Reminder ads are limited to specified content only

AI-verifiedblockerBinding lawRaised as a question — a person decides

Rule

A reminder advertisement (one naming the product without indication/dosage information) is restricted to specified content: proprietary/established names, active ingredient established names, and limited optional information (quantitative ingredient statements, dosage form, package quantity, price, manufacturer/packer/distributor name and address), or other written, printed, or graphic matter containing no representation or suggestion relating to the advertised drug product. This rule covers only the (e)(2)(i) content limit; the separate (e)(2)(i) restrictions — no reminder ads for products whose labeling bears a boxed warning, the NAS/NRC 'possibly effective' restriction, and the price-ad conditions of § 200.200 — are handled by other rules.

Check

If the ad calls attention to the drug name without stating indications/dosage, confirm it contains only the permitted content categories (names, active ingredient established names, and the listed optional items) plus, if applicable, other matter containing no representation or suggestion relating to the drug, and no other representations.

Escalate when

Whether additional written, printed, or graphic matter in the ad constitutes a representation or suggestion relating to the advertised drug product — and therefore breaks the reminder-ad content limit — requires human judgment.

Where this comes from

21 CFR 202.1(e)(2)(i). The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…o interfere with comprehension of the major statement. (2) Exempt advertisements. The following advertisements are exempt from the requirements of paragraph (e)(1) of this section under the conditions specified: (i) Reminder advertisements. Reminder advertisements are those which call attention to the name of the drug product but do not include indications or dosage recommendations for use of the drug product. These reminder advertisements shall contain only the proprietary name of the drug product, if any; the established name of the drug product, if any; the established name of each active ingredient in the drug product; and, optionally, information relating to quantitative ingredient statements, dosage form, quantity of package contents, price, the name and address of the manufacturer, packer, or distributor or other written, printed, or graphic matter containing no representation or suggestion relating to the advertised drug product. If the Commissioner finds that there is evidence of significant incidence of fatalities or seriou…

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-code:sonnet · 2026-09-21
Independent verification — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The quote is operative regulatory text from 21 CFR 202.1(e)(2)(i) defining reminder advertisements and restricting their content; the rule statement follows directly from the full sentence, which continues with the optional categories (quantitative ingredient statements, dosage form, quantity of package contents, price, name and address of manufacturer/packer/distributor). Supported.
- Authority 'binding' is correct — this is a codified FDA regulation, not guidance. Locator 21 CFR 202.1(e)(2)(i) matches the paragraph containing the quoted sentence.
- Severity 'blocker' is defensible: exceeding the permitted content forfeits the (e)(1) exemption, rendering the ad non-compliant for lack of a brief summary.
- Determinism is incorrectly set to 'deterministic'. The final permitted category in the source is 'other written, printed, or graphic matter containing no representation or suggestion relating to the advertised drug product'. Deciding whether a tagline, image, or design element conveys a 'representation or suggestion relating to the advertised drug product' turns on impression, not on presence/absence or literal match. The check's own phrase 'no other representations' confirms this is a judgment call.
- The rule is stricter than the source because its enumeration of permitted content omits the regulation's final permitted category (other written/printed/graphic matter containing no representation or suggestion relating to the product). As written, the check would flag neutral graphic matter that 21 CFR 202.1(e)(2)(i) expressly permits.
- applies_when is under-scoped relative to the source's own limits: 21 CFR 202.1(e) governs advertisements for prescription drugs, and this paragraph applies only to reminder advertisements. Tagging only 'promotional' sweeps in promotional labeling and material outside the reach of this paragraph, and leaves the reminder-ad trigger buried in the check text rather than in the scoping.
- Atomic: the rule covers a single content-scope requirement. The separate prohibitions in the same paragraph (boxed-warning products, NAS/NRC 'possibly effective' products, Commissioner withdrawal of the exemption) are correctly not bundled here.
Independent verification — revise
claude-code:opus · 2026-09-21
Reviewer's reasons
- Supported: (e)(2)(i) defines reminder advertisements as those that call attention to the name of the drug product but do not include indications or dosage recommendations, and states they 'shall contain only' the enumerated items. The rule's definition and its list of mandatory and optional content track the source, including the optional items (quantitative ingredient statements, dosage form, quantity of package contents, price, name and address of manufacturer/packer/distributor).
- Not overstated: the source uses 'shall contain only', so stating the content set as closed is faithful; the rule also does not claim the exemption is unconditional.
- Atomic: one closed-content test for a single, defined class of advertisement.
- Determinism is mis-flagged. It is marked 'deterministic', but the source's permitted-content list ends with 'or other written, printed, or graphic matter containing no representation or suggestion relating to the advertised drug product' — deciding whether a graphic, tagline, or image carries a 'representation or suggestion relating to the advertised drug product' is an impression judgment, not a presence/absence or literal match. The rule's own check ('no other representations') inherits that judgment. The rule also carries no escalate-when, which is inconsistent with a test that cannot be settled mechanically.
- Authority 'binding' is correct (regulation).
- Severity 'blocker' is defensible: an ad that exceeds the reminder-ad content limits loses the (e)(2) exemption and is then subject to the full (e)(1) brief-summary requirement it did not satisfy.
- applies_when (promotional) is justified. Locator 21 CFR 202.1(e)(2)(i) is correct.
- Scope note: the rule covers only the content limit and does not reach the separate (e)(2)(i) prohibitions (boxed-warning products, NAS/NRC 'possibly effective' products, Commissioner withdrawal of the exemption). That is appropriate for atomicity, but the rule should not be read as stating the whole of (e)(2)(i).
Revised by the drafter
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- 21 CFR 202.1(e)(2)(i) states in mandatory terms that reminder advertisements 'shall contain only' the enumerated items, so a content-limit rule follows directly from the source rather than from an example or a description of what is not required.
- The rule reproduces the source's permitted categories accurately, including the optional items (quantitative ingredient statements, dosage form, quantity of package contents, price, manufacturer/packer/distributor name and address) and the residual 'other written, printed, or graphic matter containing no representation or suggestion relating to the advertised drug product'; it does not narrow the permitted set into a stricter list than the regulation allows.
- The rule explicitly carves out the other (e)(2)(i) restrictions (boxed-warning prohibition, NAS/NRC 'possibly effective' restriction, § 200.200 price-ad conditions) as separate rules, so it is atomic on the content limit.
- 'Judgment' is correct: whether additional matter amounts to 'a representation or suggestion relating to the advertised drug product' cannot be settled by a literal match, and the escalate condition names exactly that.
- The trigger condition (an ad that calls attention to the drug name without indications or dosage recommendations) is carried in the rule and check and tracks the source's definition of a reminder advertisement; authority 'binding' is correct and 'blocker' is defensible because exceeding the content limit forfeits the (e)(1) exemption and leaves the ad without a brief summary.

Nearby rules

US-RISK-013