Fluoride Complaint – Fluoride is a regulated, unapproved drug

COMPLAINT

Abstract:

Fluoride is added to the public water supply by an unelected board (the OWASA board).  OWASA physically adds fluoride to the water in order to increase the level of this chemical.

After having requested numerous times to find out what form of fluoride is added to the water, they have remained silent.

Fluoride is a prescription drug. For instance, some of the forms of fluoride are listed under the following drug names ReNaF, and Ludent. These all have National Drug Code Numbers (from here on referred to as NDC #s).

There are plenty of reasons not to add fluoride to the public water supply. I will discuss many of them in detail during the body of this complaint. There are many technical, legal, scientific, and medical reasons why this chemical should not be added to public water supplies, and I will be outlining as many of them as possible in detail. However, what I ask the court to consider the most is whether or not it is ethical for a drug (a medicine) to be added to the public water supply and whether or not this violates the fundamental rights and freedoms of people. This current practice is especially concerning when there are many citizens who object to water fluoridation and do not consent to consume this drug. I am then left to conclude, as I hope you will, that the practice of water fluoridation is an extreme prejudice acting against those who do not want to consume the drug fluoride, because the water utility cannot be reasonably be avoided in restaurants, public places, and the environment of the town in general. Adding fluoride to the water is also the practice of medicine as defined under the laws of the State of North Carolina.

OWASA is violating both the spirit and the letter of numerous NC General Statutes by their distribution of fluoride into the public water supply.

  1. Addition of fluoride to the public water supply is in violation of North Carolina G.S. § 90-18.  Practicing without license; penalties. § 90-1.1

The following definitions from the N.C. General Statutes will be helpful to anyone attempting to ascertain the validity of my argument that addition of fluoride to the public water supply is a violation of several general statues including, but not limited to the one listed immediately above.

§ 106 – 145.2. Definition

(9) Prescription drug.

A human drug required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to 21 U.S.C. § 353 (b). Only for the purposes of the provisions of this Article, the term “prescription drug” shall include pseudoephedrine products as defined in G.S. 90.

First of all, Fluoride is a prescription drug. A quick search in the Food and Drug Administration’s website for  the National Drug Code Number 51862-171-10 will yield a result indicating clearly that this is the corresponding drug code number to fluoride and it has a categorized Product Type Name: HUMAN PRESCRIPTION DRUG (Exhibit A). Furthermore, this specific National Drug Code Number applies a brand name ReNaF fluoride tablets.  These two documents (the search result for the a drug code number of fluoride and the label of ReNaF fluoride tablets) are attached as exhibits A and B respectively.

As one can see clearly on the label of this prescription drug, the active ingredient is the fluoride ion. A finer point would be that both the prescription drug label and search of the FDA database for fluoride provide evidence that fluoride is intimately connected with the delivery of the fluoride ion (electrically charged particle). For further reference, “North Carolina General Statutes § 90-89.1 Treatment of controlled substance analogues” indicates that a drug by any other name or configuration is still that very same drug.

Furthermore, a drug is well defined:

North Carolina Controlled Substances Act Article 5

  1.      “Drug” means a. substances recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; b. substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; c. substances (other than food) intended to affect the structure or any function of the body of man or other animals; and d. substances intended for use as a component of any article specified in a, b, or c of this subdivision; but does not include devices or their components, parts, or accessories.

Fluoride is defined by the FDA as a “human prescription drug” as evidenced by Exhibit A. Fluoride is also classified under FDA marketing category as “Market Category Name : UNAPPROVED DRUG OTHER.” To better understand what this means, I looked up the following from the WWW.FDA.GOV website. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213030.htm

“What are unapproved drugs and why are they on the market?

The original Federal Food and Drugs Act of 1906 brought drug regulation under federal law. That Act prohibited the sale of adulterated or misbranded drugs, but did not require that drugs be approved by FDA. In 1938, Congress required that new drugs be approved for safety.  In 1962, Congress amended the 1938 law to require manufacturers to show that their drug products were effective, as well as safe. As a result, all drugs approved between 1938 and 1962 had to be reviewed again for effectiveness.  To be consistent with current regulations and to ensure that all drugs have been shown to be safe and effective, all new drugs are required to have an approved application for continued marketing.

