A 1975 FDA Regulatory Letter

The below 1975 FDA regulatory letter sent to an unknown pharmacy provides yet more documentation that the FDA status on Sargenti Paste has not changed in decades.  The FDA certifies this position in a 2008 letter that can be found at this link.  The FDA currently seems to only enforces their laws if the violator advertises their product on the internet.  Apparently, based upon their regulatory history, if the company gives the patient information about the product they are selling, it is wrong.  If they are like the Sargenti operation and do it behind the patient's back, it appears to be ok.  Does that make sense to you?

Thirty three (33) years later, the FDA knows that pharmacies and dentists are still -

(1) manufacturing a NEW drug/device, NOT a modified version of an existing approved drug/device. A pharmacy exemption does not apply
(2) using heavy metals such as lead and mercury
(3) selling Sargenti Paste without single patient prescriptions
(4) selling and/or using Sargenti Paste for patients without medical justification
(4) selling Sargenti Paste across state lines in bulk quantities
(5) manufacturing Sargenti Paste from chemicals bought across state lines

Rarely, the FDA investigates dentists, that is left to the state dental boards, where in the case of Sargenti Paste, have done nothing to protect the patient but look the other way until a patient shows up with damages likely already permanent. The state dental boards do nothing while they point to the FDA for regulatory guidance as did Ohio in 1991.  The Ohio Dental Board reports that they received no such guidance some 19 years later.   Apparently this topic has fallen through the cracks at the FDA.HY IS NOTHING BEING DONE?

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