Rules/misleading presentation/US-MIS-009

Disclose placebo-effect info when citing studies for human drug effectiveness

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Rule

A prescription drug advertisement that promotes the drug for use by man (i.e., human use) and that contains references to literature or studies supporting an effectiveness claim must disclose the credible information available concerning the extent to which the claimed results may be due to placebo effect. Failure to make this disclosure misrepresents the drug's effectiveness and renders the advertisement violative under 21 CFR 202.1(e)(6)(vi).

Check

Where the piece cites literature or studies to support an effectiveness claim for a human-use drug, check whether credible available information on the extent to which the claimed results may be due to placebo effect is disclosed. A violation is a prescription drug ad that cites such literature/studies for an effectiveness claim but omits credible available placebo-effect information, even though such information exists.

Escalate when

Escalate when it is unclear whether credible placebo-effect information actually exists in the available literature/data, or when the adequacy or relevance of any disclosed placebo-effect information to the specific claimed results is uncertain.

Where this comes from

21 CFR 202.1(e)(6)(vi). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ntation of information from published articles or other references that report no side effects or minimal side effects with the drug or otherwise selects information from any source in a way that makes a drug appear to be safer than has been demonstrated. (v) Presents information from a study in a way that implies that the study represents larger or more general experience with the drug than it actually does. (vi) Contains references to literature or studies that misrepresent the effectiveness of a drug by failure to disclose that claimed results may be due to concomitant therapy, or by failure to disclose the credible information available concerning the extent to which claimed results may be due to placebo effect (information concerning placebo effect is not required unless the advertisement promotes the drug for use by man). (vii) Contains favorable data or conclusions from nonclinical studies of a drug, such as in laboratory animals or in vitro, in a way that suggests they have clinical significance when in fact no such clinical significance has been demonstrated. (viii) Uses a statement by a recognized authority that is apparently favorable about a drug but fails to refer to concurrent or more recent unfavorable data or statements f…

Open the original at these words on ecfr.gov ↗Read our full copy →

Document: 21 CFR 202.1
Version: 2026-09-16 — the link above is pinned to this date, so it shows the text as it stood then
Retrieved: 2026-09-21 from www.ecfr.gov
Fingerprint: a542640a872b3f2702d549e8…

Applies when

Naturepromotional

Productdrug

Advertising typeprescription-drug-advertisement

Populationhuman-use

Content triggerliterature-or-study-effectiveness-claim

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-sonnet-5 · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The quote is from the operative list at 21 CFR 202.1(e)(6)(vi), which declares a prescription drug ad false/lacking fair balance/misleading if it fails to disclose credible available information on placebo effect. This is a genuine binding obligation, not an example, definition or preamble, so the rule is supported in substance.
- Overstated on scope: (e)(6)(vi) is triggered only where the advertisement 'contains references to literature or studies that misrepresent the effectiveness of a drug.' The rule statement drops this predicate and imposes a freestanding placebo-disclosure duty on any promotional human-use drug ad, which is broader than the source.
- Overstated in a second respect: 21 CFR 202.1 governs prescription drug advertisements; the rule says only 'drugs promoted for human use' without that limit. The parenthetical limitation the rule does capture (human use only) is correct, but the prescription-advertising scope is missing.
- The Check invents a limit not in the source ('studies with placebo control'). The provision turns on whether credible information exists about the extent to which claimed results may be due to placebo effect, not on whether the cited study had a placebo arm; an uncontrolled or open-label study reference is precisely where this concern bites. The Check is therefore both narrower than and mismatched to the rule statement.
- applies_when is under-specified: it records only 'promotional' and omits the two obvious source-based limits (human use; advertisement contains literature/study references).
- determinism 'judgment' is right — 'credible information available' and 'the extent to which' require evaluative assessment, not a literal match.
- authority 'binding' is right — this is a codified FDA regulation.
- severity 'blocker' is defensible — (e)(6) items are deemed false/misleading and violative of section 502(n), not merely 'may be'.
- Locator 21 CFR 202.1(e)(6)(vi) matches the quoted text exactly.
- Atomic: the rule isolates the placebo-effect clause and leaves the separate concomitant-therapy clause of the same subparagraph to another rule — correct.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the quote sits inside § 202.1(e)(6), whose chapeau states that 'An advertisement for a prescription drug is false, lacking in fair balance, or otherwise misleading, or otherwise violative of section 502(n) of the act ... if it:' followed by clause (vi). This is an operative prohibition, not an example, definition, or preamble, so the rule statement and check follow directly from the cited text.
- Not overstated: the rule reproduces the regulation's own scope limits rather than expanding them. It confines the obligation to prescription drug advertisements (the chapeau's subject), to human use (tracking the parenthetical 'information concerning placebo effect is not required unless the advertisement promotes the drug for use by man'), and the check conditions violation on credible placebo-effect information actually being available ('even though such information exists'), mirroring 'the credible information available.' No 'should/recommends' language was converted into an obligation.
- Atomic: clause (vi) contains two independent prongs — concomitant therapy and placebo effect. The rule correctly isolates the placebo-effect prong only and does not bundle the concomitant-therapy requirement or any other (e)(6) subclause.
- Determinism correctly set to judgment: applying the rule requires assessing whether 'credible information available' exists in the literature and whether what was disclosed adequately addresses the extent to which claimed results are attributable to placebo. That is not settled by presence/absence of a literal string.
- Authority correctly set to binding: 21 CFR 202.1 is a codified FDA regulation implementing section 502(n) of the act.
- Locator is accurate: the quoted sentence is verbatim clause (vi) under paragraph (e)(6) in the source text.
- applies_when is justified and appropriately limited: the human-use limitation is drawn from the regulation's own parenthetical carve-out (so veterinary-drug advertisements are correctly excluded), the prescription-drug-advertisement scope comes from the (e)(6) chapeau, and the literature-or-study effectiveness-claim trigger comes from 'Contains references to literature or studies that misrepresent the effectiveness of a drug.'
- Severity of blocker is defensible: the regulation declares such an advertisement violative of section 502(n), an enforceable misbranding provision, not merely a matter that 'may be' misleading (contrast paragraph (e)(7), which the rule correctly does not draw on).
- Escalation criteria are well matched to the judgment elements — existence of credible placebo-effect data and adequacy/relevance of any disclosure made.

Nearby rules

US-MIS-008