On this week’s A Different Perspective, Dr. Flynn shares a video training done by Mitch Coven, the Clinical Herbalist who manufactures The Wellness Way herbal supplements in Albuquerque, New Mexico. Mitch gives his background and training and then talks about quality control and sourcing of the herbs. He also zeroes in on sourcing, quality control, and testing. Doc then does a product knowledge training on licorice and ends with his “Last 10%,” discussing a news headline on the idea of climate change causing obesity.
(Begins at 0:00:30)
Doc begins by reviewing his favorite illustration of looking at things from “A Different Perspective.” It’s a cylinder suspended mid-air with light shining on it from two directions. That creates two shadows on the wall: one is a circle, and one is a square. Depending on where the audience is seated, they would have different guesses as to the shape of the object. We are looking at it from above – seeing the whole picture. That’s how The Wellness Way looks at health –from A Different Perspective.
Then Doc introduces a couple of doctors who are shadowing at the Green Bay Clinic. He also introduces Dr. Alex, a doctor at our Eau Claire, Wisconsin Clinic. He has an amazing story of standing up for medical freedom while serving in the military. He’s still in the military but also serves as one of our Wellness Way doctors.
Perspective: Wellness Way Herbal Supplements
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Doc then introduces a video done by our media team featuring Mitch Coven, Clinical Herbalist, President, and CEO of Vitality Works in Albuquerque, New Mexico. The Wellness Way works with Mitch to manufacture our Wellness Way herbal supplements.
A Brief History of Mitch Coven
Mitch gives his background and how he became an herbalist. He started his studies in botanical medicine back in the 1970s in Madison, Wisconsin. He was lured away from conventional Western medicine into health-oriented preventative care. Then, it was called the alternative medical field. Now, it’s called the complementary medical field. He began his studies in herbal medicine in Madison but then was drawn to a more formalized education.
So, he began his studies in historical applications of herbal medicine through the Eclectic Medical Institute. The Medical Eclectics were early 1900s to 1950s herbal medicine physicians in the United States. Mitch also studied Traditional Chinese Medicine with Dr. Jake Fratkin and some other lecturers he met in Madison. While not a TCM expert, he does use it in his work as an herbalist.
Mitch also studied quite a bit of Ayurvedic Medicine, the traditional medicine of India. The Ayurvedic Institute is right there in Albuquerque. It’s the primary institute for studies in Ayurvedic Medicine.
Western Physiologic Approach
Most of Mitch’s discipline is in Western physiologic approaches to health care. He has accumulated a lot of knowledge over time from a variety of disciplines, but what he’s learned the most, and what he feels he can offer the most comes from his clinical work.
On October 2, 1982, he started Vitality Works, a multi-disciplinary health center in Albuquerque, New Mexico. He was the herbal practitioner doing clinical intakes and putting people on programs with botanical medicine in 1982. That was the “early days” in this work.
He had Rolfers there, massage therapists, Ayurvedic practitioners, therapists… There were six of them there in 1982. By the end of the first year, they were booked with a waitlist to get into the clinic. They were having great success.
Mitch spent the next seventeen years predominantly focused on a full-time clinical practice in herbal medicine. That allowed him to apply what he learned with patients. It’s one thing to be a scholar and read about those who came before. It’s another thing to apply these disciplines in a clinic and see what works and what doesn’t. There’s nothing like working with patients to determine outcomes.
Influenced By Herbalist Michael Moore
Mitch’s primary influence in Western herbal medicine was an herbalist named Michael Moore, who had the Southwest School of Botanical Medicine. He studied directly with him initially in 1983 and then again after having been in clinical practice for ten years.
He looked at system dysfunction and how to treat systems of the body (not diseases) with botanical medicine. He matched treating system dysfunctions with plant biochemistry, then looked at how to manage health issues by treating systems.
Teaching Health Professionals Led to a Compounding Pharmacy
Mitch then got into teaching health professionals. There was a lot of demand for compounding of the herbal medicine from the clinic so they could go “over the counter.”
At that time (in the 1980s and 1990s), there were few places to go for botanical medicines, so Mitch had to study how Western pharmacists made botanical preparations and apply them currently. So, they became a compounding pharmacy for practitioners around the country.
Eventually, it was time to offer these herbal preparations they found most effective over the counter. That was the beginning of the contract manufacturing side of Vitality Works. So, seventeen years of doing clinical work were followed by 23 years of compounding botanical medicines for people all over the world. This year, 2022, is their 40th year anniversary in botanical medicine.
