123STA T . 1 8 12 PUBLIC LA W 111 – 31 —J U NE 22 , 2 0 0 9(c) ( 1 )( A )( i ) foran a p p l ica t ion fil edu nder s u b section (b) is in effect , t h e applicant shall establish and m aintain such records, and ma k e such reports to the S ecretar y , as the Secretary may by re g ulation, or by order w ith respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination of, whether there is or may be grounds for withdrawing or temporarily suspending such order .‘ ‘( 2 )A C C ES S TOR ECOR D S. —E ach person re q uired under this section to maintain records, and each person in charge of cus - tody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to ha v e access to and copy and verify such records. ‘‘(g) INV EST IGA TIONA LT O B ACCO P ROD U CTE X E MP TION F OR INVESTIGATIONAL U SE.—The Secretary may e x empt tobacco prod- ucts intended for investigational use from the provisions of this chapter under such conditions as the Secretary may by regulation prescribe. ‘ ‘ SEC.91 1. MODIF IED R IS KT O BA CCO P ROD U CTS. ‘‘(a) IN G ENERAL.— N o person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product unless an order issued pursuant to subsection (g) is effective with respect to such product. ‘‘(b) D EFINITIONS.—In this section
‘‘(1) M ODIFIED RIS K TOBACCO PRODUCT.—The term ‘modified risk tobacco product ’ means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco- related disease associated with commercially marketed tobacco products. ‘‘(2) SOLD OR DISTRIBUTED.— ‘‘(A) IN GENERAL.— W ith respect to a tobacco product, the term ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commer- cially marketed tobacco products’ means a tobacco product— ‘‘(i) the label, labeling, or advertising of which rep- resents explicitly or implicitly that— ‘‘(I) the tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products
‘‘(II) the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or ‘‘(III) the tobacco product or its smoke does not contain or is free of a substance; ‘‘(ii) the label, labeling, or advertising of which uses the descriptors ‘light’, ‘mild’, or ‘low’ or similar descriptors; or ‘‘(iii) the tobacco product manufacturer of which has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product’s label, labeling, or advertising, after the date of enactment of the F amily Smoking Preven- tion and Tobacco C ontrol Act, respecting the product 21USC387k.
