Companies seeking to do business in the fast-growing food supplement market in the United States must ensure they’re compliant with federal regs.

Since the mid-1990s, the United States has been on the cutting edge of dietary and food supplement innovation, following the passage of legislation that carved out a regulatory category as a sub-set of food. Bolstered by consumer interest in preventive health, the industry has seen steady growth even in the face of questions about the level of FDA oversight of the supplement category. One of the fundamental pieces of supplement regulation is good manufacturing practices—GMPs—that are a requirement for bringing compliant products to market. In this podcast, Dr Tara Lin Couch, senior director for dietary supplements and tobacco services at EAS Consulting, shares insights around FDA’s supplement GMPs, common misconceptions, and much more.

Tune in to hear more about:

• Shifts in the US dietary supplement landscape in the last two years, and what the ‘new normal’ looks like.
• Ways for overseas firms to stay abreast on the regulations impacting their business in the United States.
• The latest regulatory changes affecting food and dietary supplement production.
• How companies that market finished supplements can ensure their producers are compliant with GMPs.

Guest: Tara Lin Couch, PhD, senior director for dietary supplements and tobacco services, EAS Consulting Group

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Welcome to the Vitafoods Insights Podcast. Join us as we explore the latest science and innovation, helping the global health and nutrition industry, connect, develop, and progress. Today's host is Heather Granato, Vice President of content.

While the United States is known as a fast paced, innovative market for dietary and food supplements. There is also a misconception that the space is unregulated, not true. Differently regulated than pharmaceuticals, certainly; potentially under regulated by the US FDA. But with laws including the dietary supplement Health and Education Act, and the Food Safety Modernization Act, and regulations around good manufacturing practices or GMPs and facility registration. There are myriad issues the companies wishing to do business in the US nutraceutical space must address. Top of mind for many companies is GMP compliance, and the importance of staying abreast of the landscape and responsibilities. To talk us through the topic, I caught up with Tara Lin Couch, the Senior Director for dietary supplement and tobacco services at EAS Consulting Group. Tara Lin is a PhD analytical and organic chemist and provides GMP training via seminar, webinar and on-site presentations. We started out talking about the misconceptions around US GMPs.

One of the big misconceptions is that there aren't any regulatory requirements, right, which there certainly are, I've spent my career involved with those and helping companies build the quality systems that they need to be compliant with the dietary supplement regulations. And part of that misconception, I say is that there's not any barrier to entry, right, to get into the dietary supplement industry. There is, but it's kind of hidden in some ways, right? So, you have to register as a food facility because dietary supplements are technically a classification of foods by the FDA. But that's really the last step, not the first step, right. So, people think that that's what you have to do. And that's all that's involved. But what that does is demonstrate that yes, we understand what all the regulatory requirements are, and what all the statutes are that are required for dietary supplement companies, and that you're compliant with all those because once you do the registration, then you're visible to the FDA. And theoretically, the FDA can then come out and inspect your facility. And this is true, whether it's a foreign facility or a domestic facility, that's really irrelevant. We'll talk more about this later. But the FDA can do virtual inspections and does do some virtual inspections. So that is applicable around the world, really. So, the heaviest lift, in my opinion, is the requirement with good manufacturing practices. So, all of these facilities involved, whether it's the brand owner, whether it's the contract manufacturer, contract laboratory, co-packer, distribution, warehouse, whatever, everyone in the chain, even if that's all-in-one building, which increasingly is not in one building. But when that happens, all of those facilities have be compliant with good manufacturing practices. And those are dictated in 21 CFR Part 111 for dietary supplements, it's very much like a pharmaceutical regulation, not a food regulation, even though we are technically a food underneath the regulation. So that's one of the requirements and probably the heaviest lift, as I mentioned, but there are other statutory requirements as well. So certainly, complying with the labelling requirements in 21 CFR 101 to make sure your label meets all those requirements. Also making sure that in the event of serious adverse event, those gets reported to the FDA that's underneath a different law, that's underneath the same law as OTC Pharma. Then there's also 21 CFR Part 11, which is electronic records and electronic signatures. So anytime you're doing anything electronically, which of course everyone is doing, you have to comply with that. So, there's a number of regulations that are actually in play here. And the last step is doing that registration that acknowledges, yes, we know all this and we're compliant with all this.

That does make sense being compliant, and then saying, hey, I'm here, and I can show that I've got the stuff.

Right, exactly.

You mentioned this idea of electronic as well as virtual. So, let's talk about COVID. Let's talk about, you know, how did that the last couple of years of this pandemic really impact not only production of supplements, but also even the regulatory environment in the United States as it relates to the supplement industry?

