FDA Extends

Public Comment Deadline The comment period for submission of written comments in response to FDAâ€™s Electronic Cigarettes and the Public Health Workshop (Public Docket No. FDA-2014-N-1936) was extended to July 2, 2015.



This means that vapor business owners and interested parties still have an opportunity to submit comments in an effort to assist the FDA in understanding the role that e-cigs and vapor products play.



Below are the questions to which the industry can best provide answers. Many of you have conducted customer surveys or compiled data on your customer base that can be of great use. If you do not have the data to answer a question fully, go on to the next one. When answering the questions, be sure to note that your answers are based on data you have gathered from your customers.



Remember to identify comments with the docket number found in brackets at the beginning of this document. Please note: Comments submitted to the docket will not be added to other dockets, such as the docket for the proposed rule deeming additional tobacco products subject to the FD&C Act.



Interested persons may submit either electronic comment at www.regulations.gov. For electronic comments FDA will post the body of your comment on regulations.gov along with your state/province and country (if provided), the name of your representative (if any), and the category identifying you (e.g., individual, consumer, academic, industry).



Written comments can be mailed to:

Division of Dockets Management (HFA-305),

Food and Drug Administration,

5630 Fishers Lane, Rm. 1061,

Rockville, MD 20852.



Only one set of comments is necessary if you are mailing them. For written submissions submitted to the Division of Dockets Management, FDA will post the body of your comments on regulations.gov, but you can put your name and/or contact information on a separate cover sheet and not in the body of your comments.



Prevalence and Patterns of Use What proportion of e-cigarette users are current tobacco users, including cigarette smokers?

What proportion of e-cigarette users are former tobacco users, including cigarette smokers?

What proportion of e-cigarette users are never tobacco users, including never cigarette smokers? What are the reasons individuals try e-cigarettes? What types of e-cigarette devices are being used (e.g., â€œcigalikeâ€ devices vs. â€œtankâ€ systems) and by whom? How do patterns of use differ among users of different device types?

What is the volume of e-cigarette retail sales by type of sales route, including online sales, specialty retail (â€œvapeâ€) shops, and traditional outlets?

What are the product attributes of products sold via these routes?

What proportion of sales is accounted for by products using tobacco flavors, menthol or other flavors?

What types of non-tobacco or menthol flavors are most frequently sold?

Does the use of products with tobacco flavors, menthol or other flavors differ by age group (specifically for youth and young adults versus older adults) and tobacco use history? Impacts on the Use of Current Tobacco Products How does e-cigarette use affect use of other tobacco products among current tobacco product users, including current cigarette smokers?

Do cigarette smokers who initiate e-cigarette use eventually reduce or completely quit cigarette use?

What proportion of cigarette smokers who use e-cigarettes and who quit smoking continue to use e-cigarettes after quitting (and for how long)?

Is there evidence of changes in cigarette smoking frequency among dual e-cigarette and cigarette users?

What product features make an e-cigarette more or less appealing to current tobacco users, including cigarette smokers who want to quit?

How do flavors affect the appeal and use of e-cigarettes among current tobacco users, including current cigarette smokers?

What role do flavors in e-cigarettes have on experimentation and trajectory to established e-cigarette use among current tobacco users, including current cigarette smokers?

Does the presence of flavors have an impact on dual use of e-cigarettes and cigarettes?

Does the presence of flavors have an impact on complete switching from cigarettes to e-cigarettes? Attitudes, Beliefs, and Product Perceptions What beliefs and perceptions do e-cigarette users and non-users have about the risks of e-cigarettes compared to the risks of other tobacco products (both combustible and noncombustible), NRT, and cessation? How do beliefs and perceptions vary across subgroups by age and by e-cigarette and other tobacco use?

What effect, if any, do e-cigarette use and marketing have on social norms related to conventional cigarette smoking?

What beliefs and perceptions do e-cigarette users have about e-liquid contents, nicotine amount/concentration, and flavorings?

How are e-liquid ingredients, HPHCs, and nicotine levels communicated to consumers?

How does information communicated to consumers via e-cigarette and e-liquid product labels, labeling, and marketing (including advertising) influence attitudes, beliefs, product perceptions, and behaviors? Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at regulations.gov .



As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on regulations.gov . This is determined by information indicating that the submission is written by an individual, for example, the comment is identified with the category â€œIndividual Consumerâ€ under the field titled â€œCategory (Required),â€ on the â€œYour Informationâ€ page on regulations.gov . For this docket, however, FDA will not be following this general practice. Instead, FDA will post on regulations.gov comments to this docket that have been submitted by individuals in their individual capacity. If you wish to submit any information under a claim of confidentiality, please refer to 21 CFR 10.20.



Please note that your name, contact information, and other information identifying you will be posted on regulations.gov if you include that information in the body of your comments.