Sauerheber to FDA – Action Options

Print Friendly

Dr. Richard D. Sauerheber

Palomar Community College

1140 W. Mission Rd., San Marcos, CA 92069

E-mail: richsauerheb@hotmail.com   Phone: 760-402-1173

June 8, 2012

Department of Health and Human Services
Public Health Service
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Regulatory Policy
Rockville, MD 20857

Dear FDA Project Reviewers,

I write this letter in support of the petition to ban fluoridation, that is adding synthetic industrial fluoride compounds into public drinking water supplies, FDA-2007-P-0346, formerly 2007P-0400.

 

The Everett, Washington city council is currently conducting public hearings on water fluoridation. The key witness for the city in favor of fluoridation is a Dr. Goldblum who presented arguments that fluoride in public water supplies is “safe” and “natural.”  Each contention made by Goldblum is addressed in the letter below for the benefit of the FDA.

 

Secondly, the country of Southern Ireland accepted and published a treatise on water fluoridation by Chartered Environmental Scientist Declan Waugh, a 360 page document with 1,216 scientific references that request an immediate halt to water fluoridation. The document was also submitted to the European Union. A health professional offered several arguments against the document that were incorrect. A letter was written to Declan Waugh by request that addresses each point, and a copy is enclosed here for information in support of the ban petition to the FDA.

 

Again, if a ban cannot be instituted for any reason, then:

 

1)      Federal officials must be told to cease requesting or recommending synthetic industrial fluoride compounds be taken internally through ingestion since no such compound has been approved by the FDA for ingestion and only sodium fluoride is allowed as an unapproved drug to be taken internally by prescription only;

2)      a moratorium on synthetic industrial fluoride infusions into public human water supplies may be issued until controlled clinical trials data are submitted on human volunteers to the FDA for a new drug application, particularly for HF-containing fluorosilicic  acid;

3)      or letters from the FDA to fluoride chemical suppliers (currently about 49 such suppliers exist in the U.S.) requesting data in their possession demonstrating safety and effectiveness for those ingesting their product;

4)      or FDA could request that fluoride compounds only be added into water that is rich in calcium, to maintain the original 200 to 1 divalent cation to fluoride ion ratio present in  Hereford, Texas water where the idea of water fluoridation actually first began;

5)      or  calcium chloride could be added to water which is known to strengthen teeth and  to build strong enamel in childhood growth years, rather than systemic ingested fluoride ion, which is ineffective for this purpose and is unsafe long-term.  Foods rich in calcium may be suggested as fluoride water substitutes, including spinach (595 mg calcium per 100 grams), onions (135 mg per 100 grams) and broccoli (160 mg per 100 grams).

 

Thanks much,

 

Richard Sauerheber, Ph.D.

Encloed:

Letter in response to Dr. Goldblum

Letter to Declan Waugh in response to Dr. Leland

One thought on “Sauerheber to FDA – Action Options

  1. Ronald Eheman

    Under the federal Food, Drug & Cosmetic Act, 21 U.S.C. § 301 et seq., every drug must be approved by the FDA for safety and effectiveness before it can be marketed to the public. These drugs were not. Ultimately, the FDA determines whether the drug is safe and effective in its proposed use(s), whether the benefits of the drug outweigh the risks, and whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.

    RELEVANT LAW

    The Food. Drug and Cosmetic Act
    4. Under the FDCA, “label” means a display of written, printed, or graphic matter upon the immediate container of any article. 21 U.S.C. § 321(k). The term “labeling” is defined as all labels and other printed or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. 21 U.S.C. § 321(m).
    5. Under the FDCA, “drugs” are defined as, among other things: (A) articles recognized in the official United States Pharmacopeia official Homeopathic Pharmacopeia or official National Formulary, or any supplement to any of them; (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (0) articles intended for use as a component of any articles specified in clause (A), (B), or (C). 21 U.S.C. § 321(g).
    6. A “new drug” is any drug which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof. 21 U.S.C. § 321(P)(1). In order to be lawfully marketed, sold or dispensed in the United States, a new drug had to be the subject of a New Drug Application (”NDA”) which had been approved by the FDA. 21 U.S.C. § 355.
    7. A drug intended for use in man which, because of its toxicity, or other potentiality for harmful effect. or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or a drug which is limited by an approved application under 21 U.S.C. § 355 to use under the professional supervision of a practitioner licensed by law to administer such drug, can only be dispensed by a practitioner licensed by law pursuant to a lawful prescription. 21 U.S.C. § 353(b)(I). These drugs are commonly known as “prescription drugs.” Dispensing a prescription drug without a valid prescription by a licensed practitioner is deemed by statute to be an act which causes the drug to be “misbranded” while held for sale. 21 U.S.C. § 353(b).
    8. Under the FDCA, every person engaging in the manufacture, preparation, compounding, or processing of drugs in any establishment which he or she owns or operates, is required to immediately register his or her name, places of business, and all such establishments. 21 U.S.C. § 360(c). The terms “manufacture, preparation, propagation, compounding, or processing” include repackaging or otherwise changing the container, wrapper, or labeling of any drug in furtherance of the distribution of the drug from the original place of manufacture to the person who makes the final sale to the ultimate consumer or user. 21 U.S.C. § 360(a)(1).
    9. A drug is misbranded if, among other things, its labeling is false or misleading in any particular. 21 U.S.C. § 352(a). A drug is also misbranded if the labeling on the drug does not bear adequate directions for use. 21 U.S.C. § 352(1)(1). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purposes for which it was intended without a doctors supervision. 21 C.F.R. § 201.5. This regulation goes on to state: “Directions for use may be inadequate because …. of omission, in whole or in part, or incorrect specification of: (a) Statements of all conditions, purposes, or uses for which such drug is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the drug is commonly used.”
    10. Directions under which a layperson can use a drug safely cannot be written for a prescription drug because such drugs can, by definition, only be used safely (if at all) at the direction, and under the supervision, of a licensed practitioner. Approved prescription drugs dispensed pursuant to a valid prescription are exempt from having adequate directions for use by a layperson. But prescription drugs that are unapproved new drugs or dispensed without a valid prescription are necessarily misbranded for lacking adequate directions for use.
    11. Dispensing a prescription drug without a valid prescription by a licensed practitioner is deemed by statute to be an act which results in the drug being misbranded while held for sale. 21 U.S.C. § 353(b)(1).
    12. Under the FDCA, the doing or causing of the following acts, among others, is prohibited:
    a. The introduction or delivery for introduction into interstate commerce of any drug that is misbranded (21 U.S.C. § 331(a».
    b. The receipt in interstate commerce of any drug that is misbranded, and the delivery or proffered delivery thereof for pay or otherwise (21 U.S.C. § 33 1 (c».
    c. The introduction or delivery for introduction into interstate commerce of an unapproved new drug (21 U.S.C. § 331(d».
    d. The doing of any act with respect to a drug, if such act is done while the drug is held for sale (whether or not the first sale) after shipment in interstate commerce. which results in the drug being misbranded (21 U.S.C. § 331(k».

Leave a Reply

Your email address will not be published. Required fields are marked *

three × three =