The making of a dietary supplement – the long and short histories of it

 

  By Vince Giuliano  June 3 2019

This blog entry tells the stories of how our new dietary supplement 4 Herb Synergy came into being.  As such, this blog entry tells two short histories: a universal history over more than a billion years, and a highly personal history during my adult lifetime.

Regular readers of this blog have hopefully come to view me as a truth-seeking scientist who has been willing to share his views on a large number of scientific topics related to the nature of human life and longevity.  I have been doing this for over 11 years now, pursuing a pro-bono career of researching topics key to longevity, writing about them in this blog and from time to time speaking about them as an invited speaker at a professional conference, podcast or webcast.   Commercial activities did not enter my mind and I have consistently rejected suggestions that I accept advertising here or feature particular drugs, supplements, or commercial services,  Now, as I approach age 90, I am starting up a commercial venture.  Probably starting in a week from now, my LLC will be selling my 4 Herb Synergy product.  This blog entry seeks to explain how that shift in a commercial direction happened and my motivations for pursuing it.

The first history below is about important events for life itself, ones that almost all happened before I existed, events that were pre-requisite for the second personal history, or for any of us to exist for that matter.  This second history in this blog entry is my personal story related to creating 4 Herb Synergy.  Then, I discuss my motivations for doing so and address a few related questions.

I think that the science basis for the 4-Herb Synergy supplement is very strong.  I cover that in a companion blog entry to this one, Inflammation Part 6: The Science Behind the 4 Herb Synergy supplement.

First, The Billion Year Story

  • More than One billion years ago, plants began evolving sophisticated chemical responses for them to be able to maintain their health given a wide variety of stresses. The evolution of plants made them living biochemical research laboratories.

 

 

 

 

 

 

 

 

So, if you ask when the R&D leading to 4 Herb Synergy was first started, it is no exaggeration to answer it was over 1 billion years ago.

  • 600 million years ago or so, primitive animals began to separate from plants and evolve, each new species always adopting whenever it could the same genes and strategies used for healthy survival by earlier more-primitive species – including incorporating many of the original plant-based defenses.

Images source: Wikepedia, Britannaca Kids

EON ONSET MAJOR EVENTS
Hadean 4.5 Ga formation of earth and continents, chemical evolution
Archean 3.8 Ga origin of life, prokaryotes flourish
Proterozoic 2.5 Ga eukaryotes evolve, development of oxygenated atmosphere, some animal phyla appear
Phanerozoic 540 Ma most animal phyla present, diverse algae; explosive evolution of multicellular life forms

    Ga = billion years ago, Ma = million years ago  Table source

  • 150,000 years ago or so, these genes and plant survival-based strategies were finally passed on to us humans, via our countless intermediary biological ancestors.

 

 

 

 

Image source

  • 4000 years ago, strong traditions of folk medicine were evolving in India and throughout the world, based mainly on the use of plant-based substances. These provided multiple forms of biochemical support for our health and well-being – often working through the very same biological pathways that were active hundreds of millions of years ago in plants.

 

 

 

 

 

Image source

  • 4000 years ago until today, certain key herbs have been used for their powerful anti-inflammatory properties, among these Turmeric, Boswellia, Ashwagandha and Ginger. Writings about the medicinal properties of these herbs can be found in the ancient Chinese and Aryuvedic literature and they were used in many other areas of the world as well.

 

 

 

For the last 40+ years these herbs and herbal extracts of them have been sold in pill form as dietary supplements, representing a current aggregate market of hundreds of millions of dollars a year.  The safety of these supplements is unquestioned.

  • In the last 30 years the same herbs have been extensively studied for the biological pathways that they activate. The mechanisms they employ to control inflammation have been discovered and explained in tens of thousands of research publications in the biomedical literature. The four herbs we mentioned utilize somewhat different biological mechanisms and pathways and we believe they operate synergistically.

 

Image source                                                               Image source
Around 20 years ago it was becoming clear that the biggest limit to these dietary supplements for creating health and limiting inflammation was insufficient  bioavailability – ability of the injested substance to transverse numerous bodily barriers and challenges to get to the important interior areas of cells where they could make a difference.

