CASAA 2nd Call to Action for consumers regarding FDA vaping / ecig regulations
Please read below and click here to let your voice be heard!
WEDNESDAY, MAY 21, 2014
UPDATE 5/27/14: Part IIB of this Call to Action has been updated to ask that you use a DIFFERENT SUBJECT LINE in your email to OMB/OIRA. If you have already submitted your email to OMB/OIRA, we are suggesting that in an over abundance of caution, you resend the email with the new subject line (see below Part IIB).
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.
NOTE: FDA has traditionally taken the position that "Individual Consumer" comments will not be published on the Regulations.gov website due to privacy concerns. There has been some criticism of this position, and FDA has indicated that it will be publishing "Individual Consumer" comments on the website, although it intends to only publish the individual's first name. Any identifying information you provide in the Comment field will potentially be visible on the website, so we recommend that you NOT include your name, address, phone number, or email address in the Comment field.
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.
Let Others Know About this Call to Action, Including Vendors You Patronize
Posted by Julie Woessner at 10:22 AM