This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.
THE VITAMIN CONSULTANCY NEWSLETTER
Agenda 2020 - Foresight, Not Hindsight
Re: The Institute for Health Research and the Vitamin Consultancy's Business Collaborative
The natural product industry in the United States has been
growing rapidly for the past half century. As a participant in that
business, you want to know where it is going next. The next big thing?
The next regulatory assault? You need foresight, not hindsight. That's
what this private memo is about.
To paraphrase, "An industry divided will not stand." I have
been closely observing the direction the government is taking with
regard to supplements and I don't like it! Back in the '70s and '80s
there were far fewer supplement companies, and they were small by
today's standards. But those that existed pulled together, understanding
that there was safety in numbers, and by the mid-'90s we were able to
cajole Congress into giving DSHEA (the Dietary Supplement Health and
Education Act) unanimous approval.
The industry that grew from that push back is now maturing and
its participants need to pay attention to the threats, and
opportunities, on the horizon.
Since you are on my Vitamin Consultancy email list you probably know
that I practiced law for 36 years, becoming known as The Vitamin Lawyer.
Today I continue my work through my Vitamin Consultancy and as Vice
President of Natural Solutions and President of the Institute for Health
Research -- www.InHeRe.org
A plan is developing for the next few years that involves you
and your company. The plan is called Agenda 2020 as it is envisioned to
be fully implemented over the next four years -- our "20-20" vision for
The plan includes continued enhancements to the Vitamin Consultancy,
bringing additional professionals into the Consultancy. An example is
the Cosmetic Dossier Service Dr. R. Goodman and I provide.
Our core VC services will continue to be upgraded:
1. Label, literature and claims consulting
2. General vitamin industry consulting
3. SOP and GMP compliance
4. The Cosmetic Dossier
5. The Vitamin Consultancy Webinar Training System
6. GMP physical and virtual audits
These services are funded through client fees and are self-supporting.
But that is not all that we do here. Natural Solutions
Foundation and the Institute for Health Research have a significant
portion of my attention, my time and advise. Their activities need to be
self-supporting too. This memo focuses on the Institute.
But be aware there are some exciting changes coming to Natural Solutions -- to be covered in a future memo.
The Institute for Health Research was established in 1998 by Green
Turtle Bay Vitamins founder Karen Horbatt and Dr. Richard Podell, a
well-known Jersey physician and teacher. I am the third trustee. Today
Ms Horbatt remains our Chairwoman Emeritus, I am President of the
Institute and several health professionals, including Rima Laibow MD
have joined the Board.
We have begun to publish a professional Journal and seek
leading-edge health, natural approach research papers. Our focus is
providing actionable information for people in the natural products
arena. You can read the first published articles, by luminaries such as
Gary Null, ND, Sharry Edwards, MEd and Rima Laibow, MD, at www.InHeRe.org
US tax law allows your company to donate up to 5% of its gross profits
to charitable activities, and gain a significant tax break. The
Institute is authorized to accept such donations and issue the
appropriate tax receipt. We have a PayPal donation button on the main
page and are also happy to receive checks or money orders made out to
the Institute c/o Ralph Fucetola, 58 Plotts Rd, Newton, NJ 07860.
How much of your company's gross profits are you ready to allocate
toward protecting your Commercial Health Freedom? This is the time of
year when it is prudent to make those allocations.
Here is the monthly Institute budget I need your help to meet:
1. Office space, overhead and supplies: $1500
2. Web Master / Site & Journal Maintenance: $1,000
3. EList maintenance: $700
4. Educate Decision Makers system: $700
5. Social Media Intern: $750
There are other expenses. For example, we need to develop a PR budget,
including adequate funds for at least quarterly trips to venues such as
Washington, DC or trade meetings.
Bottom line: what can funding the Institute office do for you?
The Vitamin Consultancy will be able to continue to provide you with a
very high level of professional consulting for modest hourly fees, along
with the Webinar System and other special services.
