Unveiling Supplement Regulations: Asa’s Insights on Compliance and Ethical Marketing

Asa Waldstein: 0:00

Well, the FDA has a pretty big job right. Their mandate of their charter is to protect public safety, so they oversee conventional foods that’s meats, that’s eggs, that’s dairy. They oversee drugs. Dietary supplements are just a part of this. So they’ve got a pretty big job, to be fair.

Tina Smith: 0:24

Welcome to the Natural Products Marketer Podcast. I’m Tina and.

Amanda Ballard: 0:28

I’m Amanda and we’re here to make marketing easier for natural products businesses, so you can reach more people and change more lives.

Tina Smith: 0:38

Amanda, how did you hear about Asa?

Amanda Ballard: 0:41

LinkedIn. I’ve seen your name pop up everywhere. I’ve also I have a lot of industry friends that are mutual friends of yours. I was actually talking with Sarah Burden the other day and she was like, oh my gosh, I was just talking with him, so I was. I was telling her how excited I was for today’s interview. I think the first time I heard about you was from Deborah Short with Senpa. She had dropped your name for a possible speaking engagement and so I’ve heard about you through the grapevine many, many times.

Asa Waldstein: 1:14

Wonderful. I love it. Yeah, small world, even though the supplement industry is so big, it’s really not that big and so it’s great. It’s great to have colleagues like that share some kind words. And yeah, sarah is wonderful.

Asa Waldstein: 1:27

I just recently saw her at the Supply Side East and what’s Up with Subs event and it was pretty exciting because my daughter is 23. She’s never been to any industry events. She’s an environmentalist. She’s going to go to grad school and see Boulder here in Coloradoado where we live in the fall. She’s never been to any industry world events at all. So she came and met me for the tail end of the what’s up with subs event and it was so neat she every by that time people have been having a really good time, you know, drinking and celebrating. But she heard about warning letter wednesday, my weekly blog post over and over and over again. Oh, like this is my daughter nova. Oh, yeah, we love warning letter wednesday. She spoke to me at the end of the event because then we went and spent three nights in new york city having fun. She said now I kind of get it because I’m I do warning letter wednesday every week, every t Tuesday night for Wednesday, for the past two and a half plus years whether we’re in.

Asa Waldstein: 2:28

Africa or on vacation or wherever it may be. So it kind of helped her see what her dad does and why I’m always taking two hours off on her vacation to do Morning Letter Wednesday and it was kind of a fun aside there, awesome to do morning letter rides.

Tina Smith: 2:44

And it was kind of a fun aside there. Awesome, we’re really excited to talk to you because so many of our clients need you. So many retailers have a lot of questions, and manufacturers too, and they’re questions that we either don’t know how to answer or we feel really uncomfortable answering because they’re compliance related. So we want to make sure that we give people the right information from someone who knows what they’re talking about. So I would love to start with first just how you got into this industry and what brought you into compliance and regulatory related to the supplements.

Asa Waldstein: 3:23

I love that question, thank you. I followed my passion for herbal supplements and natural healing into the dietary supplement industry. So, to back up even more, I came out to Boulder. I like cool places. So I came out from Santa Cruz to Boulder, colorado, in the late nineties to study clinical herbalism. So I participated in a three-year clinical herbalism program I’m a certified clinical herbalist and then participated in a three-year clinical herbalism program I’m a certified clinical herbalist and then in 2001, I started making supplements because herbs are cool, I believe in natural healing, that type of thing, and little did I know that this whole dietary supplement industry was going to grow up around me. So I kind of just followed my passion for herbs into a dietary supplement manufacturing environment. And then it was just kind of fate and serendipity.

Asa Waldstein: 4:09

I was actually pretty good at running dietary supplement companies, formulating, talking to customers, getting products out the door in a compliant manner.

Asa Waldstein: 4:19

And then I learned the regulations kind of from the inside out. So I’ve seen the implementation of laws such as GMPs for dietary supplements, common allergy and labeling law, to name a few. So I kind of learned them again from the inside out. How do these regulations and laws, how do they affect me as a small business manager or someone who’s helping to guide different brands. How do we make sense of them in a practical way? How do we interpret the regulations in a way that’s not going to put us out of business but is actually going to make sense and allow us to continue to do our jobs, make money, sell great health giving products, but also stay in compliance?

Asa Waldstein: 5:00

So I did that for many years probably about 17 years as a dietary supplement manufacturer and marketer, and then I went out on my own. So I started my own regulatory consulting company about four years ago, and what I love about that is, instead of working with one company, I get to work with 30, 40, 50 different companies and really understand the nuances of regulatory compliance and how it applies to all these different companies, whether they’re small, emerging brands or the biggest of the big companies as well.

Tina Smith: 5:32

Yeah, so one of the big misconceptions about the supplement industry is that it’s not regulated, and we know that that’s not true. It’s very regulated, but you know we hear a lot that the FDA does not regulate supplements and so you can’t trust what’s in the bottle. So tell us a little bit about the regulations that are there and how much regulation the FDA does have over the products.