Vitality Works Today
At this point, Mitch’s company has been compounding botanical medicines for over 20 years. They have developed thousands of formulations and work with over a thousand different botanicals. Mitch has 2500 ingredients that they compound. They continue to tweak things as they learn more to maximize efficacy. If people aren’t getting better, they must do something different to make the products more effective.
Mitch is proud to say that he is still 100% owner of Vitality Works. He has no partners or investors. That means there’s no pressure to compromise on what they do. The mission at Vitality Works is to never compromise on anything because what they do is all about quality and efficacy.
Quality Control of Raw Materials & Products
It’s important to talk about quality and what that means. Botanical product manufacturing is regulated by the FDA. There’s a lot of misinformation out there saying this industry needs more regulations. It’s not true; it’s highly regulated, as you will see.
Quality Can Be Objectified
What’s confusing is that everyone who is manufacturing a supplement, whether it’s an herbal product, vitamin, mineral, nutraceutical, amino acid, or digestive enzyme, will claim they have the best quality. No one is going to say they “make average stuff.” Everyone’s going to say they have the best quality control. But it can be objectified with third-party certification, oversight, and audits.
It’s Illegal to Not Meet Label Claim
But many companies out there aren’t even following what the FDA would call minimum quality standards. So, you hear about warning letters to companies who don’t meet label claims –what the label says isn’t really in there or it’s contaminated in some way. All of that is illegal and against federal regulations. The only reason it’s not policed more is that the FDA doesn’t have the full budget to go out there and thoroughly police it.
But there are plenty of good players, including Vitality Works. Still, you shouldn’t believe Mitch, so he’ll show you what they do.
The FDA Does Regulate Dietary Supplements
What you need to know is that the FDA does regulate dietary supplements. It’s under what’s known as 21 CFR (Code of Federal Regulations) 111. Mitch shows the book, which outlines in detail the guidelines for entry-level Good Manufacturing Practices (GMP).
He then shows another reference booklet. Vitality Works is also OTC drug certified. While dietary supplements are not OTC drugs, this is a stricter code of federal regulations that drug manufacturers need to follow. This is the 21 CFR Parts 210 and 211. These are the guidelines for pharmaceutical ingredients. They don’t have to go that far, but they do on many things. They also make homeopathic products, which are OTC drugs.
The important thing to note is that the 21 CFR 111 is a 65-page booklet outlining the minimum quality levels of what you need to do to ensure you’re meeting label claims on your products –not just when you first make them, but also when they expire.
To do that, they created standard operating procedures. Vitality Works has over 200 standard operating procedures dealing with how they manufacture their products. They train their staff to follow them so that they can ensure that they meet that quality.
Vitality Works Goes Over and Beyond
They also have over 100 job aids to support processes. They have almost 200 different forms to document everything they do –with double signatures. That’s actually a pharmaceutical regulation that they apply to dietary supplements.
The FDA regulates things that you put in your mouth. On the lax side, that would be food products. Making salsa has regulations, as does any food ingredient. On the strictest side would be prescription drugs. Prescription drugs require efficacy studies.
When it comes to dietary supplements, they are a subset of the food law. But they are regulated much closer to how drugs are regulated in the Code of Federal Regulations.
The only thing they don’t have to do in the dietary supplement world is to prove efficacy. But otherwise, they must do a lot of the same things with adverse event reporting, recall procedures, and ensure meeting label claims. To do that in their facility, Vitality Works has 35 people in the quality division alone: insuring, auditing, and testing. They ensure Vitality Works can stand by its products.
The FDA can also inspect. They do random, unannounced inspections. Vitality Works gets them about once every three years. Mitch is proud to say that Vitality Works has never received a “483.” A “483” is an official document that says a company is in violation of FDA Good Manufacturing Procedures. It says that a company would need to make a change or else be put out of business with a cease-and-desist letter. They have never received that or even “corrective action suggestions.” Those would be things they would need to improve short of a 483.
Additionally, it’s common in the industry for the best folks making products to employ third-party GMP audits. So, Vitality Works, for the past 15 years, has had NSF (a third-party certifying agency) come out a couple of times a year to ensure that they can be certified for GMP in alignment with FDA regulations.
