Second Call to Action for FDA Proposed Regulations - Consumer Comment on Paperwork Reduction Act
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).
We realize that most of your estimates will be quite rough. You should just use phrasing like “over 100” or “about 30” and not worry about getting the count exactly right.Be sure to include the title line, which is required for the OIRA filing (see below).
- Number of different e-cigarette liquids you have purchased in the last year, counting each flavor variation, each strength, and each PG/VG mix as a different liquid. (So if you used both bubblegum and cherry flavors, and used them each in 1.8% and 2.4% strength, that would be 4).
- Number of different pieces of hardware you purchased in the last year, adding up each different model of battery, tank, atomizer, wick, etc.
- If you purchased disposables or prefilled cartridges that include both hardware and liquid, count up each different model/variety you purchased (again, counting each variation in flavor and strength separately). If you did not purchase these, just delete the sentence that refers to them.
- Estimate how many different products your favorite vendor or vendors sell. Again if you cannot do this or do not wish to, please just delete the relevant sentence.
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.I am writing to comment as an individual consumer on the Paperwork Reduction Act aspects of the proposed regulation. I expect to file a separate comment on other aspects of the proposed regulation later. The Paperwork Reduction Act aspects of the proposed regulation indicate that FDA expects there will be a very small number of applications for e-cigarette products. Speaking from my own experience, this would probably include only a fraction of the products that I use and that are important for me avoiding returning to smoking. I have used [FILL IN] different varieties of e-cigarette liquid over the last year. I have used [FILL IN] different pieces of e-cigarette hardware. In addition, I have used [FILL IN] different products that combine liquid and hardware. I would estimate that my favorite vendor sells [FILL IN] different products.Either FDA's estimates for the number of filings under the Paperwork Reduction Act are a huge underestimate, or FDA is admitting that the paperwork burden will drive most of these products off of the market. If it is the latter, the burden of the paperwork would fall not just on the merchants, but on myself and other consumers. [INSERT A BRIEF PERSONAL NOTE HERE. SOME SUGGESTED LANGUAGE TO USE (BUT ONLY USE IT IF IT DESCRIBES YOU ACCURATELY, OF COURSE – OTHERWISE CHANGE IT:
I was able to quit smoking and not return to it because of the variety of products available. If I had been limited to just a few products, I would have probably returned to smoking. PART II.INSTRUCTIONS ON HOW TO MAKE THE COMMENT
We are asking you to BOTH (1) submit a comment (Part IIA below) and then ALSO (2) email a copy of that comment to OMB/OIRA (Part IIB below). It is important that you take BOTH STEPS.Part IIA - Comment to FDA
- Create a document with your comment. You can use the above sample letter as a template and edit to make it your own. (KEEP A COPY OF THIS DOCUMENT BECAUSE YOU'LL NEED IT FOR PART IIB BELOW.)
- Access the comment form for the deeming regulation (FDA-2014-N-0189-0001): 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. (You may wish to copy the entire page into an email to yourself.)
Part IIB - Email to OMB/OIRAThe next step is to take a copy of your letter and copy it into an email to email@example.com 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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