Monday, June 2, 2014

Summer FDA Inspection Season

VITAMIN CONSULTANCY UPDATE eMEMO

Memorandum from Ralph Fucetola JD



June 2, 2014


To: Vitamin Lawyer Contact List:


Some reminders as we head into the Summer FDA Inspection Season... This winter was difficult and the bureaucrats mostly stayed home. Now that the weather is getting better, they are on the prowl again.

There are 400 people on this email list. Nearly all are involved in the natural products or services market. That means the people on this list are also on the FDA inspection list!

Are you ready for your inspection? If you manufacture products or own a label you will be visited by the FDA, or by a State Inspector under contract to the FDA (yes, that is happening) likely this Summer.

Are you ready for your inpection?

Since only a relatively few on this list have availed themselves of my critical services, I can answer that question: YOU ARE NOT READY.

[1] YOUR PAPER WORK MUST BE IN ORDER. My SOP service and Webinar System make sure that will happen. www.SOPcertification.com.

[2] A reminder about Virtual FDA cGMP Facility Audits... When FDA visits you, as a label-owner, the agents will remind you that, just because your manufaturer is registered with them, and has been inspected by them, doesn't mean the manufacturer is GMP-compliant. They will say that you must show the FDA that the manufacturer is compliant... "When did you last audit your manufacturer?

More about that here:  



[3] Below is an important link from Dr. Rma regarding CBD Hemp Oil and Nano Silver... The Foundation of Health.  Dr. Rima now has High Potency CBD Hemp Organic Chocolate bars available! CBDs and Chocolate! What's not to love? And when you add Nano Silver... Ebola and MERS haven't a chance.


Regards,
Ralph Fucetola JD




High Potency CBD Hemp Oil™ and Nano Silver Here:
http://drrimatruthreports.com/dr-rima-recommends-two-natural-solutions/
YES, WE HAVE CBD CHOCOLATE!
If you want to consider the CBD Affiliate Program, go here:
http://tinyurl.com/HempOilNow

Link to My Vital Connection University Intro Webinar
"Alternative Medicine" or Advanced Health Care?

http://www.vitalconnectionuniversity.com/course/category.php?id=4
Dr. Rima on GHSI: This is a threat to your business or practice!

The First Ten Years Video
Featuring General Bert, Doctor Rima and Counsel Ralph

http://youtu.be/dtWoKqrb8eY
 

Sunday, March 23, 2014

The Herbalists Charter and Modern Health Freedom Declarations



This Archive Posting is to provide a convenient place for me to post the Herbalists Charter and several modern Health Freedom Declarations.

Introduction
When the American Colonies declared their independence as Sovereign States, in July, 1776, they each adopted the Laws of England as the Common Law of the State.

Among the Laws of England so adopted is the Herbalists' Charter, an Act of Henry the Eighth (in the 33rd Year of his reign - 1542 and adopted thereafter by Parliament: Statutes at Large34&35 Henry VIII. C8. A Bill that Persons, being no common Surgeons, may minister Medicines, notwithstanding the Statute). It is astonishing to note that many of the issues confronting alternative practitioners today are the same issues that the Act of Parliament addressed.

In the Sixteenth Century, as in the 21st Century, licensed physicians and surgeons were going to Court to ban the activities of the alternative practitioners of their day, the herbalists. Parliament ordered an end to this misuse of the Courts to enforce licensure, protecting the nutritionists from "suit, vexation, trouble, penalty, or loss of their goods..." This ancient Act of Parliament applied to England and the King's "other dominions" including, of course, the American Colonies, and later, States. This Act has never been repealed, and thus remains part of our Common Law to this day, offering protection to alternative practitioners, "at all Time from henceforth..." as a perpetual Charter of Rights.


