Thursday, August 11, 2016

"Vitamin War" Stories

My Experiences in the Vitamin World

Short Link to this Blog:

[Recently traded some "Vitamin War" stories with some Vitamin Pioneers and it was suggested that I write out some of my stories, so, here are a few...]

I was 24 in 1969, in the middle of law school (I had graduated from Rutgers College, BA with Distinction and was then attending Rutgers Law School, earning my JD). 

That’s when I met future best-selling authors Durk Pearson and Sandy Shaw (the 1980s Life Extension books). My future wife Kathy Greene and I became part of Pearson/Shaw’s informal nutrient experiment group. We’d receive a bottle of, say, food grade Selenium, and have to count the requisite number of drops, being careful to avoid any toxic over serving… Life Extension Foundation was established; we became more involved with nutrients.

I started practicing law in 1971. For the first 15 years, while I continued my personal interest in nutrition and took a few courses in homeopathy and energy work, getting to know some of the people in our region, I found myself representing my family’s northeast New Jersey real estate business (which included a hotel, bowling allies, 2 shopping centers and a construction company). As the Fucetola Brothers (my father and uncles) retired in the late 1980s I was called upon to help establish Life Services Supplements, Inc., a dietary supplement company specializing in the Pearson/Shaw products. It's true, I had an office between one of the bowling allies and the construction company shop, on River Road in North Arlington. Working with my cousins and Kathy there for over a decade. Good times, in many ways!

Working with Pearson/Shaw brought me into contact with a number of the Vitamin Industry Pioneers. Companies like Keith Frankel’s Garden State Nutritionals and, Saul Kent of the Life Extension Foundation. With that Foundation and Dr. Julian Whitaker’s support, in 1994/5 I handled the DHEA cases for two Life Extension members and established the legal principle that the government could not make a normal bodily substance into contraband -

With the coming of the Dietary Supplement Health and Education Act of 1994 (DSHEA, for which I lobbied in Washington) it became possible to make meaningful marketing statements about nutrients. I remember my wife Kathy and I taking our then six year old son Drew on a bus to Washington for a rally and lobbying day. A bit over a decade later we went back to DC to interview Dr .Ron Paul about Raw Milk and Health Freedom. Drew recorded the interview which is here:  September 2007 found us back in DC, with a dozen of Drew’s high school friends (they had graduated that year) for a Peace March… the Fortieth Anniversary of the famous 1967 march by the Hippies to the Pentagon to "levitate" the building (I was there)... but those are both stories for another time!

I focused on my law career and ministry. Along the way I found myself working with Vitamin Industry Pioneers like Rev. Dr. Robert Sorge of AbundaLife (Asbury Park, NJ) and Dr. Al Fleischner of TrimSpa® fame (I was there as sales headed from ten million to a hundred million). One important case was the Diabetiks® matter, where the leading case of Pearson v Shalala allowed the company to keep the product name, although it could be taken to be referring to a medical condition. A carefully structured FDA-approved Disclaimer, which is actually a powerful claim, allowed the continued use of the name.

The growth of the Internet allowed me to expand my reach and my website became well known, connecting me with more of the growing market. After I retired from formal practice of the law (2006), my current web site became  My personal email list of clients and contacts has hundreds companies on it.

My encore consulting career centers on Claims, Labels, GMPs and SOPs. I’ve been called upon on several occasions to work in the international field. For example, in 2005 I consulted with people in the South African equivalent of the FDA. They were just writing dietary supplement regulations and I was asked to review the contents of the 300 page loose-leaf notebook draft. At my recommendation a half dozen strategic words were changed and today South Africa has one of the world’s most vibrant nutrient markets.

I’ve worked with companies in India, South Africa, Russia and Germany (Roehr Pharmaceuticals and Magister Foods) with regard to importing nutrient products. Leading lights in the nutrient marketing world, such as Dr. Joe Mercola, Alex Jones, Dr. Ed Group, Mike Adams (the Health Ranger) and Dr. Rima Laibow have asked me to review their nutrient labels and claims. I’ve worked with some of the best known holistic method or therapies teachers, such as Starr Fuentes, Sharry Edwards, MEd and the like.

I’ve appeared before Congressional Committees, at international Codex Alimentarius meetings, and was invited during July 2016 to provide consultation to the Pennsylvania Department of Health regarding the GMPs for the new Pennsylvania Medical Marijuana law.

A major effort on my part has been developing the Vitamin Consultancy Webinar System, which consists of about a dozen video webinars and workbooks covering significant areas of dietary supplement regulation. FDA says the Label Owner must be in a “state of control” over the manufacturing, QC, marketing, shipping and customer service processing systems. This requires having written SOPs, training the staff in them, and proving that to FDA inspectors.

[1] CAM Cautions
[2] DS and Medical Foods in Physicians’ Practice
[3] Lawful Copy Writing
[4] Therapy is Not Treatment
[5] Minister's Healing Practices
[6] GMP Standard Operating Procedures
    [a] SOP: Introduction
    [b] SOP: Section 1
    [c] SOP: Section 2
    [d] SOP: Conclusion
    [e] SOP: Record Keeping
[7] Health Care Practitioners SOP Training
[8] How to Form an NGO
[9] Health Claims for DSHEA Products
[10] Cosmetic Dossiers
[11] Testimonial Advertising or Review Marketing -
              Consumer Endorsements or Consumer Reviews?
[12] Writing Lawful Natural Product Ad Copy

The GMP audits I conduct either in person or virtually include a 194 item checklist that must be met to be fully GMP compliant. I extracted that list, as well as my master list of required GMP records from the FDA GMP document.

