Page:United States Statutes at Large Volume 123.djvu/1834

 123STA T . 1 8 1 4PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9mat t ersin t h ea p p l i c ati o n w hich are tra d e secrets or otherwise con f idential , commercial information ) and shall re qu est comments by interested persons on the information contained in the applica - tion and on the label, labelin g ,andad v ertising accompanying such application .‘ ‘ ( f) ADVISORYC O M MI T T E E. — ‘‘( 1 ) ING ENER AL .— T he S ecretary shall refer to the Tobacco P roducts Scientific Advisory Committee any application sub- mitted under this section. ‘‘( 2 ) R E C OMMENDATIONS.— N ot later than 60 days after the date an application is referred to the Tobacco Products Scientific Advisory Committee under paragraph (1), the Advisory Com- mittee shall report its recommendations on the application to the Secretary. ‘‘(g) M AR K ETING.— ‘‘(1) MODI F IED RISK P ROD U CTS.— Ex cept as provided in para- graph (2), the Secretary shall, with respect to an application submitted under this section, issue an order that a modified ris k product may be commercially marketed only if the Sec- retary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will— ‘‘(A) significantly reduce harm and the risk of tobacco- related disease to individual tobacco users and ‘‘( B ) 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. ‘‘(2) SPECIAL RULE FOR CERTAIN PRODUCTS.— ‘‘(A) IN GENERAL.—The Secretary may issue an order that a tobacco product may be introduced or delivered for introduction into interstate commerce, pursuant to an application under this section, with respect to a tobacco product that may not be commercially marketed under paragraph (1) if the Secretary makes the findings required under this paragraph and determines that the applicant has demonstrated that— ‘‘(i) such order would be appropriate to promote the public health; ‘‘(ii) any aspect of the label, labeling, and adver- tising for such product that would cause the tobacco product to be a modified risk tobacco product under subsection (b) is limited to an explicit or implicit rep- resentation that such tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke; ‘‘(iii) scientific evidence is not available and, using the best available scientific methods, cannot be made available without conducting long-term epidemiological studies for an application to meet the standards set forth in paragraph (1); and ‘‘(iv) the scientific evidence that is available with- out conducting long-term epidemiological studies dem- onstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely in subsequent studies. Orde r .D e a d lin e. R e po r ts .