Asa Waldstein: 5:59

Well, the FDA has a pretty big job, right? They have to. Their mandate of their charter is to protect public safety. So they oversee conventional foods that’s meats, that’s eggs, that’s dairy. They oversee drugs. Dietary supplements are just a part of this. So they’ve got a pretty big job, to be fair. And so we’re talking about dietary and herbal supplements here. So FDA inspects around 500 dietary supplement manufacturing facilities a year.

Asa Waldstein: 6:31

I’ve heard that there’s over perhaps 10,000 dietary supplement manufacturing facilities in the US. So 5%, that’s not a very good number. So I really would like to see FDA, I’d like to get some more resources to FDA to do more GMP inspections. So I think FDA is doing a pretty good job with the resources they have. Um kind of on the critical side, I think FDA could certainly do a better job at helping to remove drug spike ingredients and drug spike ingredient products from the market whenever they’re found. Again, it’s a very, very small subset of dietary supplements. Whenever they are found, I’d like to see them removed with a little more haste. So of course we know supplements are regulated by the FDA, and I’m just making up a number here. 99.8% of them are probably pretty darn good. They’re made under a good manufacturing practice compliant facility.

Asa Waldstein: 7:30

but then there’s a select few out there that I’ve talked about with the drug spike ingredients and that type of thing. So dietary supplements yeah, they have a high level of safety and you know I always love having these type of conversations. And thank you for this question, tina, because educating about the regulatory structure, the framework with dietary supplements and actually how generally safe supplements are when taken as directed, taking all the potential contraindications in mind, really is an important topic to get out to the broader public.

Amanda Ballard: 8:07

Yeah, that’s really interesting and I’m glad that you kind of clarified that. You know, I think one of the probably one of the bigger questions we get beyond that more from a retail perspective. I’ve been around the block a couple times now with different retailers and the topic of Deshaies comes up over and over again. So for the uninitiated, can you tell us a little bit about the Deshaies Act and what that did to this industry back in the 90s? And I know from many of my peers that have owned their own health food stores since, you know, the 70s, 80s, 90s. This was a big deal for them and I can’t necessarily share in that experience. And so they talk about Dachet all the time and how like, how amazing it was that that got passed. I’m like I can’t relate to you. What does this mean? And then, what does it actually mean to present day about what we can and cannot say about supplements?

Asa Waldstein: 9:07

Yeah, thank you for that. So DSHEA, the Dietary Supplement, Health and Education Act. We have so many acronyms in our world, it’s good to spell about every once in a while. So there is a world before DSHEA and after.

Asa Waldstein: 9:18

DSHEA, the world before DSHEA is, there wasn’t really a legal way to sell and market herbal and dietary supplements. I think to your point, amanda. Companies were getting rated for selling products that contain herbs like echinacea or even vitamin C and things like that. So it’s really just crazy to think about, from what we look, what it’s like now, 30 years later, and what it was like before 1994 when Deshaies passed. So again, deshaies gave us a lawful way to manufacture and market herbal ingredients. And so when we look at kind of what Deshaies did, talking about claims and how it helped clarify some of what we can say, deshaies helped clarify what is off limits, so a disease claim, and what is a structure function claim Allowable if we have substantiation.

Asa Waldstein: 10:13

So I love the example of inflammation. Right, I run a regulatory consulting company. I’m asked, hey, is inflammation a claim? So here’s a good example. If we’re talking about help support a healthy inflammatory response after exercise structure function claim, we’re talking about the body. It’s a normal non-disease state. I worked out too hard, I went snowboarding, I’ve got an inflammatory response. I’m helping to balance that pretty low risk. I’d consider that in the structure function category in my opinion, whereas the phrase chronic inflammation or helps with chronic inflammation that’s disease related. You know that’s disease adjacent. So you can’t have something that’s a normal life event that goes on all the time that it crosses that line from okay or probably okay into disease claim category. Another thing that Deshaies did was it kind of put a stake in the ground with ingredients, so anything marketed, or most things marketed, before October 15th 1994, when Deshaies passed. I know that date because October 15th is the anniversary of the first date that I had with my wife.

Asa Waldstein: 11:22

That’s how I remember it. Even though I’m a geek, I know this stuff. I remember October 15th as a date, so anyway. October 15th 1994, herbs and ingredients were marketed before then. They’re considered ODIs or old dietary ingredients and they’re most likely to be allowable under this structure.

Asa Waldstein: 11:40

Anything marketed after that Dachet date is considered a new dietary ingredient according to FDA regulations. So if it’s an NDI, a new dietary ingredient, companies are supposed to go through the safety procedures of proving that ingredient safe. Now I just wanted to demonstrate how unclear this is and how complex it is at the same time. So let’s take an ingredient like turmeric. Turmeric marketed forever and ever, probably considered an old dietary ingredient. But if we take turmeric and we highly, highly purify it, if that purification was done and was sold in the marketplace after the disheies date, then maybe it needs to become be considered a new dietary ingredient.

