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Spotlight on Toxicology at the US FDA Center for Tobacco Products (CTP)

By Ruth Roberts posted 11-17-2016 13:08

  

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By: US FDA Center for Tobacco Products staff

The US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) oversees the implementation of the Family Smoking Prevention and Tobacco Control Act. CTP’s responsibilities include setting product standards, reviewing premarket applications for new and modified risk tobacco products, requiring new warning labels, and establishing and enforcing advertising and promotion restrictions.

The work at CTP is complex and multifaceted. CTP toxicologists perform toxicological reviews of tobacco product reports and applications, including investigational tobacco products (ITP), premarket tobacco product applications (PMTA), substantial equivalence (SE) reports for new tobacco products, and modified risk tobacco product (MRTP) applications. As part of their review, they evaluate information, studies, data, and experiments provided by the applicant in their submission. CTP toxicologists also keep abreast of current, relevant advances in their scientific discipline by reviewing published literature and publicly available tobacco industry documents, as well as internal, confidential documents. In addition, CTP toxicologists develop and manage research projects that inform regulatory activities. These efforts contribute to a wide range of regulatory activities and address public health issues that arise as they pertain to toxicology.

US FDA Center for Tobacco Products staff.pngThe mission of reducing harm and associated risks of tobacco is a tremendous responsibility assigned to CTP and its toxicologists. Although not a traditional toxicology career path, CTP’s toxicologists are highly motivated and provide an essential element to the mission. Three passionate CTP toxicologists and SOT members offer their insight on the thrills of the regulatory field, unique career paths, and the positive impact on public health to which they contribute daily:

  • James Hobson, PhD, DABT, has been a member of SOT for 35 years. Like many CTP toxicologists, he considers the public health objective during his pre-market reviews of tobacco products. His hope is that his work at CTP will contribute to the public’s understanding of the hazards of tobacco products and help to communicate the risks to new and existing users, especially young adults who might start using tobacco products in high school.
  • Gladys Erives, PhD, has been affiliated with SOT since 2004. Dr. Erives transferred to CTP from another US FDA Center, motivated by the challenge of regulating tobacco products and developing policies. She is currently involved in scientific research related to understanding the toxicity of certain tobacco products and how changes in such products affect their potential for harm. The results of this research will address scientific knowledge gaps and inform regulation development.
  • Berran Yucesoy, PhD, has been an SOT member since 2004 and joined CTP for the opportunity to combine a scientific background with a strong interest in regulatory science. In addition to reviewing new tobacco product applications from a toxicological standpoint and providing expertise for regulatory decisions, she also is involved in research projects to address gaps in scientific knowledge.

A multidimensional center, CTP offers unique opportunities to contribute to mission-critical research and collaborations.

The Tobacco Control Act gave CTP unprecedented authority for the premarket review of tobacco product applications and reports. Dr. Erives notes that no other country’s regulatory agency has been given the responsibility to evaluate new tobacco products before they are marketed and to determine which products will be authorized for marketing based on public health criteria.

CTP Research quote.pngDr. Erives values not only the immediacy of her impact on public health through tobacco regulatory science, but also CTP’s research opportunities. The Center encourages staff to propose areas of study for collaborative regulatory science research projects and to develop state-of-the-art research projects to address gaps in scientific knowledge to inform tobacco product regulation. This allows employees to work with contractors and other FDA Centers to design and conduct studies that identify and evaluate different toxicological aspects related to tobacco products and public health. Dr. Hobson adds that the complexity of tobacco product mixtures is difficult to work with from a toxicological perspective. As opposed to evaluating single chemicals, tobacco, tobacco smoke, and tobacco extracts are complex mixtures of thousands of chemicals, making them more challenging to assess toxicologically.

Dr. Yucesoy shares that in addition to research opportunities and on-the-job learning, there are many training opportunities at CTP that can strengthen the knowledge base to both contribute to work quality and advance personal and professional growth. A unique aspect of her job is the diversity of the work; as a fast-growing, progressive Center, daily work involves many different tasks, from scientific reviews to research projects to writing scientific publications.

Many toxicologists at CTP are motivated by a sense of duty toward advancing public health and the Center’s impact. Dr. Yucesoy views the most distinguishing aspect of being a CTP toxicologist as the ability to serve the public in a way that makes a difference. She is motivated by knowing that her scientific contributions are essential for regulatory decisions which, ultimately, reduce the public health impact of tobacco product use and improve overall public health. Considering the tremendous global impact of tobacco use on human life, she believes the work of CTP is extremely important to reducing the harm and adverse health effects of regulated tobacco products, encouraging tobacco users to stop, and discouraging those who do not use tobacco products from starting. Involvement in activities aimed at reducing the harm from all regulated tobacco products across the entire population has been the most impactful public health-related role of her career, she adds, a sentiment she shares with many of her colleagues.

Visit the CTP Jobs webpage for more information on opportunities or send CTP Jobs an email.

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