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Tobacco Regulatory Research Measures Available in the PhenX Toolkit

A notice announcing the availability of common data elements for tobacco regulatory research via the PhenX Toolkit has been published.

The NIH Tobacco Regulatory Science Program and the FDA Center for Tobacco Products supplemented PhenX External Website Policy to provide a set of expert-recommended, prioritized common measures as a resource to investigators conducting tobacco regulatory research. PhenX Toolkit measures are meant to serve the field as common data elements to allow for a standard of comparison across studies and to facilitate collaboration and data sharing.

The Web-based PhenX Toolkit External Website Policy is catalog of freely-available standard measures to facilitate collaborative biomedical research. PhenX (consensus measures for Phenotypes and eXposures) measures help ensure that variables and constructs from different studies are collected in a consistent format. This consistency improves data quality in general, and can also aid data comparability across studies, enable combining data to increase statistical power, or facilitate replication and validation of research findings. The PhenX Toolkit currently includes 506 measures addressing multiple scientific domains.

The Tobacco Regulatory Research (TRR) collections External Website Policy, completed in August 2016, added 56 measures to the PhenX Toolkit. TRR measures are organized into 2 Cores, which are deemed relevant across all areas of TRR, and 5 Specialty Collections based on the HAVE (Host, Agent, Vector, and Environment) model:

  • Social/Cognitive (Host): intrapersonal factors influencing tobacco use
  • Biobehavioral (Host): product use, exposure, and outcomes
  • Agent: assessment of tobacco products
  • Vector: industry and retailer activities
  • Environment: environmental factors influencing tobacco use

The measures included in each Collection are chosen by domain experts who recommend measures for inclusion that are suitable for a variety of study designs, using a consensus-based process, which includes input from the scientific community.

The PhenX website has a variety of resources External Website Policy, including Toolkit guidance External Website Policy, a tutorial External Website Policy, FAQs External Website Policy, and a search function External Website Policy.

For additional information about the TRR collections, please contact Dr. Kay Wanke, Deputy Director, TRSP/OD/NIH

Funding provided by U01 HG004597, 3U01 HG004597-02S1, and U41 HG007050.

FAQs – Clinical Studies Involving Electronic Cigarettes and INDs

An investigational new drug application (IND) may be required for the clinical study of e-cigarettes examining a potential therapeutic purpose (e.g., smoking cessation). Studies designed to investigate the therapeutic uses of any tobacco product, including e-cigarettes, cannot be funded through the NIH Tobacco Regulatory Science Program (TRSP), as these studies are outside the regulatory authorities of the FDA Center for Tobacco Products.

NIDA has published a series of Frequently Asked Questions (FAQs) about INDs for studies of electronic cigarettes (e-cigarettes) in humans not funded through NIH TRSP. This FAQ series helps investigators determine the need for submitting an IND to the FDA Center for Drug Evaluation and Research (CDER), and outlines steps to get the process started. Because the FDA CDER makes determinations about INDs on a case-by-case basis, investigators should discuss their study protocol with the FDA regarding any questions on whether the IND requirements apply to their planned clinical investigation. This document does not take the place of Institutional Review Board (IRB) requirements, FDA regulations, or NIH policies.

FAQs – Clinical Studies Involving Nicotine Research Cigarettes and ITPs

The National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP) has taken steps to provide a variety of nicotine research cigarettes (NRC) to research investigators. For more information see the Notice of Availability. In order for the NRC order to be deemed complete by the NIDA DSP Director, researchers need to complete a request to use an Investigational Tobacco Product (ITP) and submit it to the FDA Center for Tobacco Products (CTP) for review and assessment. For a description of the submission process and a point of contact, please see the NIDA website on the Nicotine Research Cigarettes Drug Supply Program. October 2016, FDA CTP released Investigational Use of Deemed, Finished Tobacco Products That Were on the U. S. Market on August 8, 2016, During the Deeming Compliance Periods.

