Page:United States Statutes at Large Volume 123.djvu/1838

 123STA T . 1 8 18 PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (k)CHAPTERIVO RV .—Aproductf or whi ch th eS ecret a r y ha s issued a n order pursuant to su b section ( g ) sha l lnotbesub j ect to chapter IV or V. ‘‘(l) I M P L EME N T I N GR EG U LATION S OR G UI D AN C E.— ‘‘( 1 ) SCIENTI F ICE V IDENCE.— N ot later than 2 years after the date of enact m ent of the F amily Smoking P re v ention and T obacco Control Act , the Secretary shall issue regulations or guidance (or any combination thereof) on the scientific evidence re q uired for assessment and ongoing review of modified risk tobacco products. Such regulations or guidance shall— ‘‘(A) to the e x tent that adequate scientific evidence exists, establish minimum standards for scientific studies needed prior to issuing an order under subsection (g) to show that a substantial reduction in morbidity or mortality among individual tobacco users occurs for products described in subsection (g)(1) or is reasonably likely for products described in subsection (g)(2) ‘‘( B ) include validated biomarkers, intermediate clinical endpoints, and other feasible outcome measures, as appro - priate; ‘‘(C) establish minimum standards for postmarket studies, that shall include regular and long-term assess- ments of health outcomes and mortality, intermediate clin- ical endpoints, consumer perception of harm reduction, and the impact on quitting behavior and new use of tobacco products, as appropriate; ‘‘( D ) establish minimum standards for required postmarket surveillance, including ongoing assessments of consumer perception; ‘‘( E ) require that data from the required studies and surveillance be made available to the Secretary prior to the decision on renewal of a modified risk tobacco product; and ‘‘(F) establish a reasonable timetable for the Secretary to review an application under this section. ‘‘(2) CONSULTATION.—The regulations or guidance issued under paragraph (1) shall be developed in consultation with the Institute of M edicine, and with the input of other appro- priate scientific and medical experts, on the design and conduct of such studies and surveillance. ‘‘( 3 ) REVISION.—The regulations or guidance under para- graph (1) shall be revised on a regular basis as new scientific information becomes available. ‘‘( 4 )NE W TO B ACCO PRODUCTS.—Not later than 2 years after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, the Secretary shall issue a regulation or guidance that permits the filing of a single application for any tobacco product that is a new tobacco product under section 9 1 0 and which the applicant seeks to commercially market under this section. ‘‘(m) DISTRIBUTORS.—Except as provided in this section, no distributor may take any action, after the date of enactment of the Family Smoking Prevention and Tobacco Control Act, with respect to a tobacco product that would reasonably be expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful Deadlin e . Deadline.