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THE FDA & SARGENTI PASTE
BACK
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 WHAT IS THE ROLE OF THE FDA?
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 and drug manufacturers. They generally can 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 food and drug sales that are sold interstate (between states) and internationally. The state pharmacy boards are responsible for enforcement of laws regarding drug sales that occur intra-state. |
WHAT IS THE FDA'S POSITION ON SARGENTI PASTE?
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 yeild some state actions. The SOS is actively working with the FDA to readdress the violation of federal law by this pharmacy.
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*NEW*
FDA Correspondences with the American Endodontic Society
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. |
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.
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| *NEW* 1975 Regulatory Letter sent to an unknown pharmacy about breaking the law by selling RC2B. 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. |
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| Warning letter to Glenn S. Balas, RPh, July 12, 1991 for illegal sale of Sargenti Paste compound across state lines. |
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| FDA Commissioner, Dr. David Kessler letter to the American Association of Endodontists (AAE), 1991 |
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| FDA Commissioner, Dr. David Kessler letter to CDER Director, Carl Peck, 1991. |
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| FDA CDER (Drug) Head, Carl Peck to the American Association of Endodontists (AAE), 1991. |
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| FDA Rejects Approval of Sargenti N2 New Drug Application, February 12, 1993. (begins approximately page 12) |
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| Consumer Representative at the 1993 FDA Meeting (above) expresses concern on behalf of the public, |
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| N2 Universal: A Case Study of an NDA, Lisa Barr, Food and Drug Law, January 27, 1994 |
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| FDA Enforcement Report (search on toxavit) documents recall of another highly toxic paraformaldehyde dental paste, Toxavit. August 1995 |
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| Unapproved dental drug goes up in smoke. FDA Consumer 30(10): 29-31, 1996. FDA confiscastes and disposes of a Sargenti Paste formulation after repeated attempts to stop the activity. |
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BACK
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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.