Vitality Works also has many other companies come out and audit them. They have GMP certifications and audits through Intertek, UL, kosher certification, and organic certification. The state also comes out and audits them. Currently, they have somewhere between twenty and forty audits a year ensuring that all their claims about the quality are audited. They have never failed an audit and commonly receive A+ ratings. So, they are very proud of the quality of products they produce.
While the FDA defines “minimum quality,” but how do you define “maximum quality”? Mitch wants to go way beyond that. Here are some illustrations of what beyond maximum quality might mean. The FDA permits “skip law testing.” So, if you have a vendor and you’re consistently getting good-quality herbs, you don’t have to test every lot. Vitality Works does test every lot –every lot, every time.
Whether they are receiving one pound or 10,000 kilos of something, they do a full battery of tests. They test for:
- Microbiological contamination
- Heavy metals
- Identity to genus and species
They don’t have to do that. But it has paid off. There was one plant he was getting from a supplier for 20 straight years, but they tested it every single time. In year 21, they tested the material and, lo and behold, it was the wrong genus and species. They caught it before it went into production. Doing 100% testing on every lot and every production run goes beyond what the FDA asks for.
In terms of minimum quality and going beyond that to achieve maximum quality:
You don’t have to buy certified organic ingredients to ensure they are clean…
But Vitality Works does that.
You don’t have to be kosher certified…
But Vitality Works does that.
You don’t have to be non-GMO (you’re allowed to use them)
But Vitality Works does that. They don’t know the long-term consequences of consuming GMO plants.
You don’t have to be gluten-free
But Vitality Works is a gluten-free facility. They test for gluten in items that could have gluten, but they also test for gluten in items that should not have gluten but can be contaminated with it.
Fenugreek does not have gluten in it. But Vitality Works consistently tests its herbs as they come in. When they received a batch from India, they tested it and found gluten. It turns out the fenugreek was being grown right next to a wheat field. The wind had apparently spread some of the seed and the wheat was spread into the fenugreek field. Vitality Works had to reject a lot of fenugreek from that farm.
Vitality Works is also approved by the equivalent of the FDA in Canada, which is called Health Canada. Health Canada is even stricter than the FDA in terms of regulations. Vitality Works is ready to be inspected at any given moment.
Vitality Works does allergen testing to make sure there aren’t inadvertent allergens in the products. They do environmental testing to make sure that not only are the raw materials not contaminated by neither is the environment in which the products are made. So, they test the air and contact surfaces.
When they clean, they know it’s clean because they test afterward. They know for certain that there’s no residue from the former run of material, but there’s also no microbiological contamination.
There are plenty of recalls in the food industry and drug recalls and adverse events in the pharmaceutical industry. The testing requirements by the FDA are much looser in the food industry. You hear lots of these headlines about recalls and E. coli in food.
What you’re not hearing about are issues in the supplement world where a product was contaminated and hurting people. The CDC follows adverse events and there are little to none in the dietary supplement industry. There’s a lot of hysteria in the media about quality in the supplement industry but you just don’t see it – even though most companies are following the minimal guidelines for quality and competency. Vitality Works goes well beyond that.
Here’s another way Vitality Works goes over and beyond. The FDA says you must test for every possible contaminant. There is no list for every possible contaminant! Now, most botanicals traded in the world come in the form of powders. It’s mostly due to the cost and ease of shipment. So, one way to be sure there are no contaminants is to only purchase whole botanicals. That’s what Vitality Works does.
That way, they can actually see it. They can see if there’s a certain percentage of another plant or something else in there.
Mitch Demonstrates Whole Botanical Sourcing
Mitch then demonstrates what that looks like. He takes out saw palmetto berries from Florida. They get them whole so they can see that they weren’t harvested too early (impacting the fatty acid content). They need to be a dark purplish color to be of therapeutic value. They should also have a pronounced aroma.
Mitch also shows whole chaste tree berries. They make sure they aren’t contaminated with bird droppings or even leaf, bark, or stem material from the same tree. The active medicinal aspect is only found in the berries. They can also check the color of the berries.
Also, why do most coffee aficionados like to buy whole beans and grind them right before brewing? Because it tastes better. Why does it taste better? Because the chemical constituents and active biochemical compounds are stronger, versus coffee that was ground months ago. Those things change over time. Vitality Works keeps the plant in its whole form until the day before it undergoes the extraction process to maximize therapeutic efficacy.