Asa Waldstein: 12:29

So as we’re looking at kind of Deshaies, the initial framework there and how it affects us today, I also, of course, look at labeling. Right, I’m a regulatory person. I look at labeling. So when Deshaies was enacted, there was really no such thing as the internet. So when we look at so when Deshaies was enacted, there was really no such thing as the internet. So when we look at the complexities of Deshaies then and Deshaies 30 years later, some of the regulations of Deshaies don’t really make sense. So when we’re unclear on how to adapt regulations for the world we live in today, we look at warning letters. So that’s why I love writing Warning Letter Wednesday, which we talked about before we jumped on today, and why it’s important to read FDA warning letter trends. So I like to think of the adage of all marketing is an extension of the label. So if we wouldn’t put something on the label, such as anxiety support, we should be very careful to not let it slip by in any secondary form of marketing.

Asa Waldstein: 13:30

Hashtag social post, influencer post, that type of thing.

Asa Waldstein: 13:34

So that really shows how Deshaies provided a framework. But then we have to pay attention to enforcement trends as a way to interpret how that makes sense for our company. And I did want to give a plug to APA, the American Herbal Products Association, at Expo West. They just posted a 30 years of Dachet video and I’ll share it with you, amanda and Tina. If you can share it with the readers here, I think that’d be a great resource. I think that’d be a great resource. It’s a great video of Deshaies, what it was like before Deshaies, how we got to where we are here in the herbal dietary supplement industry. Yeah, absolutely.

Asa Waldstein: 14:24

Now there is word on the street that they might start looking at Deshaies again in the legislature. What would that mean? I think that it could mean adapting some of the antiquated verbiage that was part of the act before there was the internet, for example, so that could be good. It could also be helping to maybe further define what is education and what is a disease claim. So, for example, if we’re talking about a blog and we’re talking about an ingredient in a blog and that ingredient sold in our product, is that education or is that labeling According to FDA warning letter enforcement? That’s labeling, but it would help clarify some of those type of things.

Asa Waldstein: 15:08

Also, there’s this very antiquated rule which drives me bananas, that plaintiff attorneys have got a hold of and we’re all aware of that FDA or that Deshaies disclaimer this product has not been intended to treat, diagnose, cure, prevent disease, so on and so forth. Intended to treat, diagnose, cure, prevent disease, so on and so forth. Now, according to this DSHEA Act, that disclaimer needs to be on every label panel. It says label panel in the rules every label panel where that structure function claim is so, let’s say that the product supports joint health, on the principal or the main label panel. Now, according to the regs, we’re supposed to put that to shade disclaimer on that main label panel and on the side label panel for structure function claims.

Asa Waldstein: 15:52

It’s so, bananas, that it’s leading to several lawsuits. It’s very silly. Being able to update. Things like that are important. I also urge caution. If we open up discussion we might not get what we want. So you know, bringing Deshaies into you know now, 2024 and beyond, into more of a modern framework, I think, is not a bad idea. But we need to be vigilant if we open up that discussion to make sure that we’re not going to lose any of the protections provided by Dachet.

Tina Smith: 16:30

Yeah, I’m so curious about some of these things that you’re talking about, especially when it comes to education materials like blog posts or webinars and that kind of thing, when you start talking about scientific studies even. Is that in compliance if you sell the product in your store and you have a blog post about it, even if you don’t point from the blog post to the product?

Asa Waldstein: 16:59

I love this discussion.

Asa Waldstein: 17:02

I don’t know about a brick and mortar type discussion. We’ll come back to that. Secondly, but according again to FDA warning letter enforcement, clinical citations are considered marketing, so they are considered labeling. So let’s say that we have a blog post about turmeric and then we have a study citation about turmeric and arthritis. Now if we’re not selling turmeric on that website or connected by the social media or linked in some way pretty darn low risk, probably in the fine to no risk category. But if we are selling turmeric, then the FDA would probably consider that a labeling and therefore, citing that clinical study is saying hey, the ingredient turmeric in this example that we have in our product is being marketed for arthritis. So, citing clinical studies, even if we have all the research in the world, we’re still not allowed to make those disease claims about our products or ingredients, according to FDA.

Asa Waldstein: 18:08

Ftc is a little bit different. Now, if it’s a brick-and-mortar store and they are maybe not selling their product online but they are educating online, but they are selling that product in their store, I can’t think in reality of a situation where that would occur Then it’s probably far enough that it’s not really risky, but it’s all about how linked it is. Again, if it’s on a website or on a social or YouTube and that’s linked to where people can order products. That’s a common statement in warning letters. That’s enough to build that bridge from clinical research into disease claims and the same and I’m often asked this as well the same is true for study citations.

Asa Waldstein: 18:56

So study citations have been cited in some warning letters, mostly related to COVID and CBD, because there was some initial research about that. So simply just having a study citation with the ingredient in the disease claim, that was enough to attract a warning letter in this COVID, cbd group of warning letters from a year or two ago. So I don’t think in real world risk that just study citations are enough to tip the scale into warning letter category unless they’re very high risk. So just a quick closing thought on that is a good best practice if companies are using study citations which I think is good as long as we’re being truthful and not misleading is make sure that the ingredient name or the product name and the disease claim are not in that study citation or that URL. So if it was turmeric study for arthritis, maybe remove turmeric or arthritis from there. That greatly lowers the risk. There’s a hot tip for today.

