Toward an Ethics of Sustainability

Sustainability, Ethics and GHSI Tyranny

"Be harmless..." ("Do no harm.") has always been the first rule of humane ethics. Does it remain a valid starting point? Yes, to be either accepted or denied as the first point in the argument. I invite the readers to reach their own conclusions and join in this discussion of the Ethics of Sustainability.

IMHO, any ethical stance starts with a recognition of individual responsibility for individual actions, especially when that human action is taken "on behalf of" corporate fictions, such as a public agency, a business entity, a non-governmental organization or whatever. The collective fictions have no ethics apart from the ethical -- or unethical -- actions of the actual humans who act "on behalf of" these fictions.

It is not the "Majesty of the State" that depresses the button that sends the drone exploding into the wrong wedding party... It is one fallible individual in a darkened room, thousands of miles from the mayhem -- an individual who has separated him or herself from consciously and conscientiously chosen human action.

But that is, of course, the extreme example. Closer to home are simpler ethical decisions, many of these revolving around issues involving sustainability. Example: how carefully should I attend to reusing, re-purposing and recycling the garbage my lifestyle generates?

What is "sustainability?"

1. (economics) ability to be sustained, without causing problems such as inflation
2. (ecology) (of economic development, energy sources, etc) ability to be maintained at a steady level without exhausting natural resources or causing severe ecological damage*

While a rather straight-forward concept, akin to, if not "making a profit" at least "not making a loss" the idea of "sustainability" has become a political rallying cry for those who seek a restrained and restricted future for greatly reduced humanity -- in the name of "sustaining" a pre-industrial natural order that has been gone for centuries.

Or, as one of our sustainability mentors, Fr. Godfrey tells us, humanitarian projects need to be done "with passion, perfection and profitability..."**

If the globalist elite's plan to "sustain" nature requires the early deaths of 90% of all humans alive right now, we have a clear example of unethical "sustainability." Mega-death is not conducive to sustaining life! To believe otherwise is to wander into the nightmare of psychopathology.

I do not exaggerate! Take, for example, the Global Health Security Initiative (GHSI) -- one of those "public/private partnerships" beloved of the globalist elite. This UN sponsored agency seeks to prevent pandemic disease by reducing the human population, as the most cost-effective means to that end. See: http://tinyurl.com/EndGHSI.

This is, of course, quite mad!

In this GHSI initiative we see the true (sic) moral attitude of the globalist elite. We see the economics not of the Misean Market, seeking to satisfy consumer demand, but rather of Hitler's Economics Minister Speer who oversaw the Nazi State devouring the accumulated wealth of conquered Europe. Like the Roman Imperial State, the globalist elite are nothing but violent looters.

We, the human population, in the expressed view of the globalist elite,*** are viewed as chattel to be disposed of as the elite finds convenient and economical.

Another catch-word for this hideous process is "Agenda 21" - the globalist depopulation agenda.

True ethics seeks to sustain humanity on this, our home world, while addressing social problems with natural solutions. 

For example, contrary to GHSI, the best natural solution for pandemics is better nutrition and natural remedies like Nano Silver (see: www.DrRimaKnows.com) not genomicide engendered by the technologies of death: GMOs, drug/vaccine toxins, "phude" toxins, radiation and geo-engineering!

Thus, we seek an ethics of sustainability that recognizes the primacy of the individual and that person's inalienable rights. This is, of course, the opposite of collective claims to restrict, restrain and reduce individual choice.

As autonomous, independent human actors we have a choice. We can accept the myth that to sustain this planet's ecosystem in a particular configuration, the elite must be allowed to destroy humanity, or we can insist on our prior right to live in a world that allows freedom of action, so long as one does no harm to the equal rights of others.

As the great 20th Century praxiologist, L. von Mises taught, "All human action is predicated on dissatisfaction..." (see: www.Mises.org). We can achieve a free and sustainable world.

Man's freedom to choose and to act is restricted in a threefold way. There are first the physical laws to whose unfeeling absoluteness man must adjust his conduct if he wants to live. There are second the individual's innate constitutional characteristics and dispositions and the operation of environmental factors; we know that they influence both the choice of the ends and that of the means, although our cognizance of the mode of their operation is rather vague. There is finally the regularity of phenomena with regard to the interconnectedness of means and ends, viz., the praxeological law as distinct from the physical and from the physiological law. 

