Rules/misleading presentation/US-MIS-012

Studies on normal subjects must disclose that fact unless drug is for normal individuals

AI-verifiedblockerBinding lawCheckable — presence or a literal match settles it

Rule

If a cited study used normal (non-patient) subjects, the ad must disclose that fact unless the drug is intended for use in normal individuals.

Check

Check study populations cited; confirm disclosure if subjects were normal individuals and the drug is not intended for normal use.

Where this comes from

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

…ed in the drug package labeling. (xii) Offers a combination of drugs for the treatment of patients suffering from a condition amenable to treatment by any of the components rather than limiting the indications for use to patients for whom concomitant therapy as provided by the fixed combination drug is indicated, unless such condition is included in the uses permitted under paragraph (e)(4) of this section. (xiii) Uses a study on normal individuals without disclosing that the subjects were normal, unless the drug is intended for use on normal individuals. (xiv) Uses “statistics” on numbers of patients, or counts of favorable results or side effects, derived from pooling data from various insignificant or dissimilar studies in a way that suggests either that such “statistics” are valid if they are not or that they are derived from large or significant studies supporting favorable conclusions when such is not the case. (xv) Uses erroneously a statistical finding of “…

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

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 — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: the quote is the full text of 21 CFR 202.1(e)(6)(xiii), and the rule statement is a near-verbatim restatement of it, not an inference from an example, definition, or preamble.
- Not overstated: (e)(6) is the per se list ('An advertisement ... is false, lacking in fair balance, or otherwise misleading ... if it'), so stating a flat 'must disclose' obligation is faithful; had this come from the (e)(7) 'may be false' list, the mandatory phrasing would have been an overstatement.
- The source's exception ('unless the drug is intended for use on normal individuals') is preserved in both the rule statement and the check, avoiding the common failure of dropping a carve-out.
- Atomic: a single disclosure obligation with one built-in conditional exception, not a bundle of independently checkable duties.
- Determinism correct as 'deterministic': once the study population is identified, the test is presence/absence of a disclosure. It does not turn on adequacy, prominence, emphasis, or overall impression, unlike neighboring provisions such as (e)(7)(viii) and (e)(7)(x) in the same source.
- Authority correct: 21 CFR is a regulation, properly flagged binding.
- Locator correct: the quoted sentence appears at (e)(6)(xiii) in the enumerated list, between (xii) on fixed combinations and (xiv) on pooled statistics.
- Severity defensible: violation of (e)(6) renders the advertisement violative of section 502(n) of the act and causes misbranding, supporting 'blocker'.
- Minor reservation, not grounds to withhold a pass: 21 CFR 202.1 governs prescription drug advertisements, while applies_when is the broader 'promotional', which could reach promotional labeling that FDA regulates as labeling rather than advertising. The rule statement's own wording ('the ad') keeps the operative scope correct, and 'promotional' appears to be a coarse taxonomy tag rather than an invented expansion.