Mitch Shows Things Found in Whole Plant Material That Led to Rejection
Mitch then shows a collection of things Vitality Works found in the whole plant material that they would not have seen had it arrived in powder form:
In a myrrh shipment, they found animal parts: fur, a rodent ear(?), a used Band-Aid, bark from another tree, twine, and children’s stickers.
How do you know when you buy herbs from Third World Countries that this was all pulled out before being powdered? You don’t. Once it’s powdered, there are no tests to find out what percentage of the material is used Band-Aid or rodent, or twine. The only way to know for sure is to get your botanicals in the whole form. It costs more and is more labor-intensive, but you get a pure product.
They Want Plants That Are as Fresh as Possible
Vitality Works sources plants that are as close to harvest as possible. Just like how a fresh, tree-ripened peach is a lot different than one that is still hard, and you hope ripens, it doesn’t have the same taste profile or phytonutrient profile.
So, Vitality Works contracts with growers all over the world to get the most recent harvest of plants from that current year. They have to plan from 12 to 36 months ahead to make that happen. Again, this is beyond what the FDA requires.
Another thing that’s beyond what the FDA requires is that Vitality Works powders the herbs right before the extraction or encapsulation process. That maximizes the phytonutrient compounds in the material to make them as potent as possible. That’s just engrained in their processes.
Vitality Works as Focuses on Sustainability
Vitality Works is also very aware of sustainability. A lot of plants that were used in the history of herbal medicine are wild foraged. Goldenseal is one of them. Echinacea is another. Most of the wild goldenseal is gone. There is very little left. If we want to have it for ourselves, our children, and future generations, it must be cultivated.
So, Vitality Works is very involved with certified organic growing projects for plants that have been overharvested. Echinacea is another one that used to grow all over the roadsides of Arkansas and Missouri and now it’s hard to find it. Vitality Works only sources material that has been grown on certified organic farms. This again is way beyond what the FDA requires. They don’t even look at it.
Mitch Also Optimizes Products for Bioavailability
Another aspect regarding quality is this: Just because something went in your mouth doesn’t mean it got absorbed into you. So, Vitality Works looks at different ways to extract the botanicals in the liquid matrix so that when you put it in your mouth, you actually absorb it.
Just because you put something in your mouth doesn’t mean you absorbed it. Why? Because you have to digest it, absorb it, and then you eliminate what your body doesn’t need.
For people who already have a hard time digesting fats, protein, and carbs, how well do you digest something like woody reishi mushroom? In that case, you’re looking not for grams but milligram amounts of these phytonutrients. Your body isn’t used to this stuff. You may not be secreting the digestive enzymes required to pull the active constituents out of this material
Vitality Works researches what the active compounds are in the plants and then researches what helps to extract them out of the connective tissue of the plant. Mitch then goes into what they do for extracting all the active compounds out of reishi mushroom –both the water-soluble (beta-glucans) and the alcohol-soluble (triterpenes).
Some of the processes they use for extraction include hot water, alcohol, CO2 extraction, steam distillation, and more. Some herbs need to be fresh, and others need to be dry.
Vitality Works Testing
Vitality Works does 100% of its testing in-house. But what kind of testing?
- Identity Testing: For every proper material they get in, they go through anywhere between two and four different identity tests to make sure it really is what they say it is.
- Purity Tests: There are a few kinds of tests they do to ensure purity.
- Microbiological Testing: They do microbiological testing for every plant. You can’t see coli, salmonella, or staph. There are all kinds of other bacilli, yeasts, and molds. These are fresh plants that must dry. They need to be controlled as they dry. Their limit for pathogenic organisms like E. coli, salmonella, or staph is zero.
- Heavy Metals Testing: Vitality Works uses ICPMS to make sure crops have heavy metals that meet the standards set by the WHO, spice industry, etc. The FDA doesn’t set a maximum for heavy metals, so Vitality Works set standards for themselves through best practices guidelines.
- Pesticide Testing: American Ginseng, for example, is one of the most pesticide-contaminated crops. Vitality Works does extra pesticide testing on plants they know tend to be problematic.
- Allergen Testing: Also, way beyond FDA minimum requirements.
- Gluten Testing: They will do gluten testing on certain plants.
- pH Testing: Some plants are pH sensitive, so they will test for that.
- Strength Tests:
- Density Testing: Some, they need to test for density in the liquid. They have to make sure they have the correct density, which is a reflection of active solids in the plant.
