Page:United States Statutes at Large Volume 123.djvu/1855

 123STA T . 1 8 3 5PUBLIC LA W 111 – 31 —J U NE 22, 2 0 0 9‘ ‘ (3)theproduc t is e n dorsed by the F ood a nd D ru gA d m inis - tration f or use by consumers or ‘‘( 4 ) the product is safe or l ess harmful by v irtue of — ‘‘(A) its regulation or inspection by the Food and Drug Administration; or ‘‘( B ) its compliance w ith regulatory re q uirements set by the Food and Drug Administration; including any such statement or representation rendering the product misbranded under section 90 3 .’ ’. (c) SECTION 303.—Section 303(f) ( 21U .S. C . 333(f)) is amended— (1) in paragraph ( 5 )— (A) by stri k ing ‘‘paragraph (1) , (2), (3), or (4)’’ each place such appears and inserting ‘‘paragraph (1), (2), (3), (4), or (9)’’; (B) in subparagraph (A)— (i) by striking ‘‘assessed’’ the first time it appears and inserting ‘‘assessed, or a no-tobacco-sale order may be imposed,’’; and (ii) by striking ‘‘penalty’’ the second time it appears and inserting ‘‘penalty, or upon whom a no-tobacco- sale order is to be imposed,’’; (C) in subparagraph (B)— (i) by inserting after ‘‘penalty,’’ the following ‘‘or the period to be covered by a no-tobacco-sale order,’’; and (ii) by adding at the end the following: ‘‘A no- tobacco-sale order permanently prohibiting an indi- vidual retail outlet from selling tobacco products shall include provisions that allow the outlet, after a speci- fied period of time, to request that the Secretary com- promise, modify, or terminate the order.’’; and (D) by adding at the end the following: ‘‘(D) T he Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order.’’; (2) in paragraph ( 6 )— (A) by inserting ‘‘or the imposition of a no-tobacco- sale order’’ after the term ‘‘penalty’’ each place such term appears; and (B) by striking ‘‘issued.’’ and inserting ‘‘issued, or on which the no-tobacco-sale order was imposed, as the case may be.’’; and (3) by adding at the end the following: ‘‘( 8 ) I f the Secretary finds that a person has committed repeated violations of restrictions promulgated under section 906(d) at a particular retail outlet then the Secretary may impose a no-tobacco- sale order on that person prohibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). P rior to the entry of a no- sale order under this paragraph, a person shall be entitled to a hearing pursuant to the procedures established through regula- tions of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available.