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" 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.


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 depopulation agenda, or are, at worse, intellectual thugs willingly supporting that genocidal 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



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 -

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 an marketing of Medical Foods. And those issues will be addressed in a later blog entry.




Tuesday, January 14, 2014

Third Party FDA GMP Virtual Compliance Audits

New Vitamin Lawyer Service: Virtual GMP Compliance Audits!

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).



Saturday, December 21, 2013

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:

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...


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


Monday, November 25, 2013

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

Sunday, November 17, 2013

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: 

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!

Tuesday, October 22, 2013

Vitamin Lawyer Appears with Gov. Gary Johnson

Video Highlights from the OAI Event: http://youtu.be/JxjUW9VFrHE

November 14, 2013 Update: Drew and I were with Gary Johnson last night in Manhattan for a panel discussion of health and freedom. We have some excellent video footage which we will post here and on YouTube.

I asked the former (G)OP governor what he thought about libertarians and TEA Party people working with the (G)OP. He laughed and suggested the party leadership really doesn't want us. He sees real potential for all patriots cooperating, provided we stick to economic freedom issues. He noted that it's social issues that have divided the patriot movement but economic issues (including the Unaffordable Care Act) can unite us, especially when, as with Obamacare, both freedom and our pockets are at stake.
---------------------------------------
I spoke in NYC on November 13, 2013 at an event sponsored by OAI.


This note from OAI's Charles Frohman
"Most voters are fiscally conservative like the Republicans, yet socially liberal like the Democrats.  Neither party is a clean fit for most, though.  The same goes for grassroots movements - they're tied usually to one or the other party.  Governor Gary Johnson's movement, the Our America Initiative, DOES try to address the preference of most voters by exploiting the IRS' audit scandal with an effort to abolish the income tax on the one hand, and on the other hand by speaking Saturday, October 26th at the StopWatchingUs protest to save 4th amendment privacy from the NSA's warrantless spying. The governor is headlining events in Washington, D.C. the weekend of October 24th and then in New York the week of November 10th." 
Meet Governor Gary Johnson in New York:

Wednesday, Nov 13th - 6 pm Happy Hour at the Players Club, 16 Gramercy Park, "What Now With Health Reform?" with special guests Dr. Eck, past president of the free market doctors group AAPS, Ralph Fucetola the Vitamin Lawyer and FDA expert, and Lee Silver, Princeton genetics professor and author of Remaking Eden.


I look forward to seeing you there!

Sunday, October 20, 2013

Natural Solutions Honored for
Powerful Social Media Campaign

I am so very proud of the extraordinary work of Natural Solutions - Chile. They have been honored by Salsa Labs (Democracy in Action) for one of the most successful Social Media Campaigns of 2013.

See: http://www.salsalabs.com/support-community/blog/congratulations-2013-community-conference-award-winners


My co-trustees at Natural Solutions Foundation -- www.GlobalHealthFreedom.org -- Dr. Rima Laibow and Gen. Bert Stubblebine have been living in Chile for the past year, developing Foundation projects that need the "lower radiation" Deep South for their success (see: http://drrimatruthreports.com/fixing-fukushima-with-natural-solutions-lets-go/ ).

And that's when the cronies at Monsanto, Cargil, et al. made their mistake: they thought grabbing control over agriculture in Chile would be a simple task, as it has been in so many other countries. The National Assembly passed the proffered bill, to move Chile from the relatively organic/heritage agriculture friendly UPOV '78 (UPOV is the international seed regulation) to UPOV '91, decidedly unfriendly to the agriculture that my co-trustees went to Chile to promote, so those of us here in the ever more radioactive North can get more lower rad organic produce from the Deep South.

We are working with some of the world's major Truth Speakers regarding the continuing disaster at Fukushima (people like former Japanese Ambassador Murata, "The Conscience of Fukushims" and Professor Chris Busby, a leading EU radiation watchdog).


That hasn't stopped us from focusing on generating good, wholesome food from the Deep South to the North, so, as you can imagine, we were not happy to see Chile about to join the ranks of the GMO-infected nations. So what did Dr Rima and Gen Bert do?

They enlisted the help of our magnificent staff in Chile, Natalia and Naty, and did something that had not been done before: used the Social Media to change the course of the Chilean Government!
This year’s winner is the Natural Solutions Foundation for their Chile: Stop UPOV ’91 efforts. They used Salsa to generate more than two million emails to decision makers in Chile, stopping the passage of the new guidelines and protecting the rights of South American farmers. The other finalists for the Hell No, We Won’t Go Award were the Organic Consumers Association and New Era Colorado. (SalsaLabs.com)
 Dr. Rima, Gen. Bert and 'the two Natalias' deserve congratulations! The Social Media power unleashed by them stopped the cronies and the Senate of Chile has refused to pass the new law. Two and a half million emails through our Educate Decision Makers System has profoundly changed the farming landscape!