Tina Smith: 20:01

Thank you. I’m curious about what happens if you get a warning letter. Yeah, warning letters.

Asa Waldstein: 20:08

we definitely want to avoid them. So they’re a public record. They rank very high in search engines like Google. So it can be memorialized forever. The name of the company and the people that are in charge memorialize forever in warning letter history. So because they’re public, it can lead to credit card processing issues, insurance issues. It can also scare away distributors. So it can scare away distributors. It might be Whole Foods or whatever it may be.

Asa Waldstein: 20:39

Warning letters can affect that On face value. They require legal resources to respond to, and repeat warning letters may perhaps lead to injunction or seizure, although that’s very rare. Companies have to be kind of not very nice, be jerks to do that, really scurrying a lot, but it’s possible. So we always want to respond to a warning letter. We should respond to warning letters. It’s possible. So we always want to respond to warning letter. We should respond to warning letters. And again, we were kind of maybe there’s more of a target on companies back from the FDA, because repeat warning letters do have a more serious ramification.

Asa Waldstein: 21:17

Now in this day and age in the supplement industry there’s so much, there’s so many mergers and acquisitions happening. There’s a lot of things like that. So the quickest way to scare away M&A strategic alignment investment is to get a warning letter. Those folks with the cash. They’d rather go to someone else that maybe doesn’t have that target on their back. Now there’s some reasons to avoid a warning letter, but one of the main reasons is it alerts class action attorneys. So oftentimes plaintiff attorneys will use the warning letter as the basis of wrongdoing in the lawsuits, copy and paste that warning letter into the lawsuit and that can lead to demand letters and lawsuits.

Asa Waldstein: 21:56

And that’s very common Warning letters come out lots of demand letters and lawsuits follow.

Amanda Ballard: 22:02

Interesting. Have you seen any retailers get issued warning letters?

Asa Waldstein: 22:10

It’s usually retailers that have an online presence and so oftentimes it’s maybe retailers that are selling products that are not compliant, such as there was a bunch of ophthalmic so high product warning letters. I’m not picking on any companies like CBS, I think Walgreens big giant national retailers got warning letters for distributing these products. Now they were distributing them online, making it really easy for an FDA inspector to just look online and see that. So retailers certainly do get warning letters. It’s almost always for the disease claims or the lack of compliant product category that’s being sold online.

Asa Waldstein: 22:59

Of course, we can’t talk about retailers without talking about Amazon. Amazon continues to get better and better. Let’s hope they’re moving in more, continue to move in more compliant direction. I believe they probably are, but Amazon, I think, has gotten four warning letters over the past 16 months or so. So Amazon really is in the crosshairs of FTA just because they’re so big and, according to GMP regulations, distributors are responsible for the compliance of the products they distribute. So I’m actually glad that Amazon, who is a distributor they’re actually handling the product has been held accountable for either the disease claims or the compliance of the products that they are distributing, because according to GMPs, all distributors are compliant. So I certainly feel like if smaller or medium-sized distributors should comply with GMP distributor requirements can’t remember which subpart it is, then of course the biggest one in the world, amazon should be held accountable as well.

Tina Smith: 24:05

Yeah, so I’m just curious, based on that question, you haven’t heard about smaller independent retailers receiving these warning letters.

Asa Waldstein: 24:16

Yeah, so only if they’re thank you for clarifying that only if they’re making disease claims, almost only if they’re making disease claims. These might be smaller practitioners. These might be smaller independent retailers. These might even be farmer’s market style cottage industries that are selling their products at farmer’s markets. They snap a picture of their sign hey, our echinacea is great for flu prevention. Whatever it may be, they put that online. On that maybe I’m speaking hypotheticals on their instagram or whatever it may be, that instagram links to a shopping cart where customers can order products. That certainly, without a doubt, has attracted warning letters. So there’s a lot of these smaller retailers that, to be honest, probably just don’t know any better. I don’t necessarily think there’s very much of any malicious activity or deceptive activity. They probably just don’t know any better.

Asa Waldstein: 25:23

Taking and copying if you go onto Google or AI or whatever it may be and say what are the benefits of echinacea, you’re going to get disease, disease, disease. Taking and copying those over onto marketing doesn’t necessarily translate into compliant copy. Same thing with clinical studies, right? So branded ingredients, other clinical studies we go on PubMed, I’ll stay with echinacea studies. We go on PubMed, I’ll stay with Echinacea. There’s lots of studies about helps with mitigation of flu symptoms or whatever it may be, those don’t necessarily translate in compliant marketing, so a lot of these smaller retailers don’t know that. I guess that’s why we’re having this discussion right to help educate people about what is education and where education crosses that line into marketing.

Amanda Ballard: 26:12

So what about customer testimonials? So we recommend that to a lot of our clients to use their customer testimonials in their marketing, just because it’s you know, it’s they’re saying it, not me, right? So how does that in in the regulatory space? Like you know, customer says oh, this helped me get rid of whatever ailment that I’m dealing with. How do we handle that?