Over the past few years I've worked with Libertarian Party candidate Gary Johnson's campaigns, bringing the issue of Health Freedom and Informed Consent into the libertarian critique of Big Govt. Here is a 2013 video Drew and I did with Gov. Johnson on the issue:  

As President of the Institute for Health Research, and Vice President of Natural Solutions Foundation, I volunteer my time for public benefit. I am forever grateful to my good friends, co-trustees and colleagues at Natural Solutions, Rima Laibow, MD and Maj. Gen. Bert Stubblebine (US Army, Ret.) for making my encore career so interesting! I also work with mentors such as Nancy Orlen Weber RN and Dick Weber of Lightwing Center - and the good folks at - a rapidly expanding informative web site.

My preferred role in the Vitamin Market is as senior consulting adviser, helping companies enter the market in a sophisticated manner, and maintain proper operating procedures that meet current good marketing/manufacturing practices. Regarding anyone entering this marketing space, as a senior adviser, my goal is to bring nutrient marketing ideas (such as Medical Foods) into the corporate culture. 

Recently I have been particularly interested in Cannabidiol, CBD from Industrial Hemp, but that is, also, another story for another time, as the Vitamin War and its stories continue!

For more information you can find my Archives at and my current work at

Friday, April 8, 2016

Becoming a PC Unperson

Privatizing Tyranny: Mind Control for Profit
It's Not Just Jails and Vax Mandates Being Privatized

Assert your Informed Consent Right here:

Dr. Rima wrote one of her passionate replies to a planted pro-vaccination story that appeared out of Australia. The article was bemoaning a pregnant woman who was not vaccinated during pregnancy for Whooping Cough passing the disease on to her newborn.

You can read Dr. Rima's statement here:

In summary she says that there have been no scientific studies of what happens when the vaccine is given to pregnant women, a fact that is revealed in the vaccine package insert. Anyone who promotes use of that vaccine with pregnant women is promoting an "off label" use for which there is no scientific justification -- for which there is no known adverse reaction profile. Thus Dr. Rima says,

"Serious complications from the vaccine are not, as presented, rare. They are quite common and, if you consider the metal, excitotoxins, sterilizants, formaldehyde and other components, the logic of injecting these materials directly into the body, bypassing the natural protective barriers of lungs, mucosa and gut is absent while the dangers are obvious."

More on how vaccine reactions are not all that rare here:

So what happened after Dr. Rima posted her comments? First the comment disappeared and then the comment to which she was responding disappeared. Once again it seems we've transgressed the never-defined "community standards" of an online control system.

This is not the first time.

A couple weeks ago we got an email from GoFundMe telling us we had transgressed their proprietary, and thus not to be revealed to us, "community standards" and last year Dr. Rima got banned by the several hundred papers and outlets of the Murdock Media Empire as well as that one-time bastion of free speech, The Guardian. The Guardian had announced a policy of not allowing vaccine choice advocates access to their media.

Now before you Conservatives get all smug about how a Left Publication like The Guardian does not adhere to real free speech standards, you ought to know that just about the same time in 2015 Reason magazine was also toying with the notion that people who expressed conscientious objection to vaccination should not be given a forum on Reason. Little reason left in Reason.

Everyone knows about how Wikipedia, Google, Twitter and Facebook censor dissident communications. It's become a common joke... of the gallows humor variety. Less well known are the roles of entitles such as SpamHaus that defines what words are "spam" words... you know, words like “Free” as in “Freedom”.

We see how expression is controlled by private companies and well-placed non-governmental organizations through their control of the media. What we don't often notice is how other aspects of the control apparatus are also being privatized.

Vaccination propaganda, including a series of proven Big Lies:

  -- that vax prevent disease;
  -- that vax reactions are only "1 in a million;"
  -- that vax are safety tested by the government;
  -- that vax are efficacy tested by the government;
  -- that vax clinical studies are done by disinterested scientists

has been used to implement government policies that the public clearly opposes.

Here is how the system works:
  1. A drug company's salaried researchers concoct a vaccine from various noxious ingredients, including aborted fetus, aluminum, mercury, foreign proteins, formaldehyde, etc, etc...
  2. The drug company arranges for an initial clinical study where the new vax is compared to another vax (usually one of the most toxic) or to straight Thimerosal not against a true placebo.
  3. The clinical trial results as interpreted by the company are submitted to the FDA. Anyone who dies is deleted from the study results (“they did not finish the study”), serious adverse events are likewise dropped as often as possible for similar “reasons”. Anticipated effectiveness numbers are generated by the company from these results or from nothing atall. Pricing levels are presented.
  4. FDA rubber-stamps the data provided (80% of FDA funding comes from drug company fees).
  5. After FDA approval of the vax as a drug the CDC, a branch of FDA, considers recommending the vax.
  6. The CDC ACIP committee, where many members have conflicts of interest, recommends the vax (in one infamous example “ethicist” Paul Offitt made tens of millions of dollars “recommending” a vaccine in which he had a financial interest; no, he was not required to recuse himself).
Now things get interesting…. because various private actors, such as private prison companies, hospitals and other large employers, join state governments in multiplying vaccine mandates. At the present time we are receiving more and more communications from nurses and others who are being compelled to receive vaccines under threat of loss of livelihood. The Federal Government "recommendation" is turned into private company or state mandates.

This spreading-around of the 'responsibility' for the mandates is meant to fragment opposition and increase the cost of asserting our right of Informed Consent. It is meant to chill our expressive association rights.

Note though, much of the restrictions are being imposed by private actors. In every case, the issue is communication and the right to express Informed Consent. Whether we are dealing with Dr. Rima being blocked or a nurse being coerced, we are seeing the imposition of restrictions on communication rights "under color of law" by various public and private actors. The phrase “under color of law” comes from the Civil Rights Statutes and describes acting with apparent legal authority, but in a discriminatory manner.

When private institutions choose to use their government-granted corporate privilege to restrict people’s expressive association rights, they are acting as governments and must adhere to the strict limitations placed on government in all civilized nations.

