Communication must not suggest an indication different from labeling

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

Rule

If a product communication's representations or suggestions relate to a different indication than the one(s) in the FDA-required labeling, the communication is not consistent with the FDA-required labeling.

Check

Compare the indication(s) stated or implied in the piece to the indication(s) in the FDA-required labeling. A violation looks like the piece discussing use for a disease, condition, or purpose not reflected in the approved indication.

Escalate when

The piece's indication language is ambiguous, uses broader disease-category terms than the label, or implies a related-but-distinct use.

Where this comes from

Q.2/A.2, Factor 1 (Indication) · page 8. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…duct communication compares to the information about those conditions of use in the FDA-required labeling identified in the bullets below — If the answer to any of the following questions is yes, that indicates the product communication is not consistent with the FDA-required labeling: https://www.fda.gov/RegulatoryInformation/Guidances/default.htm </u>. Contains Nonbinding Recommendations Indication – Do the representations/suggestions about the product in the communication relate to a different indication than the one(s) reflected in the product’s FDA-required labeling? Patient Population – Is the patient population represented or suggested in the communication outside the approved patient population reflected in the FDA-required labeling? Limitations and Directions for Handling/Use – Do the representations/suggestions in the communication conflict with the use limitations or directions for handling, preparing, and/or using the product reflected in the FDA-required la…

Open the original at page 8 on fda.gov ↗Read our full copy →

Document: FDA guidance: Medical Product Communications that Are Consistent With the FDA-Required Labeling – 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: 1a18b7f242bfbbf897f198df…

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

Applies when

Basisconsistent-with-labeling

Naturepromotional

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
- Directly supported. The quote is the verbatim Indication bullet of Factor 1, and A.2 supplies the consequence the rule states: 'If the answer to any of the following questions is yes, that indicates the product communication is not consistent with the FDA-required labeling,' reinforced by 'If a product communication fails to satisfy any one of these factors, it is not considered consistent with the FDA-required labeling.' The rule therefore states a consistency determination, not an invented obligation.
- Atomic: one factor bullet, one comparison (communication's indication vs labeled indication(s)).
- 'Judgment' is correct — the bullet reaches representations and suggestions, so implied indications must be read, which no literal match settles. 'Guidance' is correct; the source is a nonbinding guidance and says so on every page.
- 'Blocker' is defensible: a communication relating to a different indication fails Factor 1 outright and carries off-label exposure. The locator 'Q.2/A.2, Factor 1 (Indication)' is exact, and the Escalate condition (ambiguous or broader disease-category language) is the realistic hard case.
- applies_when is defensible. Strictly, Q.2's factors are framed for 'product communications' generally rather than promotional ones only, so the "promotional" limiter is narrower than the source — but it under-includes rather than over-reaches, and the CFL basis matches the guidance's scope. Worth noting only that US-IND-011 and US-IND-012, drawn from the same answer, omit the "promotional" limiter, so the set is internally inconsistent about the same framework.
- The title's 'must not' is obligation-flavored shorthand for a nonbinding factor, but the rule body is correctly framed as a consistency determination, so this is a wording preference, not a fidelity error.