But, as the Institute becomes properly funded, in cooperation with the
Consultancy, I will also be able to provide Sustaining Members early
alerts critical to operating in an increasingly complex regulatory
The first Alert from the Institute that I am preparing is a
Special Report: Food Safety Regulation -- Action List. These will
include summaries of the private alerts I provide privately to my
Monthly Retainer Consultancy Clients. Biannual registration renewals are
Another powerful business's tool we are developing is the Nutrient Companies' Business Collaborative -- a private information exchange that brings best practices to the fore, keeping the Sustaining Members at the leading edge.
The goal of the Collaborative is to introduce its members to each other,
to share their special capacities for mutual benefit, and clout. "Push
Back Works" and pushing back together works even better.
As a Sustaining Member your company will be among the first to hear
about new technologies and leading edge approaches, such as using
frequency in the testing and processing of food products. Here I am
thinking of the pioneering frequency matrix work of Sharry Edwards or
the recent frequency analysis article by Mike Adams.
How does your company become a Sustaining Member?
Set up a recurring donation through our PayPal donation button at www.InHeRe.org
or send a check or money order for one year (min. $1200). We will
provide appropriate tax receipts. If it is convenient for you, I can
arrange to have the Institute send you a monthly invoice from its PayPal
Whether a clear vision for Agenda 2020 comes into sight will
depend on you seeing that vision benefiting the future success of your
business. IMHO, it's time foresee where we are going.
Call me if you have any questions, or just to let me know that you are in...
One of the challenges facing dietary supplement companies is where to
find merchant services, such as the ability to accept credit and debit
cards for your product sales. For leading-edge products this can be
quite a challenge. For example, PayPal is well-known for cutting-off
companies that sell products such as CBDs and the like.
Dan Fucetola of Winning Business Solutions has sourced a merchant account company that specializes in nutrient products.
Just click on "G.E.T. Merchant Account: START HERE."
"We are proud
to partner with Global Electronic Technology, Inc. for Merchant
Services. Yes, they do handle dietary supplement products and anything
else you can sell. Start by sending us a message to the special contact
form below. Our GET account manager Luis will contact you directly.
Please include your phone and email."
My experience will strengthen your company! I provide
private and confidential, competent electronic professional consulting
to my Dietary Supplement and advanced healthcare ("CAM") modality
clients, for the purpose of compliance with International, State and
Federal (including FTC and FDA) standards for communicating about the
advertising and sale of dietary supplements (including medical foods)
and/or providing of health care services and information. You should
consider my SOP / cGMP Certification Course, allowing start-up and
established vitamin companies and practitioners who own their own
private labeled products to meet with new FDA procedural regulations.
Mail Chimp Version CDC dangerous quarantine and treat/vax regulation
FDA offers 102 page NDI guidance
From: Ralph Fucetola JD
Welcome to the September 2016
Vitamin Consultancy eNewsletter.
The banner above, featuring yours truly
and my co-trustees at Natural Solutions Foundation, Rima Laibow MD and
Maj Gen Bert Stubblebine (US Army, Ret.) points to a very important and
The CDC has proposed a draconian quarantine and forced
treatment/vaccination regulation, giving the public until October 19th
to file comments. Under the Administrative Procedures Act, this is a
necessary step for agency action, or for litigation testing the validity
of the new rules. What does the rule say about Informed Consent? It
says your consent "shall not be considered as a prerequisite..."
“§70.18 – Agreements. CDC may enter into an agreement with an
individual, upon such terms as the CDC considers to be reasonably
necessary, indicating that the individual consents to any of the public
health measures authorized under this part, including quarantine,
isolation, conditional release, medical examination, hospitalization,
vaccination, and treatment; provided that the individual’s consent shall not be considered as a prerequisite to the exercise of any authority under this part.”
The FDA's guidelines for what is a New
Dietary Ingredient (NDI) were issued in 2011. Last month an updating was
proposed as FDA continues to implement a policy of making Dietary
Supplement rules more like Pharmaceutical Rules rather than the
food-standard regulation that Congress determined to be public policy in
the Dietary Supplement Health and Education Act of 1994 (DSHEA).
The new document is 102 pages. The Devil, as they say, is in the Details. As is the deviltry...
