Sec. 108. Exemption from premarket approval of certain tobacco products
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Section 910(a)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387j(a)(2) ) is amended— in subparagraph (A)— in clause (i)(II), by striking or ; in clause (ii), by striking the period at the end and inserting ; or ; and by adding at the end the following: subject to subparagraph (C), for the period beginning on the date of the enactment of the Reversing the Youth Tobacco Epidemic Act of 2019 and ending on September 30, 2028, the tobacco product is a cigar and— is wrapped in whole tobacco leaf; contains a 100-percent leaf tobacco binder; contains primarily long filler tobacco; does not have a characterizing flavor other than tobacco; weighs more than 6 pounds per 1000 units; has no filter, tip, or non-tobacco mouthpiece; is made by combining manually the wrapper, filler, and binder and is capped by hand; or has a homogenized tobacco leaf binder and is made in the United States using human hands to lay the 100-percent leaf tobacco binder onto only one machine that bunches, wraps, and caps each individual cigar; and has a retail price (after discounts or coupons) per cigar of no less than— for calendar years 2019 and 2020, $12; and for each subsequent calendar year, $12 multiplied by any percent increase in the Consumer Price Index for all urban consumers (all items;
U.S. city average) since calendar year 2020. ; and by adding at the end the following: The Secretary shall, notwithstanding subparagraph (A)(iii) or any determination of substantial equivalence, if any of the conditions specified in clause
(ii)are met— withdraw any exemption applicable to a tobacco product or products described in such subparagraph; require that applications for review under this section be submitted with respect to such product or products; and require that manufacturers may only market such tobacco product after the issuance of an order under subsection (c)(1)(A)(i) with respect to such product or products. The conditions specified in this clause are that— the Secretary determines that the use of a tobacco product or products described in subparagraph (A)(iii) has resulted in an emerging public health threat; data from a National Youth Tobacco Survey (or successor survey) conducted after the date of the enactment of the Reversing the Youth Tobacco Epidemic Act of 2019 identifies a rise in youth usage of tobacco products described in section 910(a)(2)(A)(iii); or the Secretary determines that a tobacco product or products no longer meets the criteria specified in such subparagraph. . The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall enter into an agreement with the National Academies of Sciences, Engineering, and Medicine under which the National Academies shall conduct a study on— the public health impact of having tobacco products described in subsection (a)(2)(A)(iii) of section 910 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387j(a)(2) ), as amended by subsection (a), exempt from premarket review under such section; the youth usage of such tobacco products; and the market share of such products. The agreement under paragraph
(1)shall include a requirement that the National Academies of Sciences, Engineering, and Medicine submit to Congress, not later than December 31, 2026, a report on the findings of the study conducted under such paragraph.
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Sec. 108
Exemption from premarket approval of certain tobacco products
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