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May 21, 2014

CASAA: Second Call to Action for FDA Proposed Regulations – Consumer Comment on Paperwork Reduction Act

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.

via CASAA: Second Call to Action for FDA Proposed Regulations – Consumer Comment on Paperwork Reduction Act.

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