Document ID: FDA-2014-N-0189-41540
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2014-07-10T04:00Z

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

General Comment:The American E-Liquid Manufacturing Standards Association (AEMSA) appreciates the opportunity to respond to the Food and Drug Administration’s (FDA or the Agency) request for comments on the proposed rule for “Deeming Tobacco Products to Be Subject to the Federal Food, Drug and Cosmetic Act,” Docket No. FDA- 2014-N-0189.  We are in the process of preparing our detailed comments in response to FDA’s numerous requests in the proposed rule, but are very concerned that we will not be able to adequately respond to those requests in the 75-day comment period (i.e., by July 9, 2014).  There are over 40 separate requests for comments in the proposed rule that AEMSA is considering responding to on behalf of the refillable e-liquid industry, many of which require obtaining, summarizing and providing supporting scientific research and other evidence.  The 75-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to many of the questions raised in the proposed rule.  Accordingly, we respectfully urge the Agency extend the current comment period by, at the very least, an additional 105-days (so that comments would be due by October 22, 2014), to provide ample time for stakeholders to provide constructive and valuable feedback on the issues raised in the proposed rule.  We do not believe that such an extension would significantly delay any potential regulatory action on these important issues, and can only aid in providing FDA with the information that it needs to regulate the growing refillable e-liquid industry in a responsible manner. 
 
If you have any questions or concerns, please do not hesitate to contact us.  We thank FDA for the opportunity to provide our views on the proposed rule.
 
Sincerely,

Lou Ritter
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Lou Ritter 
AEMSA President
Email: LRitter@AEMSA.org
Web Site: AEMSA.org
(928) 282-5588 (PDT)