Asa Waldstein: 26:38

It’s a great question. So testimonials that a company adopts, post on social, puts in a banner ad, curates in any way, interacts with, engages with, those are considered pieces of marketing and therefore their labeling. So let’s say there’s a testimonial such as this product worked great for my arthritis, a social wall or coming maybe an Amazon review or testimonial or coming in through a third-party widget that’s non-curated, non-compensated, on a website, all right, the authority has been pretty hands-off with that. Now, if I as a company then like it or say thanks on social, I’ve adopted that as my marketing and therefore it’s labeling. If I engage with a product testimonial or review on my website, then I’ve engaged with the same thing with socials. I’ve adopted it as my marketing. If I take that and then put it in a banner ad I see this mistake happening all the time.

Asa Waldstein: 27:48

Customer testimonials we’re excited when we get testimonials with companies. We’ll copy and paste them onto Instagram or whatever it may be. That’s labeling and that’s marketing. So anything we adopt as marketing is again labeling. I know I’m repeating myself, but it’s important. We must have substantiation for and we’re responsible for that. So we’s kind of. You know, we’ve we’ve kind of unpacked this a little, a little bit of where the gray area is and where the gray area crosses that line into into marketing.

Tina Smith: 28:22

And I’m curious, you just use the word substantiated. We would have to be able to substantiate the claim. What does that entail? Like what would you to be able to substantiate the claim? What does that entail? Like what would you need to have to substantiate a claim?

Asa Waldstein: 28:33

Got it. Just need to make sure that we have some firm clinical data to back up whatever we’re saying. So if a customer’s, we’ll stay on testimonials. As an example, let’s say a customer says, hey, this product helped me sleep eight hours through the night, we better have some data to back up that our product can actually do that, that that is a reproducible result in, I’ll just say, the majority of the population.

Asa Waldstein: 29:02

Now to take substantiation a little deeper, and I don’t want to scare anybody out there, but the gold standard is placebo, controlled, randomized, blinded clinical trials. So that is a well-powered study of dozens and dozens of individuals that don’t know what they’re taking. If they’re taking a placebo or an active product and it’s reproducible, that is very expensive to do. On dietary supplements, which is why a lot and it just doesn’t make sense because we’re not supplements are not drugs in many cases. So that’s why a lot of companies depend on the data that’s available, either through branded ingredient or, you know, for example, pubmed.

Asa Waldstein: 29:45

So if there is a study on a thousand milligrams of vitamin C I’m making up these numbers, so don’t quote me on that A thousand milligrams of vitamin C taken as a capsule twice a day for immune support. Let’s say there’s a well-powered study on PubMed about just vitamin C. Now companies oftentimes will use that to build out their substantiation dossier. That’s just a fancy word for the packet. So if our product has a thousand milligrams of vitamin C it’s the same study population, the same form, like the capsule then that probably helps us substantiate a claim of immune support. So it’s kind of finding the data out there, making sure like matches, like animal studies don’t necessarily they’re not, they’re not the best. We want to find human clinical trials on ingredients that we can then use to prove their products work. We have data to back it up. We’re not just, you know, looking into a crystal ball and saying, hey, this product’s really good. Let me make up a bunch of claims about it.

Amanda Ballard: 30:46

Basically, I mean a bunch of claims about it. Basically, I mean, what I’m hearing is that retailers need to be super careful in what they’re engaging with online, even if you know someone literally just comments on Instagram this is my favorite product you sell in your store. I’m sleeping better than I’ve ever slept in my life and you hit that like button next to it Like you are claiming that as a factual statement.

Asa Waldstein: 31:15

Yep, it’s true. It’s true, and with that example, that might be a calculated risk on the company’s part because there’s not any disease words, high risk disease words there. If there was word insomnia there, ding, ding, ding, we’ve really elevated the risk. It’s all about you have to be truthful, not misleading, but it is oftentimes all about that risk. So, as we’re working with retailers or whomever brands, agencies, influencers, whatever it may be, it’s great to educate about this, especially with online engagement. Here’s the best practices. Here’s a training.

Asa Waldstein: 31:56

I do this a lot in my supplement advisor group, my consulting company. Here’s the training about best practices for online and social media engagement. Here’s your parameters. Here’s your do’s and don’ts. Here’s some examples. So then we know Oftentimes the company employee who’s engaging with social media. They may be so far away, removed from regulatory or compliance they may not have any idea. The name of the game is engagement in essentially all industries except supplements. What works in tech apparel doesn’t necessarily translate over here. So making sure this frontline person that’s the front and last barrier to potential issues, making sure they’re trained, creating a company culture of compliance is really important and it doesn’t have to be complicated. It can be a 10-minute talk that your social media managers sign off on, and just making sure that they’re aware of this and that there are some written down procedures, do’s and don’ts, is usually a pretty good start.

Tina Smith: 33:07

So do you have examples of some of the biggest offenses? I know we’ve talked a little bit about some of these, but just to help us clarify a little bit, like these are big don’ts, these have really had big consequences.

Asa Waldstein: 33:22

Disease claims Disease claims. So we’ve talked about sleeping through the night that’s a lower risk. We’re the night that’s lower risk. We’re talking about insomnia higher risk. We’ve talked about supports an inflammatory response after exercise lower risk. We’re talking about chronic inflammation higher risk. Joint support lower risk. Arthritis higher risk. Cardiovascular support maybe lower risk. Prevents heart attack higher risk. So you would kind of I like this example structure function to disease claims.

