Document ID: FDA-2014-N-0189-43193
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-14T04:00Z

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

General Comment:Blac Label Electronic Cigarettes
1412 Broadway
7th Floor
New York, NY 10018

July 2, 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 BLAC LABEL ELECTRONIC CIGARETTES 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, BLAC LABEL ELECTRONIC CIGARETTES, are small electronic cigarette manufacturer, employing fewer than 350 people. Based in NYC Blac Label is a newly launched line of electronic cigarettes, cigars, hookahs and vaporizers. Through extensive and costly research and development, we have developed a full line of products. Our collective mission is simple; to provide classic flavors with a smooth draw and a timeless taste while offering the most realistic experience our customers love. These sensational flavors cater to everyone from the seasoned smoker to occasional vapers. We proudly offer both nicotine and zero nicotine solutions. We translate our passion by focusing our attention to the smallest of details; from our patented, sleek and slim spring loaded disposable pack to our unique soft tip solutions we offer in our disposable, rechargeable and vaporizer product lines. As explained further below, the initial 75-day comment period does not provide enough time for companies like BLAC LABEL ELECTRONIC CIGARETTES 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, BLAC LABEL ELECTRONIC CIGARETTES 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,
Harry Tawil
President & CEO
Blac Label LLC.