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The First 10 Years: Reflecting on Opportunities and Challenges of the Tobacco Products Scientific Advisory Committee of the United States Food and Drug Administration
Journal of Legal Medicine ( IF 0.417 ) Pub Date : 2021-04-02 , DOI: 10.1080/01947648.2020.1868938
Pebbles Fagan, Thomas Eissenberg, Dina M. Jones, Joanna E. Cohen, Patricia Nez Henderson, Mark S. Clanton

Abstract

Introduction: Tobacco control policies have helped to reduce the health, social, and economic burden of commercial tobacco use worldwide. Little is known about the long-term impact of regulatory policies and functioning bodies that make recommendations to inform policies. The Tobacco Products Scientific Advisory Committee (TPSAC) of the U.S. Food and Drug Administration (FDA) was formed in 2009 to evaluate the safety, health, and dependence of tobacco products and provide related advice and recommendations to the FDA and the Secretary of Health and Human Services. This article describes the first 10 years of the TPSAC activities and reflects on the impact of their service on regulatory actions.

Methods: We reviewed public documents from the 2010–2019 TPSAC meetings to examine the purposes, TPSAC decisions, public health participation in meetings, and concordance of the TPSAC recommendations with regulatory actions. Meeting agendas, transcripts, public testimony, and presentations were reviewed to obtain this information.

Results: Since 2010, the TPSAC held 25 public meetings with 178 speakers who provided oral public testimony. Sixty-four percent of meetings were held from 2010 to 2012, when three congressionally mandated reports were due on the topics of menthol cigarettes, harmful and potentially harmful constituents in tobacco products, and dissolvable tobacco products. Forty-four percent of meetings focused on menthol cigarettes, 32% on modified risk tobacco products, 16% on harmful and potentially harmful constituents, 12% on dissolvable tobacco, and 4% on tobacco addiction/dependence. FDA regulatory actions were largely nonconcordant with voting decisions by TPSAC.

Conclusions: The TPSAC has evaluated an enormous amount of science during the first 10 years, but their influence on regulatory policies has been limited. The TPSAC roles and functioning should be reevaluated to determine how TPSAC can better fulfill its mandate to inform the FDA’s regulatory decision making, which could ultimately reduce the burden of tobacco use in the United States.



中文翻译:

前十年:反思美国食品和药物管理局烟草产品科学咨询委员会的机遇与挑战

摘要

简介:烟草控制政策有助于减轻全球商业烟草使用的健康,社会和经济负担。对于制定政策建议的监管政策和职能机构的长期影响知之甚少。美国食品和药物管理局(FDA)的烟草产品科学咨询委员会(TPSAC)成立于2009年,旨在评估烟草制品的安全性,健康性和依赖性,并向FDA和卫生部长提供相关的建议和建议。人工服务。本文介绍了TPSAC活动的前十年,并反思了其服务对监管行为的影响。

方法:我们审查了2010-2019年TPSAC会议的公共文件,以检查目的,TPSAC决策,公共卫生参与会议以及TPSAC建议与监管措施的一致性。会议议程,笔录,公开证词和演讲都经过审查以获得这些信息。

结果:自2010年以来,TPSAC举行了25次公开会议,由178位演讲者提供了公开口头证词。从2010年到2012年,召开了64%的会议,当时有3项国会授权报告针对薄荷卷烟,烟草制品中有害和潜在有害成分以及可溶性烟草制品的主题提交。44%的会议集中在薄荷卷烟上,32%的会议放在风险改良烟草制品上,16%在有害和可能有害的成分上,12%在可溶解的烟草上,4%在烟草成瘾/依赖性上。FDA的监管行动在很大程度上与TPSAC的投票决定不一致。

结论: TPSAC在最初的10年中评估了大量科学,但是它们对监管政策的影响是有限的。应该重新评估TPSAC的角色和功能,以确定TPSAC如何更好地履行其职责以告知FDA的监管决策,这最终可以减轻美国烟草使用的负担。

更新日期:2021-04-02
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