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CASAA First Call to Action for Consumers regarding FDA Vaping / ECig Regulations

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Please read below or go to the CASAA webpage link here to let your voice be heard!

First Call to Action for FDA Proposed Regulations - Consumer Request for an Extension of Comment Period

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On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations. This is the first of several Calls to Action anticipated in CASAA's Action Plan. (You will recall from the Action Plan that we are not going to publish our suggestions for substantive comments until a few weeks before the deadline, and we urge consumers to wait until then to offer substantive comment.)

FDA, which took more than three years to issue its 241-page Proposed Regulation (and accompanying 81-page regulatory impact analysis), has given us a mere 75 days to comment. While responding in that timeframe is challenging under any circumstances, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is grossly inadequate.

The First Call to Action is for CONSUMERS to request a 105-day extension of the comment period, requesting a total of 180 days to make comments. We understand that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers.

We have prepared a suggested letter--which we encourage you to edit to accurately reflect your views and circumstances--along with instructions on how to request the extension. (Please note that submitting this request will not prevent you from later offering a substantive comment, and should not affect your subsequent comment in any way.)

FDA Comment Form

  • Click in the Comment field and copy and paste your comment from Step 1 into the box.
  • Click in the First Name field and type your first name.
  • Click in the Last Name field and type your last name.
  • If you wish to allow FDA to contact you, click to check the "I want to provide my contact information" box. Otherwise, leave this box unchecked. When you check this box, fields are displayed for you to enter your ZIP code and email address.
  • Click to uncheck the box, "I am submitting on behalf of a third party."
  • Click the arrow next to the "Category" field to display a menu.
  • Select a category from the menu. We recommend "Individual Consumer" for individuals wishing to request an extension personally and not on behalf of any business or group.

    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.
  • Click the Continue button. After clicking on the Continue button, you will have an opportunity to review your statement and, if you wish, edit it. (The Edit button is just to the right of the Submit Comment button in the lower right-hand side of the page.)
  • On the Your Preview page, click to check the box "I read and understand the statement above."
  • Click the Submit Comment button.
  • After submitting your comment using the comment form, a confirmation page will appear with your Comment Tracking Number. We recommend that you print the page AND email this comment number as directed in Step 14 below. (You may wish to copy the entire page into an email to yourself, which you can then forward as directed in Step 14 below. Copying the entire page and emailing it to yourself will ensure that you have a copy of your comment and comment number.)
  • Please send the comment number to casaa.fdacommentarchive@gmail.com. It is important that CASAA have a count of how many such requests have been made. (You may, if you wish, include a copy of your comment, but that is not necessary because all we really need is the comment number.)
  • Posted by Julie Woessner at 1:46 PM

    Labels: CTA, CTA FDA Regulations, FDA, FDA regulation