Page:United States Statutes at Large Volume 123.djvu/1828

 123STA T . 1 80 8 PUBLIC LA W 111 – 31 —J U NE 22, 200 9‘ ‘ (i)hast h e sa m e c ha r acteristics as the p re d icate t ob acco prod u ct or ‘‘(ii) has di f fere n t characteristics and the informa - tion submitted contains information , inc l udin g clinical data if deemed necessar y by the S ecretary, that dem- onstrates that it is not appropriate to regulate the product under this section because the product does not raise different q uestions of public health . ‘‘( B ) CHAR A CTE R IS TICS. —I n subparagraph ( A ), the term ‘characteristics ’ means the materials, ingredients, design, composition, heating source, or other features of a tobacco product. ‘‘(C) L I M ITATI ON .—A tobacco product may not be found to be substantially equi v alent to a predicate tobacco product that has been removed from the mar k et at the initiative of the Secretary or that has been determined by a j udicial order to be misbranded or adulterated. ‘‘( 4 ) H EA L TH IN F ORMATION.— ‘‘(A) S U MMAR Y .—As part of a submission under section 905 (j) respecting a tobacco product, the person required to file a premarket notification under such section shall provide an adequate summary of any health information related to the tobacco product or state that such informa- tion w ill be made available upon request by any person. ‘‘(B) R E Q UIRE D INFORMATION.—Any summary under subparagraph (A) respecting a tobacco product shall contain detailed information regarding data concerning adverse health effects and shall be made available to the public by the Secretary within 3 0 days of the issuance of a deter- mination that such tobacco product is substantially equiva- lent to another tobacco product. ‘‘(b) A P PLICATION.— ‘‘( 1 ) CONTENTS.—An application under this section shall contain— ‘‘(A) full reports of all information, published or known to, or which should reasonably be known to, the applicant, concerning investigations which have been made to show the health risks of such tobacco product and whether such tobacco product presents less risk than other tobacco prod- ucts; ‘‘(B) a full statement of the components, ingredients, additives, and properties, and of the principle or principles of operation, of such tobacco product; ‘‘(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, proc- essing, and, when relevant, packing and installation of, such tobacco product; ‘‘( D ) an identifying reference to any tobacco product standard under section 90 7 which would be applicable to any aspect of such tobacco product, and either adequate information to show that such aspect of such tobacco product fully meets such tobacco product standard or ade- quate information to justify any deviation from such standard; ‘‘( E ) such samples of such tobacco product and of components thereof as the Secretary may reasonably require; Public i nformat ion .De a d line.