The 2000 Wilton Declaration
http://www.lifespirit.org/wiltondec.html

The 2007 Tiburon Declaration
http://drrimatruthreports.com/?p=460

The 2012 Long Beach Declaration
http://drrimatruthreports.com/the-long-beach-health-freedom-declaration/

Herbalists Charter Text

The Herbalists' Charter

"An Act that Persons, Being No Common Surgeons, May Administer Outward Medicines

"Where in the Parliament holden at Westminster in the third Year of the King's most gracious Reign, amongst other Things, for the avoiding of Sorceries, Witchcrafts and other Inconveniences, it was enacted, that no Person within the City of London, nor within Seven Miles of the same, should take upon him to exercise and occupy as Physician or Surgeon, except he be first examined, approved, and admitted by the Bishop of London and other, under and upon certain Pains and Penalties in the same Act mentioned;

"Sithence the making of which said Act, the Company and Fellowship of Surgeons of London, minding only their own Lucres and nothing the Profit or ease of the Diseased or Patient, have sued, troubled and vexed divers honest Persons, as well as Men and Women, whom God hath endued with the Knowledge of the Nature, Kind and Operation of certain Herbs, Roots and Waters, and the using and ministring of them to such as been pained with customable Diseases, as Women's Breasts beings sore, a Pin and the Web in the Eye, Uncomis of Hands, Burnings, Scaldings, Sore Mouths, the Stone, Strangury, Saucelim and Morphew, and such other like Diseases; and yet the said Persons have not taken anything for their Pains or Cunning, but have ministered the same to poor People only for Neighborhood and God's sake, and of Pity and Charity:
"And it is now well known that the Surgeons admitted will do no Cure to any Person but where they shall be rewarded with a greater Sum or Reward that the Cure extendeth unto; for in the case they would minister the Cunning unto sore People unrewarded, there should not so many rot and perish to death for Lack or Help of Surgery as daily do; but the greatest part of Surgeons admitted been much more to be blamed than those Persons that they troubled, for although the most Part of the Persons of the said Craft of Surgeons have small Cunning yet they will take great sums of Money, and do little therefore, and by Reason thereof they do oftentimes impair and hurt their Patients, rather than do them good.

"In consideration whereof, and for the Ease, Comfort, Succour, Help, Relief and Health of the King's poor Subjects, Inhabitants of this Realm, now pained or diseased:

"Be it ordained, established and enacted, by Authority of this present Parliament, That at all Time from henceforth it shall be lawful to every Person being the King's subject, having Knowledge and Experience of the Nature of Herbs, Roots and Waters, or of the Operation of the same, by Speculation or Practice, within any part of the Realm of England, or within any other the King's Dominions, to practice, use and minister in and to any outward Sore, Uncome Wound, Aposelmations, outward Swelling or Disease, any Herb or Herbs, Ointments, Baths, Pultess, and Emplaisters, according to their Cunning, Experience and Knowledge in any of the Diseases, Sorea and Maladies beforesaid, and all other like to the same, or Drinks for the Stone, Strangury or Agues, without suit, vexation, trouble, penalty or loss of their goods;

"The foresaid Statute in the foresaid Third Year of the King's most gracious Reign, or any other Act, Ordinance or Statues the contrary heretofore made in anywise, not withstanding."



With greatest appreciation, for bringing the Herbalists Charter to my attention,
 and for his many other good works, dedicated to the late homeopath and attorney,
Dr. William H. Moore, Jr., HomMD, Esq.
Savannah, Georgia.


Monday, February 24, 2014

The Vitamin Lawyer Infographic


VITAMIN CONSULTANCY UPDATE eMEMO

INFOGRAPHIC
Vitamin Consultancy: Pulling It All Together

Memorandum from Ralph Fucetola JD
February 24, 2014
To: Vitamin Lawyer Contact List:
Here is an Infographic that summarizes my special offerings for 2014.


[Right Click and Open In New Tab for Full Size Image.]

Link to My Vital Connection University Intro Webinar
"Alternative Medicine" or Advanced Health Care?
http://www.vitalconnectionuniversity.com/course/category.php?id=4
Natural Solutions Tenth Anniversary Webinar Series
Shaken Baby Syndrome, Elder Abuse or Vaccine Injuries?
http://tinyurl.com/SBShoax
The First Ten Years Video
Featuring General Bert, Doctor Rima and Counsel Ralph
http://youtu.be/dtWoKqrb8eY


Wednesday, January 22, 2014

Vitamin Lawyer Vital Connection University Webinar

VITAMIN CONSULTANCY UPDATE eMEMO

"Alternative Medicine" or Advanced Health Care?
A Vitamin Lawyer Webinar

Memorandum from Ralph Fucetola JD

January 21, 2014

To: Vitamin Consultancy Contact List:

I am hosting a live online webinar this Saturday morning at Vital Connections University. Yes, it will be archived.

You can sign up here. You should just do it; get yourself ready for the coming year!