The elucidation and the categorical and formal examination of this third class of laws of the universe is the subject matter of praxeology and its hitherto best-developed branch, economics. The body of economic knowledge is an essential element in the structure of human civilization; it is the foundation upon which modern industrialism and all the moral, intellectual, technological, and therapeutical achievements of the last centuries have been built. It rests with men whether they will make the proper use of the rich treasure with which this knowledge provides them or whether they will leave it unused. But if they fail to take the best advantage of it and disregard its teachings and warnings, they will not annul economics; they will stamp out society and the human race.****

The moral choices remain as stark today as they were just after WWII when Mises penned these conclusions.

We live in a lawful Universe where the human mind can understand means and ends. When we make choices among means to attain ends, those choices are further restrained by the imperative that we each individually act ethically, for that is the only way we can live in an ethical society.

--------------------

* http://www.collinsdictionary.com/dictionary/english/sustainability
** http://youtu.be/IOhBtHpCtAg
*** See Dr. Rima's video on the Globalist Agenda: http://youtu.be/_gWmVtn5JsA
**** http://mises.org/humanaction/chap39sec3.asp

The "Folly of '14" -- Consensus Foreign Policy and Restoring the Constitutional Republic

Tiny URL to this page: http://tinyurl.com/Folly1914

"The only way to avoid continuing collapse is to finally reject an interventionist foreign policy, stop bailing out and subsidizing politically powerful industries, and restore a free market in money." Ron Paul*
 
 “Peace, commerce, and honest friendship with all nations —
entangling alliances with none.” Th. Jefferson **

 The core political question that Americans must ask in determining whether this country shall be an Oligarchic Empire or a Constitutional Republic is whether the "consensus" interventionist foreign policy of the "two" US tax-eater parties (the (G)OP and the Demos), followed for over a hundred years, has made the world safer for human life; has made Americans freer and more prosperous?

On all three points the lesson of history is clear: "No!"

Now we find the "Great Powers" caught in the same type of entangling alliances that led to the "Folly of '14" (that's 1914)***. 

Understandably, after the defeat of some of the totalitarian powers in WWII, the elites would enshrine "territorial integrity" as part of the system of world governance that has, it must be said, avoided nuclear holocaust, so far. That system made "sacred" the existing national borders, even, where, as with the colonial borders of Africa, such state-boundaries led to endless civil war and horrendous loss of life.

Today we see the "Great Powers" ludicrously supporting a revolutionary govt in Kiev that does seem to have some extreme nationalist participation, and further, supporting the borders that then Soviet dictator N. Khrushchev assigned to Ukraine SSR in 1955, primarily to dilute Ukrainian nationalism.

And all the while, the USA spends more than half of all the funds squandered on this planet on warfare. And borrows 40% of that... "Trillions and trillions wasted..." Ron Paul

The Folly of '14 is about to be repeated, unless we have a change of heart. And a change of foreign policy in Washington.

One foreign policy alone is worthy of a free Republic: strict non-intervention in the affairs of other state-actors. This was the policy of the Founders of the Constitutional Republic and it remains the only sane policy.

The interventionist foreign/war policy initiated well over a century ago with the invasion of Mexico, continued by Lincoln, the Roosevelts and Wilson, and by all recent Presidents, whether "liberal" or "conservative" -- (G)OPer or Demo -- has destroyed the once Good as Gold Dollar and is destroying our prosperity, our freedoms, and millions of victims around the world.

Americans bear a heavy responsibility for having allowed the Federal Establishment to become so war-like. "Wars" against poverty, drugs, terrorism... war against anyone resisting the power of that Establishment.

We now see the predictable world-wide blow-back, hurting us in so many ways. We further see the fruit of the interventionist foreign policy in the militarization and nationalization of our local police, resulting in a horrific increase in the incidents of civilians killed by out-of-control police in the United States. It is urgent that local police return to their role as lawful peace officers.

We are the only ones who can restore the Republic.
 

Soon it will August '14 again... another election... Maybe another war. Folly, folly, folly ...

-----------------

* http://ronpaulinstitute.org/archives/featured-articles/2014/may/04/why-we%E2%80%99re-no-longer-number-one.aspx

** http://www.lewrockwell.com/2004/09/laurence-m-vance/peace-commerce-and-honest-friendship/

** I first saw this phrase, "The Folly of 1914" in Mises' Memoirs - www.mises.org

This blog was also posted here:
http://www.livefreeblog.com/the_folly_of_16_consensus_foreign_policy_and_restoring_the_constitutional_republic

Health Freedom Requires a Revolution

True Health Freedom
Requires a Revolution, Not Just Reform!
Twelve Thousand Dead Babies Demand No Less!

Gary Johnson, former New Mexico governor and the 2012 Libertarian candidate for president, established Our America Initiative (OAI) to give voice to the people’s yearning for liberty. I spoke at a Players Club appearance by him late last year. More about that here: http://vitaminlawyerhealthfreedom.blogspot.com/2013/10/vitamin-lawyer-to-appear-with-gov-gary.html.  

