Sunday, March 23, 2014

PC Tyranny and Speech about Health Freedom

"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, just save your life and the lives of those for whom you care.

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

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,, 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.


[7] Time, June 10, 1946, The Shutes and Vitamin E

This blog was also posted here:

Saturday, March 8, 2014

"Medical Foods" Get a Regulatory Boost

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

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:

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.

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: