General group terms may not replace required specific side-effect disclosure

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

Required side effect/contraindication information may not be presented via a general group term instead of each specific item, unless that grouping conforms to the (e)(3)(iii) proviso.

Check

Check whether general group terms are used in place of specific disclosures without labeling-approved justification.

Escalate when

Whether the grouped term is permitted under the (e)(3)(iii) proviso needs verification.

Where this comes from

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

…f the results in such patients are not used. (xviii) Uses headline, subheadline, or pictorial or other graphic matter in a way that is misleading. (xix) Represents or suggests that drug dosages properly recommended for use in the treatment of certain classes of patients or disease conditions are safe and effective for the treatment of other classes of patients or disease conditions when such is not the case. (xx) Presents required information relating to side effects or contraindications by means of a general term for a group in place of disclosing each specific side effect and contraindication (for example employs the term blood dyscrasias instead of “leukopenia,” “agranulocytosis,” “neutropenia,” etc.) unless the use of such general term conforms to the provisions of paragraph (e)(3)(iii) of this section. Provided, however, That any provision of this paragraph shall be waived with respect to a specified advertisement as set forth in a written communication from the Food and Drug Administration on a …

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-code:opus · 2026-09-21
Reviewer's reasons
- (e)(6)(xx) lists this as a way an advertisement 'is false, lacking in fair balance, or otherwise misleading, or otherwise violative of section 502(n)' — a binding prohibition, not an illustration, so it supports a requirement.
- Not overstated, and notably the rule carries over the source's own qualifier: (e)(6)(xx) ends 'unless the use of such general term conforms to the provisions of paragraph (e)(3)(iii),' and the rule preserves that carve-out rather than stating an absolute ban. (e)(3)(iii)(b) is correctly characterized as requiring the grouping to have been previously approved or permitted in conforming labeling.
- Atomic: one checkable requirement — group term used in place of specific disclosure, without the labeling-based justification.
- determinism 'judgment' is right: deciding whether a term is a 'general term for a group' standing in for specific items, and whether the grouping was previously approved in labeling, cannot be settled by literal match against the ad alone.
- authority 'binding' is right: this is regulation text.
- Severity 'blocker' is defensible — an (e)(6) violation is a section 502(n) misbranding trigger.
- Locator 21 CFR 202.1(e)(6)(xx) is correct, and the escalation condition correctly points at the (e)(3)(iii) verification, which is an external labeling fact.
- applies_when 'promotional' is justified; the requirement attaches to advertisements.