This includes strict adherence to the law of Informed Consent. As the President of the Natural Solutions Foundation, Maj. Gen. Albert Stubblebine III (US Army, Ret.) states, "Informed Consent is the defining issue of the 21st Century."

It has been argued that wars have consequences. One of the consequences of World War II was that the international humanitarian law of Informed Consent was codified (by American legal scholars as part of the Nuremburg Trials and is now known as the Nuremburg Code) and continues binding on all nations.

What is being done in Australia, where families are being given the horrific choice of either submitting their children to unlimited vaccination or losing their access to public assistance, or in California where Gov. Jerry Brownshirt signed S277 that conditions a child's state-constitution-guaranteed "free public education" on receiving certain shots is literally a "crime againt humanity". Along  the way, traditional religious and philosophical conscientious objections to vaccination were abolished.

But the right to Informed Consent cannot be abolished by either a local government like California or a nation-state like Australia (or the US). It is an international humanitarian right not subject to being abolished by governments. See the UN Bioethics Declaration*. 

So what does this have to do with Dr. Rima being censored by Murdock, The Guardian, GoFundMe and Google?

It's all about how private, quasi-government and government actors are combining together in the continued privatization of coercion through censorship and mandates.

Informed Consent, in a world where all the instruments of communication are carefully controlled through "political correctness" and similar non-objective standards, is the central right we must assert to regain – and retain -- our absolute personal sovereignty over our own bodies and minds.

Assert your Informed Consent Right here:



Ralph Fucetola JD . 


Tuesday, March 15, 2016

Americans Want a Third Major Party

A Clear Majority of Americans
Ready for a Major Third Party

Ralph Fucetola JD

At the beginning of 2013 I analyzed the potential for a broad-based third party in American politics [1], taking as my model the extraordinary, albeit temporary, 2008 coalescence of third parties engineered by Dr. Ron Paul [2]. I also considered the Gallop Poll that, for decades, has asked whether a third major party was supported by the voters:

For generations Americans were taught that the “two party system” was a necessary part of American politics. And a strong majority always supported the “system.” The cross-over point was 2006/07

This occurred as the TEA Party coalition came together and gave the (G)OP control of Congress; since then, a majority has always wanted a third major choice. Considering the cost of launching another third major party, I urged the formation of Liberty Electoral Alliances among the existing third parties…

But first, back to Ron Paul and the top unreported political action of 2008. I wrote then:

“In a significant breakthrough for the American political system, what Dr. Ron Paul has called the "principled third parties" have challenged the US "two party" oligopoly, calling for a restoration of the constitutional republic and rejecting the US empire.

The statement was jointly written by Dr. Paul and the four third party campaigns for President … [Libertarian, Green, Constitutional, Independent]. The Statement challenges the "two" tax-supported party system which has dominated US politics in recent decades and rejects the joint policies of the Democrats and Republicans that, in this blogger's opinion, have contributed so centrally to the crisis facing the nation.”

That is why I thought the next logical step was the alliance model, and so in 2013 I wrote,

“When the (G)OP changed its rules after the Primaries to marginalize the TEA Party, by not even allowing Ron Paul's name to be put in nomination, it sealed its fate. Hundreds of thousands of "new blood" activists left that party. Three million less people voted for that party in '12 as in '08. The (G)OP lost a presidential race it should have easily won because it rejected the TEA Party activists and has new rules to make sure "we" never wrest control of that tax-eater party from its tax-eating establishment.

So we are left with several "Third Parties" that represent views "on the right' from Conservative to Libertarian.

I suspect, due to monopolistic political funding laws and regulations that erect "barriers against entry," it will not be possible to construct yet another new "major" (read: "tax-supported") party to challenge the (G)OP, so we need to consider how the existing political groupings can best move toward an electoral alliance.

I propose, not a new party, but rather an Independent Electoral Alliance. The Conservative and the Libertarian Parties have different strengths in different parts of the country. It should be possible to bring these parties together with joint candidates in some areas, leading to a joint presidential race in the future.”

 And now we come to the election year of 2016.

The third party trend has continued. In September 2015, Gallop noted, “Arguably, the U.S. political climate has been ripe for the emergence of a major third party for some time, but that hasn't yet happened.” [3] “Why?” one might ask.

That was before the Trump Election Reality Show and the perhaps not surprising disruptions of a “major party” political rally by protesters a couple days ago… in Chicago… for the first time since 1968. I do not know if Mr. Trump will succeed in his hostile take-over of the (G)OP, against the wishes of its management. 

I strongly suspect that only an indictment could stop Mrs. Clinton from gaining the Demos nomination. She will probably be the next president, despite being unliked, untrusted, and suspected of corruption. She is, however, a big-government, big-spending, Big Pharma, Federal Reserve-protecting supporter of nearly every foreign intervention and every bailout, so quite acceptable to the political establishment. But, then again, so, to a significant extent are Senator Sanders, Senators Cruz and Rubio, and Mr. Trump. And he has shown willingness to use government force, under the evil Kelo Decision, for personal gain. Maybe he is not as anti-establishment as he appears on the Trump Election Reality Show. Though I do salute him for his principled stand against vaccine mandates, a strong anti-establishment position [].

It appears every billionaire from Bloomberg to McAfee and beyond are threatening to run third party campaigns. It is rumored that billionaires Soros and the Kochs are each searching for suitable suits to be their front man or woman. They all smell an opportunity to extend their brands, with the stench of decay pervading the still-warm corpse of the (G)OP.

However, it won’t be that easy to translate their mega bucks into pollster inclusion, ballot position or national debate access. The restrictions built into the “controlled democracy” that America has become (from the limited, federal republic it was) make it very difficult to challenge the “two” tax-eater party political duopoly.

