123STA T . 1 8 1 6PUBLIC LA W 111 – 31 —J U NE 22 , 2 0 0 9‘ ‘ (B)scient i f ice v i d ence a nd o t h e r infor m ation that is made avai l a b le to the S ecretar y. ‘‘( 4 )B EN E FIT T OH E AL THOFIN D I V ID U AL S AND OF P OPU - LATION AS A W HOLE. —I nma k in g the determinations u nder p aragraphs ( 1 )and( 2 ) , the Secretary shall take into account— ‘‘( A ) the relative health risks to individuals of the tobacco product that is the sub j ect of the application
‘‘(B) the increased or decreased likelihood that e x isting users of tobacco products w ho would otherwise stop using such products will switch to the tobacco product that is the subject of the application; ‘‘( C ) the increased or decreased likelihood that persons who do not use tobacco products will start using the tobacco product that is the subject of the application; ‘‘( D ) the risks and benefits to persons from the use of the tobacco product that is the subject of the application as compared to the use of products for smoking cessation approved under chapter V to treat nicotine dependence; and ‘‘( E ) comments, data, and information submitted by interested persons. ‘‘(h) ADDITIONAL CONDITIONS FO RM AR K ETIN G .— ‘‘(1) MODIFIED RISK PRODU C TS.— T he Secretary shall re q uire for the marketing of a product under this section that any advertising or labeling concerning modified risk products enable the public to comprehend the information concerning modified risk and to understand the relative significance of such informa- tion in the context of total health and in relation to all of the diseases and health-related conditions associated with the use of tobacco products. ‘‘(2) CO M PARATIVE CLAIMS.— ‘‘(A) IN GENERAL.—The Secretary may require for the marketing of a product under this subsection that a claim comparing a tobacco product to 1 or more other commer- cially marketed tobacco products shall compare the tobacco product to a commercially marketed tobacco product that is representative of that type of tobacco product on the market (for example the average value of the top 3 brands of an established regular tobacco product). ‘‘(B) Q UANTITATIVE COMPARISONS.—The Secretary may also require, for purposes of subparagraph (A), that the percent (or fraction) of change and identity of the reference tobacco product and a quantitative comparison of the amount of the substance claimed to be reduced shall be stated in immediate proximity to the most prominent claim. ‘‘(3) L A B EL DISCLOSURE.— ‘‘(A) IN GENERAL.—The Secretary may require the disclosure on the label of other substances in the tobacco product, or substances that may be produced by the consumption of that tobacco product, that may affect a disease or health-related condition or may increase the risk of other diseases or health-related conditions associ- ated with the use of tobacco products. ‘‘(B) CONDITIONS OF USE.—If the conditions of use of the tobacco product may affect the risk of the product to human health, the Secretary may require the labeling of conditions of use.