Many healthcare providers are unaware of the unapproved status of drugs and have continued to unknowingly prescribe them because the drugs’ labels do not disclose that they lack FDA approval.   In addition, since many unapproved drugs are marketed without brand names and have been available for many years, it is often assumed that these unapproved drugs are generic drugs.  This is not correct. Generic drugs have been evaluated and approved by FDA to demonstrate bioequivalence to a brand name reference drug.  Healthcare professionals and consumers can be assured that FDA-approved generic drug products have met the same quality, strength, purity and stability as brand name drugs. Additionally, the generic manufacturing, packaging, and testing sites must meet the same quality standards as those of brand name drugs. Unapproved drug products have not been evaluated and approved by FDA. Unapproved drugs are not generic medications, and neither their safety nor their efficacy can be assured.”

OWASA (Orange Water and Sewer Authority) has several notable and relevant attributes related to this case:

  1. They are not an elected board.
  2. They add fluoride to the municipal water supply.
  3. They have been made aware that fluoride is a prescription drug and continue to add it to the water supply.

As of 2012, OWASA’s Water Quality Report Card http://owasa.org/client_resources/whatwedo/drinking%20water/02-owasa%20water%20quality%20report-2012_8-pager_r7_web.pdf  (Exhibit C), one can see how fluoride is added in the amount of .66 PPM, which is the same thing as .66 mg per liter of water. One ppm is equivalent to 1 milligram of something per liter of water (mg/L).

Fluoride as a prescription drug comes in the following doses: .25 mg, .5 mg, 1.0 mg (Please refer to Exhibits B, D, E). This means that if a citizen of the town drinks one liter of municipal tap water, he is getting more than twice the amount of fluoride legally considered to be a drug. As stated earlier, fluoride is not approved by the Food and Drug Administration (FDA). ReNaF discontinued being marketed in 2010, but Ludent is still marketed to this day.

Here is some basic information about both of these drugs, both of which are administered by prescription only:

ReNaf Fluoride Chewable Tablets 1.0 mg are round, pink, cherry flavored tablets in a 120-count bottle, NDC# 68032-384-12 and a 1000-count bottle, NDC# 68032-384-00.

ReNaf Fluoride Chewable Tablets 0.5 mg are round, white, grape flavored tablets in a 120-count bottle, NDC# 68032-383-12 and a 1000-count bottle, NDC# 68032-383-00.

ReNaf Fluoride Chewable Tablets 0.25 mg are round, cream colored, vanilla-flavored tablets in a 120-count bottle, NDC# 68032-382-12.

LUDENT: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e7a7e17-7538-4763-810c-7e56bd630494

Each tablet contains 0.25 mg Fluoride from 0.55 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed “SCI” on one side and 1006 on the other. NDC 44946-1015-2 (60 count) , NDC 44946-1015-3 (120 count), NDC 44946-1015-6 (30 count blister).

Each tablet contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed “SCI” on one side and 1007 on the other. NDC 44946-1016-7 (7 count sample size), NDC 44946-1016-2 (60 count), NDC 44946-1016-3 (120 count), NDC 44946-1016-6 (30 count blister).

Each tablet contains 1.0 mg Fluoride from 2.2 mg Sodium Fluoride. White to off-white, orange flavor, round-shaped chewable tablet. Debossed “SCI” on one side and 1004 on the other. NDC 44946-1017-2 (60 count) , NDC 44946-1017-3 (120 count), NDC 44946-1017-6 (30 count blister).

OWASA admittedly puts fluoride in the water to promote better dental health.  This is an excerpt from their website:

“Fluoridation of drinking water

In accord with recommendations of the American Dental Association, US Centers for Disease Control and Prevention and other public health-related organizations, OWASA adds fluoride to drinking water to help prevent tooth decay. The  level of fluoride in our water is about 0.7 of one part per million. (One part per million is like a penny is $10,000.)”

Source: http://owasa.org/drinking-water/#treatment

Furthermore, they have dedicated an entire webpage to explaining why they are putting fluoride in the water. http://owasa.org/fluoride-v3

OWASA does not have a medical license. Who has the authority to dispense prescription drugs in the state of North Carolina?

N.C. G.S. § 90-1.1. (5) c.  Definitions. indicates that practicing medicine includes:

Offering or undertaking to prevent or diagnose, correct, prescribe for, administer to, or treat in any manner or by any means, methods, or devices any disease, illness, pain, wound, fracture, infirmity, defect, or abnormal physical or mental condition of any individual, including the management of pregnancy or parturition.”