For example, the way the (G)OP rules were changed in 2012 will make it impossible for any “dark horse” candidate to be considered by the convention. Currently a candidate must have a majority (not just a plurality) of the votes in eight states to be eligible to have his name placed in nomination. And if not in nomination on the first ballot, there is no existing rule provision for new candidates to be included. That likely means a deadlocked (G)OP convention, with one side or the other walking out.

And not a moment too soon.

I thought, back in ’74, President Nixon’s abuse of power had finally kicked the corpse of the (G)OP the last time and that tax-eater party was going to go the way of the Whigs. Alas, not yet. The (G)OP had a couple more wars left in it after all… in cooperation with the Demos… and a couple more booms and their consequent busts (each getting bigger and bigger…).

The corruption of the “two party” political oligarchy has become so clear: the inability of the DC elite to deal with the Federal Debt and resulting collapse of the Dollar; the tragic failure to learn the lesson of endless foreign intervention (the lesson the that Founders’ policy of non-intervention is the only foreign policy consistent with a free republic) together are dooming the elite. 

They know they face the abyss… and the “unwashed masses” they fear are the best armed civilians on the planet. Will DC send in the marines, or the heavily armed alphabet agency secret police forces? We suspect we know where the federalized police forces will stand. But where will the professional soldiers stand? Keeping their Oaths or against our liberties?

IMHO, the only way to save America from another civil war is to do exactly the opposite of what the elite did in 1860. DC must let go. DC must learn humility and humanity. Return the western lands to the states. Withdraw from the hundreds of unsustainable military bases around the world. Stop manipulating the money supply and interest rates. Stop spying on patriotic Americans. The elite must give up their false enterprise of empire.

It’s been a good empire for them. For the first time in American history the highest paid population communities are no longer the upper middle class suburbs around the main city market centers; rather, they are the counties directly surrounding DC, filled with its minions. The rest of the country is being hollowed-out; left to dry-up; allowed to decay.

For the first time in centuries the cohort of middle-aged white men (presumed to be the privileged) are not living longer than their fathers [4]. Consider that the USSR collapsed when Russian men in their prime were dying younger and younger.

“What is to be done?” Lenin famously asked. His answer, terror and dictatorship, is always the grasp of a failing elite. Nonetheless, his empire ate several generations of Russians and others victims before its final collapse. The American empire is in the midst of the beginning of a similar gluttony. But America, with so much more market-generated wealth than any of the socialist states, has a much greater way to fall.

What is to be done? We the people must turn our backs on the elite. Trust none of them. We can no longer “Vote for the Lesser of the Two Evils.” We can no longer sanction their misrule by voting for any of them. We must demand third choices. We must demand the right to govern ourselves again. 

We must assert our expressive association rights: to communicate, to associate and to petition freely; we must assert our personal sovereignty rights: to informed consent [5], to hold property, to trade freely, and to keep and bear arms.

How is that to be done? There is only one political organization in America capable of standing toe-to-toe with the two party duopoly. The Libertarian Party, after 45 years laboring in the political vineyard, will be the only “other party” on the national ballot. The other “third parties” are well-meaning but really merely political clubs without significant ballot access that ought to rally around the libertarian candidate as the one hope to break the political deadlock.

The Libertarian Party [6] is the only logical choice, as it is the only uncorrupted party that will be on all fifty state ballots. 

Former New Mexico governor, and private economy entrepreneur, Gary Johnson is its likely candidate. [7] Whether climbing Mr. Everest (he’s climbed the highest mountain on each continent) or building successful businesses, Gary is a different kind of American politician. Kind, respectful, intelligent. Proven tax and spending cutter. Strong voice for non-intervention and peace. Civil libertarian. Supports the end of the "drug war" and supports equal rights for LGBTs. He was known as “Gov. No” for his national record in vetoing spending, regulating and taxing bills.

When Senator Rand Paul, the only (now former) candidate who had any understanding of the real threats facing America sought to protect the Federal Debt Limit last October, to protect us from inevitable fiscal chaos by stopping the borrow-spend-tax-borrow juggernaut, all the other candidates, (G)OPers and Demos alike, including Cruz, Rubio and Sanders, voted to suspend the Federal Debt Limit until after the 2016 election, thereby voting for unlimited Federal Debt. They are the problem; they are not any solution.

The 2016 election may be the last best chance for the people of America to take back their government -- to restore the republic. Going forward, as more and more people come to depend on a failing government, the chance for change toward liberty becomes more remote; the inevitability of violent conflict unavoidable.

Unless the two party duopoly is broken, America cannot be fixed.


Friday, February 19, 2016


Protecting the DSHEA Status of CBDs
Educate Decision Makers Here:
The Declaration

On February 10, 2016 FDA sent warning letters to certain CBD companies. The letters made two essential points:
  1. Certain claims made by the companies were “treatment of disease” claims and cannot be made without prior government prescription drug approval.
  2. CBD is not, based on “available evidence” grandfathered under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The agency claims authority under the 2010 (sic) Food Safety Modernization Act which allows the agency to ban any food that is being studied for medical use. However, that Act includes a specific clause exempting DSHEA products from this enhanced power. 

Natural Solutions Foundation led the effort to keep that clause in the law, and, although it took millions of emails, we succeeded.

Regarding #1 above, in my opinion is it always possible to revise claim language to avoid “treating disease.” Nutrients support normal function and structure, they do not “treat disease.”

During 2014 we directly confronted the FDA on a similar issue arising from the use of Nano Silver to support normal cell membrane integrity during the ebola scare. If a virus cannot penetrate a living cell there is no disease.

FDA originally said we were claiming to “treat ebola” with Nano Silver. After several letters back and forth, the agency did not object to the carefully structured support of normal cell membrane integrity claim. 

The FDA warning letter also addressed the CBDs that Natural Solutions makes available, implying that certain claims were not DSHEA claims, but made no mention of the nutrient not being "grandfathered." 

