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Richard Sauerheber, Ph.D.
(B.A. Biology, Ph.D. Chemistry, University of California, San Diego, La Jolla, CA)
Palomar College, 1140 W. Mission Rd.
San Marcos, CA 92069

November 21, 2001

 

U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Rockville, MD 20857

Dear Reviewers,

This brief letter provides additional information, not forwarded earlier, in support of FDA petition 2007P-0346.

The FDA has been indirectly involved in water fluoridation for many years, by virtue of its regulation of the prescription fluoride drug Luride, and requirements regarding its labeling.

The FDA analyzed water fluoride conditions thoroughly with regards to use of the prescription drug Luride, and included their findings in labeling and dosage instructions required for this prescription drug. The Physician’s Desk Reference, America’s first and only compendium of official FDA-approved prescription drug labeling, lists Luride (sodium fluoride) as a still-legal prescription drug. The specific dosage instructions, carefully analyzed, approved and required by the FDA, include the following statement:

Fluoride oral supplements are contra-indicated when drinking water is above 0.7 ppm fluoride. (Physician’s Desk Reference, p. 838, 48th edition, Medical Economics Data Production Company, Montvale, NJ, 1994).

In spite of recommendations issued January, 2011 from the U.S. Health and Human Services not to exceed 0.7 ppm, San Diego city water is mostly treated to 0.8 ppm fluoride and Los Angeles public water is titrated to 1.0 ppm of the free fluoride ion. Water districts which inject synthetic fluoride compounds for human ingestion are in violation of FDA regulations, by either

1)       dispensing a non-FDA approved drug (fluosilicic acid), or

2)       in some cities dispensing an FDA-approved prescription drug (sodium fluoride) without a prescription, and

3)       by not providing necessary FDA dosage information to consumers (i.e. as listed in the PDR above). FDA existing dosage instructions are being ignored.

Fluosilicic acid is not an FDA approved drug by either prescription or over the counter and is not listed in the PDR. Its dispensation for oral ingestion is a violation of the FD&C Act that requires, that any substance used as a drug to treat disease requires a new drug application and FDA approval.

We are asking for a ban on fluosilicic acid in public water supplies. However, even before the FDA issues such a ban it should issue an advisory statement such as the following:

The FDA advises those who which to consume fluoride orally to visit their physicians, consult with them regarding the proper dosage, the duration of dosage, and the appropriateness of consuming it in the form of Luride, a drug which the FDA has approved, although only with a physician’s prescription.

Likewise, the FDA should issue the following advisory to water districts which fluoridate drinking water:

Water districts which fluoridate should advise physicians not to prescribe Luride to those who live within the boundaries of their water district.

If you require the CFR regulations again that specifically apply to the violations listed above, I will be most happy to forward them.

Sincerely,

Richard Sauerheber, Ph.D.