(a) A warning statement shall appear on the label prominently and conspicuously as compared to other words, statements, designs, or devices and in bold type on contrasting background to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use, but in no case may the letters and/or numbers be less than
1/16 inch in height, unless an exemption pursuant to paragraph (b) of this section is established.
(b) If the label of any cosmetic package is too small to accommodate the information as required by this section, the Commissioner may establish by regulation an acceptable alternative method, e.g., type size smaller than
1/16 inch in height. A petition requesting such a regulation, as an amendment to this section, shall be submitted to the Dockets Management Staff in the form established in part 10 of this chapter.
[40 FR 8917, Mar. 3, 1975, as amended at 42 FR 15676, Mar. 22, 1977; 69 FR 13717, Mar. 24, 2004; 88 FR 45067, July 14, 2023]
Notes of Decisions
Cosmetic, Toiletry & Fragrance Ass'n v. Schmidt, 409 F. Supp. 57 (D.D.C. 1976).
“Plaintiffs also contend that the Commissioner’s requirement that all warning statements appear on the product “label” as opposed to anywhere on the product “labeling”, 1 see 21 C.F.R. §§ 740.2 , 740.11, is (a) beyond the statutory authority of the Commissioner, and (b)…”
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