Page:United States Statutes at Large Volume 123.djvu/1835

 123STA T . 1 8 1 5PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (B)AD D IT I ONALF INDIN GSREQU IRED .—Tois s uean o rd er under su bp ara g rap h (A) t he S e c retar ym ust a l so f ind that the applicant has demonstrated that— ‘‘(i) the magnitude of the o v erall reductions in e x po - sure to the substance or substances w hich are the sub j ect of the application is substantial , such substance or substances are harmful, and the product as actually used exposes consumers to the specified reduced level of the substance or substances ‘‘(ii) the product as actually used by consumers will not expose them to higher levels of other harmful substances compared to the similar types of tobacco products then on the mar k et unless such increases are minimal and the reasonably likely overall impact of use of the product remains a substantial and meas- urable reduction in overall morbidity and mortality among individual tobacco users; ‘‘(iii) testing of actual consumer perception shows that, as the applicant proposes to label and market the product, consumers will not be misled into believing that the product— ‘‘( I ) is or has been demonstrated to be less harmful; or ‘‘(II) presents or has been demonstrated to present less of a risk of disease than 1 or more other commercially marketed tobacco products; and ‘‘(iv) issuance of an order with respect to the application is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products. ‘‘( C ) CONDITIONS OF M AR K ETING.— ‘‘(i) IN GENERAL.—Applications subject to an order under this paragraph shall be limited to a term of not more than 5 years, but may be renewed upon a finding by the Secretary that the re q uirements of this paragraph continue to be satisfied based on the filing of a new application. ‘‘(ii) AGREEMENTS BY A P PLI C ANT.—An order under this paragraph shall be conditioned on the applicant ’ s agreement to conduct postmarket surveillance and studies and to submit to the Secretary the results of such surveillance and studies to determine the impact of the order on consumer perception, behavior, and health and to enable the Secretary to review the accuracy of the determinations upon which the order was based in accordance with a protocol approved by the Secretary. ‘‘(iii) ANNUAL SUBMISSION.—The results of such postmarket surveillance and studies described in clause (ii) shall be submitted annually. ‘‘( 3 ) BASIS.—The determinations under paragraphs (1) and ( 2 ) shall be based on— ‘‘(A) the scientific evidence submitted by the applicant; and Study.