FDA Warning - Federal Drug Addicts - Fascist Regulatory Monopoly Enforcement

How to Comply with an FDA Warning:

A Closer Look at The FDA’s Fascist Regulatory Monopolistic Enforcement Enterprise

 

by

Dr. Leonard G. Horowitz

 

(Originally published on FluScam.com)

Summary

This is a case study of my “FDA Experience” responding to, and corresponding with, officials who attempted to defraud me, in order to restrict my advertising of OxySilver and other natural products that facilitate healthcare and healing. Most natural foods and herbal healing professionals know that the FDA regularly harasses and often punishes purported “violators.” Most also know there are serious conflicts of interest between FDA officials and drug companies, often giving worse than “an impression of impropriety” but frank bribery. The malfeasance arguably amounts to Sherman Anti-Trust Act violations damaging American consumers otherwise benefited by low-to-no-risk, perceived beneficial, “alternatives” in healthcare. The suppression of natural healthcare products and services do everyone a disservice, other than drug and vaccine industrialists. In this study, there are two material misrepresentations of laws and regulatory powers that are raised in the correspondence and this inquiry. The first is a misrepresentation causing confusion over the words “and” versus “or” in 21 U.S.C. 321(g)(1), resulting in deprivation of citizens rights of free speech to truthfully advertise natural non-drug products. The second is a blatant misrepresentation of the definition of the word “drug” central to regulatory powers. This article addresses each and makes recommendations enabling advertisers to make more informed decisions affecting natural health product commerce.

Introduction and Background

For more than a quarter century I have been active in the fields of public health, “alternative medicine,” and every aspect of natural health products commerce. I document here my “FDA experience” as a Harvard-trained expert in public health, author of numerous consumer health books, dozens of peer-reviewed scientific papers, and a multiple award-winning documentary producer of films critical of federal officials serving “Big Pharma,” including: In Lies We Trust: The CIA, Hollywood & Bioterrorism, PHARMAWHORES: The SHOWTIME Sting of Penn & Teller, and UN-VAXXED: A Docu-commentary for Robert De Niro.

Nonetheless, the FDA routinely sends WARNING LETTERs to BigPharma’s companies, and persons like me in the natural healing arts and sciences. A sample of such targets is shown by clicking the “CounterThink” comic below. 

If only small companies like mine were targeted, then the public would instantly know the FDA or “Fraudulent Drug Advocates” were allied with groups such as the Partnership of New York City. This private commercial organization includes Lloyd Blankfein of Goldman Sachs (a major shareholder in AstraZeneca, implicated in both the H1N1 Flu Mist scandal and pandemic fraud, as well as the Halliburton explosion of the BP oil rig in the Gulf.) By policing people like me for making honest claims based on published peer-reviewed science, as well as issuing occasional warnings and fines to large drug makers, the FDA appears legitimate. 

But little old me is alleged to risk the public’s health by supposedly making “health claims” that FDA officials reserve for drugs. This practice clearly favors the drug industry’s monopoly over healthcare–arguably a “racket” protected by extortion in the form of such WARNING LETTERS. 

Once they claim, in a WARNING LETTER, that your product is a “drug” due to a legitimate health claim made in advertising, then the criminal branch of the “Fraudulent Deranged Aggressors” pressure citizens to comply or be fined or jailed.

One example making news at the time of this writing is the case of UNITED STATES V. GIROD in the UNITED STATES DISTRICT COURT EASTERN DISTRICT OF KENTUCKY CENTRAL DIVISION (at Lexington), Criminal Action No. 5: 15-87-DCR (E.D. Ky. Jun. 24, 2016). Mr. Girod, clearly the victim here, is an Amish herbal salve maker and advertiser convicted of, among other things, “obstructing government operations.” News about this case, and others similar, certainly produces more than public outrage versus official justifications. The “example” set by the prosecution, and such widely-publicized persecution, causes widespread fear across the natural health products industry valued, according to the nonprofit American Botanical Council (ABC), to gross more than $6.4 billion in 2014, increasing by an impressive 6.8%. The ABA’s market report is published in HerbalGram, a peer-reviewed quarterly journal. This represents less than two percent of the $425 billion annual sales of drugs that same year in America.

