123STA T . 1 78 8 PUBLIC LA W 111 – 31 —J U NE 22 , 2 0 0 9ad d e d pois o n o u so r added de l e t erious su b stan c et h at m a y render the product in j urious to health
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‘ (2) it has been prepared , pac k ed, or held under insanitary conditions w hereby it may ha v e been contaminated with f ilth, or whereby it may have been rendered injurious to health; ‘‘( 3 ) its packa g e is composed, in whole or in part, of any poisonous or deleterious substance which may render the con - tents injurious to health; ‘‘( 4 ) the manufacturer or importer of the tobacco product fails to pay a user fee assessed to such manufacturer or importer pursuant to section 91 9 by the date specified in section 919orbythe3 0 th day after final agency action on a resolution of any dispute as to the amount of such fee; ‘‘( 5 ) it is, or purports to be or is represented as, a tobacco product which is subject to a tobacco product standard estab- lished under section 90 7 unless such tobacco product is in all respects in conformity with such standard; ‘‘( 6 )( A )itisre q uired by section 910(a) to have premarket review and does not have an order in effect under section 910(c)(1)(A)(i); or ‘‘( B ) it is in violation of an order under section 910(c)(1)(A); ‘‘(7) the methods used in, or the facilities or controls used for, its manufacture, packing, or storage are not in conformity with applicable requirements under section 906(e)(1) or an applicable condition prescribed by an order under section 906(e)(2); or ‘‘( 8 ) it is in violation of section 911 .‘ ‘ SEC.903 . MI S BRAND ED TO BACCO P ROD U CTS. ‘‘(a) INGE NE RAL . — 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 con- tents 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 920(a), e x cept that under subparagraph (B) reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the S ecretary; ‘‘(3) if any word, statement, or other information required by or under authority of this chapter 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 estab- lished name prominently printed in type as required by the Secretary by regulation; Regulations.L a b eling. 21USC387c .
