Please Submit Your Comments to this FDA Petition Concerning Fluoride

August 5, 2015 Action Alerts, Featured, Fluoridation

Secure Arkansas wants to call your attention to this Citizen Petition regarding fluoride which was submitted to the FDA by an attorney in Olympia, Washington. Please read the information below and act quickly! The Comment Period will close around August 27, 2015 and the FDA should respond to the Petition about four months from now.

– – – – –

It is time to convince the Food and Drug Administration (FDA) to regulate fluoridated waters and chemicals as drugs. On June 1, 2015, ten organizations, including Food and Water Watch and Fluoride Action Network, joined together to submit a Petition to FDA requesting adoption of a regulation that would make these waters and chemicals both drugs regulated by FDA to ensure that they are safe and effective. We have until August 27, 2015 to submit comments and attachments in support of this regulation. Please help. The rest of this email gives step by step directions to submit comments. Please forward this email to appropriate others. The Petition was assigned docket number FDA-2015-P-1977 and FDA is accepting your comments in support of the Petition. To read the Petition, left click on this hyperlink: http://www.regulations.gov/ and into the Search box enter “FDA-2015-P-1977” and then left click the SEARCH button once. You will get a page similar to the one pasted below:

When you get this page, left click on any of the “Open Docket Folder” links that will be on the right side of your page. You will get a page similar to this:

2120019926_pic-of-after-click-open-docket-folder-for-FDA-2015-P-1977.jpg

Note that Petition content is summarized by FDA in red at the top of this page and states that the Petition:

Requests that the FDA issue a regulation in 21 CFR Part 250 (or in another appropriate Part) stating that fluoridation chemical additives and fluoridated drinking waters are drugs pursuant to section 201(g)(1) of the FDCA when the intended use is to aid in the prevention, mitigation, and/or prophylactic treatment of dental caries disease (tooth decay, cavities).

You can submit a comment (and attachments just based on the FDA Summary above, or you can read or skim the 10-page Citizen Petition [signed by] Gerald Steel on behalf of ten organizations by left-clicking once on “Citizen Petition from Gerald Steel.” On the next page that opens, left click on the pdf symbol. On Windows 7, you will likely get a box on the bottom of the page asking if you want to “Open” or “Save” the file. Left-click “Open.” The pdf of the Petition will then be on your screen for you to read. On Windows 7, you can left click the file button in the upper left corner and choose to print or save this document.

[Short cut: CLICK HERE to read the 10-page Petition.]

When you are ready to comment, start with the page similar to the page pasted in above and you left click once on the box that says “Comment Now!” and a page similar to the page pasted below will open:

125449819_pic-of-after-click-Comment-Now-FDA-2015-P-1977.jpg

I think the best way to submit a comment is to put what you want to say or submit in Word or PDF file(s) and then type in a very short comment (text only) that is descriptive of your Word or PDF file(s). Then you can attach your Word or PDF file(s) to your short text comment. You can type your comment in support of this proposed regulation into the “Comment” box or you can paste a text-only comment into the “Comment” box (with a maximum of 5000 total characters (but just a couple of lines is best)). You have to put something into the “Comment” box even if it is only a description of your attachments. When other people access this docket, they will see what you put in the “Comment” box, they will be able to read any attachments, and you will only be identified by your country, state or province, and your “category” which I will explain below.

If you want to submit a letter or other documents as attachments, left click on the “Choose files” box under the words “Upload file(s)” just under the “Comment” box. You can then browse on your computer for your files. Your attachments must be in Word or in pdf files. You can attach multiple files of mixed Word and pdf types but the maximum size of all attached files in one Comment Submittal is 10 MB. You can submit multiple Comment Submittals but you have to start over from the beginning for each one. You can type in your First and Last names or, if you don’t, your comment will filed under “Anonymous.” You can click either, neither or both boxes below the first and last name boxes. If you left click in the box for “I want to provide my contact information” a box will open up for you to give your state or province, country, zip code, and email address (whichever apply). If you leave the box for “I am submitting on behalf of a third party” checked, then fill in the requested information, or otherwise uncheck the box. Finally, on this page you must select a category for the person or organization making the comment. Popular are “individual consumer” or “other organizations.” Then left click the “Continue” box on the lower right corner and a new page will open for you to preview your Comment Submittal.

To make edits, click the “Back” button (upper left corner) or the “Edit” box (lower right corner) to return to the previous page. Make the edits, and again click the “Continue” box. When you are satisfied with your Comment Submittal, check the box on the lower center part of the page next to the words, “I read and understand the statement above.” Then in the lower right corner, click the “Submit Comments” box. A page should open with a Receipt saying, “Your comment was submitted successfully.”

I recommend that you print this Receipt because it has your comment tracking number or better, if you gave your email address, you can click the box “Email Receipt” and you will get even better information in an email.

Back on the page that is similar to the second pasted-in page image above, you see a category “Supporting Documents” (which shows up at the bottom of the second pasted-in page image above). To get there again, you can click on the words near the top of the Receipt that say, “Open Docket Folder.” The “Supporting Documents” section allows you to view all of the attachments to the Petition. But these attachments are not in the order submitted. So I have submitted a Comment that states: “Copy of June 1, 2015 ‘Citizen Petition from Gerald Steel’ with all attachments in a single pdf document.” If you want to view the 15 Petition attachments, I recommend that you click “View all” in the “Comments” section that is below the “Supporting Documents” section. Scroll down the “Comments” until you find the comment described above.

I have submitted a second Comment that states: “January 6, 2015 email to Secretary Burwell and Administrator McCarthy from Gerald Steel plus the two attachments to that email.” Attached to this Comment is a copy of the said January 6, 2015 email and its attachments. This January 6, 2015 email asks the Secretary and Administrator to reach a joint position on federal fluoridation jurisdiction. The email was sent on behalf of 35 organizations, 68 professionals, and 153 influential concerned citizens. There has been no substantive response to this January 6, 2015 email.

I have submitted a third Comment that states: “Detailed instructions on how to submit Comments on this Petition” which is a copy of the first draft of the document you are now reading. I thank you, in advance, for commenting and getting the word out to people who will submit comments on this extraordinarily important rule-making Petition. If there is any assistance I can provide please let me know. The Comment Period will close about August 27, 2015 and the FDA should respond to the Petition about four months from now.

Gerald Steel

[Olympia, WA]

– – – – –