The correlation between such not-so-subtle extortion and society’s disproportionate reliance on drugs benefiting BigPharma is arguably criminal. The FDA is literally aiding-and-abetting mass murder and omnicide, polluting our planet and poisoning virtually all life forms.

Another form of social control sponsored by Big Pharma is called “controlled opposition.” The above comic is an example. It was produced by Dan Berger in collaboration with Mike Adams, who like all celebrities opposed to drugs and favoring natural cures is smeared on the CIA-FBI edited Wikipedia website. Social control is administered this way, on highly trafficked “information services” providing substantial propaganda to discredit anyone and everyone promoting natural cures. Adams, however, has adequately discredited himself, raising concerns that his rapid well-financed emergence as the celebrated “Health Ranger” for “Natural News” in 2006 (from NewsTarget.com) served Big Pharma’s agenda as well as Adams’s.

These facts give the impression that Mike Adams exemplifies “controlled opposition” supported by anti-natural-cure industrialists to act like legitimate consumer activist. Evidence of this is most obvious HERE where Adams outrageously discredits himself.)

Response to WARNING LETTER

I am responding to the “Warning Letter” notice you mailed me on May 11, 2010, that states that you “have determined that [specified websites and products advertised] . . . are promoted for conditions that cause them to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. $321(g)(1)].”

This section states: “(g)(1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them;

and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful

and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement, and . . .”

Thus, kindly relay written evidence that any of our websites or products cited in your “Warning Letter,” are “recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them,” because my search has not found any.

Regarding the other concerns you raise in this “Warning Letter,” the legal interpretation of the word “and” in the aforementioned law, as per legal dictionaries means: “additionally” or “in addition to,” “together with,” or “along with;” not meaning, or misconstruing “and” to mean “or,” used to indicate an alternative, in this case the clauses (B), (C), and (D) referenced in 201(g)(1) [21 U.S.C. 321(g)(1)].

So as I always do my best to comply with laws governing commerce and proper labeling of products, I request from your legal department, or attorneys general handling such requests, a written statement specifically citing any law that requires any action by myself, or your department,

neglecting clause (A); selectively requiring clauses (B), (C) and/or (D) as exclusively requiring compliance.

Thank you very much for consideration and timely response.

Sincerely yours,

In response, Compliance Director Breen of the Seattle branch of the FDA replied as you can read by clicking this pdf file link:

FDA WARNING LETTER – May 27, 2010

Then, I replied to Director Breen through Compliance Officer Althar, as follows:

I am responding in good faith, and goodwill, in a timely fashion, with intent to comply with regulatory laws as written, and to Charles Breen’s letter of May 27, 2010, (received June 3, 2010) that responds to my question regarding 201(g)(1)(A)’s precise language pertaining to the use of the conjunctive “. . . ; and . . .”

Director Breen wrote on May 27, 2010, that “the plain meaning of the statute is that the product is a “drug” under the Act if it meets any one of those four subclauses.” Yet he neglected to respond to my request for anything in writing, from an attorney general preferably, that would provide tangible written evidence that the U.S. Congress had intended the broad interpretation of this conjunction, as the FDA, and your office, is currently demanding.

Director Breen’s letter also threatens my person and property with, “enforcement action without further notice,” if I do not respond to your office “within fifteen (15) working days of the receipt of the Warning Letter.” Thus, this response is timely; and designed to prevent armed FDA agents, and complicit law enforcement officials, from invading my office (as has been done in the past to some of my colleagues), confiscating property, products, computers and records, etc., and initiating lengthy and costly criminal proceedings.

Thus, I take this matter very seriously, as do you, and I expect that you will, likewise, comply with the reasonable respectable requests that I make to serve this lawful process.