It is patently clear that OWASA is attempting to practice medicine without a license to do so and/or the consent of each person to whom they dispense fluoride, because they say that they want to prevent or mitigate tooth decay by administering a drug to the whole population. They are not elected. Furthermore, I’d argue it’s well known that doctors prescribe drugs to individual patients. It has been demonstrated that fluoride is a human prescription drug and a prescription only drug. Corporations typically do not issue prescriptions, doctors do. I do not give my consent to be medicated or drugged with fluoride. I therefore have the right to not be discriminated against by being denied regular access to non-fluoridated water (water that has had fluoride added to it). I have the right to not consume this drug when I drink water from the faucet like everybody else.

What is a prescription label? How must a prescription drug be dispensed?

§ 90-85.29.  Prescription label.

The spirit and letter of GS 90-85.29 indicates that a prescription drug must be dispensed with a label:

“The prescription label of every drug product dispensed shall contain the brand name of any drug product dispensed, or in the absence of a brand name, the established name.  The prescription drug label of every drug product dispensed shall:

(1)        Contain the discard date when dispensed in a container other than the manufacturer’s original container.  The discard date shall be the earlier of one year from the date dispensed or the manufacturer’s expiration date, whichever is earlier, and

(2)        Not obscure the expiration date and storage statement when the product is dispensed in the manufacturer’s original container.

As used in this section, “expiration date” means the expiration date printed on the original manufacturer’s container, and “discard date” means the date after which the drug product dispensed in a container other than the original manufacturer’s container shall not be used.  Nothing in this section shall impose liability on the dispensing pharmacist or the prescriber for damages related to or caused by a drug product that loses its effectiveness prior to the expiration or disposal date displayed by the pharmacist or prescriber. (1979, c. 1017, s. 1; 1981 (Reg. Sess., 1982), c. 1188, s. 3; 1993, c. 529, s. 7.5.)”

Furthermore, see: § 90-85.28.  Selection by pharmacists permissible; prescriber may permit or prohibit selection; price limit on selected drugs. There, you will see how there are even further standards by which drugs are supposed to be dispensed by a pharmacist.

OWASA is not a pharmacist or a pharmacy. Under § 90-85.3. Definitions.

(a) “Administer” means the direct application of a drug to the body of a patient by injection, inhalation, ingestion or other means. OWASA is administering drugs without a license to do so. Patently, OWASA is violating the law and an injunction on the practice of adding fluoride to the water needs to be ordered in order for the law to be upheld.

I urge the reader of this complaint to research and contemplate the vast number number of ways in which the spirit and letter of the law is being violated by the addition of fluoride to the public water supply.

Of particular import is Ҥ 90-85.3A. Practice of pharmacy.

(a) A pharmacist is responsible for interpreting and evaluating drug orders, including prescription orders; compounding, dispensing, and labeling prescription drugs and devices; properly and safely storing drugs and devices; maintaining proper records; and controlling pharmacy goods and services.” OWASA is not a pharmacist. OWASA does not have a license, which is defined as, “‘License’ means a license to practice pharmacy including a renewal license issued by the Board.”

§ 90-85.21B. Unlawful practice of pharmacy.

It shall be unlawful for any person, firm, or corporation not licensed or registered under the provisions of this Article to:

. (1)  Use in a trade name, sign, letter, or advertisement any term, including “drug”, “pharmacy”, “prescription drugs”, “prescription”, “Rx”, or “apothecary”, that would imply that the person, firm, or corporation is licensed or registered to practice pharmacy in this State.

. (2)  Hold himself or herself out to others as a person, firm, or corporation licensed or registered to practice pharmacy in this State. (2003-284, s. 10.8D.)

The relevant statement here is that OWASA is implying that they are authorized to dispense drugs (medication) through the public water supply. By dispensing drugs through the public water supply (yes, they are dispensing the drug, fluoride), OWASA is “holding itself out to others as a corporation that is licensed to practice pharmacy.” I will again note, and please see attached labels and exhibits (A, B and C) that fluoride is a prescription only drug. Although OWASA does not state that they are a pharmacy, by acting to practice medicine without a license and dispensing drugs openly, this is the only conclusion one might come to if you were to assume they are not violating the law. The vast majority of residents to not have a prescription for fluoride, and many do not consent to drinking fluoride. I do not consent to it. This is  a form of discrimination.

http://www.ncga.state.nc.us/EnactedLegislation/Statutes/HTML/BySection/Chapter_90/GS_90-85.29.html

Not only is OWASA adding a prescription only drug to the water supply, they are adding an unapproved drug in the manner of WHOLESALE DISTRIBUTION without the consent of the people to whom they are distributing the drug. They are doing so without a license to do so or the consent of citizens who are forced to spend non-trivial money and time to obtain sources of water without fluoride (a drug and medication) in them. This complaint argues that this is wrong, unethical and illegal.