With regard to #2 above, the FDA is playing a trick: no one has provided FDA with evidence that CBD is grandfathered under DSHEA, therefore the agency says it is not grandfathered, thereby removing CBDs from the protection of the savings clause in the 2010 act.

This objection is easily handled. There are three grandfather clauses in DSHEA --

1. Sold to supplement the diet before June 1994;
2. Part of the food supply and not chemically changed since June 1994;
3. Previously approved as a drug, but sold as a food prior to being approved as a drug (and prior to June 1994).

Since humans and other mammals make CBDs as part of their neurotransmitter systems, CBD has in fact been part of the food supply and while being extracted is not chemically changed.

Furthermore, the government may not make a normal bodily substance into contraband. When I was in practice, in 1995, I won that issue when I won the DHEA Cases, keeping that nutrient available. See: How I Protected DHEA.


And here is one important step to do just that:
Declaration of Freedom to
Choose Natural Remedies

[Please Print and Post at Your Local Health Food Store.]


Tuesday, December 29, 2015

The Sources of the Law:
The Right of Informed Consent

The Sources of the Law: The Right of Informed ConsentSpCt.NcNeely.banner
Share this Law Note with this link:

This Law Note responds to the erroneous idea that the international humanitarian right of Informed Consent only applies in cases of war. When people cite the Geneva Conventions [1] as a source of the right they are told that the Conventions only apply in time of war. We assert that the Conventions recognize a right of Informed Consent (by operation of the Nuremberg Code) but are clearly not the only source of legal support for the humanitarian right of Informed Consent.

There are many international agreements that were made in Geneva, the original home of the League of Nations and now the European base for the United Nations. Among those agreements are the Geneva Conventions proper, which relate to armed conflict. Among other matters, they cover the handling of criminal charges against prisoners of war. In that context, at the end of WWII, the Nuremberg Code was proclaimed.

The Code requires respect for Informed Consent, without “the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion…”

The Nuremberg Code was drafted by American legal scholars as a "restatement" of the then-existing international law of Informed Consent. It restated the law not just in the case of war, but as applied to all persons at all times. It was used as a statement of the law during the Subsequent Nuremberg Trial of the Nazi doctors.

The Nuremberg Code is binding on the USA since it was drafted for US military trials of defeated foreigners and the Geneva Conventions say that if a power puts prisoners on trial it must apply the same law to them as to its own people, thus the Nuremberg Code must also encode the law of Informed Consent as applied to Americans and the other allies that joined in the doctors trial.

But that was over a half century ago and international humanitarian law has continued to develop.

For example, Australia's fundamental law recognizes the right of Informed Consent, as does the fundamental law of many nations. In the USA there is a federal statute applying Informed Consent to medical experiments and IRBs (Institutional Review Boards).

Significantly, there is also the UN Declaration on BioEthics, negotiated in Geneva, that uses language similar to the Nuremberg Code and clearly applies to both treatment and experiment: 

Article 6 – "Consent – 1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice. 2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law." 

Article 28 – "Nothing in this Declaration may be interpreted as implying for any State, group or person any claim to engage in any activity or to perform any act contrary to human rights, fundamental freedoms and human dignity…"[2] 

The Common Law has recognized the right to Informed Consent for at least a century.

“Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.” [3]

And nearly a hundred years later, the US Supreme Court reiterated the legal principle: even a “…diminished expectation of privacy does not diminish the... privacy interest in preventing a government agent from piercing the... skin. And though a blood test conducted in a medical setting by trained personnel is less intrusive than other bodily invasions, this Court has never retreated from its recognition that any compelled intrusion into the human body implicates significant, constitutionally protected privacy interests…” [4]

The right of Informed Consent is recognized in time of war and in time of peace; for medical treatment (including the alleged preventative intervention of vaccination) and for medical experiment; for adults and children; for all humans everywhere and at all times.

Ralph Fucetola JD
Natural Solutions Foundation
Trustee and Counsel

Further information:

[3] Schloendorff v. Society of New York Hosp.,105 N.E. 92, 93 (N.Y. 1914)
[4] Missouri vs McNeely, 569 US _ (2013)

Tuesday, October 13, 2015

Does Candidate Trump Love Health Freedom?

I replied to a point on

So, does Mr. Trump really "love" the TEA Party as he says he does?* If he does he will love our Core Values and core issues.

Since Informed Consent is the defining issue of the 21st Century, and our right to choose health care alternatives is being heavily restricted by govt policy, what does Mr. Trump propose? A single payer health care (rather, illness control) system. Replace Obamacare with Trumpcare.

One of the main issues that moved the TEA Party forward from being just the worthy successor to the Tax Payers Movement of the '70s and 80s and becoming a powerful political movement was Obamacare (another being Audit the Fed).

Trumpcare reminds us that Romney lost because there was not a fiat dime's difference between his Romneycare and Obamacare, leading to 3 million 2008 (G)OP voters not voting in the presidential portion of the ballot in 2012 (but electing a (G)OP majority in both House and Senate).

Does the (G)OP get the message? They cannot win the presidency without TEA Party support.

Does Trump get the message? He will not get TEA Party support unless he supports our Core Values.

[As an aside, let me say that the primary issue I'm personally involved in at the present time is the issue of Informed Consent (to vaccination). Trump takes the pro-liberty position on that: govt has no legitimate power to force anyone to undergo any medical intervention. So I like Trump on that (to me) all-important issue. See my article on Informed Consent here: ]

Back to the issues upon which we all must disagree with Trump, where he has to "compromise" with US to get TEA Party support. Telling us he "loves" us is NOT enough.

IMHO, here is what he has to say to get TEA Party support; if he fails us in these issues, we MUST oppose him. These are the TEA Party Core Values and we will not support any politician who flaunts them.

1. Constitutional Republic

He must make it clear that he will obey the Constitution in its Original Intent, unless formally amended.