I’ve been asked to join the Health Freedom Advisory Board for OAI and happily accepted, in order to give voice to Global Health Freedom: http://GlobalHealthFreedom.org.

People in the health freedom orbit have been reaching out in several directions in recent months. The organic farmers’ and buyers’ clubs, the autism community, even our Amish neighbors, are all finding ways to work together on issues of health, food and freedom. I think libertarians need to play a central role in bringing a powerful coalition together, not just to tinker with our nationalized health care system that is clearly failing to provide health care or contain monopolistic pricing. 

Over a hundred thousand Americans die each year from FDA-approved, properly prescribed drugs, and  over 12,000 American infants are expected to die this year from the grossly mis-named Shaken Baby Syndrome. These children are actually being killed by severe Vaccine Adverse Reactions. See: http://tinyurl.com/SBShoax

No, tinkering with Federalized “health care” will not save the babies. Only a revolutionary change of heart will make that difference.

Our goal must be a free market in health care. That means all the crony corporatists in the illness-management industry, all the pushers of deadly drugs and vaccines, all the government bureaucrats growing fat on human suffering must just “Get out of my way...” as John Galt famously said.

We can start with the bloated, overbearing bureaucracy that is the Food and Drug Administration. When this alphabet agency was formed there might have been some excuse for Federal regulation of both foods and drugs by the same agency (leaving aside the total lack of Constitutional authority for such usurpation of the States’ Tenth Amendment Police Power), since most medications were food-sourced. Today, with wholesome food and natural food remedies the main competitor of Big Pharma, and with the FDA a mere creature of the crony drug pushers, there is no excuse. Just like the DEA and the EPA were spun-off the FDA, food regulation, insofar as it exists on the Federal level must be divested from the FDA.

That is a first step. Our generation’s Leader of the Opposition, Dr. Ron Paul, offered a number of powerful bills in Congress when he served there that would make a real difference for health freedom. I wrote about these here: http://drrimatruthreports.com/112th-congress-pending-health-freedom-bills/

Dr. Paul’s example is an inspiration to us all. He understands the proper Constitutional limits on Federal “regulation” (which means to “make regular” not to “forbid”) under the Interstate Commerce Clause. Here is how he applies that to the Raw Milk health freedom issue, in an interview I recorded a couple years ago: http://youtu.be/0WhlwOojjF4

Second step: a 43% FDA spending cut - every govt department needs to cut back to a balanced budget level. This means real spending cuts, not just a decrease in the rate of increase.

MD Licenses Should Not Limit Therapy - I've told my physician clients for a long time, "a license is a limitation." But now, we need to champion the good doctors and make sure they are free to practice the best medicine, and are able to offer Natural Solutions that lead to real health.

Malpractice Protection for MD Charitable Work - and I wouldn't mind seeing that concept extended. In my home state of New Jersey there is a strong charitable tort exemption.

Promote the use of Medical Foods instead of dangerous prescription drugs: http://vitaminlawyerhealthfreedom.blogspot.com/2014/03/medical-foods-get-regulatory-boost.html -- Medical Foods are intended for the dietary management of medical conditions. State Medical Boards need to get with the times and free the good doctors to provide the best, natural therapies.

Rather than convoluted religious, medical and philosophical exemptions, end all vaccine mandates so people are free to make their own decisions. This simple step would save thousands of lives every year and remove the specter of Vaccine Induced Autism and Infertility from future generations. See: http://drrimatruthreports.com/what-if-autism-is-not-an-unintended-consequence/

The same must apply to all medical substances and procedures. High CBD Hemp Oil offers hope to many. It must remain lawful, http://tinyurl/CBDHempOil. Truly informed consent is necessary; we need to strongly support NGO initiatives like the Helsinki Declaration on medical experimentation.

Dialogue regarding the economics of health care in the post-ACA (“Obamacare”) world must continue. Coming together on health issues requires coming together on the financial issues involved. We must oppose the ACA as a bailout for Big Pharma and Big Insurance.

And of course the primary concern: the ACA is just a stepping stone to nationalized health care, which must become health care rationed by political determination (we all remember the special Section D in Soviet Hospitals, reserved for the partyarchy). In such a system, not only are the types of therapies I favor (holistic, natural remedies and noninvasive procedures) likely to be forbidden, but all that is not forbidden will be required. Show up at an ER and the first question will be, are all your CDC recommended shots up to date?