Compliance Plan and Need for Further Discovery

As I intend to fully comply with the law, my compliance PLAN of action includes the following:

1)   Review and determination of statutory requirements necessary to confirm violations of law, false claims, or improper labeling; followed by

2)   Rewording, relabeling, and/or clarifying text contained on websites and advertisements in violation of laws, improper label text, or false or misleading claims; or

3)   Requesting and receiving from the FDA appropriate disclaimers for each qualified claim necessary, identified, and legitimized by published science; followed by

4)   Posting FDA official disclaimers where warranted to remedy grievance(s).

To begin this process as detailed above, as previously written (May 17, 2010), I need to confirm any of our advertisements violate 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. $321(g)(1)], because the words “and” and “or” have two distinct meanings in common usage and law; and the word “and” is used between (g)(1)(A) and (B) of this statute, thus exempting products advertised that are not cited in “articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; . . .”

Thus, I consulted a couple of licensed attorneys in an effort to gain more clarity and certainty in this matter. I also reviewed law reviews pertaining to the legitimate interpretation of the use of the word “and,” and adjacent semicolon “;” punctuation, coupled with the conjunctive.

The attorneys have advised me that they are aware that the FDA routinely assumes Director Breen’s position, yet they were unsure this assumption is a valid interpretation of the intention of Congress in enacting this law; and I have been advised that the interpretation, and pending enforcement action(s), may be unlawful under US Constitutional, First Amendment rights.

In fact, in Thompson v. Western States Medical Center/, 535 U.S. 357 (2002), the Supreme Court was confronted with a FDA case involving abridgement of First Amendment rights. This case involved some compounding pharmacists who challenged provisions of the FDCA that restricted their advertising. In finding the advertising restriction violative of the First Amendment, the Supreme Court articulated a specific test: if commercial speech relates to unlawful activity, or is misleading, then it lacks First Amendment protection. But if the commercial speech is not related to illegal activity nor is it misleading, then there must be a substantial governmental interest in regulating the speech. “If the First Amendment means anything, it means that regulating speech must be a last — not first — resort.” /Id./, at 373. The government cannot prevent “the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information.” /Id./, at 374.

Now there is nothing unlawful about our activity, or misleading about the advertisements that you claim makes our products “drugs.” Some of our products may be insufficiently labeled, and I seek to remedy this possible deficiency during the course of these compliance proceedings.

I also found the following confirmation pertaining to the substantive material use of this “; and” conjunction (in the 201g(1) regulation) that appears to contradict Director Breen’s assumption. This is from: A Law Dictionary, Adapted to the Constitution and Laws of the United States. By John Bouvier. Published 1856, Vide Toull. liv. 3, t. 2, c. 5, n. 430; 4 T. R. 65; Barringt. on the Stat. 394, n. Vide article Points, regarding the semi-colon punctuation’s use in legal instruments:

“All such instruments are to be construed without any regard to the punctuation; and in a case of doubt, they ought to be construed in such a manner that they may have some effect, rather than in one in which they would be nugatory.”

Thus, I must insist on a written clarification, by your attorneys general. They should provide me, in writing in a timely fashion, how and why the FDA chooses, at this time, in my case, to directly disregard the meaning, and intended meaning, of the word “and.”

Otherwise, I must assume by Director Breen’s threatening letter, and disregard to this, my kindly second, request for material evidence supportive to the FDA claims against me, that you are administering a hostile un-American action on behalf of a fascist pro-pharmaceutical regime, applying harassment, and unwarranted aggression against me, damaging to my person, properties, and business interests; all consistent with organized crime and pharmaceutical racketeering.

Also, if you fail to reply to this demand for more information within 15 working days, to facilitate my timely compliance with FDA demands, then you may be held accountable for damages, and make null and void previous FDA Warning Letter and Dir. Breen’s notice.

Implementing Compliance Plan, Step 1: Ombudsman’s Clarification

Regarding Step 1 of my compliance program, if you are unable to provide me with an official Congressional, or Agency writing authorizing the FDA’s broad interpretation of this “; and” conjuction, and based on this, your agency insists that I come into compliance with a law that I may not have broken, or does not apply to my circumstance, then I demand a legal review of this matter from the FDA’s Ombudsman’s office as the next step.

