21 CFR 201.15
Drugs; prominence of required label statements
21 CFR 201.15 is the regulation titled “Drugs; prominence of required label statements” in 21 CFR Part 201, Labeling. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 201.128, in 4 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 201.15 most often, as written in the letters.
- 1 letterMISSY KAY Premium Hand Sanitizer is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because it fails to comply with 21 CFR 201.15(c)(2), which states “if the label contains any representation in a…
- 1 letterThe labeling for Alcohol Isopropilico Hand Sanitizer Limar is misbranded under section 502(c) of the FD&C Act, 21 U.S.C. 352(c), because it is not labeled in accordance to 21 CFR 201.15. For example, the label does not…
The regulation
Read the text of 21 CFR 201.15 (eCFR, as of Sep 1, 2026)
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:
(1) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;
(2) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;
(3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;
(4) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;
(5) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or
(6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.
(b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 502 (b) or (e) of the act, shall apply if such insufficiency is caused by:
(1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;
(2) The use of label space to give greater conspicuousness to any word, statement, or other information than is required by section 502(c) of the act; or
(3) The use of label space for any representation in a foreign language.
(c)(1) All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English.
(2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.
(3) If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language.
[41 FR 6908, Feb. 13, 1976]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 201.15.
- 21 CFR 201.128Meaning of “intended uses”4 letters cite both
- 21 CFR 211.165Testing and release for distribution4 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures4 letters cite both
- 21 CFR 211.100Written procedures; deviations2 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit2 letters cite both
- 21 CFR 201.62Declaration of net quantity of contents1 letter cites both
- 21 CFR 201.66Format and content requirements for over-the-counter (OTC) drug product labeling1 letter cites both
- 21 CFR 207.41Who must list drugs and what drugs must they list?1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 201.15 that FDA posted most recently.
- DrugsView Midlab Incorporatedhand sanitizer and antibacterial soap productsIssuedFeb 15, 2023PostedMar 14, 2023
- DrugsView Skyless, LLCOTC topical analgesic ointmentsIssuedJan 23, 2023PostedFeb 28, 2023
- DrugsView DongBang Cosmetics Co., Ltd.MISSY KAY Premium Hand SanitizerIssuedOct 22, 2021PostedNov 2, 2021
Put this kind of reading to
work on your own records.
Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.
Counts include every citation in a letter, as the Letters filter does. How this database is built.