Within all of the laws that regulate drugs, pharmacists and the licensing of those who are allowed to prescribe, dispense and distribute drugs is the idea that you have to be prescribed a drug and be licensed in some way to distribute drugs. This is the spirit of these laws, and their lettering indicates that prescription only drugs may not be distributed without prescriptions, and that people distributing drugs have to label the drugs they distribute, be licensed, and adhere to the rules and regulations regarding the distribution of drugs. See § 90-85.21.  Pharmacy permit.

Firstly, OWASA is administering a drug (medicine) to everyone without discretion on an individual basis. As demonstrated earlier within this complaint, the administering of a prescription only drug (fluoride) constitutes Offering or undertaking to prevent or diagnose, correct, prescribe for, administer to, or treat in any manner or by any means, methods, or devices any disease, illness, pain, wound, fracture, infirmity, defect, or abnormal physical or mental condition of any individual, including the management of pregnancy or parturition,” and in order to do this, OWASA must have a medical license. Numerous other citizens and I, within the county and town, do not consent to OWASA’s unlicensed or licensed medical administering of drugs through the public water supply (see fluoride exhibits A, B, and C).

Furthermore, OWASA is operating without a wholesale distribution license for the fluoride that they distribute to non-consenting citizens (see legal definitions of distribution and license if necessary).

Please review § 106-145.1. Purpose and interpretation of Article 12A.
Wholesale Prescription Drug Distributors for definitions and reference to the validity of the following argument:

  It has been shown that OWASA is indiscriminately putting fluoride into the public water supply, and I now argue that by doing so, OWASA is manufacturing (propagating) a prescription drug on a wholesale scale without a license and distributing it to people who do not have prescriptions for the drug they are distributing.

Wholesale distribution. – Distribution of a prescription drug to a person who is not a consumer or patient, other than any of the following types of distributions:

f. The sale, purchase, or trade of a prescription drug; an offer to sell, purchase, or trade a prescription drug; or the dispensing of a prescription drug pursuant to a prescription.

§ 106-145.3. Wholesale distributor must have license.

(a) Requirement. – Every wholesale distributor engaged in the wholesale distribution of prescription drugs in interstate commerce in this State shall obtain a license from the Commissioner for each location from which prescription drugs are distributed and shall renew each license annually.

OWASA sells the drugged water to residents in the town and does not have a license to do so. I would argue that it can be held as a common fact that many (most) residents do not have fluoride prescriptions.

  1. Fluoride is a toxin.

Aside from fluoride’s technically being a drug as codified by the Nation Drug Code Directory by the Food and Drug Administration of the United States of America, I will also illustrate how fluoride is classified by chemical companies and hazmat agencies as a toxic substances that is a verifiable health hazard, corrosive agent and poison (European Union). Most recently, the country of Israel banned the addition of fluoride to their public water supplies.

3. Addition of fluoride to the public water supply is in violation of the Constitution of the State of North Carolina

Section 1.  The equality and rights of persons.

We hold it to be self-evident that all persons are created equal; that they are endowed by their Creator with certain inalienable rights; that among these are life, liberty, the enjoyment of the fruits of their own labor, and the pursuit of happiness.

Commentary: Section 1 of the North Carolina Constitution outlines the equality of humans. That one person’s rights shall not be infringed upon by either government or other individuals is clear in this section. Section 1 indicates that all beings have the right to life. It has been shown that fluoride is a toxin. In conjunction with the other sections of North Carolina’s Declaration of Rights, I shall outline how introduction of fluoride infringes upon the very essence of liberty to decide what one puts in their own body. This section says that I am equal to other citizens. This is important when considering a free, sane man’s right not to liberty and life while not drugged against his consent by an unelected board of water and sewer engineers.

Sec. 2.  Sovereignty of the people.

All political power is vested in and derived from the people; all government of right originates from the people, is founded upon their will only, and is instituted solely for the good of the whole.

Commentary: OWASA is not an elected board, and it does not consist of health professionals, but yet it enacts health policy (See Exhibit. This in essence goes against the will of the people.

Sec. 5.  Allegiance to the United States.

Every citizen of this State owes paramount allegiance to the Constitution and government of the United States, and no law or ordinance of the State in contravention or subversion thereof can have any binding force.

Commentary: The addition of a drug into the public water supply violates the idea and spirit of this section, because the FDA has determined fluoride to be a prescription drug (as detailed earlier in this complaint). Addition of fluoride into the public water supply subverts the law of the United States that indicates fluoride to be given by prescription only.