This note is just to acquaint you with the fact that the rules are being
made tougher. Bottom line:  what is an NDI and  how much harder
will it be to have one approved by FDA?
 The definition, set by statute has not changed. The FDA now phrases it this way:
"On October 25, 1994, the Dietary Supplement Health and Education Act of
1994 (DSHEA) (Pub.L. 103-417) was signed into law. DSHEA amended the
FD&C Act by adding, among other provisions, (1) section 201(ff) (21
U.S.C. 321(ff)), which defines the term “dietary supplement”; and (2)
section 413 (21 U.S.C. 350b), which defines the term “new dietary
ingredient” and requires the manufacturer or distributor of an NDI, or
of the dietary supplement that contains the NDI, to submit a premarket
notification to FDA at least 75 days before introducing the product into
interstate commerce or delivering it for introduction into interstate
commerce, unless the NDI and any other dietary ingredients in the
dietary supplement “have been present in the food supply as an article
used for food in a form in which the food has not been chemically
altered” (21 U.S.C. 350b(a)(1))."
 How much harder? That of course translates into, how expensive?
The more restrictions, the more expense. Being "grandfathered" and thus exempt from the NDI process is not easy, for example:
"A notification is not required when the NDI and all other dietary
ingredients in the dietary supplement have been present in the food
supply as articles used for food in a form in which the food has not
been chemically altered. ... FDA interprets the phrase “present in the
food supply” to refer to the conventional food supply. Accordingly, we
interpret a dietary ingredient that has been “present in the food supply
as an article used for food” to mean a conventional food or
conventional food ingredient. We do not consider prior use in dietary
supplements to constitute presence in the food supply."
More directly impacting cost is what are the requirements to prove the safety of the NDI?
"That standard provides that a dietary supplement containing the NDI is
adulterated unless there is adequate information to provide reasonable
assurance that the ingredient does not present a significant or
unreasonable risk of illness or injury."
What evidence is sufficient to meet this standard?
"A notification should provide evidence
of a history of safe use; other evidence of safety, including clinical
testing, animal testing, or both; or some combination of history of use
and other evidence of safety. The submitted data should provide the
basis for a conclusion that there is a reasonable expectation of safety
under the proposed conditions of use of the dietary supplement
containing the NDI."
And, to the wise this interesting hint:
expects that when history of use evidence alone is adequate to support
the safety of the NDI in the supplement, notifiers will prefer to use
that route. Compared to the cost and time needed to conduct clinical or
animal toxicology studies, it is generally less expensive and faster to
gather historical information and to conduct chemistry studies to
establish the identity of the historically used materials."
So, as your vitamin business moves ahead, you will need guidance in dealing with New Dietary Ingredients.
The Vitamin Consultancy is here to help with all aspects of new product
development, from concept through testing, labeling, claim writing and
the rest of your product presentation needs.
Standard Operating Procedures Dietary Supplement and Natural Products
Development, Training & Deployment
ANNOUNCING THE VITAMIN CONSULTANCY
REGULATORY COMPLIANCE CERTIFICATION PROGRAM!
“...documentation of employee training is necessary”
This web site, www.SOPCertification.com
provides access to my Standard Operating Procedures certification
program, specially designed for the industry, with special emphasis on
small and start-up companies, but any company that has its own labels
needs this program! You need my 36 years’ experience as The Vitamin
Lawyer and half-century in the nutrient industry!
I can save your company hundreds of thousands of dollars in regulatory
costs! Just embrace my three simple steps to regulatory compliance:
 PROCEDURE – I work with your CEO to tweak my Standard Operating Procedures and Good Manufacturing/Marketing Practices for your company
 CLAIMS – I work with your company for proper claims
control, definition & substantiation... and the FDA required
S&F Claims Notice.
 TRAINING - It's not enough to have procedures, says
FDA: train your team and prove they are qualified - through my Three
Step Program: Presenting, Training, Certifying.
That third step is what this Certification program is designed to accomplish: meeting FDA training requirements.
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 The Gold Standard -
Vitamin Lawyer Consultancy Certification Program!