NOTE: After reading the instructions below, please go here to submit your comment to the FDA. Comments posted to this blog DO NOT go to the FDA. This is NOT a petition!
On Thursday, May 8th, 2014, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations.
As noted in CASAA's Action plan, this is not a battle that is going to be won based solely on comments to the proposed regulations. Accordingly, we are attacking this on several different fronts. Before the draft regulations were published, we had envisioned a single Call to Action with several suggested actions. However, upon seeing the details, we decided the best strategy to effect positive change is to prepare a comprehensive Action Plan which consists of several Calls to Action issued at staggered dates to maximize effectiveness, and extending beyond comments to the FDA docket.
- On May 11, 2014, CASAA released the first of several Calls to Action anticipated in CASAA's Action Plan.
- On May 21st, 2014, CASAA released the second Call to Action.
- On June 13, 2014, CASAA released the third Call to Action.
- On July 17, 2014, CASAA released the first Call to Prepare.
- On July 23, 2014, CASAA released the second Call to Prepare.
This is the Fourth Call to Action in CASAA's Action Plan.
In the first Call to Prepare, you created a some comments that addressed several substantive points. In the second Call to Prepare you added more content. Instructions on assembling that content and filing your comment to the FDA are listed below. Please note, the current deadline for submitting your comments is August 8th, 2014.
These guidelines are written for people who have used e-cigarettes for tobacco harm reduction. Obviously, we encourage comments from other CASAA members or other consumers, but much of this (it is obvious which parts) will not apply, and you will need to write more in third-person than first-person.
FIRST, some final notes on what you have already prepared:
- Review the paragraphs you have created according the the first and second calls to prepare. Check for editing errors and make sure you’ve made your points respectfully.
- If you have not done the preparation from the calls to prepare, go back and do that. This call to action does not include suggestions about the substance of your comments. That was in the calls to prepare.
- Set up a header in either memo form (From: [Your Name], To: FDA Center for Tobacco Products, etc.) or in letter form (Dear FDA Center for Tobacco Products,), whichever you prefer to use. Include the date.
- Make sure to include in the header the following, “FDA, Docket No. FDA-2014-N-0189, Regulatory Information Number (RIN) 0910- AG38” It can be the “Re:” line in memo form or just stand alone in letter form.
- Make sure that you save a copy of your final word processor file because we will be issuing a CQ Roll Call campaign next week to enable you to share your comments with your state and federal legislators.
THIRD, assemble your content:
- You should have already prepared, as suggested by the calls to prepare, one or a few paragraphs on each of the following:
- Why you are the real stakeholder in this process
- Your personal story of using e-cigarettes
- The role of flavors in your e-cigarette use (optional)
- What you would do if the proposed restrictions were put in place
- [possible other content]
- A closing paragraph
- We suggest assembling them in that order (though, of course, if you wrote them such that they flow better in another order, feel free to rearrange). The “other content” refers to anything you might have decided to write about the science or other observations that do not fit in one of the other points (totally optional, as we noted, and potentially tricky to pull off).
- We request that you add somewhere in the first or final paragraph that you are a member of CASAA (assuming that is true; if not, join and then say it! -- it is free and numbers matter).
- If you have any particular expertise, credentials, or experience that may distinguish your comments from others, be sure to note that in the first few sentences of your document.
- If you followed the calls to prepare, you probably wrote the individual pieces in isolation, so they might not flow together naturally. After putting them together, consider adding transition sentences between them or headers or thesis statements (e.g., “Were it not for flavors, I would have probably kept smoking”) to aid in the transition. This may not be necessary. This is your comment in your own words, so you can decide if you like how it flows or if you want to change the flow.
- If your first paragraph is not a natural introduction as written, consider adding a sentence like “I am writing as a individual American citizen who quit smoking thanks to e-cigarettes and has been vaping for two and a half years.”
FOURTH, submit your comment:
INSTRUCTIONS ON HOW TO SUBMIT YOUR COMMENT
- You have already created a document containing your comment.
- Access the comment form for the deeming regulation (FDA-2014-N-0189): FDA Comment Form
- Click in the Comment field and type, “My comment is attached” or something to that effect. Immediately beneath the Comment box is a button labeled “Choose files” for uploading. Click on that box and select the document file containing your comment. (Regulations.gov accepts the most common word processor file types: .doc, .docx, .rtf, .txt, as well as .bmp, .xls, .pdf, .gif, .htm, .html, .jpg, .jpeg, .png, .ppt, .sgml, .tiff, .wpd, .xml, .xlsx, .pptx.)
- 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.”
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.) If you have uploaded your comment as a file, you will obviously not have the opportunity to edit it on the website during this stage.
- 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 number. If you uploaded your comment as an attachment, you should verify on the confirmation page that “success” appears in green letters to the right of the file name under “Uploaded File(s).”)
- Please send the comment number to email@example.com. (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.)
FIFTH, publicize the Call to Action anywhere there are vapers.
Note that there will be two versions of this. The present version is for people who understand what is going on and are willing to spend some time to be maximally effective. But we recognize that not all consumers are even aware of the FDA’s proposed regulations and how those regulations will impact them.
In an effort to reach as many consumers as possible, we will be issuing a streamlined Call to Action in the next day or two which will be designed for vendors to forward to customers. The streamlined Call to Action will facilitate comments from those consumers who might not otherwise know about the proposed regulations or are not willing to put in the effort described here. Of course, we encourage anyone who can to complete the version described here rather than using the streamlined version.