Prepare to have your assumptions challenged as Dr. Chris Lockwood, an authority on dietary supplement regulation, joins us to demystify the layers of oversight that govern this often-misunderstood industry. You'll gain a newfound appreciation for the meticulous standards that dietary supplements must adhere to, thanks to the Dietary Supplement Health Education Act and the stringent Good Manufacturing Practices. Our enlightening discussion with Dr. Lockwood cuts through the myths, providing a detailed look at the definition of adulteration, the precise categorization of supplements, and the rigorous ingredient criteria that ensure consumer safety.
Adulteration in dietary supplements: much ado about nothing?
BIO: Dr Lockwood is one of the foremost experts in performance nutrition and bridging ideation to successful commercialization, Dr Lockwood is unique in his cross-disciplinary expertise. He currently serves as VP of Scientific Affairs for Nutrabolt, is ranked within the top 91st percentile of all published researchers within his field, is the lead inventor on six patents, and previously served as a Senior Category Director at GNC, Editor-in-Chief of Muscle & Fitness and M&F Hers magazines, and CSO of 4Life Research. He also served as Lead Nutritionist for the critically acclaimed HBO Max Series, WINNING TIME, and has provided personalized nutrition for Academy Award-winning actors Matthew McConaughey and Adrien Brody, and Grammy-nominated singer/model Ciara Harris, just to name a few.
Prepare to have your assumptions challenged as Dr. Chris Lockwood, an authority on dietary supplement regulation, joins us to demystify the layers of oversight that govern this often-misunderstood industry. You'll gain a newfound appreciation for the meticulous standards that dietary supplements must adhere to, thanks to the Dietary Supplement Health Education Act and the stringent Good Manufacturing Practices. Our enlightening discussion with Dr. Lockwood cuts through the myths, providing a detailed look at the definition of adulteration, the precise categorization of supplements, and the rigorous ingredient criteria that ensure consumer safety.
Adulteration in dietary supplements: much ado about nothing?
BIO: Dr Lockwood is one of the foremost experts in performance nutrition and bridging ideation to successful commercialization, Dr Lockwood is unique in his cross-disciplinary expertise. He currently serves as VP of Scientific Affairs for Nutrabolt, is ranked within the top 91st percentile of all published researchers within his field, is the lead inventor on six patents, and previously served as a Senior Category Director at GNC, Editor-in-Chief of Muscle & Fitness and M&F Hers magazines, and CSO of 4Life Research. He also served as Lead Nutritionist for the critically acclaimed HBO Max Series, WINNING TIME, and has provided personalized nutrition for Academy Award-winning actors Matthew McConaughey and Adrien Brody, and Grammy-nominated singer/model Ciara Harris, just to name a few.
Well, hey, thank you so much for having me. Issm, thank you very much for extending the invitation. I'm going to try to roll through this as quick as I can. I've done this lecture or parts of it before. I've done deeper dives in the industry and as far as the quality control and adulteration, so I'm going to do a speed round here for you. So I want to say this up front is that if you have questions at the end that we don't get to, or if I fly through something, by all means reach out to me. My contact information I have on the last slide or you can usually find me on any of the social media things at Dr Chris Lockwood.
Speaker 1:So with dietary supplements, we obviously have oops, we have a lot of confirmation bias that occurs in our space. We see it all the time and a lot of that just comes down to just a lack of perspective and lack of understanding of what the companies actually have to follow. And so, if you're not familiar truly with the history of the industry, there's a lot of things that are defined as adulteration or that you might believe to be problematic, but by definition and what the FDA requires of the industry. Hopefully at the end of this you'll see it's a little bit different perspective, maybe not quite so black and white here. So today's lesson really about perspective. I got two main things I want to teach you here is that we're gonna do some basics for researchers and practitioners on dietary supplements. If you see me use DS, that's just dietary supplement, and then adulteration for the adults in the room is really what I want to get at, just so that we all kind of leave here on the same page, and then also I'll give a little bit of call to action for researchers as well.
