# Smokeless Tobacco Reference Product Development, Distribution and Research

> **NIH FDA UC2** · UNIVERSITY OF KENTUCKY · 2020 · $599,723

## Abstract

Project Summary/Abstract: Since 1968 the University of Kentucky has provided reference
tobacco products (including the most recent 1R6F reference cigarette) as standards for non-clinical
investigational purposes by tobacco manufacturers, contract and government laboratories, and
academic institutions. The University of Kentucky, Center for Tobacco Reference Products
(CTRP) is committed to supply certified standards for tobacco product research and to work with
the FDA to develop new certified reference products as necessary. This project will produce and
characterize smokeless tobacco reference products representative of loose leaf chewing tobacco,
moist snuff, and pouched snus. These new certified reference products will be manufactured in
one manufacturing run each, to ensure product uniformity, and will have certified physical and
chemical characteristics to allow for proficiency testing, instrument calibration, employee/student
training, and for method validation and investigational purposes. A process for the design,
analysis, and approval is included to ensure input from stakeholders and that the new reference
smokeless tobacco products meet the specified goals. Quality control and sample testing
parameters are defined and substantial chemical analyses will be conducted to allow for
certification of product characteristics and constituent levels.
The CTRP will advance efforts to collaborate and coordinate studies with stakeholders, including
Tobacco Centers for Regulatory Science, commercial product testing laboratories, tobacco product
manufacturers, and academic researchers. This proposal outlines significant improvements to
current smokeless tobacco reference products in terms of product design and certification, product
distribution, product storage, planning for new reference tobacco products, establishing research
capability and providing new services that will benefit the tobacco research community. A web-
based interface for ordering reference tobacco products and for the secure transmission and
storage of collaborative data is under development and will be enhanced to include the smokeless
reference products. As an academic institution our proposal to coordinate and administer inter-
laboratory comparison studies on tobacco reference products and mechanisms to provide various
tobacco reference products as a service to the entire tobacco research community is an
improvement over current programs. The development of high-quality smokeless tobacco
reference products and providing those through the CTRP will strengthen the FDAs effort to
develop the science of tobacco regulation and provide a necessary resource for tobacco product
research and regulation.

## Key facts

- **NIH application ID:** 9870792
- **Project number:** 5UC2FD005671-05
- **Recipient organization:** UNIVERSITY OF KENTUCKY
- **Principal Investigator:** Orlando Chambers
- **Activity code:** UC2 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $599,723
- **Award type:** 5
- **Project period:** 2016-03-01 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9870792

## Citation

> US National Institutes of Health, RePORTER application 9870792, Smokeless Tobacco Reference Product Development, Distribution and Research (5UC2FD005671-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9870792. Licensed CC0.

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