How we can help save supplements.
When purchasing supplements quality is everything. While the supplement industry track record is pretty spotless, there are limited manufacturers and products that lack in cleanliness and quality. But there are members of congress, the FDA, and Big Pharma who want to take advantage of those few instances and monopolize their power even further.
In September a bill is being presented to Congress that would impose "mandatory filing" making the supplements you need more difficult to purchase. This bill is championed by Senator Dick Durbin, who has a history of pushing for greater and greater regulation on the supplement industry and may seem innocuous at first glance, but we believe this particular bill deserves a little more scrutiny. That's why we called in an expert on the subject, a veteran in the industry, and someone intimately acquainted with supplement manufacturing.
Meet John Mills:
John holds a Masters Degree in Chemistry and has 10 years prior experience in biochemical research where he was responsible for GLP implementation in an analytical laboratory. He has been Quality Manager for Highland Laboratories (Mt. Angel Vitamins' parent company) since 1994 and was instrumental in the design of our laboratory facilities.
Some Points We Discuss:
- 3:13 - Who is John Mills?
- 7:07 - What exactly does this bill mean for the supplement industry?
- 11:39 - Where is the evidence that supplements are unsafe?
- 12:37 - A couple of problem areas in the supplement industry.
- 13:47 - The process of bringing a new supplement to market.
- 14:36 - Let your lawmakers hear your voice through savesupplements.com.
- 16:19 - Supplement manufacturers and the importance of GMP's.
- 19:00 - What you can do to help save supplements.
- 24:50 - The sooner you take action the better.
- 27:17 - It's never too early to start taking your health seriously.
John Mills 0:01
This trend is actually filtering into the state legislatures as well. And you're looking at at least a minimum of six states, which are trying now to regulate dietary supplements relative to either weight loss or muscle building weight building. So in anything along those lines, they're trying to limit the access of individuals to those particular things. Rhode Island recently did not pass, they actually didn't do what they had thought they were going to do. And that was put all dietary someone's behind the counter. So you would have to have the old fashion store where the the customer would have convinced me Hey, can I look at this by and the person that they'll get it from behind the shell out and bring it out to them and put it in front of them, and then monitor them while they're reviewing it and then take it back and put it back away? They did not pass that but they but they are close to doing those that in a number of other states relative anyway to doctor's office are gonna be more restrictive than THC is in some of these states. And so it which doesn't make any sense at all.
Brian Strickland 1:02
You're listening to the nutrition world podcast, a show about navigating the intricacies of holistic wellness, where natural health food store located in Chattanooga, Tennessee, and we believe that optimal health and peak performance should be accessible to everyone, everyone. Welcome back to the podcast. My name is Brian Strickland. I'm the producer of the show. And on today's episode, we have the pleasure of speaking with John mills. Once again, John is the director of quality and compliance for Highland laboratories in Mount Angel vitamins. And we've done a couple episodes with him before covering multivitamins and quercetin. But today, we're actually going to be talking about a somewhat important bill coming up in September. And just the compliance and regulations of the supplement industry in general. There's a lot of misinformation floating around about what is okay with supplements and what is not, what standards companies are held to, and how much the government should be involved in its regulation. And so that's what we're going to talk about today, we have a lot of ground to cover. And this is a really interesting episode. It's a little bit different than what we normally do. But we feel that it's a really important conversation. So let's go ahead and jump into this episode with John Mills, and Ed Jones.
Ed Jones 2:17
Thank you, John Mills for joining me today on nutritionw.com. And I am excited to talk to you about a very, very important topic. I've been in this business 43 years, my whole life has been built around the world of empowering people to be healthier through many means, one of which is supplementation. And we are at a critical point off and on throughout the decades of those rights being taken from us or being diluted to a place where they will not be quite as effective. And I think we're coming around again on that same path. And so today we have John Mills, who's director of quality and compliance at Highland labs, and also is that's a lab that also works with Mt. Angel, one of my most favorite companies with tremendous quality and ethics. And so welcome to nutrition worlds podcast, John,
John Mills 3:10
thank you very much. I appreciate it. It's nice to be back.
Ed Jones 3:13
I've talked to John enough to know that He's highly experienced has a will a wealth of knowledge about not only health, formulas, nutrients, but also the bigger picture of where we are in the world as far as our freedoms as far as supplements. And we are, you know, in a kind of a scary place, I think John will admit and I've done two podcasts with John before and one of them was both of them were outstanding, the one called How to choose the perfect multivitamin, which is on the holistic navigator.com And then Corsten. With John Mills on the holistic navigator.com. Both were really really popular to people who want to learn more. In fact, the mount Angel multivitamin that what we spoke about, or multivitamins we spoke about, has become probably our number one selling multivitamin, and I probably is more impressed with that formula than any I have ever seen in 43 years. So thank you, John, for helping to put together such a comprehensive finally truly comprehensive formula. It doesn't require a handful of pills. So thank you for that.