Asa Waldstein: 33:58

Disease claims really are the easiest way to get in trouble Now, because everything’s an extension of label. This is somewhat nuanced, so hashtag is considered marketing. So let’s say, we have a compliant post and we add hashtag flu prevention, we’ve taken a perhaps compliant post and made it non-compliant. The same thing with claim statements in a video text overlay that type of thing. So disease claims really are the key.

Asa Waldstein: 34:29

Another thing that’s not talked about very often but it’s important is making sure that we don’t compare our products to drugs or saying our products are better than drugs. Natural health fanatic, but saying our herbal dietary supplement works as good or better than drugs is a great way to attract FDA attention. We’re just not allowed to say it and the higher the ramifications of someone not taking their drug, the higher risk it is. So let’s say we’re talking about ibuprofen, maybe that’s not super high risk, but if we’re talking about an SSRI, some depression med, someone goes off their depression med or their statins or whatever maybe this can create a serious health crisis. So saying, hey, you know products or opioid withdrawal is another huge one that agencies are paying a big, huge attention to, or a lot of attention to, rather, so hey, this product helps you get off opioids or this product helps you not be on your depression beds anymore, that would really tip the scale into warning letter category. So we’ve talked about FDA, of course, but another thing that I wanted to make everyone aware of is with plaintiff attorneys.

Asa Waldstein: 35:48

So there are a lot of statements that FDA and in some ways, ftc don’t pay that much attention to that plaintiff attorneys really do. No artificial flavors, no artificial colors, all natural made in the USA, although FTC really does focus on that as well. These type of statements are low-hanging fruit for plaintiff attorneys. So I can’t tell you the number of calls I get from clients and prospective clients and just colleagues in the industry saying, hey, I was making an all-natural ingredients claim, but I have citric acid in my product and I got a demand letter for between $20,000 to $50,000. What do I do? You’re making an all-natural claim, but you’re using an ingredient that’s not all-natural. Basically, settle up is kind of how it works, and the plaintiff attorneys are really smart and they understand that. So being careful, not just only from a prevent warning letter point of view, but preventing these lawsuits, is also really essential.

Amanda Ballard: 36:50

So what would you do in a situation because this happens a lot, especially with TikTok being as influential as it is you know customers will come in. Something starts trending, like Berberine is nature’s ozempic, that was pretty recent. Or I think for a while, gabba’s nature’s Adderall, or I think for a while, gaba’s Nature’s Adderall. What do you do in those situations? Because you’re not saying that as the retailer, customers are coming in but it’s a problem, and you’re like, well, I know I can’t say that, but they’re saying it. Should I make any sort of statement on this to say like, hey, we can’t say that, but some way to address a situation like that in a compliant manner?

Asa Waldstein: 37:36

Customers that are non-compensated, meaning not free samples, they’re not paid. Influencers or ambassadors can essentially say whatever the heck they want. And so if that’s on TikTok, hey, I tried this new Burberry product. I lost all these pounds. Nature’s is epic Hashtag no more obesity. Ok, now if I as a company engage with that, again back to the liking and engaging. I’ve adopted that in my marketing. Oftentimes it’ll be brand ambassadors, people that have received free product, influencers, saying these types of statements, and if the brand can’t say it, then the influencer or ambassador can’t say it as well, shouldn’t be able to say it, and so there’s no kind of loophole there other than to state that if a customer is not receiving free product, they’re just passionate. They can say essentially whatever the heck they want about the product if the brand’s not paying them, compensating them or engaging with their content.

Amanda Ballard: 38:39

So would that be something we’d have to be cautious of? So, like I mean, a customer could put out a story on their Instagram and say, hey, I got this berberine at this store and I’ve lost all this weight. It’s like Nature’s Ozempic and they tag the local health food store that they, like you, have no control over that. Do you potentially get in trouble for something like that?

Asa Waldstein: 39:04

I don’t know if I would remove the tag or not. It’s probably best to remove the tag, but I’m not. I will say I’m not aware of any enforcement for just leaving the tag on there and not engaging. And so, as a business owner, that’d be a decision, a risk reward decision. I would, you know they would, they would have to make. But again, I don’t, I don’t think that that would be superbly risky. You know, brands love these true believer, passionate folks that just get out there and sing from the rooftops. It can be an interesting way for customers to talk about products in a way that brands can’t or shouldn’t. Brands can’t or shouldn’t. But that being said, if the brand is manipulating that in any way, then that crosses that line, that ethical and regulatory line.

Tina Smith: 39:59

Yes, that’s interesting. So what if you do have a brand influencer? You’re paying someone. You’ve given them guidelines like please don’t make the following claims, but say you know these other things about it. You’re welcome to say that, but stay away from this. And they do it anyway. Then what do you do? Do you ask them to take it down? Like, how do you react?

