DTPA availability. FDA Citizen's Petition to bring DTPA back on the market in the USA. Imperative that all GDD sufferers and practitioners write a letter of support Citizen Petition FDA-2026-P-9677
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Currently DTPA is not on the market in the USA. Yes, defies reason, it is available everywhere else in the world but not in the USA. I have filed a petition: Citizen Petition FDA-2026-P-9677.
DTPA is the best chelator to treat Gd, Lead, Cadmium, and Inorganic mercury toxicity.
It is imp;eritive that all patients with GDD and all practitioners who see them, write a letter of support for this petition.
am writing to ask for your support of a Citizen Petition that I recently submitted to the U.S. Food and Drug Administration concerning access to DTPA in the United States.
The FDA has now formally assigned the petition the following docket number:
FDA-2026-P-9677
If you support the petition, I would greatly appreciate your submitting a brief letter or comment to the FDA. Your submission will become part of the official public record for this Citizen Petition.
Unfortunately, the FDA/Regulations.gov submission process is not particularly intuitive, so I have provided step-by-step instructions below.
How to submit a supporting comment
1. Go to Regulations.gov.
Open the Regulations.gov website.
2. Search for the docket number exactly as follows:
FDA-2026-P-9677
Enter this number into the search box and select Search.
3. Open the docket for FDA-2026-P-9677.
The docket should display the Citizen Petition and the associated documents.
4. Select the “Documents” tab if necessary.
Locate the Citizen Petition or document associated with this docket that has an active Comment button.
5. Select “Comment.”
Although the website calls the submission a “comment,” this is the correct mechanism for submitting a letter of support to an already established FDA docket.
6. In the comment box, write a short statement supporting the petition.
You may write your own statement or use wording similar to the following:
I am writing in support of Citizen Petition FDA-2026-P-9677. I support efforts to ensure reliable availability and access to DTPA in the United States. DTPA is an established chelating agent with important applications in the removal of certain retained metals, and continued access to an FDA-authorized product is important for physicians and patients for whom this treatment may be medically appropriate. I respectfully request that the FDA give careful and timely consideration to the actions requested in this Citizen Petition.
Please feel free to modify this wording and, preferably, add a sentence or two explaining your own professional, scientific, clinical, or personal reason for supporting the petition.
7. You may also attach a separate signed letter.
If you prefer, prepare a short letter on your professional or organizational letterhead and upload it as an attachment.
Even if you attach a letter, please place at least a short statement in the online comment box, such as:
“I support Citizen Petition FDA-2026-P-9677. Please see my attached letter of support.”
This is important because FDA advises that supporting attachments should not be submitted with an entirely blank comment field.
8. Enter your identifying information.
Where appropriate, include your:
Name
Professional degree or title
Institution or organization
City and state
Email/contact information requested by the system
If you are submitting on behalf of an organization, identify the organization.
Please remember that comments submitted to an FDA docket generally become publicly viewable, so do not include confidential patient information or other information you do not want made public.
9. Review the submission carefully.
Before submitting, verify that the docket number shown is:
FDA-2026-P-9677
10. Request the email confirmation.
Regulations.gov provides an option to receive an email confirmation. I strongly recommend selecting this option.
11. Select “Submit Comment.”
After submission, Regulations.gov should provide a tracking number. Please save that number and the confirmation email for your records.
If possible, I would also appreciate your forwarding the confirmation to me so I know that your support has been entered into the docket.
There is no need for the supporting letter to be lengthy. A concise, thoughtful statement explaining why you believe continued access to DTPA is medically, scientifically, or publicly important is more valuable than a lengthy generic letter.
Thank you very much for taking the time to support this effort.
Richard C. Semelka, MD3901 Jones Ferry RdChapel Hill, NC 27516richardsemelka@gmail.com919-602-8792
It is somewhat complicated to negotiate the site so below are the steps:
Patient letter:
The current FDA instructions confirm the operative sequence: enter the docket ID at Regulations.gov, open Documents, select the live Comment button, complete the form, opt into the email confirmation containing the tracking number, and submit. FDA also warns that electronic comments and attachments generally become publicly viewable, so the privacy warning is important, particularly for patients.
Patient support letter:
Re: Support for Citizen Petition FDA-2026-P-9677
To the U.S. Food and Drug Administration:
I am writing in support of Citizen Petition FDA-2026-P-9677, concerning access to DTPA in the United States.
As a patient, I believe that patients and their physicians should have reliable access to medically important treatments when a physician determines that those treatments are appropriate.
The availability of DTPA is important because there are circumstances in which physicians may need a pharmaceutical-grade chelating agent to help remove retained metals from the body. Patients should not face unnecessary difficulty obtaining an established medical product simply because the product is unavailable or difficult to obtain in the United States.
For patients dealing with serious or persistent health problems, lack of access to a potentially appropriate treatment can be extremely consequential. Treatment decisions should ultimately be made between a patient and a knowledgeable physician based upon the individual circumstances, available scientific evidence, potential benefits, and potential risks.
I therefore respectfully ask the FDA to carefully review Citizen Petition FDA-2026-P-9677 and to take appropriate action to help ensure reliable access to DTPA in the United States.
Thank you for considering the concerns of patients affected by this issue.
Sincerely,
[Name][City, State]
[Optional: One or two sentences describing your personal experience and why access to DTPA matters to you. Do not include any medical or identifying information that you do not want to become public.]
Treating practitioner/ Physician support letter
Re: Support for Citizen Petition FDA-2026-P-9677
To the U.S. Food and Drug Administration:
I am writing in support of Citizen Petition FDA-2026-P-9677, concerning reliable availability of DTPA in the United States.
I am a [physician/scientist/pharmacist/researcher] with experience in [specialty or relevant area]. I believe that continued access to DTPA is important for clinical medicine and toxicology.
DTPA is an established chelating ligand with strong metal-binding properties and recognized applications in decorporation therapy. Its clinical value depends not only upon its underlying coordination chemistry but also upon the availability of appropriately manufactured pharmaceutical-grade preparations for situations in which treatment is medically indicated.
Reliable access to such an agent is particularly important because chelation is fundamentally different from nonspecific supportive treatment: when the relevant metal is chemically accessible and an appropriate chelator is available, the toxicant itself may be bound and facilitated toward elimination.
From a clinical and public-health standpoint, interruption or loss of access to an established pharmaceutical chelating agent can leave physicians with few or no equivalent alternatives for selected patients. Maintaining a dependable U.S. supply is therefore important for both routine preparedness and uncommon clinical circumstances in which DTPA may be required.
I respectfully request that the FDA carefully and expeditiously consider the issues and requested actions presented in Citizen Petition FDA-2026-P-9677 and take appropriate measures to help ensure reliable availability of DTPA in the United States.
Thank you for considering this comment.
Sincerely,
[Name, degrees][Professional title][Institution or organization, if applicable][City, State]
Richard Semelka, MD
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