C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 201—LABELING › Subpart A—General Labeling Provisions

21 C.F.R. § 201.15

Drugs; prominence of required label statements

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(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]
Notes of Decisions
Cited in 6 cases (1 in the last 5 years), 1993–2023 · leading case: United States v. Scully, 108 F. Supp. 3d 59 (E.D.N.Y 2015).
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United States v. Scully, 108 F. Supp. 3d 59 (E.D.N.Y 2015). · cites it 12× “The Defendant also argues that the affidavits improperly suggested that distributing non-English label drugs, a violation of an FDA regulation, 21 C.F.R. § 201.15 (c)(1), gives rise to criminal liability.”
Ramirez v. Plough, Inc., 863 P.2d 167 (Cal. 1993). · cites it 4× “" ( 21 C.F.R. § 201.15 (c)(1) (1993).) The regulation further states that if the label or packaging of any drug distributed in the 50 states contains "any representation in a foreign language," [4] then all required "words, statements, and other information" must appear in the…”
United States v. 1500 90-Tablet Bottles, 384 F. Supp. 2d 1205 (N.D. Ill. 2005). “§ 352 (c) and 21 C.F.R. § 201.15 (c)(1) is deemed to be misbranded as a matter of law unless exempt by the Act.”
United States v. Brown, 636 F. App'x 640 (6th Cir. 2016). “Bo-tox packaging must comply with specific labeling standards, 21 C.F.R. 201.15(c)(1), and it may be administered only by a licensed practitioner, 21 U.”
Medinatura v. Food & Drug Admin. (D.D.C. 2020). “Since Section 502(c) of the Act and 21 CFR 201.15(c)(1) require that all labeling be in English, the industry is required to translate these names from Latin to their common English names as current labeling stocks are depleted, or by June 11, 1990, whichever occurs first.”
PharmacyChecker.com LLC v. Nat'l Ass'n of Boards of Pharmacy (S.D.N.Y. 2023). “§ 352 , if they are labeled in a language other than English, see 21 C.F.R. § 201.15 (c), or are dispensed without a valid prescription, see 21 U.”
— 21 C.F.R. § 201.15(c)(1) — 2 cases
United States v. Brown, 636 F. App'x 640 (6th Cir. 2016). “Bo-tox packaging must comply with specific labeling standards, 21 C.F.R. 201.15(c)(1), and it may be administered only by a licensed practitioner, 21 U.”
Medinatura v. Food & Drug Admin. (D.D.C. 2020). “Since Section 502(c) of the Act and 21 CFR 201.15(c)(1) require that all labeling be in English, the industry is required to translate these names from Latin to their common English names as current labeling stocks are depleted, or by June 11, 1990, whichever occurs first.”
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