John Mills 4:18
You're very welcome. And it was my pleasure, my pleasure to do that.
Ed Jones 4:21
And you're just awesome. And explaining it to well, we have always turns of kind of threats to this industry. What does that mean? That means the availability and freedoms that we've had for so long since I bill that was passed long ago called The che, and a che was passed in 1994. I had been in this industry since 1978. I remember the days and I want people to know this because no one seems to know it because they weren't really involved in this business back then. If we had literature that talked about how vitamin C might help you with a cold, we had to take a tape measure You're and make sure that it was a certain amount of feet away from any product that had vitamin C, we had the FDA come into my store multiple times to inspect us to make sure we didn't have one single advertisement. As far as nutrients. Nutrients were were criticized across the board, they were not talked about in any favor of any government institution. Well, times have changed. We now have credible evidence, we have so much PubMed, and studies and physicians, and functional and integrative people of highly trained credibility that are endorsing the power of supplements. Now, we didn't have that back then. And I remember having big yellow pads and most health food stores back then did where we would get customers to sign this petition, please get this bill to pass, please get this bill to pass. It passed it, I think 11pm One night, and very narrowly passed is the only reason right now you have the availability of the magic of supplementation that we offer, and many good, independent and and corporate stores can offer to the public. Well, here we are, again, where Senator Durbin has been a person who has really been attacking our industry for I think 15 years, you might correct me on that he always is trying to introduce a bill that is going to be harmful to your freedoms, always, I am not opposed to proper, ethical, healthy regulation of this industry. We have the best track record of safety of anything internally used in this country one. So and then secondly, the disabled power the FDA to a point, they have all the arms that they need to do the controls and the the supervision totally through to che and they're not accessing it. So people like Durbin should look at what we already have on the books. So maybe tell listeners, John, since I talked too much about this new bill, the US Senate Bill 44 090 that we're looking at that's going to be voted in September and what the implications may be of that and what they can do about this, which is very simple.
John Mills 7:07
There's a couple of different aspects that are going on with this particular bill. The first one that that it comes to mind is the registration, dietary supplements and prior registration. So anything that is innovative and coming into the marketplace would require a pre authorization. So I use the word authorization rather loosely here, but a pre authorization, you have to register your product way ahead of time. And then it has to be registered. And then here's the thing that really is unusual about it. If you're going to put in any kind of a marketing campaign in for any particular product, you're supposed to give FDA prior notice that's under the shade. Okay, so that's already there. But they're wanting you to register all these products now put a label onto the FDA website, FDA then can review this. But it goes even farther than that, that you know, this this this trend is actually filtering into the state legislatures as well. And you're looking at at least a minimum of six states, which are trying now to regulate dietary supplements relative to either weight loss or muscle building weight building. So in anything along those lines, they're trying to limit the access of individuals to those particular things Rhode Island recently did not pass, they actually didn't do what they had thought they were going to do. And that was put all dietary someone's behind the counter. So you would have to have the old fashioned store word where the the customer would have to come and say, Hey, can I look at this by and the person that go get it from behind the shell out and bring it out to them and put it in front of them, and then monitor them while they're reviewing it and then take it back and put it back away. They did not pass that but they but they are close to doing those that in a number of other states relative anyway to doctor's office, they're gonna be more restricted than THC is in some of these states. And so it which doesn't make any sense at all, to be very frank. And you know, as you've already mentioned, the safety profiles relative to dietary supplements, just a remarkable safety record there. They really do not induce a harm individuals as long as the individual is taken in with some some amount of thought. And I say that because you can buy a bottle of vitamin D, for instance. And if you buy several of these and you take the entire bottle at one time, yes, it can cause a problem over a very short period of time. But if you're taking it regularly at 10,000 or fewer I use a day. There's no issues associated with that. There's no health related issues at all. And in fact, it's been shown to demonstrate been demonstrated to elevate your own hydroxy levels hydroxy vitamin D levels in your blood and support your immune system and a variety of other applications within you. So and prevent disease as opposed to you know actually having to treat disease. That's what dietary sellers do not treat disease. And that's one thing that people do don't understand is that with dietary supplements, it's meant as a preventative measure and to help you not get the diseases that are associated with vitamin or mineral deficiencies. But as far as going back to what Durbin is doing, Durbin is trying to make that registration process a little more heinous. And as part of that process, they are removing some of the bioterrorism safeguards. Right now, FDA has bioterrorism or the congress passed rather Bioterrorism Act until 2004. And in that, in that process, they placed in the hands of FDA very specific responsibilities, and Durbin is trying to undo some of those responsibilities now, by going through this process. The whole idea behind this is that they it will empower the state legislatures in some way to make a decision whether or not you can or cannot have very specific supplements and mean simple things like CBD CBD, or NAC N acetyl cysteine. It becomes in kind of a controversial type of a supplement at all the state legislator could unilaterally decide you don't have the the authority anymore who to sell that buy it or use it. And so that becomes a serious problem in the long run, because some of these things are very safe to use. Most of them are very safe to use. And as long as you're using within a relative amount, which is there is no danger in them at all.