And while we mention the USSR, I urge support for the Health Freedom initiative to let health care providers "go on record" refusing to become complicit in political medical abuse: http://www.HealthKeepersOath.org

The Health Keepers Oath must be our response to the most evil health care development of the new millennium: the so-called “Global Health Security Initiative” (GHSI) which is touted as a “public/private partnership” among the usual suspects: WHO, the US and other governments, and the crony NGOs that push dangerous drugs and vaccines world-wide. Whenever the word “security” is mentioned, watch out for your freedom!

GHSI is Global Medical Tyranny. The primary “theory” behind GHSI is that the most “cost-effective” way to prevent pandemics is to reduce world population! I kid you not, the global elite Fascists in charge of GHSI have quite openly published its Depopulation Agenda.

Dead babies, or babies never born, cannot be pandemic vectors. So, say the Elite, kill them!

Stand for health freedom and against the globalist depopulation agenda: http://tinyurl/EndGHSI .

There is much to do to re-establish health freedom as a primary human right. 

We must oppose all the crony corporatists and their allies in govt. We must work for a change of heart, a revolution in how people perceive their own autonomy. 

Freedom starts with the personal choice to be free.

http://www.drrimatruthreports.com/aboutus/accomplishments

Proud Anti-Vax! New Podcast Video

Be A Vaccine Refuser With Me!
ANTI-VAX & PROUD!

Here is a new video podcast featuring Dr. Rima and the Vitamin Lawyer.

http://www.youtube.com/watch?v=VWHHxW-pm8Q&feature=share&list=UUpgvIebAMVqdN8kvYxzLBfw

PC Tyranny and Speech about Health Freedom

www.HealthKeepersOath.org

"Political Correctness" - PC - is the statist dogma that certain speech, and speakers, may be proscribed by political authority whenever the speech is deemed "hurtful" to some specified group "protected" by the  dominant political power. 

In practice, this means at the whim of bureaucrats in govt, NGOs and crony corporations who have access to power. 

This is the antithesis of each individual's fundamental human right to Freedom of Expressive Association, and also, by the way, to the First Amendment to the US Constitution, for those under its protective jurisdiction. Even when couched in academic terms and practiced in the protected environment of the crony universities and institutions, this control ultimately rests on the coercive power of the state, even if initiated by supposed non-state actors.

In the past few days a major media outlet, the Wall Street Journal [1] broke the story that YouTube has now established "Super Flag" users who can expedite the removal of "offending" videos... "Down the memory hole..." as they said in the distopian novel 1984 (and just a few decades late in coming) 

But of course, nothing to worry about, say the UK censors: "British officials say they use the program to refer videos to YouTube that they believe have violated the U.K.’s Terrorism Act. ... More than 90% of the videos identified by super flaggers are either removed for violating guidelines, or restricted as not appropriate for younger users..."

In the few days since the exposure of this control system we have seen increasing reports of videos posted by critics of this govt or that govt disappearing, without any opportunity to rebut the often absurd "terrorist" connection.

In recent months we have noticed an increasing attempt by crony corporatists and their journalist or academic toddies to extend the evil notion of PC speech control to issues of Health Freedom.

Even in so believed-to-be stalwart defenders of speech as Reason Magazine [2] and The Guardian Newspaper [3] , statements have appeared calling for banning "vaccine deniers" oe "vaccine refusers" or "anti-vax" ideas from posting rebuttals to pro-vaccination assertions from the cronies.

Speech about Health Freedom is under threat.

Of course principled defenders of free inquiry and expression continue to make the case, with passionate persuasiveness, as in this from JD Tuccille:

Let's allow that they do—and that a majority of scientists agree about man-made climate change and a host of other issues. Just when does the Tribunal of the Holy Office of the Inquisition meet to decide what is still subject to debate, and what is now holy writ? And is an effort to "undermine the public’s understanding of scientific consensus" always criminally negligent? Can it ever be simple scientific inquiry? Or even heroic? [4]

The history of PC Medicine, the official govt licensed and approved method for talking about and doing something about disease, is repeatedly pocked with examples of how very wrong govt medicine has been over the centuries. 

Without going back as far as the Herbalists' Charter of Rights [5] just look at the modern era.

Start with the Doctor in Vienna who was hounded from the profession for daring to suggest to his fellow physicians that they wash their hands... and many thousands of mothers and babies died over the following generation until hygienic practices slowed the spread of infectious diseases.[6]

Consider that somewhere around 50,000,000 Americans died of heart conditions between the time the world first learned of the relationship between Vitamin E and heart health [7] and when the medical profession, just recently, began to accept that this food is essential to heart health.

How can health-conscious people world-wide protect their access to "second opinions" -- to dissenting views, that may, as in the case of vaccines and other Genome Disrupting products of crony corporatism (see the Five Big Lies, www.DrRimaTruthReports.com) just save your life and the lives of those for whom you care.