He must make it clear that he will sign a wholesale repeal of the Obama Regulations and Executive Decrees on inauguration day. Like Reagan did, he must be ready to abrogate unlawful executive authority from Day One.

He must acknowledge that there is not provision in the Constitution for a Central Bank. The Fed Reserve must go and we must return to Constitutional Money. Will he even acknowledge that there is an issue with the FRN fiat "money"? This must be a core TEA Party litmus test.

Any candidate who will not END the FED cannot have TEA Party support.

2. Free Markets

He must acknowledge the role of enterprise and private businesses. He must show the distinction between govt-entangled crony corporations that cooperate in the growing tyranny and truly free markets that are self-regulating through market forces. As health care should be.

He must acknowledge that socialism can never work. Obamacare will work no better than the old post office.. But, more importantly, he must acknowledge that the attempt by the Federal authorities to fix the price of money (interest rates) is doomed to failure. Just like "one payer" public schools are rapidly collapsing under the weight of bureaucracy and polypharmacy, one central bank, socialized media of exchange are not just doomed to failure, but will rob us of our prosperity (and have!).

Is Trump ready to stand for the Market and against the Cronies? I seriously doubt it.

3. Fiscal Responsibility

Has anyone in the TEA Party heard Trump utter a word about restraining Fed spending? Would a President Trump expect Congress to obediently raise the Fed Debt every time he wants to spend more? Maybe on "single payer health care" for the cronies in Big Pharma?

The Fed Debt has been frozen since this past March and the sky has not fallen. Will Trump call for a continuation of the present Debt Limit? Will he call for a steady reduction in the so-called "ceiling"??
Let's see if Mr Trump really loves the TEA Party.

Well TEA Partiers, are you ready to go on record by joining me in asking candidate Trump to be candid and either stand with us or stop telling us he loves us.

We love our Core Values. If he loved us, he'd share those values. Does he?


Monday, September 28, 2015


Ralph Fucetola JD

Informed Consent is a Fundamental Human Right
Protected Against Diminishment Through
Legislative and Administrative Agency Denial
of Philosophical or Religious Conscientious
Objections to Mandated Vaccination.

In order vindicate International Humanitarian Law regarding Informed Consent to any and all medical interventions, including vaccination, even during any declared local, national or international Health Emergency, the right to refuse any vaccination must be respected, whether that refusal is grounded in philosophical, medical, religious or no reasons at all.

 The Bill of Rights’ Speech, Privacy and Association Rights underpin Informed Consent.  The United States Code recognizes Informed Consent in Section 3512 of Title 19 and specifically, 19 USC 3512(a)(1) and (a)(2). 

This implements the general law as applied to the protection of human life, mandated, in the instance of vaccination, by the United States Supreme Court in the case of Jacobson vs Commonwealth of Massachusetts[1].

In 1914, Judge (later Supreme Court Justice) Benjamin Cardozo validated the concept of voluntary consent when he noted that every human being has a right to decide what shall be done with his or her body, deeming medical intervention without Informed Consent an unlawful trespass.[2]

Federal Regulation acknowledges Informed Consent for formal Institutional Review Board (IRB) overseen experimentation.[3] The recognition of the application of Informed Consent during the less formal “final stage” of experimentation on drugs (including vaccines) released to the public is not adequately implemented by law or regulation, “…Phase 4 trials are conducted after a product is already approved and on the market to find out more about the treatment's long-term risks…”[4]

With regard to all communications about health care decisions, the members of the public have the right to make informed consent decisions, even if a decision may be considered a “bad” decision by the Government. The Supreme Court indicated, in Thompson v Western States[5]:

"We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information."

“Section 3512. Relationship of [trade] agreements to United States law and State law, of Title 19 of the United States Code:

(a) Relationship of agreements to United States law
(1) United States law to prevail in conflict...
(2) Construction: Nothing in this Act shall be construed –
(A) to amend or modify any law of the United States, including any law relating to -
(i) the protection of human, animal, or plant life or health,
(ii) the protection of the environment, or
(iii) worker safety, or
(B) to limit any authority conferred under any law of the United States, including section 2411 of this title, unless specifically provided for in this Act.”[6]

Additionally, the Statutes authorizing the various Agencies contain general provisions that support the actions requested herein. Federal Law includes provisions that grant the Cabinet Secretaries broad authority to promulgate rules and regulations “necessary to carry out the Act[s].”

The United States is bound to observe the Nuremberg Code by virtue of the Subsequent Nuremberg Trials[7] and subsequent exacting of justice through penalties, including the death penalty. The Geneva Conventions[8] require that the United States be bound by these international humanitarian principles. Thus the United States is treaty-bound to implement fully Informed Consent.

Even in an emergency situation the Government Agencies involved must take a pro-active role in the full implementation of Informed Consent without “the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion…”[9] The public has a right to know, and the governments on the federal and state levels have an obligation to provide, clear information regarding the Informed Consent, to the end that government approvals, requirements, mandates and recommendations are understood to be subject to the Right of Informed Consent. Intervention by the courts must vindicate this Right.

Legitimate Government Regulation

Government Agencies have No Legitimate Interest
in Promoting FDA-Approved Vaccination Mandates
in Violation of Informed Consent.

In the case of State v Biggs (46 SE Reporter 401, 1903) the North Carolina Supreme Court dealt with a person who was advising people as to diet, and administering massage, baths and physical culture. In the Biggs case, the defendant "advertised himself as a 'nonmedical physician'... [and] held himself out to the public to cure disease by 'a system of drugless healing'..." p.401. That Court held that there could be no "state system of healing" p.402 and while "Those who wish to be treated by practitioners of medicine and surgery had the guaranty that such practitioners had been duly examined...those who had faith in treatment by methods not included in the 'practice of medicine and surgery' as usually understood, had reserved to them the right to practice their faith and be treated, if they chose, by those who openly and avowedly did not use either surgery or drugs in the treatment of diseases..." p.402.

