Sargenti Opposition Society

Sargenti Opposition Society
WHAT YOUR DENTIST MAY NOT TELL YOU
but you need to know before your next root canal

Injured patients should file an adverse event report with the FDA. Absent reports from the public, the FDA will not realize the extent of the dangers of Sargent Paste. Click here to file report. Also ask your doctor to file a report on your behalf. Since reports are voluntary over 90% of adverse events go unreported.

THE FDA & SARGENTI PASTE "When you have a choice to make and don't make it, that is in itself a choice." -- William James

WHAT IS THE ROLE OF THE FDA?	WHAT IS THE FDA'S POSITION ON SARGENTI PASTE?
To understand the relationship between the FDA and Sargenti Paste, you have to know the true role of the FDA. The FDA has enforcement power over food. drug and medical device makers. They generally can not or will not allow or disallow a dentist to use an unapproved drug. They do not take action against a dentist for using an unapproved drug. That is left to the State Dental Board. The FDA's enforcement jurisdiction is only for products sold interstate (between state lines) and internationally. The state pharmacy boards are responsible for enforcement of laws regarding drug sales that occur intra-state.	*NEW* On September 24, 2009, NBC 10 Philadelphia reporter LuAnne Cahn reported being told by the FDA, "The public cannot be assured this product is safe and effective". As late as the mid-1990s, the FDA was using their enforcement authority to stop Sargenti Paste and similar product manufacturing and sale. The FDA recently certified (2007) that their status of Sargenti Paste has not changed and is still unapproved. So why are they allowing small compounding pharmacies to manufacture and sell in bulk quantities across state lines with ingredients (chemicals) that were bought across state lines; and all without single patient prescriptions? That is our question. These behaviors do not meet the criteria for an FDA "pharmacy exception" which pushes regulation down to the State Pharmacy and Dental Board level. Also, because Sargenti Paste is a completely new formulation and not a minor change to an already approved drug/device, it should never be granted a pharmacy exemption under FDA laws. To the FDA, a pharmacy exemption is nothing more than a jurisdiction issue. A pharmacy exception does not mean FDA approval for use. The Dr. David Kessler letter listed in the first column in the table below is often misinterpreted as an approval to use Sargenti Paste. It is not. It simply states that if you sell less than 5 grams of the non-heavy metal version (without lead and mercury) in interstate commerce, the FDA will defer to the regulations of the state pharmacy and dental boards. Anything over the 5 grams or with heavy metals, falls into FDA jurisdiction. The heavy metal formulation was sold across state lines to the Alabama dentists who treated one of the founders of the Sargenti Opposition Society. A report of this pharmacy yielded no federal action against the pharmacy but did yield some state actions. The SOS is actively working with the FDA to readdress the violation of federal law by this pharmacy.
*NEW* Read FDA Correspondences with the American Endodontic Society
Although originally thought this documentation was indicating that Sargenti Paste was likely proceeding with the FDA's 510K process for devices, we have been told by the FDA that Sargenti Paste falls under the Center for Drug Evaluation. This means they are required to go through stringent testing, including acknowledgement and effects of failure cases. We have also been told that there are no medical drugs or devices, approved or cleared by the FDAwhich have formaldehyde as its active ingredient, as Sargent and permanently sealed within the tooth. We believe that the AES, in support of N2 Products FDA activities, are attempting to test the new formulation that contains the liquid formaldehyde and, on xray, looks more like gutta percha when dried.. Since they refuse to accept failures and, as in the 1993 attempt, may likely exclude those cases completely, they will never be granted NDA approval or even clearance should they actually be following CDRH's 510K process. This material is too toxic to nearby tissues for it to be approved. There are safer alternatives used for decades by ethical law abiding dentists.
FDA DOCUMENTATION FOUND REGARDING ACTIVITIES WITH SARGENTI PASTE
The table below contains documentation that we have obtained from the FDA on Sargenti Paste. These documents demonstrate the FDA's failure to protect the public from the perils of this dangerous material. They are aware that it is being sold against regulations, yet, they continue to do nothing about it. The SOS is contacting our legislatures to get action on this issue. The FDA is funded by taxpayer's dollars to protect our safety. Somehow, Sargenti Paste has falled off of their radar screen. As we know there are many FDA documents missing, we would appreciate information that any one has. We will not divulge our sources and the information can be mailed without any identification of the sender. Please mail to: Lorrie Hellier 101 Cotton Row, Huntsville, AL 35806, or email to info@sargentipaste.org. We greatly appreciate any help that our dental community can provide.

THE FDA THEN WHEN THEY ATTEMPTED TO ENFORCE THE LAWS (BUT DIDN'T FOLLOW THROUGH)	THE FDA NOW WHEN THEY DON'T ENFORCE THE LAWS. WHY? THE PUBLIC DESERVES BETTER THAN THIS
NEW 1975 Regulatory Letter sent to an unknown pharmacy about for breaking the law by selling RC2B interstate and in bulk. This letter further states the FDA position that a pharmacy can not manufacture Sargenti formulations if chemicals are bought across state lines (another violation of FDA laws)	NEW FDA certifies no change in their position since 1991 Commissioner Dr. Kesser's letter
FDA Letter to Senator Howard Metzenbaum, 1990	FDA investigates Long Beach, California pharmacy selling to an Alabama dentist office against FDA regulations. Turns investigation over to CA Pharmacy Board who took no action related to interstate sale. Did take action against pharmacy violations. Where is the enforcement of the FDA laws?
NEW 1991 Ohio State Dental Board request to FDA Commissioner David Kessler asking for guidance to state regulatory boards (dental and pharmacy). Where is that guidance 17 years later? Our regulatory boards need it. The public deserves it.	In September 2009, the FDA told NBC 10 Philadelphia reporter, Lu Ann Cahn, the following regarding the status of Sargenti Paste. "The public cannot be assured this product is safe and effective". *NEW*
Warning letter to Glenn S. Balas, RPh, July 12, 1991 for illegal sale of Sargenti Paste compound across state lines.
FDA Commissioner, Dr. David Kessler letter to AAE, 1991.
FDA CDER (Drug) Head, Carl Peck to the American Association of Endodontists (AAE), 1991.
FDA Rejects Approval of Sargenti N2 New Drug Application (full transcript), February 12, 1993. (begins approximately page 12). Click here for summary of the transcript published in "The Pink Sheet".
Consumer Representative at the 1993 FDA Meeting (above) expresses concern on behalf of the public.
N2 Universal: A Case Study of an NDA, Lisa Barr, Food and Drug Law, January 27, 1994.
FDA Enforcement Report (search on toxavit) documents recall of another highly toxic paraformaldehyde dental paste, Toxavit. August 1995
Unapproved dental drug goes up in smoke. FDA Consumer 30(10): 29-31, 1996. FDA confiscastes and disposes of a similar formaldehyde based formulation after repeated attempts to stop the sale of it. The FDA is aware that other pharmacies are manufacturing and selling equivalent formulations after 1996 but regulatory enforcement is absent.

It is the policy of the Sargenti Opposition Society to post only the most current and verified information obtained from credible sources. If you have documentation that conflicts with any information on our site or demonstrates a violation of any type, please contact us and we will correct our site as necessary.