Risk information should increase as benefit information increases

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

Rule

As a piece devotes more content to benefit claims, it should correspondingly devote more content to risk information.

Check

Compare the volume (word count, time, space) of benefit content to risk content; the piece does not need identical amounts of benefit and risk content. The test is whether risk content keeps pace with benefit content given how many risks the product actually has, so flag pieces where benefit content grows substantially without a comparable increase in risk content. Do not flag a piece for a product with a minimal number of risks when all of those risks are conveyed with prominence comparable to the benefit information, even if the piece has several more benefit claims than risk claims. Matching volume alone does not show compliance and mismatched volume alone does not show a violation; volume is one factor in the overall net-impression judgment.

Escalate when

When benefit content is extensive relative to a comparatively thin risk presentation, and the product does not fall within the minimal-risk, comparable-prominence carve-out.

Where this comes from

Section III.B.1, Quantity · page 13. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…. B. CONSIDERATIONS OF CONTENT This section discusses how FDA evaluates the content of risk presentations in determining whether a promotional piece is accurate and non-misleading. 1. Quantity One content factor FDA considers is the amount or quantity of information conveyed by a promotional piece. For example, a 30-second broadcast ad is likely to present less information than a 60-second broadcast ad. As the amount of benefit information conveyed increases, the amount of risk information conveyed should similarly increase. The quantity of information presented can affect the net impression of the piece. The amount of information presented is one component that, together with choice of words, color, graphics, voiceover, and other aspects of the piece, can affect cognitive load, the mental effort required to understand the various components of information in the piece. If the benefit information is easily understo…

Open the original at page 13 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. 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
- The quote is a complete sentence from the Quantity subsection ('As the amount of benefit information conveyed increases, the amount of risk information conveyed should similarly increase.') and the rule statement restates exactly that proportionality, keeping 'should'.
- The check tracks the source's own comparability factors, which expressly include 'The amount of time (in both the audio and visual portions) devoted to benefits and risks' and 'The amount of space devoted to benefits and risks in a print communication', so measuring volume of benefit content against volume of risk content is the source's own method.
- Atomic: a single proportionality comparison.
- Judgment determinism is right — the source says 'Promotional pieces do not have to convey an identical number of benefits and risks' and that satisfying one factor 'will not necessarily make a promotional piece accurate and non-misleading', so no literal match settles it.
- applies_when (promotional) matches the guidance's subject, promotional pieces; no narrower limit is implied by the source, which discusses print, broadcast and audio alike. Locator 'Section III.B.1, Quantity' is correct and 'warning' severity is defensible for a net-impression balance factor.
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 from Section III.B.1 (Quantity), and the rule keeps the guidance's 'should'.
- The Check and Escalate text leave out limits the same section sets. The source says '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.' Footnote 30 says a product with a minimal number of risks, all conveyed with comparable prominence, is 'accurate, non-misleading and balanced even if the ad presented several more benefit than risk claims.' The current escalation trigger ('benefit content is extensive relative to a comparatively thin risk presentation') would flag exactly the case footnote 30 approves. That makes the check broader than the source.
- The Check uses word count, time and space as a volume metric. The source warns that 'Simply satisfying one of the above factors (e.g., devoting the same amount of time or space to risk and benefit information) will not necessarily make a promotional piece accurate and non-misleading.' Volume is only one input to a judgment, so 'judgment' is the correct determinism.
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 III.B.1 Quantity and supports the rule statement, which uses 'should'. The minimal-risk carve-out in the Check comes from footnote 30 on page 14 and is faithfully stated. The Check also correctly says that volume is one factor, not the test.
- The title 'Increase risk content in proportion to benefit content' is a bare command for a non-binding recommendation. 'In proportion' is also stronger than the source's 'similarly increase'.
- Judgment is correct. applies_when (promotional) matches the general content section.
Revised by the drafter
claude-code:sonnet · 2026-09-21

Nearby rules

US-FB-013