 

 

 

 

 

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  • Particularly in the last 15 years it is becoming increasingly clear that all of the major diseases that kill people with aging – cancers, dementias, cardiovascular issues, diabetes, etc. – are characterized by chronic unresolvable inflammation. And that control of such inflammation could have major implications for healthy aging and extending lifespans.

 

 

 

 

 

 

Image source                                                                    Image source

  • Particularly in the last 5 years there have been major developments in the practical application of nanotechnologies for enhancing the bioavailability of drugs and herbs such as those mentioned. This involves using high technology approaches to encapsulate drugs or herbs in tiny containers, ones too small to see by an optical microscope, containers that can easily pass through bodily barriers that limit bioavailability. An important category of nano-delivery techniques is the use of liposomes, tiny vesicles that are used in nature. For example mother’s milk contains liposomes, probably to enhance the bio availability of its ingredients for tiny infants.

 

 

 

 

 

Image source                                                        Liposome

This has been the billion-year impersonal history, background to the personal history story which follows.

My personal 47-year story

The prehistory and history of 4 Herb Synergy

I go on here with some highly personal material, namely a history of what led to 4 Herb Synergy and my personal motivations now for wanting to see it on the marketplace.   This involves telling a quite personal story. A N=1 story.  To be clear here I am making no medical claim for 4 Herb Synergy or any actual product I may be associated with. The statements in this blog have not been evaluated by the Food and Drug Administration. 4 Herb Synergy or any similar dietary substance being sold is not intended to diagnose, treat, cure, or prevent any disease. I intend that at some point it will be possible to have a clinical trial for 4 Herb Synergy with results that allow medical claims to be made for it.

About 1972

Some 47 years ago, when I was in my early 40s, my professional focus was related to the unfolding computer/information revolution.  This was a long time before I got seriously into the health sciences.   I was getting morning bouts of joint stiffness and pain, particularly in my joints, arms, legs, knees and hands.  At first these symptoms were mild but gradually they became more serious and debilitating.  I was an early follower of Adelle Davis back then, an early exponent of nutritional approaches to health, and looked up what was she said in her books about arthritic pains.  My look was superficial but I soon learned that the problem could be related to my super-pressured life and work style and could be due to overexpression of the stress hormone cortisol.  I was typically making 2-3 business trips a week, often to the West Coast or overseas.   I could not change my lifestyle but found a suggestion that I cut back on my coffee load.  I cut back from 5-8 cups a day to 2 cups a day.  The arthritic symptoms became very mild, worsening if I went back onto too much coffee.  Problem was solved and my active life went on.

Gradually, however, as the years rolled by, the pain and swelling symptoms came back.

 

 

About 1987

So, about 32 years ago I hit the alternative medicine books again, and this time settled on an approach of taking 1gm of vitamin C a day. Vitamin C was regarded to be a nostrum for almost anything back then in the heyday of Linus Paulings advocacy of it.   Again, my inflammatory joint problems improved a lot.  I figured that between the Vit C and the coffee limitation I had solved the problem again.  And I had plenty of other matters to be occupied about.

 

 

This seemed to work fine for another 10 years or so.

About 1997

Yet again, the joint pains very slowly worsened over the years until about 20 years ago, when I had an inflammatory flare of joint pain and stiffness so severe that I rushed to an emergency appointment with a rheumatologist.  He immediately put me on 75 mg prednisone and Plaquenil, ordered a variety of blood tests, and soon definitively diagnosed me as having rheumatoid arthritis (RA).  He told me I would have to be on increasing doses of anti-arthritic drugs the rest of my life.  He suggested I start with methotrexate, which I did not do.  I hated that idea.  Emboldened by my earlier successes, I hit the herbal science books again.  This was before serious research on Internet was possible. I read several books on traditional herbs and other supplements for the control of RA, and came up with a dietary supplement regimen which I have essentially followed since.  Central to this regimen, in addition to the usual suspects like vitamin C and D, were four herbs of Ayurvedic origin that were also each touted by the book authors to be powerful anti-inflammatories that could control RA – Curcumin, Ginger, Ashwagandha and Boswellia.  These were readily available in pill form as dietary supplements, so I decided to take them all. After taking this regimen for about 3 months my arthritic symptoms had all but vanished again and I was off of prednisone and on a reduced dose of Plaquinil.  My rheumatologist was amazed but pleased and my inflammatory/RA indicators like CRP and sed rate where nearly down to normal.  But he still thought I should start on methotraxate, which I still did not do.