And that's not all... GMOs and organic/heritage farming has become a major issue in this year's elections in Chile! PUSH BACK WORKS.



Tuesday, August 20, 2013

FDA Illegally Claiming
Dietary Supplement Reinspection Fees

FDA Warning Letters to Vitamin Companies
Now Demand Reinspection Fees.

We fought hard to exempt Dietary Supplements from the unnecessary, misnamed 2011 "food safety" (really Federal Food Monopolization) law*. Others told us not to bother since Dietary Supplements were not even named in the law. We knew better and one Push Back weekend of 150,000 emails to the members of a certain Congressional Committee kept the Dietary Supplement Exemption in the bill; further Push Back effort kept the exemption in during the House/Senate Conference and the provision was enacted, reading:
21 U.S.C. 305(d) Rule of Construction.--Nothing in this section shall be construed to affect the regulation of dietary supplements under the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417).

This remains the law, although FDA showed, with its unlawful banning of a certain form of Vitamin B-6 a year later that it was willing to ignore the explicit order of Congress.

Another part of the 2011 law let FDA charge unspecified fees for reinspecting food facilities. Starting last December and continuing as recently as last month, FDA began including the following language in its warning letters to Dietary Supplement label-owners:
"Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act..."
(Emphasis added.) http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm339936.htm

The Congressional intent was clear, although obscured when the Exemption Section was oddly codified in section 305 which is about inspecting foreign food facilities. The intend was to exempt Dietary Supplements from the new, very strict, "food safety" rules.

FDA has a history of ignoring Congress and legal restrictions, prompting many Court decisions against FDA assertions of power. It was former Congressman Ron Paul who opined that giving more power to FDA was giving it "more power to abuse..."

The agency is at it again, this time seeking to impose a bureaucratic "tax" on companies when they are reinspected. Since the Obama Administration has rapidly increased the number of inspections and reinspections we can expect this new fee to become a significant burden on small and start-up companies. More crony corporatist monopolization.

In my humble opinion, the FDA is barred by law from imposing reinspection fees against DSHEA regulated Dietary Supplements.

The question is, will the industry assert its rights under the law or just allow yet another usurpation by this most overreaching of the Federal "alphabet agencies?"

One thing each Dietary Supplement label-owner MUST do is to make sure "your papers are in order..." so there is no excuse for a reinspection.

See my site at: www.VitaminIndustryCompliance.com




* http://drrimatruthreports.com/responding-to-fda-assaults-on-health-and-food-freedom-current-action-items/

Thursday, July 25, 2013

FDA Targeting Vitamin Companies



FDA TARGETING VITAMIN COMPANIES
The Regulatory Compliance Network Responds
www.VitaminIndustryCompliance.com 

FDA News, an industry information source, put it succinctly a couple weeks ago:

"FDA on the hunt..."
Dietary supplement makers: The party’s over. The grace period on inspections has expired and the FDA is on the hunt. More warning letters were issued in 2012 than in the previous two years combined. GMP compliance is the FDA’s focus...”
When health freedom advocates convinced Congress to unanimously adopt the Dietary Supplement Health and Education Act of 1994 (DSHEA) it was no easy task. I remember those days, before the internet, well. We rallied at FDA locations around the country; we lobbied Congress the old-fashioned way, with phone calls, letters, petitions and faxes. I remember bringing my then 5 year-old son to DC for the march on the Capitol that lead to adopting DSHEA, the law that allowed us, for the first time, speak truthfully about the nutrient benefits of dietary supplements. It was a breakthrough and the bureaucracy has been trying to take back those concessions to our freedom of inquiry and speech ever since! We didn’t give up in ’94 and we will not let the stimulus-money, beefed-up FDA regulate our industry out of existence. The Regulatory Compliance Network, a collaboration of industry professionals, is ready to react proactively: www.RegulatoryComplianceNetwork.com.

We knew at the time, in ’94, that the bill was a compromise between our right to seek natural means for health and the power of the Big Pharma lobby, aided and abetted by their cronies in the federal agencies. But Congress not only acknowledged our right to communicate about, and market dietary supplements, it also told the FDA that any regulations about good manufacturing procedures must be modeled after food regulations, not drug regulations. That difference is significant. Dietary supplements are foods, not drugs. Foods support normal structure and function. Drugs change the body to suppress symptoms of disease.