There is no compelling government interest in controlling people associating together for the improvement of their well-being. 

The North Carolina Supreme Court concluded, nearly a century ago in 
State v Biggs, supra., at p.405: 
"Medicine is an experimental, not an exact science. All the law can do is to regulate and safeguard the use of powerful and dangerous remedies, like the knife and drugs, but it cannot forbid dispensing with them. When the Master, who was himself called the Good Physician, was told that other than his followers were casting out devils and curing diseases, he said, 'Forbid them not.'" (p.405).
 FDA approved drugs, including vaccines, remain in an experimental state, which the FDA calls “Phase 4” of the clinical trials system.[10]
Unless affirmatively and effectively asserted an individual’s Fundamental Right to Informed Consent, the legal ability to resist unwanted medical interventions, such as vaccines and other invasive techniques, may be ignored by the medical system under government directive. Based on the ancient legal principle that “silence is acquiescence”[11] martial law or medical emergency authorities may presume that you consent to even experimental medical interventions, as we saw imposed by WHO dictum during the 2014 Ebola Panic[12]. The same is true of medical practice in “ordinary times”.

After the horrors of the Second World War, including the murder and abuse of millions with the complicity of the “health care” authorities of various warring parties, the international community developed conventions and declarations to the end that “Never Again!” would – or could - the health system or health professionals be used to harm either individuals or whole populations. Those prohibitions and protections remain binding today.

A key element in the international protections secured by the Allied Victory and subsequent codification of health-related international law was recognition that no person could be forced to accept any medical intervention that was contrary to conscience and that all medical interventions were to be carried out only with fully informed [and therefore meaningfully willing] consent.
This has been international law for millennia, starting with the Hippocratic Oath in which doctors swore “I will take care that [my patients] suffer no hurt or damage” and
“Nor shall any man's entreaty prevail upon me to administer poison to anyone…:[13]

Among the Post World War II protective codifications were the Universal Declaration of Rights, Geneva Declaration[14]and the Nuremberg Code which state, concerning the rights of all human beings and the obligation for ethical action by health personnel:

“Everyone has the right to life, liberty and security of person… No one shall be subjected to … inhuman or degrading treatment… Everyone is entitled in full equality to a fair and public hearing by an independent and impartial tribunal, in the determination of his rights… No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence…”[15]

“I WILL NOT USE my medical knowledge to violate human rights and civil liberties, even under threat…”[16]

“The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make an understanding and enlightened decision.”[17]

This salutary development of international law has continued with international standards promulgated, such as the UNESCO Universal Bioethics Declaration, UNESCO Universal Bioethics Declaration[18] about which it has been said:

Even apart from article 7 of the ICCPR, ethical requirements for informed consent before medical or scientific treatment probably constitute international law as involving “general principles of law” under article 38 (1) (c) of the Statute of the International Court of Justice. The reference to “civilised nations” in this context could well introduce an ethical requirement to such evaluations that many contemporary developed nations may fail.[19]

Defining Informed Consent

“Informed consent is a process for getting permission before conducting a healthcare intervention on a person… In the United Kingdom and countries such as Malaysia and Singapore, informed consent in medical procedures requires proof as to the standard of care to expect as a recognized standard of acceptable professional practice (the Bolam Test), that is, what risks would a medical professional usually disclose in the circumstances (see Loss of Right in English law). Arguably, this is “sufficient consent” rather than “informed consent.” … Medicine in the United States, Australia, and Canada take a more patient-centric approach to ‘informed consent.’ Informed consent in these jurisdictions requires doctors to disclose significant risks, as well as risks of particular importance to that patient. This approach combines an objective (the reasonable patient) and subjective (this particular patient) approach.”[20]

Where there is no recognition of the legal duty to obtain informed consent, the individual or guardian must assert the Right or it may unlawfully assumed or deemed to have been waived. International Humanitarian Law is clear: without clear, affirmative, memorialized informed consent, it must be concluded that Informed Consent has been withheld.

The essential importance of asserting the Right to preserve it is shown by the 2013 US Supreme Court case of Missouri vs McNeely, where the warrantless extraction of blood was ruled illegal as the defendant “refused to consent.” Had McNeely remained silent, the blood test would have been allowed.[21]

The Court opined,
 “…diminished expectation of privacy does not diminish their privacy interest in preventing a government agent from piercing their skin. And though a blood test conducted in a medical setting by trained personnel is less intrusive than other bodily invasions, this Court has never retreated from its recognition that any compelled intrusion into the human body implicates significant, constitutionally protected privacy interests…” (page 15; emphasis added).
If the removal of blood “implicates significant, constitutionally protected privacy interests…” it is fair to assume that other invasive medical techniques including the introduction of vaccine toxins into the body that have been held to be “unavoidably unsafe”[22] will also give rise to such concerns.
The Constitution of the United States recognizes certain Rights held by people and delegates certain limited Powers to the government. Without clear respect for those Rights, the judicial system and the administration of government will fail to protect the truly fundamental interests of civil society, including the Right to Informed Consent.

An earlier Supreme Court understood this, when in 1905 in Jacobson v Massachusetts, the Court declared the judicial power to extend to protecting people from forced vaccination.

While giving due deference to the State authorities, the Supreme Court reserved for the Federal Courts the right to intervene in matters where health and life may be at stake:

…if it be apparent or can be shown with reasonable certainty that he is not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death.”  [Emphasis added.][23]

In a regime of verbal obscuration of fundamental Right, only the clear assertion of the Right will prevent degradation of the Right “by a thousand (bureaucratic) cuts…” If McNeely had not engaged in protected speech stating he did not consent, the taking of his blood would probably have been allowed.

