Make Webo

TPNOWRNLBL

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is a tobacco product which appears to be misbranded under section 903(a)(8)(B)(i) and 903(a)(1) because its package label does not include a brief statement of the relevant warnings (i.e., one of the four warnings required by section 3 of the Comprehensive Smokeless Tobacco Health Education Act).

INCONSPICU

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except 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)).