Fast-forward about a decade. FDA finally got around to implementing the regulatory authority granted by the dietary supplement law. Two primary sets of regulations, with associated guidelines, were proposed, adopted and phased in, over the several years. These were the “Structure and Function” regulation that tells companies what types of “support” claims can be made for dietary ingredients and the cGMPs – the Current Good Manufacturing Practices regulation. Today, with those regulations in place, and with thousands of new compliance offices hired with Federal stimulus funds, the FDA is, as our industry source says, “On the hunt…”

The Natural Products Association opined,
"FDA is concerned with the current lack of GMP compliance and is preparing to take a closer look during inspections. FDA has also said they are circling back to companies who have already been inspected. Dr. Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs recently stated, “'the majority of inspections [the FDA] have done have resulted in a non-compliance atmosphere, whether resulting in a warning letter or just observations on the 483s.'..."
One FDA Compliance Officer told me:
Your company, as label-owner, must be in a state of control with its training, labels, claims, manufacturer, shipping & customer service…”
In the past I would tell my dietary supplement clients that they might be inspected by the FDA once in a decade, or not at all. Today, every company that owns its own labeled products can expect yearly or almost yearly inspections. The supplement industry is being held to strict standards and those companies that are well-organized businesses will have a competitive advantage.

To make the best of that advantage, or even to effectively communicate to the customers, “your papers must be in order…” Gone are the days when “mom and pop” vitamin companies could bottle their own products and just start marketing. Today, companies need to have a sophisticated approach to doing business. 

Standard Operating Procedures are intended to ensure that the public is offered products that are consistent as to “purity, identity, composition and strength…

But it is not enough to have written procedures, according to FDA (Federal Register, pages 34811):
"...each person engaged in an activity covered by these cGMP regulations must have the education, training, or experience to perform the person's assigned functions. Some employees will be considered qualified based in part on training taken as company employees. To show that such training is appropriate to the employee's functions and has in fact occurred, the training must be properly documented. 
This documentation is an important aspect of ensuring adequate training and, therefore, helping to ensure the result of having qualified employees who perform their functions properly.

The FDA introduced the cGMPs by reminding us all:
"The dietary supplement market has changed significantly since the passage of DSHEA. The industry itself has grown exponentially and so has the number of Americans buying these products. Access to dietary supplements has also changed. Today a wide range of dietary supplements can be purchased in supermarkets or through the Internet...”


Conducting the Certification Training at
Global Healing Center, Houston, Texas

The Federal authorities understand that Americans want their supplements. 

The strong public support that caused Congress to do that which it hardly ever does, adopt a controversial law unanimously, with no dissent, proves that. Nonetheless, the natural tendency of bureaucracy is to expand into every nook and cranny of voluntary human action. The unregulated is seen as a threat. Marketers, on the other hand, see the unregulated as an opportunity to meet consumer demands expeditiously. The tension between American industry and bureaucracy has grown for generations.

The regulatory pendulum swings this way and that way. Today, with a Federal bureaucracy emboldened by gridlock in Congress, and with ever more taxpayer or borrowed money to spend for enforcing regulations, those regulations are being interpreted in the most onerous manner, leaving little room for small companies to continue their critically important roles as innovators.

What is to be done? An aware public needs to keep the pressure on the Congress so the bureaucracy is not able to ratchet-up controls without limit. As one of the trustees of Natural Solutions Foundation – Health Freedom USA.org – I am very aware of the strong support that our dietary supplement market has from the public. You can help educate decision-makers here: http://tinyurl.com/SaveOurSupplements.

Dietary supplement company management will do what management must always do: manage. That means complying with the cGMPs to assure the public that Americans can still buy the best, highest quality and potency nutrients available anywhere on earth. To do that, the companies need to get much more serious about how they organize the ways and means they have to satisfy the consumer. My experience is that very few dietary supplement companies are in full compliance with all requirements.

The Natural Products Association sees the same issue:
"Dietary supplement manufacturers are facing a high level of regulatory scrutiny from the government as a result of the study … by the U.S. Dept. of Health & Human Services Office of the Inspector General. This study raises new concerns that structure/function claims are not accurate and misleading to consumers.  A sample of 127 dietary supplements were reviewed and concluded 'Overall, substantiation documents for the sampled supplements were inconsistent with FDA guidance on competent and reliable scientific evidence.'..."
The science behind the benefits of dietary nutrients continues to advance. 

The problem the market faces is how to substantiate the claims that can be made about those nutrients. WHO, the World Health Organization, told us in 2002 that the chronic diseases of modern life – cancer, heart disease, diabetes, obesity, are all the “noncommunicable diseases of mal- and under-nutrition.” It is the role of the dietary supplement companies, whether large or small, new or well-established, to educate the public about the tremendous health benefits of good nutrition.

To do that, the companies need to stay in business by effectively meeting the increasing regulatory standards.


Education is the key. 

The companies are now required to adopt written Standard Operating Procedures and engage in third-party training and certification, to meet the higher standards expected from companies that are providing essential nutrition for our health and well-being.

That’s why I’m working with some of the leading educators in the natural products field, to form the Regulatory Compliance Network. Learn more here: www.VitaminIndustryCompliance.com


Dr. Group about the SOP / cGMP Certification Training Program