Document ID: FDA-2014-N-0189-6685
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:Re: Request for Extension of Comment Period: Docket No. FDA-2014-N-0189

I am the owner and sole proprietor of E llusion.   E llusion is a small electronic cigarette retailer employing only myself.  I manufacture electronic cigarette liquid, which I sell retail locally, along with electronic cigarette hardware that I purchase elsewhere.  

I have initially reviewed the proposed regulations and respectfully request that the 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.”

I feel as though the initial 75-day comment period does not provide enough time for companies like mine to effectively consider the entire proposal and provide relative comments on the numerous questions posed by the agency.  Frankly, I need more time to address this 240-page document whose contents will deal a devastating economic blow to my business.

The preamble to the proposed rule lists approximately 70 topics and issues the
FDA has requested comments on.  Many of these issues are multipart, difficult to understand and relate to an diverse array of products; the time period that the FDA took to propose these regulations is evidence itself that the issues in this proposal are challenging, to say the least.  The FDA cannot reasonably expect any interested party, especially a retailer, to conduct a proper review and analysis of these issues and provide detailed  comments within the 75-day period allotted.

Therefore, E llusion again respectfully requests that FDA extend the comment period
to a full six (6) months.  Doing so will help to ensure that the final rule is based on an adequate administrative record. 

Thank you in advance for your consideration of this request.

Sincerely,

  E llusion

Laurie J. Elgin

Owner/Operator