Speaker 1:So a couple of things here. So true or false. First thing you see a lot right I mean, so I don't want to have you in front of me here to get answers, but dietary supplement industry is not regulated. We see this a lot in media. We hear this a lot all the time. If you answered true to that, you were wrong. So it is false. The dietary supplement industry is regulated. This is directly from the FDA site. This is a quote from that page. Fda regulates both finished dietary supplement products and dietary ingredients. These are just two of the guidelines that we as a dietary supplement industry are under. There's so many others the Food Safety Modernization Act, or otherwise known as FSMA, just got amended again for adulteration, intentional adulteration, and so there are a lot of rules. There are a lot of rules, and so you're going to see me keep referring to automobile laws similar to what we have. There's a lot of rules on the books and then it really comes down to enforcement. Right, I mean.
Speaker 1:So if you're not familiar with DSHEA Dietary Supplement Health Education Act of 1994, this is just a really brief speed round through some of the key markers that you should be aware of. If you're a researcher or a practitioner, you know, or strength coach, and just so you can identify what is or isn't a dietary supplement One. You know one of the most important things, that happens a lot as you see things marketed as dietary supplements or making very strong structure, function claims. You know that. It does. You know, take this, it does this. But dietary supplements must be consumed orally and they have to pass through the digestive system. So topicals, out of the question. You know there's, which is a common one. Other types of, you know, sprays and things, mists, which are starting to come out, you know, unless the on the instructions it says and swallow for like sublinguals, I mean, those also kind of fall into a gray area. But there's the several different elements. The red highlighted section that I've got here are some things that you should really be aware of.
Speaker 1:Dietary supplements are a subclass of foods. Infant formula is a subclass of foods, and we don't tend to hear the same adulteration concerns with infant formula. But they are a subset of foods and so, by definition, infant formula has to follow a lot of these same requirements they have. They must contain ingredients present in the food supply approved food additives, grass substances, what we call odis uh old dietary ingredients that you know prior to dishe, that had a long history of use, or, through this new, uh an ndi, a new dietary ingredient application process, which essentially works like a pre-approval, and so you have to give a prior notice to the FDA if you're going to use something that doesn't fall within one of these other requirements. And so also when Dachet was enacted and then addendums that have been added to it since, good manufacturing practices.
Speaker 1:So the gmps came in line in 2007, started with large, large companies. So, like my first entries, uh, running brands, I worked for what used to be weeder nutrition back when they were a thing uh, joe weeder over my shoulder here, shoulder here was one of my early mentors, and so, you know, american bodybuilding was the first brand I took over and ran. You know, joe Weider's company was the first company to be made an example in the industry. The second company I must've been, you know, just wanting to get beat down as I went to GNC and ran their diet, energy, food and beverage division. They're your second company to get hit. After all, these new laws came in line, right and so, with what was called a consent decree, and so regulatory compliance has been something I've kind of grown up with.
Speaker 1:But in 2007, the FDA began enforcing the new GMPs, started with large companies, your GNCs of the world at the time, and then, by 2010, all companies had to be adhering to the new good manufacturing practices. And that's going to come in important here in a second when I bring up something else that brings some perspective to what you see in the literature and out in mainstream media. And so you know the FDA also has significant enforcement. You know authority, which a lot of people fail to recognize or they choose to overlook by believing that we're not in a regulated industry. Again, I'm for people like, you know, doug Kalman or Rick Collins or others that you know. This is what you do every day. I'm flying through this and I know I'm missing a lot of other things, but that's for a different lecture. So so there are.
Speaker 1:I'm not saying because we do have laws, it's not to say that that there aren't a lot of abusers. I I've I've done consulting, you know, uh, off and on, you know, for the most part, since, uh, around 2005, when I went back for a PhD or started, you know, back for a PhD. And then, um, and I will say I mean it's I often use this term and it's 90%, uh, you know there's, of the companies that are out there, there are a large percentage, uh, uh, percentage that I've been, you know, and then this goes for foods as well, but for dietary supplements that are not following the regulations that are required of them. What I have found is that a large you know probably I'm using a loose number, but of the thousands of companies that I've consulted with and have worked with and spoken with over the years or provided regulatory support as an expert, as I went back and did more on the research side, is just that about 50% of them just aren't aware of the laws that they are required or they assume somebody else is handling them, and so you see a lot of the adulterated. You know, under the GMPs those come up a lot. Those are the most common and I'm going to show you a website you can go to. You can see these things in real time when they achieve a certain level of concern.
