Thursday, August 11, 2016

"Vitamin War" Stories

My Experiences in the Vitamin World

Short Link to this Blog: http://tinyurl.com/VitaminWarStories


[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.

My encore consulting career centers on Claims, Labels, GMPs and SOPs. I’ve been called upon on several occasions to work in the international field. For example, in 2005 I consulted with people in the South African equivalent of the FDA. They were just writing dietary supplement regulations and I was asked to review the contents of the 300 page loose-leaf notebook draft. At my recommendation a half dozen strategic words were changed and today South Africa has one of the world’s most vibrant nutrient markets.

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?
[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

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