No Shortcuts: Tony Lukas on Supplement Safety, Compliance and Consumer Trust

What does it really take to deliver safe, high-quality dietary supplements—and protect consumer trust along the way? In this episode of Supplement Source, CRN’s Jeff Ventura sits down with Tony Lukas, Director of Food Safety and Dietary Supplements at The Acheson Group (TAG), for a practical, wide-ranging look at the compliance challenges companies face from ingredient sourcing all the way through manufacturing, labeling and marketing.

Lukas shares expert insights on supplier verification, identity testing, allergen labeling, product claims, social media and influencer marketing, and the regulatory considerations surrounding new ingredients. He also explains why strong SOPs, careful risk assessment and a rigorous commitment to quality can help companies avoid costly compliance problems and strengthen confidence in their products.

For supplement manufacturers, marketers and anyone responsible for quality or regulatory compliance, this episode is packed with practical takeaways for getting it right—and a clear reminder that when consumer safety and trust are on the line, there are no shortcuts.

About the Council for Responsible Nutrition (CRN) 
The Council for Responsible Nutrition (CRN), founded in 1973 and based in Washington, D.C., is the leading trade association representing the dietary supplement and functional food industry. Bringing together manufacturers, ingredient suppliers, and service providers, CRN unites its member companies around a shared commitment to science, transparency, and responsible business practices—advancing a strong, credible marketplace that supports consumer health and industry growth.

In an increasingly complex regulatory and media environment, CRN serves as the industry’s front line—shaping science-based policy, defending market access, and countering misinformation. Through strategic advocacy, self-regulatory leadership, voluntary guidelines, and evidence-based communications, CRN ensures that responsible companies are recognized, protected, and positioned to innovate and compete. Learn more at crnusa.org and follow @CRN_Supplements on X and LinkedIn.

Transcript

SPEAKER_00 0:00

Please note the Council for Responsible Nutrition, CRN, does not endorse any guests appearing on this podcast or any products or services they may discuss. The views and opinions expressed by guests are their own and do not necessarily reflect the views or positions of CRN. Thank you and enjoy the episode.

SPEAKER_01 0:29

You are listening to Supplement Source, the official podcast of the Council for Responsible Nutrition. And now your host, Jeff Ventura.

SPEAKER_03 0:38

Hello, and thank you for listening to Supplement Source. My name is Jeff Ventura, and I am the Vice President of Communications here at the Council for Responsible Nutrition. I am delighted today to be joined by TAG's Tony Lucas, who is the Director of Food Safety and Dietary Supplements. Tony, welcome to the show. Thank you very much. Glad to be here, Jeff. And TAG stands for something, does it not? Is it the Acheson Group? Is that right?

SPEAKER_04 1:04

That's correct. We are a uh food safety consulting service that uh was started by Dr. David Acheson, formerly of the FTA a number of years ago. So David works very closely with a number of other industry leaders from all over North America and into the rest of the world, where we focus on food supplements and a few other categories and helping uh manufacturers and companies get through improvements, try to make sure that the uh the food and dietary supplement food chain and supply chain is a little bit better.

SPEAKER_03 1:37

I think a lot of people don't realize, and I'm I'm really glad that you're on the show. I just don't think that a lot of people realize how many steps exist between sourcing an ingredient and putting a finished supplement on the shelf. So I'm I'm curious, now that I've you know got an expert here, where in that process do you see the greatest potential for quality or compliance issues?

SPEAKER_04 2:01

Yeah, if we're focusing on dietary supplements, one of the largest issues that I think a lot of companies first start with is the belief that if you want to start a supplement company, that's as simple as what what we would refer to as the cottage industry, such as selling at your local farmers market or just putting something on a website and selling it. When you approach a certain level that would be considered mass manufacturing, the FDA actually has requirements for how much you bring in from a volume and monetary perspective. And at that point, that's when the more difficult requirements are, where I've heard a number of clients make the comment it's no longer just somebody producing something in a kitchen or in your garage or whatever it was. Now you have to follow all the red tape, you have to follow the regulations, you have to follow every step of the process, and it's not just a kitchen, it is truly manufacturing, just like you would manufacture a car or anything else substantial. That's how detailed every step of the way is when you're doing proper manufacturing, safely for dietary supplement. Now, the biggest problems come in all over the board, and you hear it from consumers, right? So one of the biggest issues is fraud. So who are you buying from? That is a huge problem in uh that has been identified not just in the supplement industry, but in the food industry. Uh people have for years have been trying to find ways to cut products, to make them when when I say cut, um, I don't know if that's the appropriate term.