Speaker 1:But other things that commonly are abused are adverse events. Serious adverse event. Reporting isn't being done properly. Section six, notifications, as we call them, is your claim substantiation? Is it real? Can you use this? Most companies are not filing this information. Ndi, pre-market notifications I mean that's a whole nother area, and there is a new NDI guidance that FDA has just published as well. I'm not going to get into that today.
Speaker 1:And so, but for some point of reference from a testing standpoint, because if we're concerned with adulteration, you should be. You should compare apples to apples here, right? I mean so, just when we look at analytical testing in particular ingredients, dietary supplements, absolutely it's required before use in production. I mean for foods there is, if you look at 21 CFR, 110.8, I mean other than the FISMA, you know, kind of loophole changes that have recently made and I'm not going to claim to be an expert, but dietary supplements do have higher enforcement requirements from a standpoint of ensuring that the identity, potency, purity and composition of those active ingredients before they go into production are what they say they are Finished products. Same thing. You see that there is a requirement for, again, that the specifications for that product are met analytically, and then, as far as the facilities where these products are made, also there are significantly more requirements, but there are exemptions in the food side, and so just to be aware of those and so I'm not to try to make you fearful of the foods you eat, but just be aware that dietary supplements, by law, by the regulations, there's a lot of testing that should be going into it, right. And so you say okay, well, but wait, I mean just because there are those laws, right, I mean if somebody violates them, the FDA doesn't have that authority. And if you paid attention to my earlier one, that there are laws in place that gave FDA significant authority above and beyond, you'll know that this is a false statement, as they do Absolutely. And thanks to my good friend Rick Collins and his legal firm, you know I ran this past him before when I first started adding this into my slides and so thank you, rick, if you're watching.
Speaker 1:But again, just kind of the civil and criminal enforcement capability the FDA has, based on how egregious that crime is. In my experience, you know, fda has always been very good. They come in with guns and a badge when they audit your facility and as long as you have a lot of your ducks in a row and you're respectful, it tends to go pretty well. We all see the examples when it doesn't. And so for companies that are not doing what they're supposed to, not aware and, you know, get very belligerent when they don't want to accept responsibility, but you say, well, okay, they're not doing this or they're not doing it.
Speaker 1:Very often FDA, you know, comes back to the point that they have five moral imperatives for the FDA. The first one is when you see the FDA truly take action against something, an adulterant or something that's egregious, and you say, well, why are they only doing it from time to time? And it really comes down to the Dachet. Ever since Dachet was enacted it's never been fully enforced because the FDA has never been fully funded, Congress has never fully funded them. You consistently see, and I would definitely advise you to get involved. If you at all like your liberties to be able to have access and choice on what you consume and make it affordable is get involved with the NPA. You'll see. You know, as far as new laws that are put out there or laws that are being proposed to remove those rights or add extra hurdles, but the FDA has never enacted the basic ones, which would, which would secure a lot of the problems that exist, and maybe you know there's a recent one on that. They want, you know, the full registration. Well, if companies were doing section six notifications like they're required then in submitting new product claims substantiation, then they would have that database. Fda has been consistently underfunded and undermanned in that area, and so they tend to only jump in when there is some kind of health hazard.
Speaker 1:Some of you might remember when Kratom got pulled from the market, and this was the reason why it was in 2018. It was the only dietary supplement in years that had risen to the level of the CDC having complaints weren't doing their quality control testing like they were required, and so these raw materials were making it into production, and I can't remember if it was salmonella or what the bacterial contaminant that was present, but a real simple test that could have prevented that. And from these 50 hospitalizations and 199 sick. But when you look at just the top ones and I just pulled out some from that year you know karetam was the only dietary supplement ingredient that year that even hit the CDC's radar and you say, well, wow, I mean there were zero deaths, there's 199 sick and they removed it from the industry. Right, I mean, so were zero deaths. There's 199 sick and they removed it from the industry. Right, I mean so they did take action. Kind of surprising. I still do see Honey Smack cereal on the market, but you know that's not getting pulled, so it is worth noting here.
