enough to the claim they qualify

DraftwarningFDA guidance · non-bindingRaised as a question — a person decides

Rule

A qualifying SUPER should appear close enough in time/position to the claim or risk statement it qualifies; otherwise a misleading impression of the product may result.

Check

Check the temporal proximity of each qualifying SUPER to the claim it modifies; flag SUPERs that appear well before or after the relevant claim.

Escalate when

When proximity is borderline and the audience's ability to connect the SUPER to the claim is unclear.

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.

…ying 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: — SUPERs, if used, should be reasonably visible to a person under typical viewing conditions. — All SUPERs should be on screen long enough to allow …

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. Not yet independently verified — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: the quoted sentence follows directly from FDA's statement that it assesses the temporal location of SUPERs in a broadcast ad or video, and it states the consequence of insufficient proximity.
- Not overstated: although the rule opens with 'must appear close enough', it carries the source's own hedge — 'or the piece may be misleading' — so it conveys the guidance's conditional risk-of-misleading formulation rather than an absolute prohibition, and it does not claim regulatory obligation.
- Atomic: one checkable property, the proximity of a qualifying SUPER to the claim or risk information it qualifies.
- 'judgment' is correct: 'close enough' is a proximity/impression assessment, not presence/absence.
- Authority 'guidance' matches the source document, and the applies_when limit to broadcast is justified by the Section III.C.2 non-print/SUPER context. Category, severity 'warning' and the locator are appropriate.
- The quote is a complete sentence with its subject ('SUPERs') intact and does not run into the following, separate recommendation about multi-line qualifying information.
- Distinct from US-MIS-048: that rule covers the means of delivering a qualifier, this one covers where a SUPER that is used appears relative to the claim, so it is separately violable.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a complete sentence and supports a proximity concern: SUPERs not close enough to the claim or risk information they qualify 'may' create a misleading impression.
- The Rule text says a qualifying SUPER 'must appear close enough', turning a non-binding guidance observation (in a paragraph framed by 'we recommend') into an obligation. The title is acceptable as phrased.
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is a whole sentence from Textual Elements, and the rule statement keeps its 'may result' hedge while using 'should'. The context recommends that a qualifying SUPER run concurrently with the claim, so the proximity check is well founded.
- The title 'Place qualifying SUPERs close enough to the claim they qualify' is a bare command for guidance whose operative wording is 'may result' and 'we recommend'.
- Judgment is correct. The broadcast medium limit fits this section, which covers broadcast ads and videos.
Revised by the drafter
claude-code:sonnet · 2026-09-21

Nearby rules

US-MIS-048 US-MIS-050 US-MIS-051 US-MIS-052 US-MIS-053 US-MIS-054