Right. Well, as you mentioned, you know, the production for dietary supplements in the interest in dietary supplements has gone up, over COVID, people just being more aware of their own health and trying to support their immune system, and have a healthy diet and when needed, supplement that diet, you know, so that's been occurring, you know, you probably know the numbers better than me, but, and you've heard 20 25% up over the last couple of years. And then of course, we've had a lot of supply chain challenges as with every other industry in the world, right. So, there's been a lot of challenges getting raw materials, a lot of raw materials for dietary supplements do come from foreign facilities, not within domestic facilities. I mean, I've heard statistics of anywhere from 60 to 70%, are coming from a different place. So that's been a challenge getting those materials. And what that means is, you know, dietary supplement companies underneath those GMPs in 21 CFR 111, they have to make sure that all those incoming materials meet identity, purity, strength, composition and limits of contaminants. And typically, what they've done with a particular supplier, they've qualified them. So, they can go to a reduced testing schedule, and not have to test all of those things every single time. If you're changing the raw material supplier, you're going to have to do more testing. So that's been one of the challenges on the raw material side is getting those materials. And then some things, particularly botanicals, have been harvested early, or they're coming from different fields and this sort of stuff. So, contaminants and purity issues that didn't exist before popped up over the last couple years. So again, another reason why doing the testing on that raw material side is so important. If there's anything changing in that supply chain, which has been drastically impacted over the last couple of years. Some of that has settled down a bit more recently. But the other big regulatory change is really sort of the absence of the FDA. As with everyone, FDA should basically shut down and everything go virtual and in house. And the nature of what they do is go out to facilities and do inspections. And so, they haven't been able to do that. So, they shut down for a while and then started back up and shut down and started back up. And I think shut down again. So, there's been multiple times with various strains of the virus and such that have occurred, they are technically back out there doing inspections. But those are limited. And they put out a guidance in 2021. A resiliency map is what it was called that indicated how they were going to get through and catch up with some of these inspections that they're so far behind with. And they're using this prioritised approach, that means that they're only prioritising certain groups that have very specific relevance to the pandemic, as well as people that have already been in trouble. So, they're not getting out to a lot of facilities and what they are doing, virtually, they are announcing even domestic inspections to make sure that people are going to be there. And you know that sort of stuff that they have the right people in the house and that sort of thing. So, a lot has changed because of all of that. And obviously, international inspections, they can't do pretty much at all right? So, I was actually just at a conference last week, where FDA was present, but only virtually because they're not allowed to travel for conferences yet. So still, they're kind of lagging behind the rest of the world when it comes to starting to get out there and do things again. But what that's meant is that there's been a huge decrease in the number of inspections that occurred. So, it was a 47% decrease in 2020. And it was even worse in 2021. So, I was actually just got a hold of some of the numbers. And from a colleague of mine, and I expected the numbers to come up a bit, not be back to a pre pandemic state, you know, but come up a bit and no, they were down even more. So, what was very disappointed. There was only, you know, some 780/90 inspections in 2021. That compares to a typical average year prior to COVID of more than 1600. So, it's very significant drop in the number of inspections that are taking place. And what's happened is that that vacuum that's created, a lot of people have jumped in to do these certifications, you know, third party certifications to demonstrate GMPs. I think some of those are well intended, certainly, but unfortunately, some of the worst facilities I've ever seen in the world have all whole wall of certifications, right? It's pay to play kind of situation. So, it's not the same as the FDA coming in and doing an inspection. So really the best thing companies can do and what the big companies are doing is having third parties come in not a certification body, but having third parties, consultants and such come in and do evaluations and make sure their quality systems are instilling good order, especially given COVID, like there's a lot of hiccups with all of that.

I appreciate that. And certainly, having folks come in and you know, take a look around, give you some pointers. But there's also this idea of training, certainly, and making sure that your personnel have the resources and the information that they need. So, tell me a little bit about why training is so important in the supplement space?

