Each specific side effect and contraindication in labeling must be disclosed

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Rule

The brief summary must disclose each specific side effect and contraindication from the drug's labeling for the advertised dosage form(s), subject only to the permitted limited disclosure and grouped-term provisos.

Check

Compare the brief summary's listed side effects/contraindications against the full labeling; flag omissions not covered by the provisos.

Escalate when

Whether an omission falls under the permitted limited-disclosure or grouped-term proviso requires review.

Where this comes from

21 CFR 202.1(e)(3)(iii). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… effectiveness shall include specific indications for use of the drug for purposes claimed in the advertisement; for example, when an advertisement contains a broad claim that a drug is an antibacterial agent, the advertisement shall name a type or types of infections and microorganisms for which the drug is effective clinically as specifically as required, approved, or permitted in the drug package labeling. (iii) The information relating to side effects and contraindications shall disclose each specific side effect and contraindication (which include side effects, warnings, precautions, and contraindications and include any such information under such headings as cautions, special considerations, important notes, etc.; see paragraph (e)(1) of this section) contained in required, approved, or permitted labeling for the advertised drug dosage form(s): Provided, however, (a) The side effects and contraindications disclosed may be limited to thos…

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
- Supported: (e)(3)(iii) states that the information relating to side effects and contraindications 'shall disclose each specific side effect and contraindication ... contained in required, approved, or permitted labeling for the advertised drug dosage form(s)', subject to the two provisos at (a) and (b). The rule reproduces both the obligation and the dosage-form scoping, and expressly preserves the provisos.
- Not overstated: this is mandatory regulatory text, and the rule does not drop the provisos, which is where an overstatement would normally creep in. If anything the rule is slightly narrower than the source, since it frames the duty as one on 'the brief summary' while (e)(3) applies the true-statement requirement to the entire advertisement — narrowing is not overstatement, and the brief summary is where the specific-disclosure duty is discharged in practice.
- Atomic: one obligation (disclose each specific side effect and contraindication for the advertised dosage forms); the provisos are exceptions to that same obligation rather than separate requirements, and the grouped-term proviso is separately operationalized by US-RISK-015.
- Determinism 'judgment' is correct and appropriately conservative: although the raw comparison of two lists looks mechanical, deciding whether an omission is covered by the (a) limited-disclosure proviso (pertinence to the advertised indications plus prior approval) cannot be settled by a literal match.
- Authority 'binding' is correct (regulation).
- Severity 'blocker' is defensible: omitting a labeled side effect or contraindication defeats the (e)(1) true-statement requirement and is a core misbranding risk under 502(n).
- applies_when (promotional) is justified. Locator 21 CFR 202.1(e)(3)(iii) is where the quoted text sits.

Nearby rules

US-RISK-015