Document ID: FDA-2014-N-0189-7202
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-06-17T04:00Z

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

General Comment:
15 May 2014

Dockets Management Branch (HFA-305) 
Food and Drug Administration 
5630 Fishers Lane 
Room 1061 
Rockville, MD 20852 

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

The Utah Vapers Association 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.” 

The Utah Vapers Association is a volunteer run consumer advocacy and trade association employing fewer than 350 people. We represent 42 retail and liquid manufacturing small businesses in the state of Utah who individually employ 10 or less employees each.  

As explained further below, the initial 75-day comment period does not provide enough time for our organisation 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 the businesses we represent and to the wider Utah economy.

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. The 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, the Utah Vapers Association 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, 
Aaron Frazier, Director