Well, I mean, knowledge is power, right? So training is always good. So, I'm a lifelong learner myself. And so, you can't fix something if you don't know it's broken, and you're not looking right. So, you definitely want to always think that way. And training your workforce is the best thing you can do. For regulatory compliance, I mean, the more that they understand why they're doing something, the more apt they are to do it, and to understand how to do it, and probably how to do it more efficiently, right. So, you definitely want to involve all of your people in training. And that should be a place where you have budget this year, we get allowed to have one person train, I mean, that really shouldn't be the idea. GMP training is a regulatory requirement. So underneath 21 CFR Part subpart B, which is personnel, you do have to have people trained with good manufacturing practices, as well as all other regulatory requirements. And we've seen from warning letters, that that's expected to happen every year. So there does need to be an annual GMP training that takes place every year. And really going through all of the regulations at least once and then periodically for everyone, I think, is very wise. Because even if it's not necessarily their area, then they understand what some of their colleagues are doing on the other side, and why they're doing that, because we relate to them. And if they give out quality and production, for example, we always seem to be butting heads with each other right. That's sort of the nature of the beast right. Like, having some appreciation for what each side has to do for both of you is very, very helpful. But then, you know, refining that training to specific areas, right, so and really getting more into the weeds of what it is that they're doing and how they're going to meet these GMP requirements. I mean, I hear sometimes people complain that they'll say, the GMP s are very vague, and they'd like to have more specific instructions. And I completely disagree, I think it's good for them to be a bit vague, because how one company is going to do it in their particular scenario with their products, their facility, their personnel is going to be very different than another facility. And it's not just based on size, I mean, size can matter and does matter in a lot of cases. But that's not the only reason that you're going to have different kinds of systems. So having the GMP training that's specific to that group is very beneficial.

And I also would expect that that gives everyone who's involved more of an understanding of their place, and really, you know, their buying in like, this is something really exciting that we're all doing together to bring these safe, compliant products to market.

Right. So I, you know, I always say I don't blindly follow I'm not good at that. But if I understand why I'm supposed to be doing something, then it makes you be part of the fix, right? And part of the system itself. And you have, like you said, more buy in, in that situation. That makes the whole company stronger when everyone is participating in that kind of a way.

So let's wrap up here. How do you suggest that companies that market finished dietary supplements ensure their producers are compliant with GMPs? You have a lot of companies that are marketing, but they're outsourcing. What should they be doing to ensure these companies they're working with are compliant?

Being an own label distributor, or an OLD, is big business in the dietary supplement world for sure. So that's the term that the FDA coined back in like 2015 or something. So that OLD is ultimately responsible for all those contracting partners, right. So the FDA is going to climb up the chain to that OLD, and they will be the one that's ultimately responsible for compliance with everyone. So, there's some critical quality systems that they have to have also from 21 CFR 111. And those GMP requirements, so they themselves should go through the training, to understand what the responsibilities are and what the regulatory requirements are, they may not be doing all of those in house themselves. Some of them may do have to do themselves, but others they'll contract out to other people, but they have to still understand what those other people are doing and what their regulatory requirements are, right, because they are ultimately responsible. We've seen this in numerous warning letters, you know, over the last seven years, there's tonnes of them to pick from. One of the important systems that they have to have is specifications, is developing their finished product specification to comply with 111, because ultimately, that's the document you take to your various partners and say, this is the product I want you to make for me. And you need to make sure that that document is as it's required to be in accordance to 21 CFR 111 writing, and 111 70, which is the requirement for specifications is the most enforced regulation in the industry and has been since 2010. So having that in good order is critical, right, because that's what would be the first thing that the FDA looks at during an inspection. And the FDA will come to these brand owners OLDs, and say, I want to see your master manufacturing record, walk through it with me, you can't say, oh, that's my contract manufacturer. That's not an excuse, right. And that's not a Get Out of Jail Free card. You have to be able to walk through that. So you don't want the first time you do that to be in front of the FDA. So, the other important thing you have to do is qualify all of those contracting partners. And certainly, you think about the contract manufacturer, the CM, CMO, co-man, you know, take your term, you've certainly you think about them, but there are other partners as well contract labs, a co-packer if you're using a co-packer, even a distribution warehouse. So if a product were to pop back to a distribution warehouse after it's been shipped, which happens, and it would pop back with a complaint, potentially, and that even could be a serious adverse event. The owner is the one, OLD is the one that has to get that reported to the FDA within 15 business days, which is pretty tight. I mean, three weeks sounds like a lot of time, but it is not to get all that done and get that investigated and reported. So, it's really important that you work with all of those contracting partners. And I also highly recommend that they have quality agreements with all of those contracting partners, to lay out who is responsible for what in terms of quality, not your business agreement, you'll have to take care of that with attorneys, but with quality, because there's a lot of quality requirements in the GMTs. And laying out who's doing what and mapping that out is beneficial, certainly from a, you know, logistic point of view, but also just from a regulatory point of view to make sure all of the things that need to happen are happening.

Well, Tara Lin, thank you so much for your real, insightful knowledge share today on this topic. There's so much happening as always in the very innovative market in the US supplements, but certainly ensuring compliance with the regulations is critical. So appreciate you sharing how firms can ensure that they are.

Thank you so much, Heather. I really appreciate the opportunities. And I thoroughly enjoy working with Vitafoods.

Thank you so much, and we'll be talking with you again soon.

Thank you.

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