123STA T . 1 805PUBLIC LA W 111 – 31 —J U NE 22 , 200 9Befor e is s u i nga nor d er under th is su b se c tion , the S ecretar y sha l l consult w ith the p ersons who are to gi v e notice under the order .‘ ‘ ( b )NOEXEMPTI O NFR OM O T H ER L I AB I L IT Y . —C o m pliance with an order issued under this section shall not relieve any person from liability under Federal or State law. I n awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided under such order shall be ta k en into account. ‘‘(c) R E C ALL AU THORITY.— ‘‘( 1 )IN G ENERAL.—If the Secretary finds that there is a reasonable probability that a tobacco product contains a manu - facturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health conse q uences or death, the Secretary shall issue an order requiring the appropriate person (including the manufac- turers, importers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco product. T he order shall provide the person sub j ect to the order with an opportunity for an informal hearing, to be held not later than 1 0 days after the date of the issuance of the order, on the actions required by the order and on whether the order should be amended to require a recall of such tobacco product. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds e x ist to sup- port the actions required by the order, the Secretary shall vacate the order. ‘‘( 2 ) AMEN D MENT O F ORDER TO RE Q UIRE RECALL.— ‘‘(A) IN GENERAL.—If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the tobacco product with respect to which the order was issued, the Secretary shall, except as provided in subparagraph (B), amend the order to require a recall. The Secretary shall specify a timetable in which the tobacco product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall. ‘‘(B) NOTICE.—An amended order under subparagraph (A)— ‘‘(i) shall not include recall of a tobacco product from individuals
and ‘‘(ii) shall provide for notice to persons subject to the risks associated with the use of such tobacco product. In providing the notice required by clause (ii), the Secretary may use the assistance of retailers and other persons who distributed such tobacco product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons under section 7 0 5 (b). ‘‘( 3 ) REMEDY NOT EXCLU S I V E.—The remedy provided by this subsection shall be in addition to remedies provided by sub- section (a). ‘ ‘ SEC.90 9. R EC O R D S AN DRE P OR T SONTO B ACCO PROD U CTS. ‘‘(a) IN G ENERAL.—Every person who is a tobacco product manu- facturer or importer of a tobacco product shall establish and main- tain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure Regulations.21USC387 i. N oti f i c ation. T i m eta b le. Re p o r ts. D ea d line. O rder. Consultation.