Speaker 1:Right, I mean, why are there so many you know adverse events that we see and recalls that we see from foods that are sold in grocery? And it's because there's no mandatory adverse event reporting your grocery store. You know, I bring it up to my wife all the time to an annoyance is that you know when you buy something and it's moldy or bad, you know we've gotten in such a habit of just you know we throw it out, right, yeah, we go back to the grocery store instead of. You know, in the dietary supplement side and I'm going to give you a little bit of understanding why adverse events are so high in dietary supplements is A there's mandatory reporting, and B the definition of adverse events is beyond what you might assume. It's not just getting sick, and so so I. This is from CRN. It's a little bit modified Pre-market approval. I just kind of add this little note here for dietary supplements is that for new dietary ingredients, technically you could say that that is a pre-market notification that is required that FDA has to see. So but over again, when you compare against foods and I left other categories out, and it's again not to make you scared of foods, but I left other categories out, and it's again not to make you scared of foods, but just to be realistic on what is and isn't required.
Speaker 1:Dietary supplements have a lot of rules in place that should be followed and should have those protections if people are following what they should do To put adverse events and serious adverse events in perspective, right, and, by the way, the difference between an adverse event and serious adverse event, an SAE, a serious adverse event means you went to the doctor, the emergency room or the morgue. That's really what shifts it over to an SAE is that there is an actual medical visit that is required because of some thing, and you see it, a lot is that somebody. There are case reports of people that go to the doctor. They also are taking a dietary supplement. That dietary supplement gets added into that you know kind of list of multiple things they're taking and because it's a dietary supplement, not just a food, it gets added as an SAE because that patient went to the doctor.
Speaker 1:But when you broke it down and when I look at the year 2018, again, and I could do this for any year and you see the same kind of trends is that a mandatory adverse event reporting is required for dietary supplements, not for food or cosmetics is something to pay attention to. But when you go to the third column and you look at total serious adverse events, relative to the total adverse events, it's a very low number in dietary supplements. So you know, be aware that animal supplements are added into that number, the reporting through that open database, whereas for foods there's so many different exclusions, right, and so I think from a safety standpoint, we have to keep these things in perspective as well. You definitely see more adverse events and serious adverse events through food, and that's a numbers game too. There's just more people eating, obviously, than taking supplements.
Speaker 1:But just so that nobody thinks that the problem is worse than it may be, keep in mind adverse events is a very broadly defined term from a quality control standpoint that if you happen to be easily influenced by the retail partner's SPF program to push you to buy a product and you get home and your spouse or loved one makes fun of you and you decide you want to return it, just return it and tell them you bought it and didn't mean to. Don't tell them you got sick off it or it tasted bad. That creates a whole nother area of adverse event reporting for the brands that follow the laws, area of adverse event reporting for the brands that follow the laws. So adverse event is anything. It can be a quality problem. That can mean that the label was messed up, there wasn't a scoop in the powder container, and so I kind of give this example here right, a customer complaint it tasted bad, I wanted to throw up. That's an adverse event, non-serious, you know, labeled under nausea. If you're using you know kind of a classic GMP compliance and that dietary supplement, you've got to notify the FDA if there's any serious adverse event reports and anything in connection with that for up to a period of years to again foods don't have to, and that's why you tend to see, you know, problems in your produce section rise to the level of needing to do recalls because of multiple people getting sick or something else, and so just kind of keep that in mind.