It's not just about speech: it is about life.

www.HealthKeepersOath.org

The answer to PC Tyranny
Is to Speak Out.
Take the Oath!

Your health keepers have to understand the issue and confront it not just to keep truth safe, but to keep YOU safe and, ultimately, themselves.

If they are afraid to speak the truth to you about what you need, and what you do not need, about what is effective and what is not, because of PC and professional censorship, they cannot deal frankly and openly with your health and practice their arts properly.

How can they keep you safe and protect your life?  By taking the Health Keepers' Oath, www.HealthKeepersOath.org, and adhering to it.

By fearlessly speaking truth both to power AND to patients!

And if your health keeper will not do so, get a new one!  The sooner we stand up to the PC concept bullies, the sooner they will back off and find some other pit of madness in which to flail about.

Those who seek to impose PC Tyranny on Speech about Health Freedom are, at best, misguided "useful idiots" for the global elite's market control agenda, or are, at worse, intellectual thugs willingly supporting that coercive intent.

--------------------

[1]  http://blogs.wsj.com/digits/2014/03/17/youtube-enlists-trusted-flaggers-to-police-videos/
[2]  http://www.infowars.com/pseudo-libertarian-reason-magazine-calls-jenny-mccarthy-an-enemy-of-freedom-for-daring-to-question-vaccines/
[3]  http://www.theguardian.com/commentisfree/2013/oct/16/anti-vaccination-activists-should-not-be-given-a-say-in-the-media
[4]  http://reason.com/blog/2014/03/17/prosecuting-people-for-saying-stuff-you
[5]  http://vitaminlawyerarchives.blogspot.com/2014/03/the-herbalists-charter-and-modern.html
[6] http://publichealth.artsci.wustl.edu/handwashing
[7] Time, June 10, 1946, The Shutes and Vitamin E

This blog was also posted here: 
http://www.livefreeblog.com/pc_tyranny_and_speech_about_health_freedom

"Medical Foods" Get a Regulatory Boost

Back in May, 2013 when I wrote about Medical Foods on the Vitamin Lawyer Health Freedom Blog -

http://vitaminlawyerhealthfreedom.blogspot.com/2013/05/medical-foods-under-orphan-drug-act.html -

I had little material to work from. The term "Medical Food" was mentioned as early as the late 1990s in FDA enactments, and more formally defined in the 2005 Orphan Drug Act; that definition remains basic:

"…a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation....”  Section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) 

Starting later last year, FDA began reviewing the statute and the short, just several paragraphs, FAQs the FDA had issue on the topic the year after the Statute, although the comment period has been extended, as often happens with a controversial regulation offered under the Administrative Procedures Act.

The new regulations both broaden the class of health care givers who can recommend Medical Foods (by clarifying that Medical Foods are not subject to "prescription") and tighten-up what constitutes a Medical Food. There is clearly no requirement that only physicians provide the evaluation and recommendation for the use of Medical Foods.

Federal law continues to preempt state regulations of the use of Medical Food for the dietary management of medical conditions. This preemption is made more complete by the establishment of these further regulations, thereby further nullifying restrictions by state medical boards and legislation. For example there was a Medical Board regulation in New Jersey that forbid NJ licensed physicians from earning more than a ten-percent return from selling his patients dietary supplements, if the vitamins were "intended to treat disease..." But if intended for the dietary management of medical condition, the use of Medical Food is taken out of the category of "intended to treat disease" and the limits thereupon.

The Draft Guidance is located here:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/MedicalFoods/ucm054048.htm

The purpose of which is:

This guidance is intended to provide industry with a convenient place to find answers to frequently asked questions (FAQs) about medical foods.  The responses to these FAQs address common questions about the definition of and regulations for medical foods.  

Some of the significant points made in the Guidance relate, for example, to the question whether formal medical prescriptions are required. FDA answered that question with a direct "No."

The Guidance documents further define the use of Medical Foods:

...a medical food must be intended for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone.  

Elsewhere FDA reminds us:

Medical foods do not have to undergo premarket approval by FDA. But medical food firms must comply with other requirements, such as good manufacturing practices and registration of food facilities. Medical foods do not have to include nutrition information on their labels, and any claims in their labeling must be truthful and non-misleading.

http://www.fda.gov/forconsumers/consumerupdates/ucm047470.htm

Further restricting the category, we find the following language in the Guidance:

Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition, and all foods fed to sick patients are not medical foods.[3]  Instead, medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who is seriously ill or who requires use of the product as a major component of a disease or condition’s specific dietary management. 

