Kelsey John Helland - Comment

Document ID: FDA-2012-N-1032-0004
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: February 24 2013, at 12:00 AM Eastern Standard Time
Date Posted: April 12 2013, at 12:00 AM Eastern Standard Time
Comment Start Date: January 29 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: April 1 2013, at 11:59 PM Eastern Standard Time
Tracking Number: 1jx-83v9-4nhr
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Current safety warnings on tobacco vaporization products may impede public understanding of the risks associated with vaporization as compared to other tobacco use. While vaporization shares many of the same health risks as tobacco use generally, it may be less carcinogenic and less addictive than smoking or chewing. (See Letter from B.J. Westenberger to Michael Levy, Supervisor Regulatory Counsel, Center for Drug Evaluation and Research, May 4, 2009, available at http://www.fda.gov/downloads/drugs/Scienceresearch/UCM173250.pdf; Mitch Earleywine and Sara Smucker Barnwell, Decreased Respiratory Symptoms in Cannabis Users Who Vaporize, 4 Harm Reduction J. 11 (2007), available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1853086/.) More importantly, some users perceive vaporization to be less carcinogenic than smoking. Users may conclude that tobacco health warnings do not apply to vaporization products. If consumers disregard the warnings they are more likely to use the product. Safety warnings could address this problem in at least two ways. First, warnings on vaporization products could specifically mention that they apply to vaporization; even if they have the same content as other tobacco product warnings, at least they would directly remedy the perception that they don’t apply. Second, the content of vaporization product warnings could be updated to convey the relative risk of vaporization as compared to smoking and other smokeless uses. This may establish greater trust in the warnings, but if the content suggests that vaporization is the safer use, it may also send the signal that vaporization is “safe,” and result in increased use. Consumers should be able to make informed choices about their tobacco use. If vaporization is safer than smoking, but still not completely safe, users should be able to understand that from the warnings. Those that insist on using tobacco could then choose a safer method, while others will avoid using tobacco altogether.

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Kelsey John Helland Comment Westenberger Letter

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