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Use of Investigational Tobacco Products Guidance for Industry and Investigators DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments regarding this draft
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01
Obtain the investigational tobacco from a reliable source.
02
Read and understand the instructions provided with the investigational tobacco.
03
Open the investigational tobacco package carefully.
04
Take out a small amount of investigational tobacco and place it in a designated container.
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Prepare the smoking apparatus following the guidelines specified in the instructions.
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Ignite the investigational tobacco using a match or lighter.
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Inhale the smoke produced by the investigational tobacco.
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Observe and document any physical or sensory effects experienced.
09
Dispose of the remaining investigational tobacco and clean the smoking apparatus.
10
Store any unused investigational tobacco in a cool and dry place for future use.

Who needs use of investigational tobacco?

01
Individuals who are conducting scientific research on tobacco and its effects.
02
Researchers who are studying the health benefits or risks associated with tobacco use.
03
Companies or organizations involved in the development of new tobacco products.
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Regulatory agencies that require evidence-based data on tobacco for policy-making.
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Medical professionals who are studying the potential therapeutic uses of tobacco.
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The use of investigational tobacco is for research purposes to study the effects of tobacco products on human health.
Anyone conducting research involving investigational tobacco products is required to file the use of investigational tobacco.
The use of investigational tobacco can be filled out by submitting a completed form to the appropriate regulatory body.
The purpose of the use of investigational tobacco is to ensure the safety and compliance of tobacco products being studied.
Information such as the name of the investigator, study objectives, participant eligibility criteria, and details of the investigational tobacco product must be reported.
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