Ad ingredient order must match order on product label

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

Rule

In a prescription-drug advertisement as defined in 21 CFR 202.1 (this section does not govern promotional labeling), if the advertisement includes the section 502(n) ingredient listing referenced in 21 CFR 202.1(a)(1), the ingredients must be listed in the same order as they appear on the label of the product. If the advertisement contains no ingredient listing, this rule does not apply.

Check

First confirm the piece is an advertisement (not promotional labeling such as a package insert, detail aid used only as labeling, etc.) and that it contains a 502(n) ingredient listing; if either condition fails, mark not applicable. Otherwise, compare the sequence of ingredients as listed in the advertisement to the sequence on the label of the product — any difference in order is a violation.

Escalate when

Escalate when it is unclear whether the piece qualifies as an "advertisement" versus "promotional labeling" under FDA's distinction, or when the current, controlling version of the product's label is ambiguous or unavailable for comparison.

Where this comes from

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

…ct or § 201.105 of this chapter, applicable to drugs intended for use by humans and to veterinary drugs, respectively. (a)(1) The ingredient information required by section 502(n) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary 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…

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

Mediumprintbroadcastdigital

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 — revise
claude-opus-5 · 2026-09-21
Reviewer's reasons
- The quote is verbatim regulatory text from 21 CFR 202.1(a)(2) and states the order-matching requirement directly in mandatory terms ('shall be the same as'), so the rule statement follows from the source rather than from an example, definition, or preamble.
- Locator is correct and specific: the quoted sentence sits in paragraph (a)(2) of the excerpt.
- Authority 'binding' is correct — this is a codified FDA regulation, not guidance.
- Determinism 'deterministic' is correct: the check is a positional comparison of two ingredient sequences, settled by literal match, with no dependence on prominence, adequacy, or overall impression.
- Atomic: the rule isolates the order clause of (a)(2) and does not bundle in the separate quantity-information clause of the same sentence.
- Overstated on scope: Section 202.1 governs prescription-drug advertisements, but applies_when is set to all 'promotional' material, which would sweep in promotional labeling (e.g., detail aids, brochures) that this section does not govern.
- Missing an obvious limit: (a)(2) presupposes that the advertisement carries the section 502(n) ingredient information referenced in (a)(1). The rule as stated fires unconditionally, including on pieces that list no ingredients, where there is no order to compare.
- Severity 'blocker' is defensible — it is an affirmative binding requirement and a mismatch is a facial non-compliance.
- Minor: the check says 'approved label' whereas the source says 'the label of the product'; the comparator should track the source wording.
Revised by the drafter
claude-sonnet-5 · 2026-09-21
Independent verification — pass
claude-opus-5 · 2026-09-21
Reviewer's reasons
- Supported: 21 CFR 202.1(a)(2) is operative mandatory text ('shall be the same as the order of listing of ingredients on the label of the product'), not an example, definition, or preamble gloss. The rule statement and check track it directly.
- Not overstated: if anything the rule is narrower than the source. The regulation refers to 'the order of listing of ingredients in the advertisement'; the rule conditions applicability on presence of the section 502(n) listing referenced in (a)(1), which is a fair reading of (a)(1)-(a)(2) together and narrows rather than expands the obligation.
- Atomic: covers only the sequence-match requirement. The second half of the same sentence (quantity information must match) is correctly excluded rather than bundled in.
- Determinism correct: the check is a sequence-to-sequence comparison against the product label, settled by literal match. It does not turn on impression, prominence, or adequacy, unlike neighboring provisions in the same section such as (a)(4) 'impression of value' and (b)(2) 'prominence commensurate'.
- Authority correct: 21 CFR is a regulation, so 'binding' is right.
- applies_when justified: section 202.1 governs prescription-drug advertisements; the media list (print, broadcast, digital) does not carve out anything the regulation reaches, and the promotional flag matches the advertising scope.
- Locator 21 CFR 202.1(a)(2) is exact for the quoted sentence.
- Severity 'blocker' is defensible: a mismatch is a facial violation of a mandatory regulatory requirement bearing on misbranding, not a stylistic concern.
- Minor imprecisions noted but not disqualifying: the rule says 'advertisement as defined in 21 CFR 202.1' when the excerpt actually defines 'prescription drug', and the parenthetical that the section does not govern promotional labeling is not stated in the excerpt though it follows from the section's title and scope. Both narrow rather than expand the duty, and the escalation clause routes the advertisement-versus-labeling boundary to a human instead of resolving it silently.

Nearby rules

US-NAME-003