Page:United States Statutes at Large Volume 123.djvu/1829

 123STA T . 1 809PUBLIC LA W 111 – 31 —J U NE 22, 2009 ‘ ‘ (F)specim e n s ofth e lab elin g p r opose d to be u sed for such tobacco product and ‘‘( G ) such other information rele v ant to the sub j ect matter of the application as the S ecretar y may re q uire . ‘‘( 2 ) REF E R R ALTO TO B A C CO P RO DU CT S SC I E N TIFIC AD V ISOR Y CO M MITTEE. —U pon receipt of an application meeting the requirements set forth in paragraph ( 1 ) , the Secretary— ‘‘( A ) may, on the Secretary ’ so w n initiative; or ‘‘( B ) may, upon the request of an applicant, refer such application to the T obacco P roducts Scientific Advisory C ommittee for reference and for submission (within such period as the Secretary may establish) of a report and recommendation respecting the application, together with all underlying data and the reasons or basis for the recommenda - tion. ‘‘(c) ACTION ON APPLICATION.— ‘‘(1) D EADLINE.— ‘‘(A) I N G ENERAL.—As promptly as possible, but in no event later than 1 80 days after the receipt of an application under subsection (b), the Secretary, after considering the report and recommendation submitted under subsection (b)(2), shall— ‘‘(i) issue an order that the new product may be introduced or delivered for introduction into interstate commerce if the Secretary finds that none of the grounds specified in paragraph (2) of this subsection applies; or ‘‘(ii) issue an order that the new product may not be introduced or delivered for introduction into interstate commerce if the Secretary finds (and sets forth the basis for such finding as part of or accom- panying such denial) that 1 or more grounds for denial specified in paragraph (2) of this subsection apply. ‘‘(B) RESTRICTIONS ON SALE AND DISTRIBUTION.—An order under subparagraph (A)(i) may require that the sale and distribution of the tobacco product be restricted but only to the e x tent that the sale and distribution of a tobacco product may be restricted under a regulation under section 9 0 6 (d). ‘‘(2) DENIAL OF APPLICATION.—The Secretary shall deny an application submitted under subsection (b) if, upon the basis of the information submitted to the Secretary as part of the application and any other information before the Sec- retary with respect to such tobacco product, the Secretary finds that— ‘‘(A) there is a lac k of a showing that permitting such tobacco product to be marketed would be appropriate for the protection of the public health; ‘‘(B) the methods used in, or the facilities or controls used for, the manufacture, processing, or packing of such tobacco product do not conform to the requirements of section 906(e); ‘‘(C) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any par- ticular; or ‘‘(D) such tobacco product is not shown to conform in all respects to a tobacco product standard in effect under