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GAO-16-676R 1 (2016-05-25)

handle is hein.gao/gaobadsgl0001 and id is 1 raw text is: cAO U.S. GOVERNMENT ACCOUNTABILITY OFFICE 441 G St. N.W. Washington, DC 20548 B-328083 May 25, 2016 The Honorable Lamar Alexander Chairman The Honorable Patty Murray Ranking Member Committee on Health, Education, Labor, and Pensions United States Senate The Honorable Fred Upton Chairman The Honorable Frank Pallone, Jr. Ranking Member Committee on Energy and Commerce House of Representatives Subject: Department of Health and Human Services, Food and Drug Administration: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products Pursuant to section 801 (a)(2)(A) of title 5, United States Code, this is our report on a major rule promulgated by the Department of Health and Human Services, Food and Drug Administration (FDA) entitled Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products (RIN: 0910-AG38). We received the rule on May 10, 2016. It was published in the Federal Register as a final rule on May 10, 2016. 81 Fed. Reg. 28,974. The final rule extends FDA's tobacco product authorities to all other categories of products that meet the statutory definition of tobacco product, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of covered tobacco products to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages, and in advertisements. The requirements that will apply to the products deemed to be tobacco products include establishment registration and product listing, ingredient listing, harmful or potentially harmful testing and reporting, premarket submissions prior to the introduction of new products, and labeling requirements. Free samples of newly deemed tobacco products will also be prohibited. Enclosed is our assessment of FDA's compliance with the procedural steps required by section 801 (a)(1)(B)(i) through (iv) of title 5 with respect to the rule. Our review of the procedural steps taken indicates that FDA complied with the applicable requirements. GAO-16-676R

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