Ed Jones 11:39
Wonderful explanation and you know, on the NAC itself, of course, has been used in the medical field for quite quite some many years. It is so safe, that actually there's an adverse reporting agency, and so far, they've had zero reports of NAC on that particular thing. And you're right about nutrients, if used intelligently. The worst thing that can happen is a bellyache normally or if you mixed it with the wrong drugs, of course, but you that's where common sense comes back in. We have a such a clean record of health where I asked the question, Where are the bodies? Where are the damage? Where are the lawsuits? They're non existent, because we have that safety, that is incredible. Could we be better? Yes, all industries could. But if you take the athletic part market out, and the sexual potency herbs out of this, that we are really have cleaned a clean slate, those are the only two that I'm concerned about, at times,
John Mills 12:37
when you look at the sexual health market, I don't want to use that word kind of broadly, right. And you're looking at male health versus female health and the like. The main problems associated with those are the ones where individuals are wanting to have improved performance. And a lot of times that dietary supplements are coming in because they're not coming from reputable companies are not being they're not being tested there actually have drugs in them already. And that's where the where that's where the harm is coming from is the actual contamination of drugs. It is not the supplement itself is the drugs that are in the supplement that are causing the problem. So if you were to take the drugs out, you'd have the students have some of the positive benefits associated with that, but not have any of the the negative the seriously dangerous side effects of the drugs.
Ed Jones 13:26
Absolutely. And the thing is, again, it's the perfect example to shake gives them the power to eliminate that it's just because there's not enough enforcement agencies, and they're not grabbing on to the power they already have is the only reason that it sneaks through. So we don't really need a more power for the FDA, they already have plenty in the legislation,
John Mills 13:47
it needs to be enforced. So that's the trick, it really does need to be enforced. And if they have a new ingredient, a new supplement they want to bring to market there is a met, there is a a venue to do that with there's two ways to approach that you can either go through the grass method, which is generally recognized as safe the grass method, or you can go through a new dietary ingredient. And either way, FDA has a chance to review it. And so they can see the safety data, they can see it and they can give you, they can actually then approve or disapprove it based on that safety and efficacy type application. I mean, that really does fall back on me as the manufacturer to make sure that my product is safe and efficacious. And we go through all the troubles in trying to assure that they are both those.
Ed Jones 14:36
Well, you know, as the old saying goes, if you tell a lie often enough, it just becomes a truth. Well, the lies has been told us we're a totally unregulated industry. What you're saying absolutely shows that what they're accusing us of is not valid, it simply isn't. And so what do we do about this? I mean, you know, there is the site that I'm recommending and you may have a different one is saved. supplements.com Sav e supplements.com. And I've had all my staff, my customers, we've sent out an e mails, you go on there and literally in 40 seconds, you can just put in your zip code and name and it goes to your representatives. The thing is, I think these representatives are going to be having a difficult decision because this bill, which was going to come up in September was a was attached. Durbin's Bill was attached to another bill that has to be voted on every five years to fund the FDA. Well, 40 to 60% of all the money the FDA gets is from pharmaceutical companies and most Americans don't realize that they are really funded by the pharmaceuticals. Well, how are they going to be truly ethical when that is the case? I mean, even the best of us can be swayed if our if our paycheck comes from those people. But again, safe supplements.com is the only way at this point that we're going to put any impact on the people who may vote, let's just, you know, hope and pray that you know that somehow it's either removed from that other bill because that Bill has to be voted on September or the FDA has no money. So this is not like a normal bill that could be delayed and delayed and delayed, won't be any delays probably on this bill. And that's even a little bit more threatening and frightening to me.
