Regulatory Counsel

0910-AG59 201410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives

The Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act, requires the Food and Drug Administration to promulgate regulations that require the testing and reporting of tobacco product constituents, ingredients, and additives, including smoke constituents, that the Agency determines should be tested to protect the public health.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes Private Sector Not Yet Determined 21 USC 301 et seq 21 USC 387 The Family Smoking Prevention and Tobacco Control Act Statutory Final 04/00/2013 sec 915(a) of the Federal Food, Drug, and Cosmetic Act Final rule must issue no later than 36 months after April 1, 2010--see section 915(a) of the Federal Food, Drug, and Cosmetic Act and section 6 of the Family Smoking Prevention and Tobacco Control Act. No NPRM 05/00/2015 Yes Businesses Undetermined Undetermined No Yes No Carol Drew Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3505 carol.drew@fda.hhs.gov Office of Good Clinical Practice, WO 32, Room 5105, 10903 New Hampshire Avenue, Silver Spring MD 20993