I give a lot of credit to this supplement regimen for keeping me agile for my age and largely free  of inflammatory  aches and pains for some 16 years after then, until about six years ago when I was about 83).

 

About 2007

Backtracking a bit here to about 12 years ago (2007, age 77), I decided about then to enter a whole new career trajectory that would involve deep study of the sciences associated with longevity. The personal health experiences I had had up to this point including the ones with inflammation were strong motivating factors.  After publishing the initial version of an online treatise in 2008 featuring my “anti-aging firewall” dietary supplement regimen, I started this blog in 2009.  Now my research was no longer based on books but mainly on the Internet – the Internet I had helped create in an earlier reincarnation of my career.  Through the years as I studied the various topics covered in this blog, I retained a strong interest in herbal substances and on the topic of chronic inflammation.  Among other matters I delved into the current research in the same four Aryuvedic herbs and into the different biologic inflammatory pathways they impacted.  I characterize some of this research in the companion blog entry Inflammation Part 6: The Science Behind the 4 Herb Synergy supplement.

.About 2014

Some five years ago (age 84), I noticed yet-another initial re-appearance of the old inflammatory joint condition.  It was threatening to re-arise yet again!  I was beginning to experience a bit of “trigger finger” in the smallest finger on left hand.  That is, pain and discomfort as it is popped from open to closed position.  A symptom I had noticed and then had vanished 40 years before.  The typical pro-inflammatory constitutional effects of aging where starting to present themselves in me!  This was despite controlling the coffee, despite taking the vitamin C, despite my taking the four key anti-inflammatory herbs, and despite my exercising regularly and observing other anti-aging protocols.  I thought I had to do something further to stay ahead of inflammation and rheumatoid as well as osteo-arthritis.  Fortunately this time around I was better prepared to take up the challenge.  In the course of my research:

  1. I had learned that the books I had read years before about the four Aryuvedic herbs and arthritic inflammation were correct according to quite current research studies. There are large bodies of contemporary research on the anti-inflammatory and anti-arthritic effects of each of these 4 herbs.  There are thousands of research publications in the government database pubmed.org relating to the properties of medicinal effects of these herbs  Some of the herbal components of 4 Herb Synergy have been in clinical trials for disease treatments, some 150 clinical trials for curcumin alone
  2. I also learned how the healthful biological impacts of the herbal substances were restricted when you ate them in pill form by their limited bioavailability – limited ability to survive the journey to get to the insides of the cells of the body where they are needed.
  3. And I had learned that there is a high-technology nanoscience approach to multiplying the bio-effectiveness of the four herbal ingredient, through encapsulating herbal extracts in nano-sized liposomes, a system used in nature.
  4. Best of all, my colleague and frequent co author Dr. James Watson pointed out to me that there is an approach to making liposomal preparations in your own kitchen. In fact there were amateur YouTube videos on how to make liposomal Vitamin C.  All you needed was a very powerful mixer and a tool-cleaner ultrasound unit.

So, over five years ago (early 2014, age just turned 84) I started making and taking a liposomal preparation of the very same four herbs.  This was at start only for my personal use. In the family we called it “Lipomix,” and we often still call it that,

You guessed it – almost all of the inflammatory symptoms yet-again soon vanished.  The trigger finger went away again and it or other arthritic symptoms have not so far reappeared again.  After about a year (2015) my wife also developed some inflammatory symptoms and she too started helping me to make Lipomix and to take it.