SPEAKER_03 3:34

Yeah, like adding basically like adding something to them that bulks them up, that would be an hopefully an inactive ingredient, not another active ingredient. Yeah.

SPEAKER_04 3:45

So you're hoping what you're buying is pure wheat flour, and you hope that your supplier is doing everything correctly, but there's instances where people put cheaper types of flours in to bulk it up, so it's not 100% what you think they're getting. Exactly. Um and so fraud is a huge issue in food and dietary supplements because everyone's always trying to make a little bit more money. Um and the other issue is you know, when you start selling in botanicals and ingredients that are not grown everywhere in the world, um, and so there are limited supply chains, there are limited growers out there, and having proper audits, having proper validations of what they're doing, those are all extremely important. And that's just sourcing. When you're dealing with manufacturing, of course, you have to have the right equipment, you have to have the right processes for making sure whether it's a kill step or proper controls like water activity. Uh you know, these products sit on the market for quite a while before people buy them. It could be a week, could be a year or two because of the great shelf life of some of these dietary supplements. And you have to ensure consumer safety the entire entire time that they're going to consume them. In addition to that, you know, you want to make claims about your products. So claims such as nutritional content and things like that, those are often difficult to properly label because they're, as we know, some vitamins, for example, do degrade over time where you think you're putting in a certain percent or gram amount, and over time, during that shelf life, it may reduce. So you have to be very careful for that. And then some of the other issues that come up are just making sure the products or your manufacturing environment are safe. Uh, having a proper testing program in your facility when you're doing wet washes, dry washes, whatever it is. Um, sanitary design and making sure your facility is laid out in the most advantageous way so that you can clean and sanitize everything appropriately is a real benefit to any company looking to manufacture.

SPEAKER_03 5:49

Let me go back to labeling, because I I heard you mention labeling and labels. And it's one of those areas where a seemingly small detail can create a much bigger problem. I've heard that. What are some of the most common or say easily overlooked labeling mistakes?

SPEAKER_04 6:09

Yeah, Jeff, this is probably the largest issue with across food and dietary supplements. As we know, uh allergens are by far the number one cause for recalls in the space in general, and not just labeling allergens and identifying them, but correctly labeling them. Um and that sometimes becomes difficult with uh processing aids. Sometimes you're buying ingredients such as flavors that have that may have certain carriers, or you may be looking at sub-ingredients such as maltodextrin, dextrin, things like that. You have to verify that these ingredients, when you purchase them, you have to know what all the sub-ingredients are, especially from an allergen standpoint. Now, there may be some ingredients such as oils that, such as, let's say, refined soybean oil that might come from a plant, such as the soy plant, uh the uh the soybean plant that has an allergen, but it's been refined so far that an allergen no longer exists. Then you have to do a risk assessment and get documentation from your supplier to guarantee the allergens on not in there, and determine if you want to take the risk of not labeling. Legally, of course. Another big issue with labels is obviously determining whether an ingredient is a processing aid by definition or not. You have to label anything that's not officially a processing aid. And in the determination, uh I've seen a lot of companies take a very wide definition, a very broad definition about what a processing aid is, and you have to justify that when you do deal with the FDA coming into your facility and asking. And then, of course, with labeling, the biggest concerns beyond allergens are probably dealing with nutritional content claims. Are you making correct statements? Because using an incorrect word, such as the word contains. The word contains itself. If you want to say this product contains vitamin C, that's a claim. That's stating that you have at least 10% of a DV by the end of the shelf life in your product. You can't just say it has it because you want to say it's in there. Um additionally to that, the big ones are structure function claims. How does this affect a certain part of the body, an organ, a process? You have to stay away from disease claims. This can't cure anything, right? Your product is designed and everybody knows the label. You know, this product cannot prevent, diagnose, treat, cure any disease. And then finally, health claims. Uh, health claims are a big one. Um obviously, there's qualified health claims that the FDA has provided guidance so that if you have this ingredient and this amount in it, you can make these qualified health claims. But there are health claims that are not considered qualified that people have been using research to help push along, and the FDA seems to be in agreement with a lot of those. However, I've noticed very recently there have been a lot of lawsuits going into things like omega-3s and fish oils. And so there are that is going to be a changing landscape as we go forward, depending on the results of those lawsuits. And this is all labeling.

