Document ID: FDA-2014-N-0189-42480
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-11T04:00Z

Comment Info: =================

General Comment:05/14/2014
 
Dockets Management Branch (HFA-305) 
Food and Drug Administration 
5630 Fishers Lane 
Room 1061 
Rockville, MD 20852 
 
Re: Request for Extension of Comment Period: Docket No. FDA-2014-N-0189 
 
We Pure Cigs, LLC have conducted preliminary review of your lengthy proposed 
regulations and respectfully request that the Food and Drug Administration (FDA) extend the 
comment period for the proposed rule entitled “Deeming Tobacco Products to be Subject to the 
Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and 
Required Warning Statements for Tobacco Products.” 
 
We, Pure Cigs, LLC, are small electronic cigarette retailer, 
employing fewer than 350 people. Founded in Q4 2009 after tremendous success as consumers
of the product ourselves, Pure Cigs strives to provide adult tobacco consumers with 
high quality and effective electronic cigarette hardware and e-liquid.
As explained further below, the initial 75-day comment period does not provide 
enough time for companies like Pure Cigs to adequately analyze the entire proposal and 
provide substantive comments on the many questions posed by the agency. We need more time 
to address this 240-page document whose contents will deal a devastating economic blow to our 
business. 
 
The preamble to the proposed rule identifies approximately 70 topics and issues the 
agency has requested comments on. Many of these issues are complex and difficult and relate to 
an extremely diverse array of products. Clearly, the lengthy time period that the Agency 
required to propose these regulations is evidence that the issues addressed in the proposal are 
multi-faceted and challenging. FDA cannot expect any interested party, and in particular, any 
manufacturer, to conduct a meaningful review and analysis of these issues and provide detailed 
and thoughtful comment in a 75-day period. 
 
Therefore, Pure Cigs again respectfully requests that FDA extend the comment period 
by 105 days and agree to accept comments filed to the docket on or before October 22, 2014. 
This will help ensure that the final rule is based on an adequate and meaningful administrative 
record. Thank you in advance for your consideration of this request. 
 
Sincerely, 
 
Mark Nowak
President
Pure Cigs, LLC - Melbourne, FL