MWDFDAletter (1)By Dr. Richard Sauerheber, Ph. D. Chemistry – February 11, 2016 –
TO: Jeffrey Kightlinger and the Metropolitan Water District Board, Los Angeles, CA
Dear President Kightlinger and the MWD Board,
The many letters sent to you since 2007 on fluosilicic acid infusions MWD performs in public water supplies for the Los Angeles area basin have not been made clear. This letter serves to do that.
The U.S. Food and Drug Administration Criminal Investigations division is in the process of halting the sale of fluoride compounds intended for ingestion without a prescription. The FDA has also placed a written notice on details of the Federal laws being violated by those who supply fluoride compounds for ingestion without a prescription. These laws include provisions in the Food Drug and Cosmetic Act (henceforth, the Act).
The crux of the FDA criminal division action is that fluoride intended for ingestion requires not only 1) a prescription, but also 2) proper dosage instructions, and 3) proper public labeling. Laboratories that manufacture fluorides intended for ingestion are now being reprimanded for not labeling the materials “for prescription only” or “Rx only.” And no fluoride compound is permitted to be ingested by children under age 3. Also, the ONLY fluoride material that is allowed to be swallowed are fluoride mouth rinses specially formulated for use ONLY under the direct supervision of health professionals and are NOT to be provided to the general public.
MWD disseminates fluoride into public water supplies intended to be consumed by all ages of children, which is a violation of 21CFR 355.60. MWD disseminates fluoride into public water supplies intended to be consumed without prescriptions, which violates section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)]. MWD disseminates fluoride into public water without proper dosage instructions that must accompany prescriptions for any need, which violates Section 502(f)(l) of the Act [21 U.S.C. 352(f)(1)].
Fluoride for oral ingestion is not recognized as safe and effective under conditions of improper labeling. In light of its toxicity and potential for harmful effects with the method of use, they are not safe for use except under the supervision of a licensed practitioner. Because fluoridation is intended for consumers that are not amenable to self- diagnosis and treatment by those who are not medical practitioners themselves, adequate directions cannot be written so that a layman can use them safely.
The labeling of fluosilicic acid by MWD of this unapproved prescription drug product fails to bear adequate direction sfor intended use. This causes fluosilicic acid infused by MWD to be misbranded under section 503(b)(4)(A) of the Act [21 U.S.C. 353(b)(4)(A)]. .
The forced addition of any chemical substance, including fluoride, into public drinking water (not required to sanitize the water) is a Federal offense. It is absolutely necessary for MWD to halt fluosilicic acid dissemination for fluosilicic acid fluoride into public water supplies. In addition, the interstate commerce for this material from your supplier fails to bear the “Rx only” symbol, which violates section 301a of the Act 21USC 3331(a).
Please understand that the Governor of Michigan is expected to be terminated from public office due to the attempt to save money by supplying corrosive-laden water to the city that coursed through pure lead pipes as service lines.
Criminal charges are expected to be filed for some officials who have no protection from collection of personal assets. The U.S. Congress is now examining the mechanism by which corrosives leach lead from plumbing. The attached reference explains this, where chloramines plus silicic acid from fluosilicic acid, at levels widely used to “fluoridate” water supplies, cause lead leaching from lead salts in various plumbing fixtures including brass, in addition of course to lead piping such as are found in many older homes, not only in the Eastern U.S., but also in Los Angeles and North San Diego County that MWD serves.
For all other Federal violations that MWD is committing by infusing fluoride compounds into public water supplies, please consult the attached FDA letter.