Asa Waldstein: 40:18

Influencer contracts are essential because they kind of handle. They should lay out a few things Parameters of what the influencer or ambassador can and can’t say and ramifications for what happens. So brands can’t just say, hey, here’s a contract, you sign it and go nuts. There should be some type of review that the brand does. I review 50 posts from 10% of our influencers once a quarter, whatever it may be. So the brand should have that as part of their internal documents. That’s really important. Then, on the influencer contract, it should lay out what the ramifications are. What’s the stick there? So if influencers are making serious disease claims or anything out of line, the company does have the right to, I’m sure, ask them to take down the post. If there are repeat issues, then the termination of contract happens. That’s pretty common. I know that brands are hesitant for really high value influencers to do that, but let’s hope it never comes to that.

Asa Waldstein: 41:30

I’ve worked with gigantic companies on their influencer outreach and training program and I’m just making this up. It may be after two offenses. The influencer needs to participate in a complimentary influencer best practice training program, of which I’ve done several of those, so they understand how to talk about the products in their own authentic brand voice without crossing the line. Another part of that influencer contract that I want to make sure I didn’t forget is disclosing material connection. Most of the enforcement with influencers is not related to disease claims, yet it’s related to not disclosing material connection. That would be, if there’s an image that would be hashtag, ad or sponsored or brand ambassador, whatever it may be above the fold, not buried. Disclosing material connection is really important. So we’d want to make sure that that’s part of the influencer contract.

Asa Waldstein: 42:26

Now, with the new FTC guidelines on disclosure, now with the new FTA FTC, rather, guidelines on disclosure, if an influencer is making a statement or a benefit statement out loud, verbally, then the disclosure should also be verbally. It’s kind of bananas, I don’t necessarily. I mean, I understand it, but it’s also difficult. So let’s say there’s a story, an influencer, says hey, I took this product.

Asa Waldstein: 42:51

Thanks so much. You know it’s helping my joints be better. Hey, I took this product, thanks so much, it’s helping my joints be better and I’m sleeping through the night. Is it really fair to ask them to then say thanks to brand ABC for being my sponsor here? Is it fair to ask them to say that in a 30 second video? I don’t know, but that’s what the rules are. However, the endorsement is made, then the disclosure should be made in the same way. So I know I went a little sidetracked, but I want to make sure I didn’t miss that important point about influencer disclosures as well.

Tina Smith: 43:21

No, that’s awesome. I mean, obviously we’re sort of nitpicking, going down rabbit trails a little bit, but this is what you do every day and it’s really nice to have an expert to be able to ask these questions. So I’m curious what is Apex Compliance? Because I feel like a lot of our retailers and manufacturers might be interested in that service.

Asa Waldstein: 43:42

Thank you. Apex Compliance is my software as a service compliance program, and what it does is it helps find and replace risky marketing phrases on websites, videos or content before publishing, and this really grew out of a need for my own consulting practice. So Supplement Advisor Group, my consulting company, I was asked to do website compliance reviews. Hey, look at my website, tell me what’s wrong, tell me what I need to do. Hey, look at my website, tell me what’s wrong, tell me what I need to do. I went looking. I’ve got a list of top top 50 or 75 words that are trigger words, disease words, insomnia. We’ve talked about a lot of them cancer, alzheimer’s, that type of thing.

Asa Waldstein: 44:21

I went looking for a product that would actually find, a computer product that would actually search these websites for these risky words and give me a report. Guess what? There was none out there and so I invented it. I had some programmers build me a program. This was a kind of entry-level product that worked well for my own consulting company. I type in the words, I can search the website. It gives me a report. I customize that, I give that to the client. Greatly reduces their online marketing risk.

Asa Waldstein: 44:51

And then all my colleagues started asking me for this, tina. They started to say, hey, can I license it, can I buy this product? And that’s when Apex Compliance was born. So I launched about nine and a half or 10 months ago or so. So very new startup.

Asa Waldstein: 45:06

And again it’s a subscription software. You can upload your videos, your podcasts, your content before publishing blogs, social posts. It’ll scan for risky words, give it a risk rating, suggest low-risk alternatives. There’s AI powered. I’ve trained the Apex AI on compliance principles, wording, letter trends, lawsuit trends, that type of thing.

Asa Waldstein: 45:27

And then a really new exciting feature that we’re launching soon is with being able to scan full YouTube channels. So right now we can do YouTube videos one by one. Pretty soon, like in the next week or two or three, we’ll be able to put in a YouTube channel and I’ll scan those top 250 videos on the YouTube I’m really, really excited about too. So Apex is great for companies that are coming into the US that might not understand the nuances of the regulatory structure here, kind of for peace of mind, and it’s also great for established brands, retailers, to make sure that their online marketing is compliant. It’s not going to come back and it should not come back and bite them old blogs, ingredient statements, whatever it may be. But it’s also really valuable for streamlining that content review process. Before I post a blog, any social post run it through the Apex engine and it should flag many risky words. So it cuts down on that back and forth between marketing to regulatory, marketing to regulatory.