John Mills 16:19
Absolutely. You know, in 1994, the winter Shea was passed, they established at that time that GNPs were required. And it took 11 years for FDA to implement GMP s. And it took another year and a half to two years for them to visit me and my facility the first time. So to actually review my GMP s at that time. And what does it mean? For me what is good manufacturing, good manufacturing practices, GMP, Good Manufacturing Practices means I am following the regulations that have been established by FDA. And these are practices which assure the the cleanliness of my facility cleanliness of the product, the potencies of the materials that I'm putting into those products, as well as the method that I'm using to make the products that they are not compromising that quality at all. So it's it's a whole, it's a whole package from start to finish raw materials, going into a product and finished goods coming out in a bottle. That's where it starts. That's where it ends. And so it goes the whole way. And it also involves me running studies on these things to make sure that the supplements that I am selling, continue to meet label claim for the for the entire expiry section of it. So we have a whole period of time that I say yeah, these vitamins are still good at two years, three years, whatever that timeframe is, and and my vitamins actually need those stability studies as well. So that way we have Yeah, we you have a chance as a customer, as a consumer to actually have a product which makes sense and works.
Ed Jones 18:02
And how could anyone say we are unregulated when you just explain how that almost has to happen for that label to be on your product that ensures the quality from start to finish, not just a finished product, but raw materials and blank blank blank. So it's not true. We are regulated. Secondly, again, I've been in his business 43 years I've seen the FDA come in, remove products that were not supposed to be sold who did have contaminations, and sometimes it's contaminations. Just like all things could be bacterial, it just those fluky things happen. And then sometimes it is the few non ethical manufacturers could let things slip into they could do the wrong thing. But generally, it's such a safe industry. So let's get to the bottom level here. What do people again I'm voting for this safe? supplements.com Is there anything else people can or should do? Or would that be enough? Or what are we talking about?
John Mills 19:00
Well really that that will help but to if you could go even into your state legislatures if you have a chance to do what they call a you know it was legislature day when everyone can go in and meet with the state legislature you can just go in and talk to your own representative and express your your desire for the state to remain within the DOJ a guidelines even you know and there's always opportunities if you ever happen to make a trip to DC stop it and see your representative and talk to them. I mean those things are all good and they will meet with you because you are their constituent you vote for them. And if you're if you're not if they're not willing to meet with you, and then they know they don't probably have a vote next time. And so unless they're in committee meeting or something else going on, it's crazy in there, they're going to meet with you they will always be with you and your aides will always meet with you so you can express the A be able to share every bit of displeasure or encouragement that you have to share with that Representative So it's I mean, it's a long drawn out process. But this is a, this is what America is about right is representation is actually voicing your concern and being heard in that process. But you know, definitely save supplements.com is an excellent way to go and get you right into that Representative drops you into their mailbox. And they're and the representative or the aide will read that. And they'll compile a list of pluses and minuses. So it gives you a chance to have your voice heard at that Representative level. And that's incredibly important that you make your voice heard.
Ed Jones 20:37
Well, that's wonderful. And thank you for that, because and also the numbers of people who do it would be impactful. So we are here going to do all we can to get the word out. And I think this video right here, as soon as we post it, we're I'm going to try to send it to every representative to to see if maybe they would be able to watch this. Because it's a critical time. It's a profound time that we need to protect ourselves. And again, I'm not against good ethical legislation to further define our company is as credible and professional. This because Durbin has a history of pretty despicable activities. As far as being an enemy of us. He doesn't believe in anything about nutritional supplementation, he wants it off the table. He has strong pharmaceutical influence, we know from his history, and it's just not fair to the American people. Because about 70% of all people who are going to the doctor or using alternative treatments. So 70% of the country is using what might be limited and in Europe, at the European stores, they now have such limitations on potency 1000 unit vitamin D is the most you can buy you and you can't buy most things like magnesium, they took magnesium off in Europe because it causes a loose stool. Absolutely. Nonsense. Because it's extremely safe. Of course, magnesium takes gives loose stools. That's why some people use it for regularity. But in that it won't if you do the right con and the right form of the right dose. So we have enemies everything
John Mills 22:05
right? I mean, so of course ours are parsed, was it? Yeah, of course, Ellis, I said that. Yeah, I said that, you know, the poison, the treatment is all on the dose. And, you know, it gets everything's a poison. It's just a matter of how much you take as to whether it's a treatment or not. So and that's the whole point of the dietary supplement. Right, you want to get the right dosing in, as you mentioned, magnesium, magnesium, yeah, if you're gonna take 1200 to 2400 milligrams at a time that yeah, Hitchin loosen you up. But that's the whole point of Philips milk and bank, Asia. And if you don't want to do that, that much, then it becomes a magnesium supplement to. So you know, and it's the form also, magnesium citrate is totally different than magnesium sulfate, which is what is in the goat's milk of magnesia. So if you're doing an a proper proper dosing cycle, you're using it as, as you mentioned, the proper times these all become nutritional values and not deleterious effects. And that,