Natural Solutions Tenth Anniversary Retrospective Video
Featuring General Bert, Doctor Rima and Counsel Ralph
http://youtu.be/dtWoKqrb8eY

Thursday, January 16, 2014

AER Reporting Portal: New from the FDA

VITAMIN LAWYER UPDATE eMEMO

Natural Solutions Tenth Anniversary Retrospective Video
Featuring General Bert, Doctor Rima and Counsel Ralph
http://youtu.be/dtWoKqrb8eY  



Memorandum from Ralph Fucetola JD
FDA Unveils New Website

January 16, 2014

To: Vitamin Lawyer Contact List

Latest "shot across the bow" from the FDA: it will now be easier than ever before to report dietary supplement "adverse reactions." You may remember last year when certain Congressional critics of dietary supplements were surprised at the very low numbers of "adverse reactions" being reported for dietary supplements, as compared to, for example, drugs.

This couldn't be due to the relative safety of dietary supplements, could it? Of course it could be! It must be a "reporting problem" to be corrected by more bureaucracy...

Natural Products Insider reports:

"Distributors, manufacturers and packers of dietary supplements now can submit AERs (adverse event reports) through an electronic filing system, FDA announced Monday. Companies can submit the AERs through the Safety Reporting Portal ..."


If you have your own dietary supplement label, you need to be aware of the increased level of regulation you need to prepare for in 


You really and truly understand that this is the year when you must get your paperwork in order!

That means having meaningful Standard Operating Procedures for your company or practice. In means being in a "state of control" with your manufacturer, shipper and other service providers.

AND BEING ABLE TO PROVE THAT TO THE INEVITABLE FDA INSPECTION! 

In short, you need the Vitamin Lawyer SOP/GMP Training Program!
#914.966.8053 - SOPclienthelp@gmail.com

Thursday, January 9, 2014

Memorandum of January 9, 2014: Virtual Audits

VITAMIN LAWYER UPDATE eMEMO

SPECIAL TO MY LIST: BOB CONNOLLY'S HEART RATE VARIABILITY TRAINING!
Special Offer Has Been Extended!

Memorandum from Ralph Fucetola JD

January 9, 2014

To: Vitamin Lawyer Contact List

Looking forward to a prosperous new year!

Three important ideas for your new year! And, next issue of the eMemo, look for my exciting new Webinar to be provided through Vital Connection University Online -- January 25, 2014.

[FIRST] The Advanced Health Care practitioners on this list should be very interested in an educational program Robert E. Connolly, D.Sc., L.Ac. has made available especially for the Vitamin Lawyer eList. I've known Bob for decades and can personally attest to his skill as an Advanced Health Care Practitioner.

He has become quite the expert in Heart Rate Variability and wants to share what he knows about this FDA-permitted evaluation system.  NOW, and until the end of business Monday, December 30th, you can receive his amazing training FREE (I promise you, this is worth thousands!) when you buy the HRV device for a special low price... and time payments are available. I've reviewed Bob's training materials. They are more than good. And the device is... spectacular!

"HRV Measures The Difference Between Expenditure or Discharge of Energy, and the Regeneration or Consolidation of Energy." -- Bob Connolly

IF YOU WANT TO LEARN, CALL SHER KOMISAR RIGHT NOW!
#914.966.8053 - SOPclienthelp@gmail.com


[SECOND] SPECIAL INTRODUCTORY OFFER!
FDA expects label-owners and manufacturers to have third-party compliance audits on a regular basis. Following a standard twenty page, 190+ item check list, we take a virtual tour of your contract manufacturer facility (using Skype or similar) to provide my third-party FDA eGMP compliance audit. 

The audit tour is recorded and the Audit Report includes extensive review of all GMP requirements together with still images from the tour, confirming compliance.

Contact me for pricing and reservation of time. The average audit takes 6 hours of my time; about an hour of your time. Reserve your Virtual Audit now; you should contact my Certification Program Coordinator, Sher Komisr here: #914.966.8053 - SOPclienthelp@gmail.com


[THIRD] You really and truly understand that this is the year when you must get your paperwork in order! That means having meaningful Standard Operating Procedures for your company or practice. In means being in a "state of control" with your manufacturer, shipper and other service providers. 

AND BEING ABLE TO PROVE THAT TO THE INEVITABLE FDA INSPECTION! 

In short, you need the Vitamin Lawyer SOP/GMP Training Program!
#914.966.8053 - SOPclienthelp@gmail.com