FDA's Center for Tobacco Products State Department of Health Electronic Cigarette Adverse Event Survey

Generic FDA Rapid Response Surveys

State Health Officer final 3pm

FDA's Center for Tobacco Products State Department of Health Electronic Cigarette Adverse Event Survey

OMB: 0910-0500

Document [doc]
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February xx, 2012


Name of State Health Officer

Address

Address



Dear Dr. xxxxx


The U.S. Food and Drug Administration (FDA) has received adverse events reports with respect to electronic cigarettes. These adverse event reports may raise concerns about the safety of these products. Accordingly, FDA is reaching out to the state health officers in every state to ask if you have had any adverse event reports, or other complaints, submitted to your office regarding these products.


As background, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the FDA with authority to regulate “tobacco products.” Although the statute places certain “tobacco products” (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) immediately under FDA’s regulatory authority, the law also permits FDA, by regulation, to extend those authorities to other categories of “tobacco products.”


If you have received an adverse event report or other complaints with respect to electronic cigarettes, we would greatly appreciate it if you could share that information with FDA. Please send your response to the following address by April 30, 2012:


Center for Tobacco Products

Food and Drug Administration

Attn: Document Control Center – State Request on Electronic Cigarettes

9200 Corporate Boulevard

Rockville, Maryland 20850


Thank you for your consideration of this request. Please contact Idara Udoh, Regulatory Health Project Manager, by email at [email protected] and at (301)796-3074 if you have questions.



Many thanks for helping FDA to address this public health matter.


Sincerely,




David Ashley, Ph.D.




Paperwork Reduction Act Statement


An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is OMB No. 0910-0500, which expires June 30, 2014.



File Typeapplication/msword
File TitleFebruary 23, 2012
AuthorCorinne.Husten
Last Modified ByColburn, Christopher
File Modified2012-02-28
File Created2012-02-28

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