The question then becomes, “How is one to effectively assert the Right to Informed Consent, enshrined in International Humanitarian Law, for oneself and those over whom one has guardianship?” Thus, there is a need for a clear Regulation that protects the Right whether exercised by Advanced Medical Directive or otherwise, in situations that do not involve a formal IRB.

The Government Action Imposes an
Unconstitutional Condition
on the Constitutionally Protected
Right to Informed Consent

The well-established law of Unconstitutional Conditions has particular relevance in any case before the Court where a party is faced with the harsh choice of vaccinating the child or having the child banned from the public benefit of public education, required by law for all children. The regarding school vaccine mandates where the parent is faced with with denying her own expressed religious beliefs (beliefs thereby protected under the First Amendment) or denying the child access to public education.

This is precisely the type of duress condemned by the Nuremberg Code.

It is also clearly conditioning the acceptance of a public benefit on the surrender of a right.

The law of Unconstitutional Conditions is well-represented in the jurisprudence of the United States Supreme Court and the Courts it oversees. We do not pretend to more expertise on the issue than the Court’s own pronouncements.

The Supreme Court first mentions the phrase in Doyle v. Continental Ins. Co., 94 U.S. 535, 543 (1876) (Badley, J., dissenting) “Though the State may have the [police] power… it has no power to impose unconstitutional conditions…”

In Frost v Railroad Commission, 271 U.S. 583,594 (1925) the Court held it “would be a palpable incongruity to strike down an act of state legislation which, by words of express divestment seeks to strip the citizen of rights guaranteed by the federal Constitution, but to uphold an act by which the same result is accomplished under the guise of a surrender of a right in exchange for a valuable privilege which the state threatens otherwise ot withhold… it may not impose conditions which require the relinquishment of constitutional rights.”

More recently the Court applied the principle to First Amendment speech rights arising from expressive association issues directly in point here where First Amendment protected religious expressive association is involved. In Speiser v Randall, 357 U.S. 513, 526 (1958) 
“In practical operation, therefore, this procedural device must necessarily produce a result the State could not command directly. It can only result in a deterrence of speech which the Constitution makes free.”
And finally, of particular note is the statement in Perry v Sindermann, 408 U.S. 593, 597 (1972):
“…this court has made it clear that even though a person has no ‘right’ to a valuable governmental benefit and even though the government may deny him the benefit for any number of reasons, there are some reasons upon which the government may not rely. It may not deny a benefit to a person on a basis that infringes his constitutionally protected interests – especially, his interest in freedom of speech. For if the government could deny a benefit to a person because of his constitutionally protected speech or associations, his exercise of those freedoms would in effect be penalized and inhibited. This would allow the government to “produce a result which (it) could not command directly.”
It was not for no reason that the Founders grouped together in the First Amendment Religious Liberty, Speech, Assembly and Petition Rights. Rather, these stated Rights have been held by the Supreme Court to be, together, “expressive association.”


We consider meaningful Informed Consent to be the sine qua non of humane health care required by International Humanitarian Law. Truly, no free person should be forced to consent to mandated medical interventions.

There can hardly be a more fundamental or central freedom issue than whether agents of government, or persons acting under color of state law, as are those who act to abrogate conscientious objections to mandated vaccines, can force a free and competent adult (or a child under the protection of such adult) to receive any medical treatment. That the treatment may be vaccination, which is not merely experimental and (sic) preventative but uninsurable and, according to many courts, “unavoidably unsafe” gives greater emphasis to the unconscionable personal sacrifice the individual is mandated to make. Such a mandate is inconsistent with status as a free person, rather than a slave. 

No free society can tolerate any such imposition.

 “Liberty is to the collective body what health is to every individual body. Without health no pleasure can be tasted by man; without liberty, no happiness can be enjoyed by society.” – Thomas Jefferson[24]

[1] Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905) wherein the Supreme Court reserved for the Federal Courts the right to intervene in matters where health and life may be at stake: “…if it be apparent or can be shown with reasonable certainty that he is not at the time a fit subject of vaccination or that vaccination, by reason of his then condition, would seriously impair his health or probably cause his death.”  [Emphasis added.]
[2] “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.” - Schloendorff v. Society of New York Hosp., 105 N.E. 92, 93 (N.Y. 1914)
[5] Thompson v. Western States Medical Center - 01-344, decided on April 29, 2002 - 535 U.S. 357)
[6] 19 USC 3512
[10] “Phase 4 trials are conducted after a product is already approved and on the market to find out more about the treatment's long-term risks, benefits, and optimal use, or to test the product in different populations of people, such as children.” Downloaded July 8, 2015:
[11]qui tacet consentire videtur” – “Thus, silence gives consent.” Sometimes accompanied by the proviso "ubi loqui debuit ac potuit", that is, "when he ought to have spoken and was able to".
[14] The Geneva Conventions comprise four treaties, and three additional protocols, that establish the standards of international law for the humanitarian treatment of war. The singular term Geneva Convention usually denotes the agreements of 1949, negotiated in the aftermath of the Second World War (1939–45), which updated the terms of the first three treaties (1864, 1906, 1929), and added a fourth.
[18] which provides: Article 6 – Consent - 1. Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice. 2. Scientific research should only be carried out with the prior, free, express and informed consent of the person concerned. The information should be adequate, provided in a comprehensible form and should include modalities for withdrawal of consent. Consent may be withdrawn by the person concerned at any time and for any reason without any disadvantage or prejudice. Exceptions to this principle should be made only in accordance with ethical and legal standards adopted by States, consistent with the principles and provisions set out in this Declaration, in particular in Article 27, and international human rights law. Article 28 - Nothing in this Declaration may be interpreted as implying for any State, group or person any claim to engage in any activity or to perform any act contrary to human rights, fundamental freedoms and human dignity… [Emphasis added]
[22] See Justice Sotomayor’s 2011 dissent in Bruesewitz vs Wyeth, where she discusses the history of “unavoidably unsafe.”
[23] Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11 (1905)