2016

By 2016, we were providing our home-made product to a selected number of other people as well who had heard about it via word-of mouth. Unfortunately we were unable to manufacture in our kitchen on a scale that could meet the demand. So it dawned on us that it would be good if there was a commercial version of the product that people could simply order.  We sought to find a manufacturer who could develop a commercial version of the product: one with a small form factor, good taste, and long shelf life.  Our first two tries at this with supplement manufacturers were not successful.  Otherwise reputable supplement manufacturers simply lacked the depth of experience with making liposomal products to be able to reliably make our relatively complex 4-ingredient product.  In 2016 we finally established a relationship with an established manufacturer of liposomal supplements, a small but very reputable company with proprietary liposome-making technology.  This manufacturer already had developed several liposomal products; some were being sold under its own name, others produced on a contract bases and sold under different names

2017

By 2017 my colleagues and I (my wife Melody Winnig and my son Michael Giuliano were actively engaged in steps to be in business, with intention to make our Lipomix available as a commercial product.  A long period of R&D ensued with the manufacturer tweaking samples, and sending to us for review.  We formed a formed a LLC, now called Synergy Bioherbals LLC, got trademark protection for our product, finally renamed the product as 4 Herb Synergy, took out a provisional patent on the product and have applied for a regular patent on the product which is now being reviewed by the Patent Office.  But most of our active energy went into the process of R&D. We participated in multiple rounds of sample product evaluation, for example,and comparisons with existing commercial products.

 

 

 

 

Product samples during development period.  On left: early samples showing ingredient separation.  Center:  samples showing unwanted variation in smoothness and taste.  Right: bottles for some of the samples and other products we examined.

June 2019

In the course of the last four years until now (June 2019, age 89), we have shared Lipomix with perhaps 30 people collecting their anecdotes, had 4 Herb Synergy tested using very sophisticated light scattering technology on two occasions to verify that it is indeed liposomal and not just an emulsion.  We have learned about problems with it, and taken steps to rectify the problems.  We have made many small improvements to it.  And we have seen what it does for our own health and vitality.

As part of my research reported in this blog, I have dug much deeper into learning about inflammation and its associated pathways.  I have come to appreciate how extensive the topic of inflammation is.  I have learned how universal and important the inflammatory response is, about the roles of chronic inflammation in all of the age-related degenerative diseases and conditions that kill older people, the key biological involved in inflammation.  I learned about NRF2, NF-kappaB, resolvins, protectins, histone acetylation and de-acetylation.  I learned how NF-kB, the “master pathway of inflammation” is inhibited by the four Aryuvedic substances as well as by a number of other plant-based substances.  To read about these check my recent blog entries in the inflammation series and earlier ones on closely related topics.

Only now do we believe the R&D on 4-Herb Synergy is sufficiently complete that we can go live in selling the product, which we expect to happen within a week or so.  Compared to our home-made Lipomix, the 4 Herb Synergy product:

  • Uses the most concentrated standardized extracts available for the most bio-active ingredients in Curcumin, Boswellia and Ashwagandha.
  • Is in a concentrated liposomal emulsion form factor, with a 30-day supply being in a slim 180 mg plastic bottle instead if filling a quart jar.
  • Has a pleasant citrus flavor instead of tasting like strong herbs.
  • Has an expected shelf life of 30-45 days, once opened if refrigerated.
  • Is made in a GMP-certified manufacturing facility that has had its products tested in a number of ways for safety and authenticity of its liposomal content.

We have been making and taking our homemade Lipomix every day until a few days ago when we received some bottles of the first batch of the 4 Herb Synergy manufactured product, and weswitched to that.

We call the manufactured product 4 Herb Synergy because of multiple improvements and enhancements to it, some made by us, some by the manufacturer.  4 Herb Synergy was developed through collaboration with a company that has long focused on making liposomal products and is produced under contract for our LLC by that company.  We own trade secrets and the patent pending on the product.  The manufacturing company own trade secrets and patents relative to manufacturing it.

 

About 2 years ago (2015, age 85) we decided to make Lipomix into a commercial product, a dietary supplement.  Others could do as we do and make it at home, but the process is rather fussy and messy. And the original kitchen process leaves tiny herbal fragments in the liposomal product, albeit that these are harmless. It takes us about two hours to make a couple of quarts of it, including utensil cleanup time.  The process is probably beyond what most older people could or would be willing to do.  We established a close relationship with a manufacturer experienced in making liposomal supplement products, and started developing a commercial version   I call it 4 Herb Synergy here because of multiple improvements and enhancements to it, some made by us, some by the manufacturer in close collaboration.  The commercial 4 Herb Synergy is more compact than the original version, better flavored, free from herbal fragments, easier to take and has longer shelf life.   We are only new switching our personal consumption from the home-made lipomix version to 4 Herb Synergy.