And further:

FDA does not interpret either the Orphan Drug Act or FDA’s implementing regulations at 21 CFR 101.9(j)(8) to require that medical foods be made available by prescription.  Instead, the statute requires that a medical food be consumed or administered enterally under the supervision of a physician.  FDA considers this requirement to mean that the intended use of a medical food is for the dietary management of a patient receiving active and ongoing medical supervision (e.g., in a health care facility or as an outpatient) of a physician who has determined that the medical food is necessary to the patient's overall medical care.  The patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food.  FDA does not consider foods that are simply recommended by a physician or other health care professional as part of an overall diet designed to reduce the risk of a disease or medical condition or as weight loss products to be medical foods.

The new Guidance does not materially change the provisions for recommending Medical Foods by health care providers, but now seems to suggest that any qualified health care provider can recommend Medical Foods, so long as they are "administered" under a physician's "supervision" (as that word is defined in State law).

However, other Federal standards apply to the actual labeling and marketing of Medical Foods.

The FDA FAQs on medical foods, published in 2016, after this blog entry was originally posted, can be found here:

http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM500094.pdf

Third Party FDA GMP Virtual Compliance Audits

New Vitamin Lawyer Service: Virtual GMP Compliance Audits!

www.RegulatoryComplianceNetwork.com

Over the past couple months FDA "label owner" inspectors have been asking, "When did you audit your manufacturer for GMP compliance?" and then the agents add, "The FDA does not guarantee GMP compliance by manufacturers; that is your responsibility..."

Therefore, to better serve the natural nutritional market, I have created a Virtual Audit program where the Manufacturer takes me on a Skype video tour of the facility, meeting certain criteria that I have from the GMP regulations (a 194 point checklist).

 

I then prepare the full report, with images from the video; about 30 pages.

 

 

 

This service takes about 4 hours of my time so I can offer it to my current clients for a special intro educational investment of $997.00 (regularly $1,497).

Hope for Liberty: Three Opinion Polls Indicate Major Public Opinion Changes

Health and Food Freedom to Lead the Way?
The Tenth Global Health Freedom Anniversary!

Over the past several months three polls, two conducted by Gallop, Inc. [http://en.wikipedia.org/wiki/Gallup_(company)] suggest, IMHO, that a real "sea change" is occurring among American voters. These polls cover (1) Trust in Government, (2) Support for the "Two Party System" and (3) Freedom Threat Identification. We are seeing a powerful rejection of the status quo.

The polls, which have been conducted repeatedly, for decades, show a powerful change starting in late '06 and accelerating into the astounding results of the latest polls. Trust in government is gone. Support for the so-called "two" [tax-eater] party system has evaporated. Big government is seen by practically everyone as the biggest threat to our futures.

Here is the Poll summary images, posted here for comment.

TRUST IN GOVT

THIRD PARTY SUPPORT

BIGGEST THREAT

 A number of possible conclusions may be drawn from these astounding trends. Clearly there is a megaquake waiting in the political landscape. What we used to fear were only minority trends in favor of Liberty are becoming nearly universal opinions.

My concern here is how that extraordinary change in political consciousness will impact health and food freedom. With under 20% of the population "trusting" government, will people continue to support Big Govt coercive interventions such as mandated vaccines? Or mandated health insurance? Will people demand that crony govt finally get out of the way of heritage, non-GMO and organic farmers, co-ops and marketers?

This coming year is the Tenth Anniversary of the founding of Natural Solutions Foundation by Dr. Rima E. Laibow, MD and Maj. Gen. Bert Stubblebine (US Army, ret.) in 2004. It has been my privilege to work with them and the Foundation since shortly after its founding. The past decade has been amazing!

Nearly a hundred Accomplishments are chronicled here:

http://drrimatruthreports.com/aboutus/accomplishments/

Buoyed by a powerful tide rejecting Big Govt and its crony anti-health corporatist allies, we expect to see the sacred cows of illness and hunger control, the FDA, the EPA, the USDA, Codex, WHO and FAO, among others, come under increasing public scrutiny by a population battered with the Five Big Lies...

http://drrimatruthreports.com/5-big-lies/

WE WILL BE LIED TO NO MORE!

The time has come to take back control over our own health and food, and that of our families. The first step: make sure you are on the Health Freedom eList. Go here to join the list:

http://drrimatruthreports.com/action/step1/

Then make sure dr.laibow@gmail.com is "white listed" by your email provider. You will not receive the vital information we make available every week without volunteering for the eList!