- Viscosity Testing: They will look for precipitation over time.
- Stability Testing: That refers to how compliant the product is at its expiration date. They test it throughout its life: at “born on” date, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 months, and 48 months, etc.… depending on its shelf life. Most supplement companies aren’t doing this.
When they make a liquid or even a capsule product, by the time they are done, it will commonly have had between 30 and 50 tests and inspections. That ensures it meets Vitality Works’ specifications, which are well beyond what the FDA asks for.
When you get a Wellness Way branded supplement, you know what you’re getting. Companies talk about their high-quality products, but we can prove it.
Product Knowledge: Licorice
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Licorice is one of Doc’s favorite herbs to deal with –especially when it comes to menopausal women. It has so many qualities: It reduces heartburn and acid reflux, nausea, and indigestion. It regulates cortisol and aids adrenal fatigue. It boosts immunity and serves as a general pain reliever. You can read more about licorice on our website.
Herbs have been studied significantly. Here are some studies about licorice and its health effects:
- The healing effect of licorice (Glycyrrhiza glabra) on Helicobacter pylori infected peptic ulcers. Researchers concluded: “Our findings showed that licorice could be suggested as a replacement in treatment for quadruple therapy when this regimen is not available while licorice has a low-cost, highly tolerable and with minimal side-effects.” It could replace drugs! But we can’t say that.
- Glycyrrhizin: An alternative drug for the treatment of COVID-19 infection and the associated respiratory syndrome? An alternative drug for what? Hmm.
- The potential of glycyrrhizin and licorice extract in combating COVID-19 and associated conditions. “Pooled effect size of articles provides information about the rationale for using glycyrrhizin and licorice extract to treat COVID-19. Fifty studies demonstrate antiviral activity of glycyrrhizin and licorice extract. The most frequent mechanism of the antiviral activity is due to disrupting viral uptake into the host cells and disrupting the interaction between receptor-binding domain (RBD) of SARS-COV2 and ACE2 in recent articles.” They are talking about it like it’s a drug! And 50 studies demonstrate its antiviral activity. The study came out in August of 2021.
That’s why The Wellness Way used licorice right away in 2020. We had everyone on licorice. We knew how beneficial it was in supporting the immune system.
Now, we haven’t even talked about how licorice can support the adrenals, and how it helps them produce your major anabolic hormones which can create needed estrogens, and progesterone… and then you see effects on hot flashes. While most women with hot flashes will have some positive effects, it’s still important to come in and get tested. You still need to dig deeper into hormone imbalances. You don’t want to waste money just trying things.
Doc’s Thoughts: Last 10%
(Begins at 1:25:22)
Doc concludes with his “last 10%.” There’s some crazy stuff going on out there. To demonstrate, Doc pulls up a news headline about a study showing climate change causes obesity:
The study said that climate change is the reason kids today are so fat and obese. Now, does a sedentary lifestyle cause obesity? No, it doesn’t. Not everyone who is sedentary is obese. But is it more common in sedentary people? Absolutely. But what if you have a sedentary lifestyle but eat well? Let’s say you reduce your calories to accommodate a sedentary lifestyle. You eat organic, stay away from bread, and stay away from sugar. You could have a sedentary lifestyle (which Doc doesn’t encourage), but you could still avoid obesity.
The study is saying that because it’s hot outside, kids don’t get out and get exercise. Well, can’t they walk around the house? They give you the dumbest excuses. But as we know, they are trying to blame something so they can do more studies to back up their narrative. We saw the same thing with SARS Cov2. It’s the same B.S.
So, let’s say it is warm outside. Doc was in Florida recently and was sweating. He doesn’t have any hair… so he put a hat on! Otherwise, he could get sunburn. But he was fine. People can still go outside –just go outside a little earlier in the morning. They always try to come up with excuses for why people are the way they are. That’s in every area of life.
It’s as if we were to blame obesity in Wisconsin on the cold and long winters, rather than on all the beer, cheese, and deep-fried foods.
People say, “Knowledge is power.” Well, with the internet we all have knowledge. If knowledge is power, then everybody would be healthy, happy, and skinny. It’s applying that knowledge. Start thinking for yourself. You might upset some people. But do you like everyone you meet? No? Well, that means not everyone is going to like you, either. Everyone has a different perspective. Even ADP doesn’t resonate with everyone. That’s okay. You get to choose.
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