CSD170201: A Study to Evaluate the Exposure to Tobacco Constituents From Two Moist Snuff Products

This will be an unblinded, single-center, randomized, two-way crossover study, conducted in
generally healthy, adult moist snuff users who will be randomly assigned to the order in
which they will use two moist snuff study products (comparator product, test product).
Enrolled subjects will use one of each of the study products exclusively for approximately
one week (seven days +1/-2 day) prior to a test visit, with a different product used each
week over a two-week period. During each test visit, subjects will use study product ad
libitum during a 6-hour period. Expectoration will be collected from the subjects during each
product use. The used study product will be collected after use. Blood samples will be
collected at each test visit, prior to study product use, for determination of plasma
cotinine levels.

Inclusion Criteria:

1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) written
in English;

2. Generally healthy males and females, 21 years of age or older, at Screening-Enrollment
Visit;

3. Self-reports currently using at least two cans of moist snuff per week;

4. Self-reports that moist snuff is the only tobacco- or nicotine-containing product used
within 30 days of the Screening-Enrollment Visit;

5. Usual brand (UB) of moist snuff is one of the products specified in the protocol;

6. Used their UB product for ≥ 3 months;

7. Subject is not delaying a decision to quit using moist snuff to participate in the
study;

8. Agrees to exclusively use the study products and not use any other tobacco- or
nicotine-containing products during the course of the study;

9. Able to safely perform the required study procedures, as determined by the
Investigator.

Exclusion Criteria:

1. Self-reported history of heart disease, kidney disease, diabetes, liver disease,
uncontrolled hypertension, or uncontrolled hypercholesterolemia;

2. At risk for heart disease, i.e., obesity (body mass index [BMI] > 43 kg/m2), as
determined by the Investigator;

3. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception,
or hormone replacement therapy;

4. Use of any medication or substance that aids in smoking cessation, including but not
limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge,
patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract
within 30 days prior to the Screening-Enrollment Visit;

5. Females who are pregnant or breastfeeding, or plan to become pregnant during the
course of the study;

6. Participation in another clinical study within 30 days prior to the
Screening-Enrollment Visit. (The 30-day window for each subject will be derived from
the date of the last study event in the previous study to the Screening-Enrollment
Visit of the current study);

7. Determined by the Investigator to be ineligible for the study.