The second decade of health and food freedom begins!

www.GlobalHealthFreedom.org

Ingesting: DSHEA-Required Dietary Supplement Delivery System

DSHEA-Required Dietary Supplement Delivery System: Ingesting

The Dietary Supplement Health and Education Act of 1994 (DSHEA) states, that a Dietary Supplement protected by the law is, in part, "...a product that - "§3(2)(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i) [21 USC § 350(c)(1)(B)(i)]. Section § 350(c) further clarifies, "...intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or (ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet."

I recently exchanged emails with one of my clients that offers sophisticated liquid dietary supplements. The company was concerned that its product directions might be risky, considering some recent FDA warning letters, relayed to them by an attorned well-versed in FDA regulation [my comments about the cited warnings in [brackets] below].

The company's product directions was, "Dissolve in mouth and swallow."

My response:

It would not surprise me that the FDA is continuing to tighten the rules, as the agency seeks to make Dietary Supplement regulation more like Drug Product regulation.  

However, the examples given by counsel are all dependent on the delivery being "topical" or "sublingual."   I don't see how "dissolve in mouth and swallow" is a "sublingual" delivery intended to "treat"-- unless there is some language in the product literature that leads to that conclusion. 

However I must further caution that FDA likes to create "per se" rules, although the law requires a showing of "intent." The FDA language below, that products "intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements." is the key to their thinking. 

What do I mean by that? As the statutory and warning language information above shows, that "intent" is a key element in the definitions. That's because foods are generally recognized as safe when used as directed. The use direction must match the intent of the marketer. The more clearly we can state the directions to the users, the safer the public will be. 

I suggest language such as, "Ingest product by dissolving in mouth and swallowing."

Regards,

Ralph Fucetola JD
www.VitaminIndustryCompliance.com


------ Original Message ------
Received: 11/19/2013
From: E.
To: Ralph Fucetola
Subject: Delivery of supplements

Dear Ralph,

    Last week at the natural products expo in Las Vegas I met a regulatory attorney, Chris Celeste, who voiced some concerns about the permissibility of delivering a dietary supplement in the mouth and then swallowing.  He has provided some references to FDA Warning Letters (below) I'd like for you to look at to see if they apply to us. 

    Thanks,

    E. 

    Begin forwarded message:

>     From: Chris Celeste, Esq.

>     Subject: sublingual tables
>     Date: November 19, 2013 6:16:10 AM PST
>     To: E.
>
>     Dear E,

In follow-up to our discussion at the SupplySide West conference I wanted to provide you with the information we had discussed regarding sublingual tables. Dietary Supplement Health and Education Act (DSHEA) of 1994 amended the Food Drug and Cosmetic Act to establish standards for dietary supplements. Under Section 201,(ff)(2)(A)(i) a dietary supplement must be for ingestion in a tablet, capsule, powder, softgel, gelcap, or liquid form... that "is intended for ingestion..."

FDA has issued several Warning Letters to firms regarding the use of “sublingual” tablets. I have provided links to these letters for your reference:

Griffon Marketing [Topical product; not ingested.]

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2002/ucm145320.htm

“Tranzabol is topically applied for transdermal absorption to achieve its intended effect. Cyclobol Sublingual Tablets is a sublingual product. These products cannot be dietary supplements because they are not intended for ingestion since they are topical or sublingual products that are intended to bypass the alimentary canal by direct absorption through the skin, or oral mucosa. The Federal Food, Drug and Cosmetic Act (the Act) defines the term, “dietary supplement” in Section 201,(ff)(2)(A)(i) to mean product that is “...intended for ingestion...” Consequently, a product that is not intended for ingestion cannot meet the definition of “dietary supplement”. “

Pinson’s Fitness Products [Topical product or intranasal; not ingested.]

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2002/ucm145314.htm

“Test-4-Blast, Deca Derm and Dermadrol are topically applied for transdermal absorption to achieve their intended effect. Primavar SCC Sublingual Tablets and Pharmalogic XRX Inn-a-Oral (nasal) Androgenix Spray are sublingual or intranasal products. These products cannot be dietary supplements because they are not intended for ingestion since they are topical, sublingual or intra-nasal products that are intended to bypass the alimentary canal by direct absorption through the skin, oral or nasal mucosa. The Act defines the term, "dietary supplement" in Section 201 (ff)(2)(A)(i) to mean a product that is ". . . intended for ingestion.. .". Consequently, a product that is not intended for ingestion cannot meet the definition of "dietary supplement".”

Supplement Giant [This is the key language: "intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements...."]

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/CyberLetters/ucm059049.pdf

“In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.”

Golden Creek LLC [Same as above.]

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/CyberLetters/ucm127113.htm

“In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter into the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.”

