Wednesday, December 14, 2016

US Govt Attacks Informed Consent

2016: The Empire Struck Back:
Three Brutal Govt Attacks on Informed Consent

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During the final months of 2016, and the dying days of the Obama Administration Democrats and Republicans joined together to attack our universal right to Informed Consent, a right which General Bert Stubblebine, President of the Natural Solutions Foundation has called "the defining issue of the 21st Century..."  

What were these dastardly attacks? Three bureaucratic maneuvers in the Federal Govt.  

First, CDC proposed a new Quarantine Regulation, giving the public until mid October to register objections. Thousands did so, joining Natural Solutions Foundation condemning the proposed regulation which explicitly states the unlawful proposition that the "consent of the individual is not a prerequisite..." See:  

Second, on November 4th, just before the election, lame-duck President Obama issued an Executive Order seeking to make the falsely-named "Global Health Security Agenda" American Pubic Policy. The basic "idea" of GHSA is that dead people don't get sick. Yes, just that stupid and just that evil. See:  

Third, just last week, the lame-duck Congress, as it fled Washington for the Holidays, adopted, with bi-partisan Republican and Democrat support, the falsely-named "21st Century [sic] Cures Act" wherein, in addition to all sorts of welfare for Big Pharma, there is a clause that illegally says the drug companies do not have to get your Informed Consent before including you in a drug test if less than 8,000 [!!] people are involved. 

Think mass spray vaccine experiments without consent, in complete violation of international restrictions. Endorsed by both Houses of Congress and both ruling parties. See:  

And what about the fourth attack that could kill General Bert? He has been denied supplemental nutrition for 11 days, after having been permitted to have the medical food his admitting physician authorized for 70+ days. This is being done, why? Because the Hospital Policy says only FDA approved medicines can be used through a feeding tube and there is no provision in law for FDA to approve dietary supplements. 

Catch 22. You're dead if you do, or if you don't.  

Well, without letting too much information out, let us say that we are not going to let an unlawful Hospital Policy (apparently the Hospital never heard of the Orphan Drug Act of 2005) stop General Bert from receiving the nutrition he has clearly expressed his consent to receive. And we are going to hold the Hospital accountable for stopping that supplemental nutrition without his Informed Consent.  

It is all about Informed Consent. That's what Health Freedom means. That's what Dr. Rima and General Bert have fought for -- for the past dozen years. We need your help to PUSH BACK and preserve your precious right to Informed Consent.  

[1] Tell the Trump Transition Team to protect Informed Consent by backing Natural Solutions Foundation's call for a law to enforce Informed Consent. It's called the FIRM Act (Freedom of Informed Refusal of Medication) and it authorizes law suits against any government agent or private party that violates, or attempts to violate the right of Informed Consent. Tell Trump here:  

[2] Natural Solutions Foundation urgently needs your donations to allow us to do what we must do to legally protect Informed Consent. General Bert and Dr. Rima are ready to stand up with you, before our representatives, and in Court if need be, to vindicate the right of Informed Consent and your access to vital nutrition, to achieve and maintain health.

I would appreciate it if you would donate here now:

It's do or die. Which do you choose?

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. Because the vaccine is patented (and federal agencies are required by call law to accept allowed patent claims as "substantiated"0 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

2018 Election Update: Libertarian Party Now the Major Third Party

---------- Original Blog ----------

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.]