My Experiences in the Vitamin World
[Recently traded some "Vitamin War" stories with some Vitamin Pioneers and it was suggested that I write out some of my stories, so, here are a few...]
I was 24 in 1969, in the middle of law school
(I had graduated from Rutgers College, BA with Distinction and was then attending
Rutgers Law School, earning my JD).
That’s when I met future best-selling authors Durk Pearson and Sandy
Shaw (the 1980s Life Extension books).
My future wife Kathy Greene and I became part of Pearson/Shaw’s informal
nutrient experiment group. We’d receive a bottle of, say, food grade Selenium,
and have to count the requisite number of drops, being careful to avoid any
toxic over serving… Life Extension Foundation was established; we became more involved
with nutrients.
I started practicing law in 1971. For the first 15 years, while I continued my
personal interest in nutrition and took a few courses in homeopathy and energy work, getting to know some of
the people in our region, I found myself representing my family’s northeast New
Jersey real estate business (which included a hotel, bowling allies, 2 shopping
centers and a construction company). As the Fucetola Brothers (my father and
uncles) retired in the late 1980s I was called upon to help establish Life
Services Supplements, Inc., a dietary supplement company specializing in the
Pearson/Shaw products. It's true, I had an office between one of the bowling allies and the construction company shop, on River Road in North Arlington. Working with my cousins and Kathy there for over a decade. Good times, in many ways!
Working with Pearson/Shaw brought me into
contact with a number of the Vitamin Industry Pioneers. Companies like Keith Frankel’s Garden State
Nutritionals and, Saul Kent of the Life Extension Foundation. With that Foundation and Dr. Julian Whitaker’s support, in 1994/5 I handled the DHEA cases for two Life
Extension members and established the legal principle that the government could
not make a normal bodily substance into contraband - http://www.lifespirit.org/dhealegal.html.
With the coming of the Dietary Supplement
Health and Education Act of 1994 (DSHEA, for which I lobbied in Washington) it became possible to make
meaningful marketing statements about nutrients. I remember my wife Kathy and I
taking our then six year old son Drew on a bus to Washington for a rally and
lobbying day. A bit over a decade later we went back to DC to interview Dr .Ron
Paul about Raw Milk and Health Freedom. Drew recorded the interview which is
here: https://youtu.be/sAQdjjXCN6A.
September 2007 found us back in DC, with a dozen of Drew’s high school
friends (they had graduated that year) for a Peace March… the Fortieth Anniversary of the famous 1967 march by the Hippies to the Pentagon to "levitate" the building (I
was there)... but those are both stories for another time!
I focused on my law career and ministry. Along the way I found myself working with
Vitamin Industry Pioneers like Rev. Dr. Robert Sorge of AbundaLife (Asbury Park, NJ) and Dr. Al Fleischner of TrimSpa® fame (I was there as sales headed
from ten million to a hundred million). One important case was the Diabetiks®
matter, where the leading case of Pearson
v Shalala allowed the company to keep the product name, although it could
be taken to be referring to a medical condition. A carefully structured
FDA-approved Disclaimer, which is actually a powerful claim, allowed the
continued use of the name.
The growth of the Internet allowed me to
expand my reach and my www.VitaminLawyer.com
website became well known,
connecting me with more of the growing market. After I retired from formal
practice of the law (2006), my current web site became www.VitaminConsultancy.com. My
personal email list of clients and contacts has hundreds companies on
it.
I’ve worked with companies in India, South
Africa, Russia and Germany (Roehr Pharmaceuticals and Magister Foods) with regard to importing
nutrient products. Leading lights in the nutrient marketing world, such as Dr.
Joe Mercola, Alex Jones, Dr. Ed Group, Mike Adams (the Health Ranger) and Dr.
Rima Laibow have asked me to review their nutrient labels and claims. I’ve
worked with some of the best known holistic method or therapies teachers, such
as Starr Fuentes, Sharry Edwards, MEd and the like.
I’ve appeared before Congressional
Committees, at international Codex Alimentarius
meetings, and was invited during July 2016 to provide consultation to the Pennsylvania Department of Health
regarding the GMPs for the new Pennsylvania Medical Marijuana law.
A major effort on
my part has been developing the Vitamin Consultancy Webinar System, which
consists of about a dozen video webinars and workbooks covering significant
areas of dietary supplement regulation. FDA says the Label Owner must be in a
“state of control” over the manufacturing, QC, marketing, shipping and customer
service processing systems. This requires having written SOPs, training the
staff in them, and proving that to FDA inspectors. www.SOPcertification.com
[1] CAM Cautions
[2] DS and Medical Foods in Physicians’ Practice
[3] Lawful Copy Writing
[4] Therapy is Not Treatment
[5] Minister's Healing Practices
[6] GMP Standard Operating Procedures
[a] SOP: Introduction
[b] SOP: Section 1
[c] SOP: Section 2
[d] SOP: Conclusion
[e] SOP: Record Keeping
[7] Health Care Practitioners SOP Training
[8] How to Form an NGO
[9] Health Claims for DSHEA Products
[10] Cosmetic Dossiers
[11] Testimonial Advertising or Review Marketing -
Consumer Endorsements or Consumer Reviews?
Consumer Endorsements or Consumer Reviews?
[12] Writing Lawful Natural Product Ad Copy
The
GMP audits I conduct either in person or virtually include a 194 item checklist that must be met to be fully GMP compliant.
I extracted that list, as well as my master list of required GMP records from
the FDA GMP document.
Over the past few years I've worked with Libertarian Party candidate Gary Johnson's campaigns, bringing the issue of Health Freedom and Informed Consent into the libertarian critique of Big Govt. Here is a 2013 video Drew and I did with Gov. Johnson on the issue: https://youtu.be/JxjUW9VFrHE
As President of the Institute for Health
Research, www.InHeRe.org and Vice President of Natural Solutions
Foundation, www.GlobalHealthFreedom.org I volunteer my time for public benefit. I am forever grateful to my good friends, co-trustees and colleagues at Natural Solutions, Rima Laibow, MD and Maj. Gen. Bert Stubblebine (US Army, Ret.) for making my encore career so interesting! I also work with mentors such as Nancy Orlen Weber RN and Dick Weber of Lightwing Center - www.LightwingCenter.org and the good folks at www.NutaSpace.com - a rapidly expanding informative web site.
My
preferred role in the Vitamin Market is as senior consulting adviser, helping companies enter the market in a
sophisticated manner, and maintain proper operating procedures that meet
current good marketing/manufacturing practices. Regarding anyone entering this
marketing space, as a senior adviser, my goal is to bring nutrient marketing ideas
(such as Medical Foods) into the corporate culture.
Recently I have been
particularly interested in Cannabidiol, CBD from Industrial Hemp, but that is,
also, another story for another time, as the Vitamin War and its stories continue!
For more information you can find my Archives
at www.vitaminlawyer.com and my current work at www.vitaminconsultancy.com