Asa Waldstein: 46:31

Hey come on, I’ve told you marketing 10 times, we shouldn’t say this. It cuts down that and saves a lot of time, and so it’s really exciting. I’m happy to announce that Apex has been invited to VitaFoods Geneva next month. So it’s VitaFoods Europe and Geneva biggest supplement trade show in Europe, I believe and so we are actually a top six finalist in the new technology solution category. So little old Apex Compliance me. You know I get to go pitch on behalf of the small company we’re going up I should say that in quotes because it’s all fun and games against five really large companies for this startup award. So I get to be on stage in Geneva in just a few weeks, so I’m excited to share that with you today.

Amanda Ballard: 47:18

That’s so awesome. I can’t help but just be just in awe of that whole program just existing. I think it’s very, very needed especially in the world that we live in that’s so digital marketing driven to be able to be in compliance and just know what we can say and what we can’t say and how to limit our risk. I love that. So thank you for that service that you’re providing. I think that’s fantastic.

Asa Waldstein: 47:48

Thank you, and I did want to add that we just launched an Amazon prohibited word list so it helps scan for a lot of the trigger words that Amazon may. That may lead to delisting ingredients and more resources, that type of thing, and it is completely customizable so companies can add all natural made in the USA, whatever it may be, and then use that use that to that to search their content, which is, you know, I made it for the dietary supplement industry but several industries are using it law firms, that type of thing as well.

Tina Smith: 48:22

Amazing. Okay, so two things around disclaimers what disclaimer or type of disclaimer do you think should be on every retailers or natural products manufacturers website? And second, what disclaimer do we need to make about this being legal advice on this podcast episode.

Asa Waldstein: 48:44

Thank you for that. So this is informational purposes only, does not constitute any legal or regulatory advice. We’re just having an open discussion. It’s not specific to any individual’s company. So if you want referrals for lawyers or consultants, please contact me and I’m happy to send you in the right direction.

Amanda Ballard: 49:03

That’s my disclaimer.

Asa Waldstein: 49:05

The other disclaimer is where we talked about the FDA to Shea disclaimer these statements are not intended to treat your diagnosed preventive disease, so on and so forth. That’s a good idea to have on websites to I’m using a lot of air quotes here comply with that dishe regulation that the disclaimer must be on every label panel where the claim is made. It’s a good idea, but I don’t know how much it protects you. For example, it doesn’t allow us to say whatever we want. We can’t put a hey, this is informational purposes only, not approved by the FDA, and then say turmeric’s great for.

Asa Waldstein: 49:46

Alzheimer’s if we sell turmeric, so it’s not a get out of jail free card. They have to match. So other than that, on websites, I don’t know whatever makes sense for your own, of course, terms and conditions. Privacy policy, americans for Disability Act compliance is really important. A lot of small retailers and companies practitioners, continue to get sued for their websites not being ADA or Americans for Disability Act compliance and making sure that your website is ADA compliant is really essential to help avoid some of these pesky lawsuits.

Amanda Ballard: 50:24

Well, I just really appreciate your time with us today, asa, if people want to get in touch with you or learn more about Apex Compliance or your consulting business, how can they get in touch with you?

Asa Waldstein: 50:36

Sure. Thank you for that.

Amanda Ballard: 50:38

I am really active on.

Asa Waldstein: 50:39

LinkedIn. As some of you may know, I write my weekly post-warning letter Wednesday, which I post to it. So connecting on LinkedIn is a great way to find out what I’m up to. That’s my name, Asa Waldstein, on LinkedIn, same as on Twitter X, or you can visit asawaldsteincom. That’s my website and from there you should be able to direct it to the Warning Letter Wednesday, my consulting services. And then just to throw one more URL at you apexcomplianceprogramcom is our standalone website. That’s apexcomplianceprogramcom, for Apex Compliance. But really connecting on LinkedIn, I’d love to chat with any of the listeners here. Through the Asa Waldstein website, you can set up a free initial consult. I don’t care how big or small you are. I’m happy to donate 15 minutes of my time to help point you in the right direction, provide any resources I can as well.

Tina Smith: 51:33

That’s so generous of you. Thank you so much. I know that our listeners will appreciate that, and what I imagine, though, is that we will also get a lot of follow-up questions from this, so what I’m hoping is that we can invite you back once we have a full list of questions to ask you again.

Asa Waldstein: 51:48

Yes, without a doubt. You know my day in the life is I’m asked very, very, very, very difficult questions, so even very large brands that when they have hard ones, they send them over to me and so it’s great. It helps my, helps my brain, you know, work well. So hard questions, easy questions. I look forward to the opportunity coming back on the show and chatting with you about this Awesome. Thanks so much for your time, asa. I look forward to the opportunity coming back on the show and chatting with you about this Awesome Thanks so much for your time, Asa.

Amanda Ballard: 52:15

Have a good rest of your day. Thank you so much.

Asa Waldstein: 52:17

Thanks so much. Have a great day.

Amanda Ballard: 52:20

Thanks so much for listening to the Natural Products Marketer Podcast. We hope you found this episode to be super helpful. Make sure you check out the show notes for any of those valuable resources that we mentioned on today’s episode.

Tina Smith: 52:30

And, before you go, we would love for you to give us a review. Follow, like and subscribe on Apple Podcasts, Spotify, YouTube or wherever you’re listening today, and make sure you join us for our next episode, where we give you more marketing tips so that you can reach more people and change more lives.