21 U.S.C. § 387c - Misbranded tobacco products

Cite as:21 U.S.C. § 387c
Currency:Current through P.L. 116-158 (08/14/2020)

(a) In general

A tobacco product shall be deemed to be misbranded-

(1) if its labeling is false or misleading in any particular;

(2) if in package form unless it bears a label containing-

(A) the name and place of business of the tobacco product manufacturer, packer, or distributor;

(B) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;

(C) an accurate statement of the percentage of the tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco; and

(D) the statement required under section 387t(a) of this title,

except that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary;

(3) if any word, statement, or other information required by or under authority of this subchapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, or designs in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(4) if it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name prominently printed in type as required by the Secretary by regulation;

(5) if the Secretary has issued regulations requiring that its labeling bear adequate directions for use, or adequate warnings against use by children, that are necessary for the protection of users unless its labeling conforms in all respects to such regulations;

(6) if it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 387e(b), 387e(c), 387e(d),or 387e(h) of this title, if it was not included in a list required by section 387e(i) of this title, if a notice or other information respecting it was not provided as required by such section or section 387e(j) of this title, or if it does not bear such symbols from the uniform system for identification of tobacco products prescribed under section 387e(e) of this title as the Secretary by regulation requires;

(7) if, in the case of any tobacco product distributed or offered for sale in any State-

(A) its advertising is false or misleading in any particular; or

(B) it is sold or distributed in violation of section 387f(d)(5) of this title or of regulations prescribed under section 387f(d) of this title;

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