Treat risk information comparably to benefit information throughout

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

Rule

The depth, detail, and manner of conveying risk information should be comparable to how benefit information is conveyed in the same piece.

Check

Compare the level of detail, repetition, and reinforcement given to benefit claims against that given to risk statements.

Escalate when

When benefit claims are reinforced (e.g., repeated, illustrated) while risk information is stated only once and plainly.

Where this comes from

Section III.B.1, Quantity · page 14. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…FDA will look to see that promotional communications allot sufficient time and space to convey the important benefits and risks of the product being promoted to ensure that, as a whole, the communication provides an accurate and non-misleading impression of the product. A promotional piece with several paragraphs of information regarding benefits differs from a piece consisting mainly of one-line benefit claims. The treatment of risk information in each piece should be comparable to the treatment of benefit information, including how it is conveyed. Promotional pieces do not have to convey an identical number of benefits and risks, and a given drug or device may have few or many risks. FDA considers these factors when determining the comparability of benefits and risks in a piece: — The number of statements about benefits and risks — The completeness and depth of detail given about benefits and risks — The amount of time (in both the audio and visual port…

Open the original at page 14 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

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 complete sentence and is preceded in the source by its own illustration ('A promotional piece with several paragraphs of information regarding benefits differs from a piece consisting mainly of one-line benefit claims'), which is exactly the comparability the rule describes.
- The rule statement's terms — depth, detail and manner of conveying — are the source's own comparability factors ('The completeness and depth of detail given about benefits and risks', 'The use of audio or visual components that enhance or distract from the presentation'), and the check's focus on repetition and reinforcement comes from the source's statement that 'If the benefit information is easily understood and maintained through repetition or other reinforcing techniques, and the risk information is not similarly reinforced, the net impression may not be appropriately balanced.'
- Not overstated: 'should be comparable' is preserved, with no conversion to an obligation or to a requirement of identical treatment.
- Atomic: one comparability judgment about treatment, distinct from the quantity-scaling rule at US-FB-012 (that one is about amount growing with benefit content; this one is about how the information is handled).
- Judgment determinism, guidance authority, 'promotional' scope, the Section III.B.1 Quantity locator and 'warning' severity are all correct.
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 from Section III.B.1. It makes sense on its own and states the recommendation directly, using 'should'.
- The rule's 'depth, detail, and manner of conveying' is a fair paraphrase of 'treatment ... including how it is conveyed'. The Check's focus on repetition and reinforcement comes from the same section ('If the benefit information is easily understood and maintained through repetition or other reinforcing techniques, and the risk information is not similarly reinforced, the net impression may not be appropriately balanced').
- It is not a duplicate of US-FB-012. That rule covers how much risk content there is; this one covers how the risk content is treated. Judgment determinism, guidance authority and warning severity are all appropriate.

Nearby rules

US-FB-012