Kansas Administrative Regulations
Agency 28 - DEPARTMENT OF HEALTH AND ENVIRONMENT
Article 21 - FOOD, DRUGS AND COSMETICS
Section 28-21-203 - Drugs and devices; forms of making required statements
Universal Citation: KS Admin Regs 28-21-203
Current through Register Vol. 43, No. 12, March 20, 2024
(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 K.S.A. 65-669(c) 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 K.S.A. 65-669(b) or (e) 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 K.S.A.
65-669(c); 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.
(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.
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