Sec. 7.  Suspending laws.

All power of suspending laws or the execution of laws by any authority, without the consent of the representatives of the people, is injurious to their rights and shall not be exercised.

Commentary: By adding fluoride to the public water supply, OWASA has suspended the law that a physician must write a prescription for a prescription drug and a pharmacist must dispense that prescription drug to the patient in a prescription labeled bottle according to the letter and spirit of § 90-85.29.  Prescription label. OWASA is not elected. OWASA’s behavior is injurious to the rights of the people, for their behavior violates the law and the people have no representation in their actions.

Sec. 13.  Religious liberty.

All persons have a natural and inalienable right to worship Almighty God according to the dictates of their own consciences, and no human authority shall, in any case whatever, control or interfere with the rights of conscience.

Commentary: The framers of the constitution found religious freedom so important that they specifically noted that conscience must play a role in ethical governance. Muslims as well as many different religions believe that it is wrong to ingest toxins. This is a commonly known fact. Fluoride has been shown through the attached exhibits to be a toxin. It is against many people’s religions including my own to ingest toxins. It is against the way in which I and many others worship Almighty God to ingest fluoride, and in combination with sections 1, 19, and 35  of the NC Constitution, specifically, my religious freedoms are being violated. People who worship Almighty God in such a way so as to avoid toxins, which is a perfectly natural and common way (acceptable on its face) of practicing the worship of Almighty God, are having their liberty infringed, because they are forced to spend costly time and effort avoiding this toxin, because it is so ubiquitously introduced into society (through the tap water). People who worship Almighty God and in doing so, feel the need to avoid the toxin (drug), fluoride, are thereby being discriminated against by the state in this matter via the unelected OWASA board.

Sec. 19.  Law of the land; equal protection of the laws.

No person shall be taken, imprisoned, or disseized of his freehold, liberties, or privileges, or outlawed, or exiled, or in any manner deprived of his life, liberty, or property, but by the law of the land.  No person shall be denied the equal protection of the laws; nor shall any person be subjected to discrimination by the State because of race, color, religion, or national origin.

As just described in the commentary on religious freedom, fluoride, being a toxin, deprives one of life, liberty, and in a certain sense, property, because we are forced to spend extra money to purchase water that does not contain fluoride, which other members of society are not forced to do if they accept the consumption of fluoride or are not aware that they are consuming fluoride. Those who do not want to drink fluoride have the right to not to consume fluoride, as it has been classified as a drug and it has not been prescribed to them, and they are free citizens. Their rights are protected by the constitution.

Sec. 35.  Recurrence to fundamental principles.

A frequent recurrence to fundamental principles is absolutely necessary to preserve the blessings of liberty.

We must examine the ethics of adding a drug to the water supply. This chemical is not approved by the FDA as a drug, yet it is being added to the public water supply. In many counties, there has never been a referendum on addition of fluoride to the public water supply.

Sec. 36.  Other rights of the people.

The enumeration of rights in this Article shall not be construed to impair or deny others retained by the people.

Please acknowledge that the right of the people to not have a drug forced upon them is present in the constitution through the enumerated ways, but also see how it is unethical in and of itself. People who do not wish to ingest a drug have that right insofar as they are sane, rational individuals who have committed no crime. If a drug is administered on a mass scale, this is wrong. Those who wish to abstain from partaking in the ingestion of a drug have the right to access water that does not have drugs in it, since public water ought be provided equally to people regardless of religion or  drug preference.

Having followed this train of thought, these expositions of violations of the North Carolina General Statutes, can one be any more sure that the issuance of a PERMANENT INJUNCTION should be immediately issued? Furthermore, ought not the one who brought about the PERMANENT INJUNCTION and brought a halt to this terrible violation be rewarded monetarily while the perpetrator of this abuse be punished monetarily? Please issue a permanent injunction to stop the practice of putting fluoride into the public water supply. Please issue a permanent injunction against the administering of a drug to the whole population of the county by the OWASA.

From Article 5.

North Carolina Controlled Substances Act.

(12)      “Drug” means a. substances recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; b. substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; c. substances (other than food) intended to affect the structure or any function of the body of man or other animals; and d. substances intended for use as a component of any article specified in a, b, or c of this subdivision; but does not include devices or their components, parts, or accessories.

North Carolina General Statutes § 90-89.1 Treatment of controlled substance analogues

http://law.onecle.com/north-carolina/90-medicine-and-allied-occupations/90-89.1.html

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