Thus, please pass this request for the Ombudsman’s review of the US Congress’s intent in the wording of 201(g)(1)(A) that includes the precise reason any reasonable person would interpret the word “and” to mean “or,” and why the FDA is not overstepping its authority in assuming the assumption Dir. Breen provided is reasonable and constitutionally valid.

Implementing Step 2

Assuming you are positioned to advance an armed attack against my person and premises, and that you intend to do so promptly, as Director Breen has threatened, then under protest, with this NOTICE becoming part of my legal record, I propose to administer in the next 30-days:

b)Adding the following NOTICE, and official company disclaimer, to every page of our websites containing text the FDA finds objectionable. The following notice uses OxySilver as an example, but can be easily modified for other products referenced in Director Breen’s Warning Letter of  May 11, 2010:

Implementing Step 3:

Now assuming we cooperatively advance my compliance plan as stated, your administration is required to acknowledge the legitimacy and legality of qualified claims, that I believe, at this present time, we have made, as listed in your WARNING LETTER of May 11, 2010.

I am aware that your authority requires you, in service to the American people and your commission, to supply me with appropriate disclaimers for posting where necessary, as per a US District Court For The District of Columbia decision (May 27, 2010; Alliance for Natural Health US, et al., v Kathleen Sebelius, et al; Civ. No. 09-01470 (ESH)) wherein the Court remanded to the FDA proposed claims “for the purpose of 1) drafting one or more disclaimers to accompany plaintiffs’  . . .  claims, or, alternatively, setting forth empirical evidence that any disclaimer would fail to correct the claims’ purported misleadingness . . .”

So providing we can resolve the first substantive matter of statutory language regarding the intended meaning of “and” versus “or,” requiring some kind of written legal opinion from the FDA’s Ombudsman’s office initially, subject to appeal, then I pledge to advance, in a timely manner, remedies to specific FDA objections, step by step, item by item, as referenced in Director Breen’s WARNING LETTER of May 11, 2010.

For example, in reference to the FDA’s objection to the phrases, “Destroy viruses, Bacteria, and Fungi,” “Eliminate the need for harmful vaccines and antibiotics,” and “Silver hydrosols, in general, are superior powerful broad spectrum anti-microbials,” qualified claims, provided by the FDA, will be posted that:

1)Shall reference the mountain of science, as per the University of Wisconsin’s nano-silver science literature review freely available online here:http://www.nanoceo.net/nanorisks/silver-particles, that proves silver hydrosols, as a general class of products, destroy viruses, bacteria, and fungi; eliminate the need for harmful vaccines and antibiotics, and are, in general, superior powerful broad spectrum antimicrobials.”

Furthermore, I propose constructing a website, linked from all of the websites cited in the Warning Letter that I administer, that displays the FDA’s Warning Letter(s), communications, and our interrogatories for optimal transparency, service to our customers and for the benefit of the general public.

I pray that our collaboration and remediation of issues raised herein shall serve, far beyond our offices, the general good.

Thank you very much, in advance, for your cooperation and timely response.

Sincerely yours,

Healthy World Distributing, LLC

By: Leonard G. Horowitz, Overseer, Managing Member

and

Healing Celebrations, LLC

By: Leonard G. Horowitz, Overseer, Managing Member

                                     – end –

Footnotes and Supplemental Intelligence:

(1) FDA officials and agents must maintain ethical standards of conduct free from conflicting interests, as evidenced by Title 21, Chapter 1, Subchapter A, Section 19.6 of their Code of Ethics.

(2) The FDA, in some circumstances, does not need to send Notice of criminal allegations to permit a response, according to: §7.84   Opportunity for presentation of views before report of criminal violation, although it is unethical to deprive suspects of their Constitutional rights, and such deprivation may be actionable and counterclaimed.

(3) Key Definitions of legal terms used by the FDA are published HERE.

