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    Subject Term: "Tobacco products"

    2 publications with a total of 3 open recommendations
    Director: Crosse, Marcia G
    Phone: (202) 512-7114

    2 open recommendations
    Recommendation: To improve CTP's ability to operate efficiently, achieve effective results, and plan appropriately, the Secretary of Health and Human Services should direct the Commissioner of FDA to establish performance measures that include time frames for making final decisions on SE submissions and Exemption from SE submissions.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has established performance measures that include time frames for reviewing and acting on some of its new tobacco product submissions, including regular Substantial Equivalence (SE) submissions and Exemption from SE submissions, received in fiscal years 2015 through 2018. However, as of September, 2017, FDA has not developed performance measures for provisional SE submissions, the type of SE submissions that represent new tobacco products that may continue to be marketed unless and until FDA's Center for Tobacco Products finds that they are not substantially equivalent. We are keeping this recommendation open until the agency establishes performance measures, including time frames for making final decisions, for provisional SE submissions.
    Recommendation: To improve CTP's ability to operate efficiently, achieve effective results, and plan appropriately, the Secretary of Health and Human Services should direct the Commissioner of FDA to monitor FDA's performance relative to those time frames, such as evaluating whether staff are performing reviews of these submissions efficiently and effectively.

    Agency: Department of Health and Human Services
    Status: Open

    Comments: FDA has established and monitors performance measures that include time frames for reviewing and acting on regular SE submissions, Exemption from SE requests, and Modified Risk Tobacco Product applications for fiscal years 2015 through 2018. However, because the agency has not yet reported establishing and monitoring performance measures for provisional SE submissions, we are leaving this recommendation open as of August 2017.
    Director: Gootnick, David B
    Phone: (202) 512-3149

    1 open recommendations
    Recommendation: Disparities in tax rates on smoking tobacco products have negative revenue implications because they create incentives for manufacturers and consumers to substitute higher-taxed products with lower-taxed products. In light of that fact, as Congress continues its oversight of CHIPRA and Tobacco Control Act implementation, it may wish to consider modifying tobacco tax rates to eliminate significant tax differentials between similar products. Specifically, Congress may wish to consider equalizing tax rates on roll-your-own and pipe tobacco and, in consultation with Treasury, also consider options for reducing tax avoidance due to tax differentials between small and large cigars.

    Agency: Congress
    Status: Open

    Comments: As of April 2017, Congress had not passed legislation to equalize taxes on roll-your-own and pipe tobacco and small and large cigars. In the 114th Congress, two bills were introduced to equalize taxes on roll-your-own and pipe tobacco, as GAO suggested in its April 2012 report. Additionally, in January 2017, House Bill 729, which would create tax parity for these products, was introduced in the 115th Congress. However, these bills have not been enacted. GAO's April 2012 report noted that prior federal and state legislation has aimed to discourage tobacco use and raise revenues by increasing excise taxes on tobacco products. Modifying tax rates to eliminate the tax differentials between similar tobacco products could address potential future revenue losses stemming from the substitution of higher-taxed products with lower-taxed products.