On my motivations

Before wrapping up the personal part of this blog entry I want to say a few words about the motivation for going in a commercial direction after ten years of purely volunteer effort in my longevity science career.  And also, state the motivation for making it a dietary supplement instead of a pharmaceutical product.

Why do I want to get into a commercial business this late in my career?

To make money?  Frankly yes, hopefully, ultimately, in time.  Though that’s not the main reason I tell myself.  An 89 year-old intellectual researcher-blog writer guy starting a risky new venture business and putting my limited retirement resources at risk to do so?  Give me a break!  Why?   In heavens name why?  The reason is that I think the marketplace is a potentially very powerful way to reach a lot of people, and my family and I might make a significant difference that way, a different kind of difference than made by the blog.  I love you loyal blog readers, but let’s face it.  Most people out there can’t follow the technospeak of the biological and medical sciences that we have to serve up, and will never read and understand many of the entries in this blog. So the social impact of this blog is likely to be very limited.  But most everybody is willing to buy things that they think may make a difference in their lives even if they have no inkling how those things actually work.  And they do that all the time, like with their cars, refrigerators and cell phones.  So that’s why this 89 year-old is doing the business thing.  Because I think just possibly (and even likely), some of you who get to taking 4 Herb Synergy may be healthier and lead longer productive lives.  And I am wise enough or crazy enough to think that might turn out to be a whole lot of people in time.

What is the nature of the business?

Our involvement with 4 Herb Synergy is a family business, involving a limited Partnership of my son Mike aged 39 who has a business background and managerial capabilities, my wife and fellow longevity researcher Melody Winnig, and I.  You may know from my early bio that I have a good deal of business and business consulting experience.  So does Melody who is currently acting as CEO and who has additional background in marketing.  We are the sole owners of the LLC, Synergy Bioherbals, and holders of the patent pending on the product.  And Mike was in business for himself for a long time too.  As to the money part, my work in research for this blog and writing it has been strictly pro-bono for 10 years now.  No advertising or commercial touting on this blog, no university appointments or research grants, no sugar daddies in or venture biotech guys in the background.  I had a fairly good retirement bundle from my earlier careers and have been living on that and supporting my longevity activities for some 16 years now.  However, one of the consequences of living a long long time and being generous to family is that over time the retirement bundle has been getting smaller.  Since I expect to keep up my longevity science career through my 90s and perhaps even beyond 100, it would be very useful to establish an additional income source. So, we can make very good use of any additional income from the business to keep up my family’s present quality of lifestyle.

Why a dietary supplement?  This is an easy question.  Because to play in the “legitimate pharmaceutical substance” game would require tens of millions or even billions of dollars, would require at least 10 years for clinical trials, and, worst of all, would require turning over control of the business and 4 Herb Synergy’s future to money-hawk venture investors or to a big pharma company.   Gone would any ability to influence scientific integrity.  A supplement company on the other hand can be started on a shoestring with lots of sweat energy, and that is exactly what we have been doing. And, for now at least, we can stay in complete charge.

Again, for a review of the science behind 4 Herb Synergy, you can check out the companion blog to this one The Science Behind the 4 Herb Synergy supplement.

MEDICAL DISCLAIMER

THE PURPOSE OF THIS BLOG ENTRY IS TO PRESENT GENERIC AND PERSONAL INFORMATION RELATED TO A DIETARY SUPPLEMENT RECENTLY DEVELOPED BY THE AUTHOR AND HIS COLLEAGUES.  OVER THE 10-YEAR HISTORY OF THIS BLOG, WE HAVE REFRAINED FROM ACCEPTING ANY ADVERTISING OR ADVOCATING ANY COMMERCIAL PRODUCT.  WE HEREIN WISH TO CONTINUE THE LONG-ESTABLISHED POLICY OF THIS BLOG , WHICH IS TO PRESENT ESTABLISHED SCIENTIFIC FACTS AND PERSONAL COMMENTARIES RELATED TO WELLNESS AND HEALTH, NOT TO  PROVIDE MEDICAL ADVICE OR ADVOCATE ANY TREATMENT FOR CURE, PREVENTION OR DIAGNOSIS OF ANY DISEASE.  

