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May 21, 2014
On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations. On May 11, 2014, CASAA released the first of several Calls to Action anticipated in CASAA's Action Plan. This is the second Call to Action in CASAA's Action Plan.There is an interim deadline for comments on the deeming regulation. Specifically, any comments on the Paperwork Reduction Act aspects of the proposed regulation are due on Tuesday, May 27, 2014. To a large extent, these are comments that merchants and manufacturers should be making rather than consumers, and we understand that the vendors are being mobilized to do it. However, we have determined that it would be useful for consumers to make one particular comment in response to that, as appears below.For those who do not know, the Paperwork Reduction Act is intended to force regulators to consider the costs of merely doing the paperwork and such needed to comply with a regulation (i.e., not the actual substantive requirements of the regulation). We believe that FDA has used completely inappropriate estimates for the paperwork costs of this regulation. In particular, they have estimated that there will be only 25 applications for premarket review of new tobacco products filed in connection with e-cigarette products. They have estimated very low numbers for the various other filings -- not as low as 25, but far fewer than there are merchants and products.We all know that these numbers are far below the number of actual e-cigarette products on the market, and we need comments that make that known. Basically FDA is either wrong about their estimates or are explicitly saying that all of the other products will be driven off the market. While consumers cannot effectively comment on the question of whether that is accurate, you can definitely make the point about what you would be losing and that perhaps their estimates are naïve.This Call to Action consists of three parts. The first part (Part I) is preparing a comment. Part II described how you make the comment (Part IIA contains instructions on how to comment to FDA and Part IIB contains instructions on how to comment to OMB/OIRA--both are necessary). Part III asks you to share this Call to Action with others.PART I. SUGGESTED LETTER COMMENTING ON PAPERWORK REDUCTION ACT ASPECTS OF PROPOSED REGULATIONS YOU SHOULD EDIT AS APPROPRIATEPlease count up the following and insert the numbers into the comment below (which, of course, you can edit in any way you want).
Part IIB - Email to OMB/OIRAThe next step is to take a copy of your letter and copy it into an email to firstname.lastname@example.org The subject line of the email should be: Comment on Paperwork Reduction Act in Connection with FDA Proposed Regulations Deeming Tobacco Products.Please ensure that the title of your letter from Part I remains in the body of your email:Re: The Food and Drug Administration Deems 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 Restricting the Sale and Distribution of Tobacco Products and Required Warnings for Tobacco Product Packages and Advertisements.Part III.Let Others Know About this Call to Action, Including Vendors You PatronizeOur understanding is that industry organizations such as SFATA will be issuing guidance to their members regarding commenting on the Paperwork Reduction Act, which may include suggesting that members of industry request an extension of time to comment. Given that the timeframe on this is so short (deadline for comment on Tuesday, May 27, 2014), we're asking our members to let their vendors know about this issue and suggest that they seek guidance from industry leaders.X
*Reposted from the CASAA Website
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