

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

General Comment:E Vapormaker LLC
1030 SE 9th Ave. #150669
Cape Coral, FL 33990
239-558-8787
 
 
5/12/14
 
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, E Vapormaker 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, E Vapormaker LLC, are a small electronic cigarette distributor, employing fewer than 350 people.  We are a B2B wholesaler and have 9  products in our line of vaporizers and e liquid.  As explained further below, the initial 75-day comment period does not provide enough time for companies like E Vapormaker LLC 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, E Vapormaker LLC,  again respectfully requests that FDA extend the comment period to 180 days as 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,
 
 
Sarah Bernardo
V.P. E Vapormaker LLC
 