Title 21 → Chapter I → Subchapter A → Part 3 → Subpart A → §3.2

(4) The FDA’s provision of its definition of “DRUG” is not easy to locate. It appears to be concealed within a labyrinth of other regulations as shown by this statement in the General Provisions:

(g) Drug has the meaning given the term in section 201(g)(1) of the act.

Then, that reference states the following HERE:

“a) A drug or drug product (as defined in 320.1 of this chapter)”

Further obfuscating and redirecting, the regulations provide:

The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.”

Now, if that is not bad or confusing enough, the reference to  § 314.3 does NOT actually define the word “DRUG.” It defines the word “drug substance” only, as shown in this screenshot:

This definition states:

“Drug substance is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.”

Key words in this definition include: “active ingredient,” “intended,” and “pharmacological activity.”

An “active ingredient” link provided by this code states:

“Active ingredient is any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.”

The definition of “pharmacological activity” is not provided for in this section of FDA code. This omission requires going into a medical dictionary to learn more. Here is where the “smoke and mirrors” game gets a lot worse, “pharmacological activity” is not defined, for instance by the Free Online Medical Dictionary, citingMosby’s Medical Dictionary, 9th edition. © 2009, Elsevier. This definition redirects to “biological activity,” as proven by this screenshot:

Further searching results in the clear impression that the entire  matter of claiming the FDA code validly regulates natural medicines such as herbs, tinctures, homeopathics, etc. IS A COMPLETE CONSUMER FRAUD and regulatory racket. Further inquiry into the term “pharmacological” returns results such as this screenshot, again from the online medical dictionary.

 

From this definition, it is clear that the definition strictly applies to the drug industry, and certainly not the natural healing industry.

5) The preceding information has great practical and legal implications in, for instance, the case of the Kentucky Amish herbalist persecuted and prosecuted by federal officials in the case of UNITED STATES V. GIROD in the UNITED STATES DISTRICT COURT EASTERN DISTRICT OF KENTUCKY CENTRAL DIVISION (at Lexington), Criminal Action No. 5: 15-87-DCR (E.D. Ky. Jun. 24, 2016)

Under Kentucky criminal code, and federal criminal code, a retrial or reversal may be obtained due to the aforementioned newly obtained evidence of fraud, in favor of Defendant Samuel Girod. The federal rule states:

Rule 33. New Trial

Relevant case law, such as the following from Brady v. Maryland, 373 US 83 – Supreme Court 1963, should be considered:

The Third Circuit in the Baldi case construed that statement in Pyle v. Kansasto mean that the “suppression of evidence favorable” to the accused was itself sufficient to amount to a denial of due process. 195 F. 2d, at 820. In Napue v.Illinois, 360 U. S. 264, 269, we extended the test formulated in Mooney v. Holohanwhen we said: “The same result obtains when the State, although not soliciting false evidence, allows it to go uncorrected when it appears.” And see Alcorta v.Texas, 355 U. S. 28; Wilde v. Wyoming, 362 U. S. 607. Cf. Durley v. Mayo, 351 U. S. 277, 285 (dissenting opinion).

By suppressing the actual definition of “drug”, and making it extremely difficult for a reasonable citizen to discern the fraud in the malicious prosecution of cases, citizens’ rights, as with Mr. Girod, are violated. The mistrial and prosecution’s fraud should not go unchallenged.

___________________

About the author: Dr. Leonard Horowitz is the author of sixteen books including three American best-sellers,Emerging Viruses: AIDS & Ebola–Nature, Accident or Intentional?, Healing Codes for the Biological Apocalypse, and Healing Celebrations: Miraculous Recoveries Through Ancient Scripture, Natural Medicine and Modern Science. Dr. Horowitz, of Healthy World Organization (HWO), had been advancing an alternative to the duplicitous World Health Organization (WHO), until agents for Big Pharma’s protection racket libeled and cyber-bullied his good work and smeared his reputation using the FDA Warning Letters attached hereto, as aforementioned. Consequently, the doctor believes it is his public duty to expose the fraud and crime damaging consumers and others like him in the natural healing arts and sciences.