SPEAKER_03 9:24

And when we talk about claims, which we are talking about, I think it's important, I'm stating the obvious here, but it's important to realize, is it not, that the claims don't just stop at the label anymore. I mean, you've got websites and social media and influencer marketing. I mean, all of that is in the mix. So what should companies be thinking about when reviewing claims across sort of the universe of different channels that they're that they're looking at?

SPEAKER_04 9:51

Absolutely. Uh Jeff, the social media landscape has dramatically changed the marketing techniques for every industry out there, and especially dietary supplements. Now, these structure function claims, your health claims, anything you want, as long as it's truthful and not misleading, and you have the data to back it up, you can make that claim on your website or on social media. However, we seem to be in an age where whether it's an Instagram, TikTok, YouTube, there's a lot of influencers out there or just people talking about your products. If you have a great product, a lot of people are going to talk about it. And the big part of that is sometimes they say things that you don't want them to say. That could be talking about something that they believe it helped cure, could be talking about something that they believe it does for them, that is not an accepted term that your company would not state. Now, if you are using this influencer, uh when I say you're you're paying them, they can't be making those statements. They're seen as an extension of your company if they're on your payroll. Now, if they chose to buy the product to review it uh by themselves, they can do whatever they want. Um, however, it still means that you are not able to go onto their page, onto that video, that TikTok, Instagram post, whatever it is. And if they say something that is not acceptable for your company to say, as a representative for the company or even under the company's social media, you cannot promote or interact with that message. Uh, you can't give it a thumbs up or give it a heart or anything like that if it goes beyond the scope of what you as a company can say about it. If there are any comments on a message board or a uh a rating system, someone gave you five stars because their comment was, This product helped cure my rheumatoid arthritis. If that's on a comment board or a page that you have control of, you can't let that sit there. That's essentially basically saying that you agree with that or that it's okay that it's on there and you're you want people to see that. Um you're you would be considered complicit in that. So if it's a message board you control, you have to control those messages and make sure those those comments that are not allowed do not stay on there. You can thank them for their for their comments and uh and reply on a personal message. We're happy that this product has helped you, um, but you can't allow that message to stay on there if you have control.

SPEAKER_03 12:33

Well, and speaking of control, uh it seems like new ingredients in particular kind of require maybe an extra sense of you know how to navigate certain questions, uh whether it's NDINs or grass or other regulatory requirements. What should they be asking early in product development to avoid problems later?

SPEAKER_04 12:57

There's so many ingredients out in the world, uh whether it's you know plant-based, mush, you know, whether it's a mushroom, things like that, and buzzwords, right? Adaptogens, nootropics, things like that. There's always new products coming along. They all have a very unknown quality about them initially, despite maybe there being support for them in a local region in the world. Now, that's fine. You can use that information to help you, but when you're doing considering using a product, the the number one question should be is this safe for our consumers? Understanding the safety should be the very first question, and that that begins with research. One of the first things to do is or to understand is just because it's from a plant, or just because it's natural, I'm putting that in quotes for those listening, just because it falls into one of those categories does not automatically make it safe. There's plenty of plants out there that certain people, because of certain conditions, cannot take. There's a lot of supplements out there that have contraindications to medications. And the the product, the ingredients, the botanicals, the vitamins themselves have been demonstrated true over years of safety studies. But that doesn't mean they're safe for everybody. For example, St. John's Wart is a fantastic product that a lot of companies sell. It's a great product, but it does have issues, uh, contraindications to people who are using antidepressants. Calcium and iron can cause issues with people who are on thyroid medications. Kava can have issues with people who may already have existing issues with kidney, liver. Um I don't know if this is absolutely true. So uh forgive me if this one's wrong, but generally advised against people who are pregnant or may have uh Parkinson's already just due to medication issues. So I think that's a big issue when you're starting looking at a new ingredient and a new product is first identifying safety. But people have been using some of the grass loopholes that exist in the food space to pass ingredients through that maybe haven't gone through what many of us would consider a thorough and deep dive into the safety reviews of these products. Well, unfortunately, yeah, go ahead. Sorry. Unfortunately, the the reality of it is if you're the first one to market, you're gonna reap the most benefits, but it also means you probably have to spend more money and time on the research. That's just the nature of being the first one to that to that ingredient. And that's that's just what happens. It's unfortunate. Um But the safety concerns are by far the number one concern.

