123STA T . 1 8 1 0PUBLIC LA W 111 – 31 —J U NE 22 , 200 9section907,a n d t h e r eisa l ac k o f ade qu ate infor m ation to j ustif y the de v iation from such standard .‘ ‘ (3)DENIAL IN FORM A T ION. —A ny denial of an a p plication shall, insofar as the S ecretary determines to b e practicable, be accompanied by a statement informin g the applicant of the measures required to remove such application from deniable form ( w hich measures may include further research by the applicant in accordance with 1 or more protocols prescribed by the Secretary). ‘‘( 4 ) B A S IS FOR FIN D IN G .— F or purposes of this section, the finding as to whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account— ‘‘(A) the increased or decreased likelihood that e x isting users of tobacco products will stop using such products
and ‘‘(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products. ‘‘( 5 ) BASIS FOR A C TION.— ‘‘(A) I N V ESTIGATIONS.—For purposes of paragraph ( 2 )(A), whether permitting a tobacco product to be marketed would be appropriate for the protection of the public health shall, when appropriate, be determined on the basis of well - controlled investigations, which may include 1 or more clinical investigations by experts qualified by training and experience to evaluate the tobacco product. ‘‘(B) O T H ER EVIDENCE.—If the Secretary determines that there exists valid scientific evidence (other than evi- dence derived from investigations described in subpara- graph (A)) which is sufficient to evaluate the tobacco product, the Secretary may authori z e that the determina- tion for purposes of paragraph (2)(A) be made on the basis of such evidence. ‘‘(d) W ITHDRA W AL AND T EM P ORAR Y S U SPENSION.— ‘‘(1) IN GENERAL.—The Secretary shall, upon obtaining, where appropriate, advice on scientific matters from the Tobacco P roducts Scientific Advisory C ommittee, and after due notice and opportunity for informal hearing for a tobacco product for which an order was issued under subsection (c)(1)(A)(i), issue an order withdrawing the order if the Sec- retary finds— ‘‘(A) that the continued marketing of such tobacco product no longer is appropriate for the protection of the public health; ‘‘(B) that the application contained or was accompanied by an untrue statement of a material fact; ‘‘(C) that the applicant— ‘‘(i) has failed to establish a system for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 909; Notice.H e ar i ngs . S tate m ent.