THE STATEMENTS IN THIS BLOG ENTRY HAVE NOT BEEN REVIEWED OR APPROVED BY THE FDA.

FROM TIME TO TIME, THIS BLOG MAY DISCUSS RESEARCH DEVELOPMENTS RELATING TO DISEASE PROCESSES.  THE INTENTION OF THOSE DISCUSSIONS IS TO CONVEY CURRENT RESEARCH FINDINGS AND OPINIONS, NOT TO GIVE MEDICAL ADVICE.  THE INFORMATION IN POSTS IN THIS BLOG IS NOT A SUBSTITUTE FOR A LICENSED PHYSICIAN’S MEDICAL ADVICE. IF ANY ADVICE, OPINIONS, OR INSTRUCTIONS HEREIN CONFLICT WITH THAT OF A TREATING LICENSED PHYSICIAN, DEFER TO THE OPINION OF THE PHYSICIAN. THIS INFORMATION IS INTENDED FOR PEOPLE IN GOOD HEALTH.  IT IS THE READER’S RESPONSIBILITY TO KNOW HIS OR HER MEDICAL HISTORY AND ENSURE THAT ACTIONS OR SUPPLEMENTS HE OR SHE TAKES DO NOT CREATE AN ADVERSE REACTION.

About Vince Giuliano

Being a follower, connoisseur, and interpreter of longevity research is my latest career. I have been at this part-time for well over a decade, and in 2007 this became my mainline activity. In earlier reincarnations of my career. I was founding dean of a graduate school and a university professor at the State University of New York, a senior consultant working in a variety of fields at Arthur D. Little, Inc., Chief Scientist and C00 of Mirror Systems, a software company, and an international Internet consultant. I got off the ground with one of the earliest PhD's from Harvard in a field later to become known as computer science. Because there was no academic field of computer science at the time, to get through I had to qualify myself in hard sciences, so my studies focused heavily on quantum physics. In various ways I contributed to the Computer Revolution starting in the 1950s and the Internet Revolution starting in the late 1980s. I am now engaged in doing the same for The Longevity Revolution. I have published something like 200 books and papers as well as over 430 substantive.entries in this blog, and have enjoyed various periods of notoriety. If you do a Google search on Vincent E. Giuliano, most if not all of the entries on the first few pages that come up will be ones relating to me. I have a general writings site at www.vincegiuliano.com and an extensive site of my art at www.giulianoart.com. Please note that I have recently changed my mailbox to vegiuliano@agingsciences.com.
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7 Responses to The making of a dietary supplement – the long and short histories of it

  1. Pingback: INFLAMMATION PART 6: THE SCIENCE BEHIND THE 4 HERB SYNERGY DIETARY SUPPLEMENT - AGINGSCIENCES™ - Anti-Aging Firewalls™AGINGSCIENCES™ – Anti-Aging Firewalls™

  2. dlyness says:

    Link to purchase the product?

    • Can’t legally give you the link here because of regulatory reasons. but you can search under our LLC’s name for the site. As of 6/19 we are awaiting our insurance binder before we can turn the site on and start actual selling. Hopefully by the end of this week.

      Vince

  3. Pingback: FUNNY THINGS ARE HAPPENING TO ME ON THE WAY TO 100 - AGINGSCIENCES™ - Anti-Aging Firewalls™AGINGSCIENCES™ – Anti-Aging Firewalls™

  4. Pingback: INFLAMMATION PART 6: THE SCIENCE BEHIND THE 4 HERB SYNERGY DIETARY SUPPLEMENT - AGINGSCIENCES™ - Anti-Aging Firewalls™AGINGSCIENCES™ – Anti-Aging Firewalls™

  5. Stephen Miller says:

    Vince, you have been and continue to be a trailblazer.

    I look forward to trying your anti-inflammatory, liposomal, four herb supplement.

  6. Pingback: Inflammation Part 7: Neurohormesis, neuroinflammatory diseases, and their treatment by mushroom substances (Section 1) - AGINGSCIENCES™ - Anti-Aging Firewalls™AGINGSCIENCES™ – Anti-Aging Firewalls™

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