SPEAKER_03 15:44

Well, and and all of this uh kind of falls under the heading of compliance and you know, having a compliant, a strong compliance system in place, whether it's a new product or not, uh, is gonna really uh pay off in the long run. Because if the FDA shows up and with inspectors and you know, there could be subsequent warning letters, all of those things kind of reveal the weaknesses in your compliance system. Um so what can companies do to make sure, whether it's a new product or or if they're dealing with existing products, that that they're gonna be prepared uh for that regulatory review if and when it comes?

SPEAKER_04 16:27

Yeah, the first thing is obviously making sure you are fully in compliant with part 111. I understand uh for those who are new into manufacturing, I mean that is an absolute textbook to follow. Um so the first thing you have to do is obviously go through each section line by line. You have to absolutely verify that you are following um or believe what you are is following that. The second option is to hire a third-party group that may have full may be full of experts. Again, uh I'm part of tag, but there are and we're gonna be able to do that.

SPEAKER_02 17:03

I was gonna say, do you do you know of a do you do you know of a group? Do you know of such a group?

SPEAKER_04 17:07

Absolutely. Um and that's what I I I love being a part of Tag because we get to go in and help uh many of these companies and make sure that give them the second opinion that they are doing things correct, or if they're not, help them with that and point them in the right direction, tell them what they need to do in order to comply. Because everybody knows a number of the FDA regulations, and I'm saying a number, but I think we would think that a lot of them are, are rather vague and they can be interpreted in multiple ways. Um and again, there are many consulting companies, there's there's a number of good consulting firms out there that can help you with this and point you in the right direction, and we're all full of people that have been in the industry that have been down this road that can help you with it. Now, some of the side effects of not doing things right, as we know, those warning letters, the 483s, all of that, that stays on your record forever. You don't want to get to the point where that is public knowledge. Another thing, if you're an ingredient supplier, or even if something about your finished product company comes to light, you're now considered a high risk. I as a finished product company, if I know a supplier has had a number of run-ins with the FDA due to whether it's safety issues or sanitation or identity problems with their ingredients and not doing proper testing, I don't know if I'm going to want to do business with you. You are too high of a risk. And there are a number of other things that can fail along the way where knowing how to do things right and setting up proper SOPs, that would be your you know, your policies, your standard operating procedures, making sure that everything is written down and followed to a T is absolutely paramount and documented is absolutely paramount for making sure your product complies with all regulations.

SPEAKER_03 19:10

Last question, and I think this is a really fitting one to end on because it's a little bit of a it's a little bit of a freebie for those listening who may be in need of good solid advice. So if if you're a supplement company out there and you know you can do kind of one thing today that would strengthen you know your overall practices when it comes to manufacturing and labeling and and just you know all of the regulatory compliance issues we've been talking about uh today. What is it?

SPEAKER_04 19:43

Oh, Jeff, that's difficult to narrow down to one topic. Um I I see one of the largest concerns right now is probably has to be fraud and identity um testing. When it comes down to consumer trust in the supplement industry, they have to know that your product is what it is, it's exactly what you label it as, because they're putting this in their body. And not only that, they're putting it in their body to help themselves. And making sure that your consumers understand that if I want to sell you an ashwagandha, that that ashwagandha is 100% pure ashwagandha and not filled with anything else, that is extremely important from a consumer trust and safety standpoint. From a manufacturing standpoint, you can't take the easy way out. Let's just say that. That's a nice way to phrase it. If there is any concerns, whether it's risk for safety, if you have a potential um listeria finding in your plant, um, whether you have issues with sourcing and you don't know if you trust this ingredient, you have to correct those. You you can't take that risk as a company. You have a target on your back, you have a consumer that could get hurt, and you have a reputational risk. Those are all extremely important when it comes to manufacturing, and you have to be on top of all of them. So properly assessing your risks and then remedying them in whatever way you have to is just extremely important for anyone looking to manufacture supplements.

SPEAKER_03 21:30

Good advice from somebody who is keeping his eye on all of these issues, and that is a comfort, I'm sure, to a lot of your clients. Tony Lucas uh of TAG, thank you so much for joining us today. We really do appreciate your insight.

SPEAKER_04 21:45

Thanks a lot for having me, Jeff. I really appreciate this and uh look forward to working with CRN going forward and having a lot of great discussions and um helping improve the dietary supplement industry.

SPEAKER_03 21:58

We'll have you back on soon. Thank you, sir. Take care.