Speaker 1:Adverse events is really anything. Anything that caused a return product, didn't taste the same, whatever, and so it is a very broadly determined mechanism. And so when papers are published that talk about the adverse events have risen, you know, when they go on to the FDA's open access sites to look at adverse events and serious adverse events, they see this significant rise and you're like, well, well, that's a, that's a serious problem. Well, it could just be, and if you remember what I mentioned before about, so this one came out by the way in in 2007, 17,. You know well-intended, you know researchers, but you know they use the CDC's poison control data. They, they, you know 70% of these calls, they, they failed to kind of bring this out. You know where children under the age of six, accidental ingestion of products, and yeah, there is a rise from 2002 to 2005,. You know, compared to 2005,.
Speaker 1:There was a significant rise in these you know poison control calls, however, or adverse events, I should say, that were reported when they went to the sites and what they failed to recognize. If you remember, in 2007 to 2010, gmps were implemented that made mandatory adverse event and serious adverse event reporting a requirement for dietary supplement companies. I often look at this and use this as this is an example that the industry actually was following the rules that were asked of them, and so, bravo. There was a significant number of companies that were reporting. If food companies had to, and your grocery stores had to do the same, or restaurants you know where you get food poisoning had to do the same, you'd see a rapid, you know an increase in that number as well, and so I got to bring it back to the automobile side Again.
Speaker 1:There are multiple laws out there, and so it really does come down to whether somebody is going to follow the law, know that they're not supposed to be speeding through a certain area, or they're going to come to a stop, or a California stop at a four-way, and if it is to keep it in that perspective, is that there are those rules and there's multiples of them, and it really does come down to kind of the three musts to get this enforcement right. You got to have the parties musts to get this enforcement right. You got to have the parties must adhere to the laws. There's obviously going to be people who are ignorant to it and hopefully once they learn, whether that's through FDA, ftc action, some other legal action, that they, that they begin complying. There's always going to be those actors in anything, whether it's in our cars, whether it's in in dietary supplement industry, that just choose not to. And that's where you hope, you know, the true hammer of the law comes down on people.
Speaker 1:The authorities have to be able to enforce, right, I mean. And so again what I said before FDA has never been fully, fully funded, hasn't, is not manned to. To enforce the shade the shade has never been fully enacted the way it is written. To enforce Dachet and Dachet has never been fully enacted, the way it is written and so many of the laws that are on the book and regulations that if they were just followed and adhered there would be no need to add additional. And then, third and this was really my challenge for this group here is the industry in trade has to establish and require standards, right, I mean and so we can, as researchers, do a better job at being able to, as we test products in research and understanding some of this background, when we are reporting on things or identifying different products and potential adverse events, and so this is kind of one of these cases when it's unfortunate.
Speaker 1:We see these a lot. You know some brilliant, brilliant people, and I really do mean this. I think that their hearts are in the right place and they want, I want the same. I want my kids and my neighbors and every one of you to be able to go buy any supplement that's in a store and know that what it says it contains in the label, you know, and if they have an expiration date, is what you should be buying. It should be safe to consume, it should meet all those regulations and requirements. Unfortunately, I'm also realistic. You know there's there are a lot of actors who who don't right, but there are also a lot of great, brilliant researchers who aren't aware of the laws and also what can and cannot be done, and so when you kind of combine these great intentions, you know, with with really remedial expertise, we just these things end up in the, in the press and people make more out of it than it is. So, you know, one of the things I would you know it's very common is that you see, these articles will, will give kind of the I got you moments, right, I mean. So this is one you know example.
Speaker 1:So these are, you know, obviously, water banned substances, you know that are this list down the left-hand column, the doses that are put into the different cells, are what these studies at the bottom, you know, identified the presence of these banned substances being present. Right? So I mean, by definition, if we are saying there should be no banned substances whatsoever, if that's the requirement for a dietary supplement, if that's what you believe, then these products that I'm about to show you, I mean they should all be banned, right, I mean. So you know, hormone-based banned substances in some trace amount. Does trace amount mean efficacious amount? Absolutely not, right, I mean. But that's where more research is required. How much of a trace amount is required to cause a physiological effect? And then you know, mere presence shouldn't be what deems something adulterated, and so if that was the case, I mean I wouldn't be giving cuties to my kids as much. Right, I mean they should be banned, and so we need to, as a research community, get better about understanding mere presence versus physiological spiking. I would challenge any researchers as well to do more research in that area, like, at what point, you know, are these, you know, present? Is mere presence physiologically active?