Ed Jones 23:03
absolutely, and of course, I've lived my whole life and the premise that we can, if we build our resistance, we build our our ability to have a strong immune system, we build our ability to not lose muscle and bone mass as we age, we are going to live a better quality life that is not going to come from overuse of drugs and bad lifestyle habits. But when you do the right habits, and then you back it up with the right supplements of quality origin like Mount Angel and all the other brands that of course, nutritional world sales were so cautious, it's crazy. But you are going to to Father Time is very crucial to us as we age, you're going to minimize father times, injuries to us as a fast aging person. And you know, I might not live another day longer because I take all my supplements, but I'm going to live a lot better quality life here I'm 65 Heck, if I dropped down tomorrow, I've lived a really good 65 years of life with with a lot of energy and get to do what I wanted and no diagnosable disease that doesn't happen on its own. You have to work toward that. Because the average 65 year old is on multiple drugs a year they're not able to function sleep they have many different disorders. So the power of supplementation is far more than most physicians realize it's certainly more than even most consumers except the ones who have learned by their own means that it is powerful if the right product with the right advice. It is magical to your life. So again, safe supplements.com I encourage everyone to go on there right now. And please take 40 seconds and go click click click and send this to your representative. This bill will be voted on in September. Please don't put it on I will list to do later because time is of the essence please, please please people,
John Mills 24:50
the sooner they hear and the more they hear the more effect it has. Okay so and they do keep like you've already mentioned they need to Get it in now. Because they they will they tally the number of they don't say the person's name, they tally the number of input they have. And they compare the positives and negatives of that for that input. So if they have, you know, 100 people, they assume that's really 1000 people. So only if they use the 10% rule, if they have 10,000 people, they assume 100,000 of their constituents are saying, hey, please don't do this. So it's really important, the more people contact them, the more effect than voices heard the more effectively than voices. So the more effect we have, as consumers. And I want to say this as a consumer, not necessarily as a manufacturer, but as a consumer, I use supplements, I use them all the time. And I use my supplements from Highland lab, I use other people's supplements as well. And I use these, you know, effectively to build a program for myself. And if I lose the ability to build this program, I seriously believe the quality of my life decreases at that point. So you know, I started trying to improve my health and well being well guess when I was about 62, I decided I'd start doing push ups again. And I could do 10 Push Ups. I'm 65 today, and I did 60 This morning, getting ready. So you know, it's, you know, what do you want to do? You want to live all your life, you want to have your core, literally your core, right? You have the four core program, but that four core feature or being and that core being is strength as part of your, your process, you have to have that strength. And without supplementation? I don't think that'd be your answer.
Ed Jones 26:45
I love it. I love it. You know, I live in my life, to be living it and not living a life of looking to die. I know that will happen. And to do that and and be optimal. It takes action, it takes putting a plan together a plan. And that plan, I have witnessed it for 43 years has to include supplementation, because we don't have the foods necessary anymore because of soul depletion. Secondly, digestion. Thirdly, as blank, go down a whole list. This is a backbone of a vibrant, senior life. It simply is absolutely.
John Mills 27:17
So you know what, and the one part that I, I'm trying to convince my kids, they're in their 30s now, and I'm trying to convince them that they need to start with some supplementation, specifically, multivitamins, and then they can add to that product if they want it. But that's an absolute core critical to me to have a really good multivitamin. And then, and then the nutritional side as you're looking at organics and things like that, to actually supplement the fold to round out that full. Because the multivitamin only gives you that very basic essence, this middle ground, the very piece of it, the very starting point, and then the food that you eat in your life, fill out the rest of it. And they they make this whole program for you. That's absolutely essential, and to protect our rights to have those multivitamins in our cupboards so that we can ingest them and get that quality of life. That's what's important.
Ed Jones 28:15
Words, well spoken and very wise and I cannot thank you enough. I mean, we get up every day to try to plant the right seeds in my life and hopefully spread it to the right people at the right time. So again, save supplements.com I'm really pleading with people to take this 45 second action for your rights your children's and and the whole public at large. Because once we start slipping down a slippery slope to the European levels, there probably won't be a way to pull it on back. So let's save it while we can. And John Mills, your your hero and an angel and thank you for taking your time to share your wisdom with us on nutrition world today.
John Mills 28:54
Or you're very welcome. It's always a pleasure to be here. Always a pleasure. Thank you.
Ed Jones 28:59
And we will be talking to you. I know about some other great health topic in the coming months so you take care of my friend, and thanks everyone for listening and being a partner on this journey to your health. Thank you again,