Document ID: FDA-2014-N-0189-8161
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-18T04:00Z

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

General Comment:
5/21/2014
 
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, Vapetec, LLC t/a Evaporate 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, Evaporate, are a small electronic cigarette retailer employing fewer than 350 people. We are a family owned brick and mortar store dealing in high quality electronic cigarettes, personal vaporizers, and e-liquids. We are consumers of these products , as well as a vendor, and strongly believe in the benefits they provide to us and many others. We have spent numerous hours attempting to address the proposed rule. As explained further below, the initial 75-day comment period does not provide enough time for small businesses like Evaporate to adequately analyze the entire proposal and provide substantive comments on the many questions posed by the agency. We desperately need more time to properly address this 240-page document whose contents will undoubtedly deal a devastating economic blow to our business and ultimately, our livelihood. 
 
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, Evaporate 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. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame. I also realize that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.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, 

Christopher Cook
Owner