No fanciful name implying unique effectiveness of a common substance

AI-verifiedwarningBinding lawRaised as a question — a person decides

Rule

A fanciful proprietary name may not be used to suggest a common drug/ingredient has unique effectiveness or composition it does not have.

Check

Assess whether the proprietary name creates a false impression of uniqueness for what is, by established name, a common substance.

Escalate when

Reviewer is uncertain whether the proprietary name creates a false impression of uniqueness versus legitimate branding.

Where this comes from

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

…tary names of ingredients, which may be included with the listing of established names. (2) The order of listing of ingredients in the advertisement shall be the same as the order of listing of ingredients on the label of the product, and the information presented in the advertisement concerning the quantity of each such ingredient shall be the same as the corresponding information on the label of the product. (3) The advertisement shall not employ a fanciful proprietary name for the drug or any ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition, when, in fact, the drug or ingredient is a common substance, the limitations of which are readily recognized when the drug or ingredient is listed by its established name. (4) The advertisement shall not feature inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the formulation. (5) The advertisement shall not designate a drug or ingredient by a proprietary name that, because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredi…

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
- The quote is operative regulatory text ('The advertisement shall not employ a fanciful proprietary name ... in such a manner as to imply ... unique effectiveness or composition, when, in fact, the drug or ingredient is a common substance'), not an example, definition, or preamble gloss. The rule statement is a near-paraphrase of that prohibition and does not extend it.
- Not overstated: the source is a mandatory 'shall not' prohibition, and the rule mirrors both prongs of the prohibited implication ('unique effectiveness or composition') without adding conditions or expanding to, e.g., all brand names regardless of implication. The check likewise tracks the regulation's 'common substance / established name' predicate.
- Atomic: a single prohibited practice (fanciful proprietary name implying uniqueness for a common substance). 'Effectiveness or composition' are alternative manifestations of the same prohibition in one sentence, not two independently checkable obligations; the adjacent prohibitions in (a)(4) (inert ingredients) and (a)(5) (confusable names) were correctly left out.
- Determinism 'judgment' is correct: the violation turns on whether the name 'implies' unique effectiveness and whether the substance is 'common' with 'readily recognized' limitations — an impression-based assessment, not a literal presence/absence test. The escalation condition (uncertainty between false uniqueness implication and legitimate branding) is consistent with this.
- Authority 'binding' is correct — 21 CFR 202.1 is a codified regulation, and the quoted subsection is a prohibition.
- Locator is accurate: the quoted sentence is verbatim paragraph (a)(3) of § 202.1 as it appears in the source text.
- Severity 'warning' is defensible: the finding is a binding prohibition but its application rests on a contestable impression judgment, so flagging for reviewer attention rather than a hard block is reasonable.
- applies_when 'promotional' is justified — § 202.1 governs prescription-drug advertisements, which fall within promotional material; the tag neither invents a condition nor omits a limit expressible in the available vocabulary. Note for downstream use: the source's own scope is prescription-drug advertising, so reviewers applying this to non-advertising promotional pieces should treat it as analogous rather than directly binding.