Type size is measured by actual letter height, not point size

DisputednoteFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

FDA interprets the type-size comparison between the proprietary and established name as based on the actual printed letter size, not the nominal point size of the font.

Check

When checking the half-size requirement, measure actual rendered letter height rather than relying on the stated point size of the fonts used.

Where this comes from

Section II.B · page 6. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

…ing text (21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2)). In addition, when the proprietary name is presented outside the running text, such as in a headline, the established name is also required to be printed in letters that are at least half as large as the letters of the proprietary name within that designated section (e.g., headline) (21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2)). Please note that FDA interprets this type-size requirement to relate to actual size, not point size, of uppercase and lowercase letters in the proprietary and established names. For example, in situations when the established name is required to be printed in letters at least half as large as the letters of the proprietary name, FDA recommends that the smallest letter of the established Contains Nonbinding Recommendations name (upper- or lowercase letters) be printed in letters at least one half the actual size of the largest letter of the proprietary name (upper- or l…

Open the original at page 6 on fda.gov ↗Read our full copy →

Document: FDA guidance: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (final)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: f6f78606542ef91596ef21f6…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Naturepromotional

How this rule was checked

The verifier and drafter could not agree. Waiting for a human decision — not used in reviews.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — reject
claude-code:opus · 2026-09-21
Reviewer's reasons
- The statement is faithful to Section II.B ('FDA interprets this type-size requirement to relate to actual size, not point size, of uppercase and lowercase letters'), but accuracy is not the issue.
- This is a measurement convention, not a requirement. No promotional piece can violate it — its check ('measure actual rendered letter height rather than relying on the stated point size') is an instruction about how to run other rules, not a test that can produce a finding on a material. It is therefore not something a reviewer could check as a rule.
- It cannot stand alone: it is meaningless except as a modifier of the half-size rules US-NAME-024 and US-NAME-025 and the same-size rule US-NAME-023, all of which it silently depends on.
- It also drops the operative half of the source's convention. Section II.B continues: 'FDA recommends that the smallest letter of the established name (upper- or lowercase letters) be printed in letters at least one half the actual size of the largest letter of the proprietary name (upper- or lowercase letters).' Without that smallest-against-largest instruction, 'measure actual size' does not tell a reviewer which letters to compare — which is the part that actually changes outcomes.