Speaker 1:You know, and, and so one of the study, one of the papers that just really opened my eyes to this when I was running American bodybuilding and Andra Sina Dion was, you know, being, you know, on Congress with, you know, certain of our Congress people wasting, you know, millions of taxpayer dollars about. You know, cheating in sports, you know, from politicians. The great irony is that this paper came out. I have and, by the way, as a group we really lost one of the OGs of this space and really we all owe a debt to Dr Don Catlin, the lead researcher on this, former head of the WADA Antiband Substance Testing Lab, founded Banned Substance Control Group, bscg, which does WADA banned substance testing, now third party. He recently passed away, oliver, if you're watching again. My sincere condolences, your dad, we all owe just a great debt to him and he opened so many doors and eyes for so many of us in the exercise physiology side and they depend on clean supplements, and so again my condolences to you and your family.
Speaker 1:This article came out. If you've never seen Icarus, you really should. Dr Catlin is in that documentary but this paper here and nobody reads. You know the discussions and the results well enough, but the section off to the top right that I circle was one of my favorite things he was such a brilliant and unbiased researcher in this space is that he referenced that he gave a discussion on that. Of all these things that he had tested, none of them would achieve the threshold level that is allowed in of adulterants allowed in OTCs and drugs. So OTCs and drugs have an allowable level of adulterant based on total weight, because dietary supplements explicitly was void of any kind of adulterant level being allowed. It means mere presence makes it adulterate, and I thought his argument was just so well-balanced and you rarely see this. Unfortunately, as more and more articles come out about adulteration, nobody puts that in perspective. Again, to come back to mere presence versus physiological spiking, and so I would definitely recommend you go back and read this and a lot of. And so it's easy to do testing right. I mean nowadays you can for banned substance testing. I use I use Informed Sport a lot. For the studies that I do, I have used a banned substance control group. You know NSF for Sport is another group that is used a lot. Hey, chris, sorry to interrupt you.
Speaker 1:In the interest testing standpoint, again, you know, is what you're testing real? We do test, retest, reliability, you know, for our methods in our labs, you know, are we truly discussing what is? Are we making conclusions based on facts? I would say, instead of trusting certificate of analysis that show up from the companies that send it to you, make sure to start utilizing third-party independent testing or utilize your chemistry departments there at your universities to ensure that the products that are being reported on or that you are performing testing on is actually what they're supposed to be. I did just a quick numbers on this and this requires more detail on what a true quality specification looks like.
Speaker 1:If you're a researcher and you want to send out for testing, and you want to send out for testing, you know, but you know only the two of these seven studies. You know in this most recent issue. You know where the methods are reported and the labs reported on where the third-party testing was done, both for QC verification, you know, does it meet what's in the label and then you know. Secondly, you know on water ban substance testing, to make sure nobody's spiking the product they're sending to your lab for testing. And so, just from a challenge, I would highly recommend that and happy to offer any help on that. I'd give you a couple of different resources If you are looking, if you are a researcher and in need of some some third party analytical testing. Analytical testing Edgar at Dyad Labs, or Miuru now, is just a dear friend and has been used him for years. That's who I use for the studies that I invest in and then for banned substance testing, either Informed Sport or BSCG. Both Andy and Oliver's information is here. Definitely recommend that you reach out to them.
Speaker 1:A couple other resources to look at. If you're unfamiliar with where to go these inspections and actions, there might be warning letters on there. Don't let that freak you out, I think, just like getting caught in a speed trap where you didn't know the speed limit. Companies are free to improve. My mentor, I mean weeder, ended up kind of writing the book on a lot of that stuff after getting hit, and so you know people can uh, uh, you know have some grace if they learn from their lessons. So go and take a look, see if somebody brands you trust might be hit with warning letters and actions. Um, and that's it. Uh, hopefully that helped to some degree. By all means, reach out to me if you have questions. I want to say thanks again, joey, and everybody at the ISSM for the invite. Sorry, I ran a little bit long there.