Chris Celeste
www.easconsultinggroup.com

Regulatory Compliance and Return on Investment

Vitamin Lawyer Health Freedom Blog
DIVESTING THE FDA
I Spoke in NYC on November 13, 2013
http://vitaminlawyerhealthfreedom.blogspot.com/2
013/10/vitamin-lawyer-to-appear-with-gov-gary.html

Memorandum from Ralph Fucetola JD November 17, 2013 To: Potential Natural Product Company Investors This Memorandum is to acquaint you with the benefits to your Company raising sufficient capital to comply fully with FDA/FTC SOP/ GMP & Clinical Study Guidelines. Good Studies lead to good claims. Good claims lead to increased ROI! Properly Structured Standard Operating Procedures and Trained Employees lead to significant regulatory savings. Getting Ready for the FDA & FTC -- www.VitaminIndustryCompliance.com Even more evidence that the agencies are serious about nutrient & natural product claims; this from the Natural Products Association in March 2011: “A new and completely different type of safety website is now open for business. Almost anyone can post information onSaferProducts.gov about a consumer product they believe might be dangerous or has already caused a safety problem. Not only will this database of consumer comments be public, it also will be searchable. "Through this database consumers will have open access to product safety information that they’ve never seen before, and this information will empower them to make safer choices," said Inez Tenenbaum, chairman of the U.S. Consumer Product Safety Commission.” What does that mean? It means your Company reputation can be ruined by willful false posters; it means the govt will be trolling the site to find companies to harass… And consider these “data points” from the last two editions of my Vitamin Lawyer Update eMemo: the UK advertising agency, the ASA now states, according to WINSH.org, “research on the ingredients was not the same as research on the product itself…” Let’s repeat the key phrase: “…research on the ingredients was not the same as research on the product itself…” – and “research on the product itself” means a Clinical Trial, of course! The substantiation generated by the Clinical Trial is the legal basis for making product claims. The Natural Products Association (NPA) said in February ‘11 – “Time's Up: FDA has begun real enforcement of dietary supplement GMPs. Companies of all sizes are being inspected.  Are you ready?” Is your Company ready? What does it take to be ready? See Below. The above Red Letter warnings from the NPA & ASA urgently restate what I’ve been telling my perceptive clients regarding the vitamin or natural products companies. Are you ready for the FDA inspectors?  Below are the 4 essential steps you must take with estimates of the investments these essential steps require from your Company. You need to budget this investment now and start to do what you can to be prepared; in this way you will outperform the competition who will not be so prepared. HHS Secretary Sibelius admitted a couple years ago that she has a $16 Billion slush fund under Obamacare that can be used to fund activities like the FDA’s 4,000 new inspectors… and FDA has already dramatically increased inspections, without those new bureaucrats! SOP Certification Training is what your company needs. Says FDA - "...documentation of employee training is necessary to track which employees have been trained in which operations. Therefore, final Sec. 111.14(b)(2) requires you to keep documentation of training, including the date of the training,  the type of training, and the person(s) trained." Federal Register, page 34811 What do you need to survive an FDA inspection? Go here:  www.VitaminIndustryCompliance.com 1.       Standard Operating Procedures – in place and up-to-date. GMP compliant detailed SOP documentation not only satisfies FDA & FTC, but also helps you organize your business! 2.       Product Substantiation Notebook – in place and up-to-date; this Notebook is a MUST if you get inspected! The Notebook should includs copies of the Structure and Function Claims Notices companies are required to file with the FDA within 30 days of marketing any claim. 3.       Your ROI can be strongly enhanced by copy-writers who know how to avoid Red Flag claims & Illegal Testimonials! 4.       A Third-Party Clinical Trial of your product; you can no longer fully rely on published science about isolated ingredients. The Dietary Supplement and Natural Remedies market is at a unique moment in its recent history. The market has grown from under a billion dollars when the Dietary Supplement Health and Education Act (DSHEA) passed in 1994 (the first law allowing claims to be made for such products) to about $50 billion in 2009. The current recession is only having a marginal effect on the nutrient market and one survey shows that 51% of the purchasers would cut back on food purchases rather than vitamin purchases. At the same time, significant regulatory initiatives have occurred during the past years with potential impact on the market. After 14 years, FDA finally issued Good Manufacturing Practice (GMP) regulations for the industry during June, 2007 which became completely effective in June 2009. All of these factors contribute to a growing industry that typically sees, after initial investment, a cost of goods, for start-ups, at about 20 to 25% of retail, rapidly moving down to 10% as new companies are able to order product runs in the hundreds of thousands of capsules. Bottom line: savvy investors, seeking reasonably assured ROI, will find in the natural products market potential opportunity, if the Company invests in in Regulatory Compliance!