CTP-Supported Tobacco Regulatory Research Projects Search Tool

In addition to the research that the Center for Tobacco Products (CTP) supports though the NIH, CTP also conducts its own research and supports research projects through partnerships with different governmental agencies such as the Centers for Disease Control and FDA's National Center for Toxicological Research. To learn more about CTP's full research portfolio, CTP has a research project search tool that provides access to information about the research projects in CTP's research portfolio. Currently, this tool includes active research projects funded by CTP's Office of Science in fiscal years 2010–2015. Subsequent updates to the tool will include projects funded in previous years, new projects, and projects funded by other CTP offices. This tool includes research-based projects only, and does not include those that support infrastructure purchases such as equipment.

Videos on Tobacco Regulatory Science

CTP Videos on Tobacco Regulatory Science in Action

Meet some of the people who are leading important tobacco regulatory research. In their own words, they share the work they are doing, and not only why it is so important to public health, but also to each of them personally.

These 10 videos in the series represent a cross section of the work under way around a variety of topics, including perceptions and misperceptions of tobacco products, use of tobacco products and preferences of tobacco users, and the behavioral and physiological effects of using various tobacco products.
*The opinions in these videos reflect the views of individual researchers, and not necessarily the official position of the FDA's Center for Tobacco Products nor the National Institutes of Health. These videos represent accurate information about the design of these CTP supported studies at the time the interviews were conducted (Spring 2014).

Tobacco Regulatory Science Research

"E-cigarettes: Back to the Future," Lecture by Stanton Glantz, University of California, San Francisco. National Institute of Dental and Craniofacial Research Clinical Research Fellowship Grand Rounds, March 15, 2015
Promoted as a safer alternative to conventional cigarettes, the use of e-cigarettes has grown rapidly. This growth in e-cigarette users—particularly among teens and young adults—raises the question of how to respond to the introduction of a new product when the possible health and behavioral effects have not been defined. Dr. Glantz's presentation reviews what is known about the health and behavioral effects of e-cigarettes and identifies important determinants of the long-term population health impacts of e-cigarettes.

Public Committees and Meetings

NIH TRSP Webinar: The FDA Docket and Public Comments

On June 20, 2014, the Tobacco Regulatory Science Program (TRSP) held a webinar for researchers on submitting comments to the FDA Docket. The webinar discussed the public comment/docket process and suggestions on submitting comments for public record on proposed FDA regulation. Allison Hoffman, Ph.D., Associate Director for Science Coordination and Communication, Center for Tobacco Products, FDA presented and answered questions.

In April 2014, the FDA published a proposed rule 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; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products. Publication of this proposed rule elicited questions from tobacco regulatory scientists about submitting comments to the docket—a process unfamiliar to many researchers. To help answer these questions, this webinar:

  • Explained what dockets are and how they are used
  • Walked participants through the process of submitting comments to a docket
  • Provided suggestions for ensuring that comments are effective and useful
  • Provided an opportunity for researchers to ask questions about the submission process.

More information about the proposed rule and resources can be found at the sites below:

In May 2016, FDA issued a final rule to deem products meeting the statutory definition of “tobacco product,” except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). More information about the final rule can be found on the FDA CTP website.

Frequently Asked Questions

Several webinar participants asked questions about submitting comments to dockets—here are some helpful links where interested persons can find more information about how to submit as well as answers to frequently asked questions: Comment on Proposed Regulations and Submit Petitions and Regulations.gov Frequently Asked Questions. If interested persons have further questions about the comment process they can contact FDA Dockets Management, (301) 827-6860. Hours are 9 a.m. to 4 p.m., Eastern time, Monday through Friday.

Tobacco Products Scientific Advisory Committee (TPSAC)

Tobacco Products Scientific Advisory Committee (TPSAC) advises the Commissioner or designee in discharging responsibilities as they relate to the regulation of tobacco products. The Committee reviews and evaluates safety, dependence, and health issues relating to tobacco products and provides appropriate advice, information and recommendations to the Commissioner of Food and Drugs.

Topics reviewed by TPSAC:
  • Menthol in Cigarettes
  • Dissolvable Tobacco Products
  • Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke

FDA Center for Tobacco Products Information

Statistics

TRSP and FDA Tobacco Products-Related Press Releases