Saturday, December 28, 2013

Memorandum of December 28, 2013 - Heart Rate Variability

VITAMIN LAWYER UPDATE eMEMO

SPECIAL TO MY LIST:
BOB CONNOLLY'S HEART RATE VARIABILITY TRAINING!

Memorandum from Ralph Fucetola JD

December 28 2013

To: Vitamin Lawyer Contact List

I trust your holiday season has been joyful and you are looking forward to a prosperous new year!

[1] 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 MORE, CALL SHER KOMISAR RIGHT NOW!
#914.966.8053 - SOPclienthelp@gmail.com


[2] 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

Tuesday, December 10, 2013

Third Party FDA cGMP Compliance Audits

VITAMIN LAWYER UPDATE eMEMO


Memorandum from Ralph Fucetola JD
December 10, 2013
To: Vitamin Lawyer Contact List

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




Thursday, December 5, 2013

Minister's CAM Practices Webinar

VITAMIN LAWYER UPDATE eMEMO

Minister's CAM Practices Webinar Screen

Memorandum from Ralph Fucetola JD
December 5, 2013
To: Vitamin Lawyer Contact List
There are now eleven webinar videos posted on the Vitamin Lawyer Webinar System.
    1. CAM Cautions
    2. DS and Medical Foods in Physicians’ Practice
    3. Lawful Copy Writing
    4. Ministers’ CAM Practices
    5. Record Keeping for GMPs
    6. SOP1: Introduction
    7. SOP2: Section 1
    8. SOP3: Section 2
    9.  SOP4: Conclusion
    10 SOPs for Health Care Practitioners
    11 Therapy is Not Treatment
Today I'd like to feature the Minister Practitioner Certification Course
That course consists of:

[1] two main Webinars:
     the 52 minute Ministers' CAM Practices and 
     the 46 minute CAM Cautions, and 

[2] two bonus Webinars:
     Therapy is Not Treatment and 
     Lawful Copy Writing.
Each Webinar also includes its eBook, with all of the Webinar slide text and bonus information. Just $337 .
Here is my Video Tour of the  Webinar System: 
Reserve your access now; you should contact my Certification Program Coordinator, Sher Komisr here: 
#914.966.8053 -  SOPclienthelp@gmail.com

Thursday, November 28, 2013

Lawful Vitamin Delivery Systems


New Vitamin Lawyer Blog Entry



Memorandum from Ralph Fucetola JD
November 28, 2013 - Happy Thanksgiving!
To: Vitamin Lawyer Contact List
Still working on my new eBook, Advice from the Vitamin Lawyer . It will be available gratis to this list. More about that next time! If you didn't see my appearance in New York with Gary Johnson earlier this month, it is posted here:
FDA inspectors are not going away any time soon... YOU SHOULD REALLY CALL MY CERTIFICATION COORDINATOR, SHER KOMISAR! She has the program your company or practice needs.
You need your SOPs in order; you need to train your staff and have them certified. I've set up an extensive system to do just that, with minimum expense. See this video: http://www.youtube.com/watch?feature=player_embedded&v=FRPgPlaYml0
And, contact Sher here:  #914.966.8053 -  SOPclienthelp@gmail.com

Thursday, November 7, 2013

Investing in Regulatory Compliance RoI



Memorandum from Ralph Fucetola JD


Re: Investing in Regulatory Compliance

Date: November 7, 2013
  
To: All 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 on SaferProducts.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!

 © 2013

The Vitamin Lawyer.com Consultancy

Notary Public of the State of New Jersey #2398815
Attorney at Law in NJ – 1971 - 2006 – All Rights Reserved.

Thursday, October 24, 2013

SOP Certification Program Options




SOP Certification Program Options
 
At Global Healing Center, Houston
Date:  10.24.13

From: Sher Komisar
Certification Program Coordinator

Ralph asked me to send you this short video explaining how the Vitamin Lawyer Webinar Training System works:

And below is an outline of Program Options.

Regards,
Sher

PROGRAM DESCRIPTIONS
The Program that is Right for Your Company
For individual Webinar offerings and pricing see:http://vitaminlawyercertification.weebly.com/program-options.html

Index:
[I] Supplement Company Certification Programs
[II Health Care Practitioner Certification Program
[III] Minister Practitioner Certification Program

[I] Supplement Company Programs

[3] CERTIFICATION PROGRAM THREE: Customized Gold Standard

      Access to the Webinars, Documents, Certification Test and Update Forum; time with your staff online [includes up to  TEN Certifications without extra charge]. Counsel Ralph works with your CEO to complete the SOP document and provides a live online, recorded discussion with your staff as part of the training. Your recording is for your use only.

[2] CERTIFICATION PROGRAM TWO: Customized

      Access to the Webinars, Documents, Certification Test and Update Forum [includes up to  FOUR Certifications without extra charge]. Your CEO and Counsel Ralph discuss customizing the SOPs.

[1] CERTIFICATION PROGRAM ONE: Bare Bones

      Access to the Online Webinars, Documents, Certification Test and SOP Format [includes ONE Certification without extra charge].

All levels include the Four Certification Webinars and the Bonus Record Keeping Webinar.

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

[II] Health Care Practitioner Certification Program

If you own your own labels, even if you contract with suppliers, manufacturers, encapsulators, bottlers, labelers, shippers, even customer service... YOU must be in "a state of control..." by having Standard Operating Procedures (SOPs) that required proper contracts. If you carry-on any of these processes "in house'you must have appropriate SOPs, must train your staff in those SOPs and prove it.

This program does just that.

Includes: SOP Format, eBooks and the following Webinars:

DS and Medical Foods in Physicians’ Practice
Therapy is Not Treatment
Record Keeping

With a Bonus Webinar:

CAM Cautions
Lawful Copywriting

[III] Minister Practitioner Certification Program

This program is designed for ministers engaged in healing ministries. Professional Education.

The program includes  eBooks with extensive addenda and these Webinars:

Minister's Healing Practices
CAM Cautions
Therapy is Not Treatment
Lawful Copy Writing

Counseling / Training / Certification
www.VitaminIndustryCompliance.com

  From the FDA’s GMP Regulation: “…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

Commit 10 Hours to Your Company’s Protection Today!

"The FDA showed up unannounced. Said they’d be here for at least six days.  We showed them the SOPs Counsel Ralph prepared for us. They left after two days. It was comforting to know we could call Ralph any time during this, and he was there for us." A. C. Company CEO