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S: WPSHR LEGCNSL \XYWRITE CONSUMER TABAC. 75 1 the risks and benefits to the population as a whole, 2 including users and non-users of the tobacco prod- 3 uct, and taking into account— 4 "(A) the increased or decreased likelihood 5 that existing users of tobacco products will stop 6 using such products; and 7 "(B) the increased or decreased likelihood 8 that those who do not use tobacco products will 9 start using such products. 10 "(5) BASIS FOR ACTION.- 11 "(A) For purposes of paragraph (2)(A), 12 whether permitting a tobacco product to be 13 marketed would be appropriate for the protec- 14 tion of the public health shall, when appro- 15 priate, be determined on the basis of well-con- 16 trolled investigations, which may include one or 17 more clinical investigations by experts qualified 18 by training and experience to evaluate the to- 19 bacco product. 20 "(B) If the Secretary determines that 21 there exists valid scientific evidence (other than 22 evidence derived from investigations described 23 in subparagraph (A)) which is sufficient to 24 evaluate the tobacco product the Secretary may 25 authorize that the determination for purposes S. 1415 RS April 29, 1998 (2:39 p.m.)