In this episode, Wilson and Asa Waldstein, the principal of the Regulatory Compliance and Supplement Advisory Group and the creator of the #WarningLetterWednesday. Asa and Wilson discuss how herbalists, TCM practitioners, naturopaths, and functional medicine doctors should make claims.
Claims you make as a practitioner are different from claims you make products, as product claims move out the practice scope and more into the realm of marketing (and regulation comes in). It's really important to remember which hat you're wearing when you're doing what. Just because a practitioner or doctor may be able to make a statement in one environment and one setting, doesn't mean they can make it in another setting.
2022 and 2022 Warning on Testimonials and Paid Influencer Claims
The FDA and FTC, they look at really the 30,000 foot view of a company's online persona, and the FDA investigator with probably no knowledge of TCM, Recently, the FDA, FTC and National Advertising Division, sent out 700 letters to 700 individual companies to put them on notice for their product review testimonials. When using any testimonials, they must be truthful, not misleading. Whoever is giving the testimonial, has to have tried the product before. And testimonials get even dicier when it comes to online statements made about herbal products, especially from social media influencers.
The First Amendment
The First Amendment gives a person the right to say a lot of things. But there's a difference between you as a public citizen and you as a practitioner/commercial marketer and commercial speech. They're regulated quite differently. As a practitioner, when you apply the first amendment to your customers and what they may say about your products or services, your customers are allowed to say whatever they want, that's uncompensated.
Now if you as a practitioner then said, "Oh, that's so cool. I want to use that in my marketing." Then, if that practitioner reposted that or used that on their website, they're substantiating that claim. And you inadvertently bridging that gap between potentially protected speech and that commercial connection. Oftentimes, you may not know any better.
As a practitioner, you're not responsible for what anyone else says. But the second that you start playing with it or interacting with it, then the government says, "Well, now you're sort of adopting it." This applies to simply sharing it on social media. You can comment on it, on their page, and it could still, if the totality and the sum parts indicate that's what you're trying to do, then you might get in trouble as well.
Listen to the complete episode to learn more about product claims, identifying high risk buzzwords, how to use lower risk words and statements, how to use the FDA Small Entity Compliance Guide to your advantage, and how to use your discretion in one-on-one consultations and selling compounded formulas.
Read The Full Transcript and Watch YouTube Videos
Good morning. I'd like to welcome my dear friend Asa, who is the Principal of the regulatory consulting group Supplement Advisory Group, specializing in finding online risk in providing low risk solutions backed by over 20 years as a certified clinical herbalist and worked in many, many, many supplement companies. And Asa has great operational backgrounds so he knows where the road meets the rubber. Or the rubber meets the road, I should say. Check out Asa's regulatory education series, which I love, called Warning Letter Wednesdays. Is that correct?
Yeah, Warning Letter Wednesdays. And that's the hashtag, #WarningLetterWednesdays. Just, I go through different warning letters each week and talk about enforcement trends and what we can learn from them to try to make our audience of viewers here, the regulatory experts.
Yeah. And I was listening to one of your Warning Letter Wednesdays and they involved a supplement company specializing in TCM. And this was sort of the genesis of having you on the show, was to really talk about when does a practitioner make claims under their scope of practice, versus when they're making product claims more like a marketer, as any supplement company would make. So I think that was very enlightening your conversation, so I'd recommend checking it out. But what are some samples of something you could say as a practitioner, but you may not be able to say as a marketer of products or a product claim?
Yeah. Love that question. Thank you, Wilson. And thanks so much for having me. People out there, we are alive. So it's great to see everyone in this virtual format. Quick disclaimer, I'm not an attorney. This is just a discussion for informational purposes only. So we're not giving any legal or regulatory advice.
So a really good example, Wilson, is with pain. So practitioners, they commonly talk about relieving pain. And that's why I go to my acupuncturist every two weeks to help relieve my pain, relieve my discomfort. Now, if that same practitioner talked about an herbal product being used for pain, then they've really crossed that bridge into the high risk, disease-oriented category.
Yeah. And as people that wear many hats, just like the practitioner that we're talking about, who also is a marketer and a practitioner, and maybe have other hats. I am an attorney. So I am not offering legal advice or regulatory advice. This is for conversation sake only. So it's really important to remember which hat you're wearing when you're doing what. I think that's going to be very key to what we're talking about today, just because you could say it in one environment and one setting, doesn't mean you could say it in another setting.
One of the things that there's been a lot of warning letters on is testimonials, and how you can use them. And what do they mean? And do you make them, or the person making them make them? Or do you adopt them? Tell us a little bit more about that, Asa, and how people and practitioners can avoid trouble when using testimonials.
Yes, I love that. Well the FTC just sent out 700 letters, not warning letters, but kind of put 700 different companies on notice for their product reviews testimonials, and then their influencer type of testimonials, which is a whole other discussion. Maybe I'll be able to come back and talk more about that someday.
So testimonials are top of mind for FDA, FTC and National Advertising Division, but to really get to the core of testimonials or product reviews, we'll have to go back to the dawn of time. So think about in our ancient tribal culture, we used testimonials to give health advice or for tips on how to avoid danger. "Don't eat that berry. Don't go over there. There's a lion over there." So it's really written into our genetic code as human beings.
And of course now in the digital era, whenever we say something, it's amplified 50,000 times more. So testimonials really are so important to health decisions. So when using any testimonials, of course, they must be truthful, not misleading. Whomever is giving the testimonial, actually, it has to be truthful. They have to have tried the product or the service.
So if a practitioner is selling herbal products and also, for example, their acupuncture services or TCM services or herbal services, I like to suggest using strong caution because it can really be difficult to separate the two. So if someone is talking about their, "Oh, I went to this acupuncturist for pain." That's not likely to be scrutinized, at least what I've seen from FDA and FTC warning letter precedent. Now, that same practitioner then talked, and also had herbal products. And then one of the testimonials they were talking about, "And I used Wilson's great pain relief formula." Then they've really crossed the line. And it's really difficult for the practitioner to parse those or separate those apart.
So think about how difficult it is for an FDA investigator with probably no knowledge of TCM, to use that example wording, it's really difficult for the FDA investigator to know the difference between services and product benefits. So that's really the thing, differentiating product benefits from services.
Yeah. And I think it is the sum of all the parts. So although one claim could be, "Dr Waldstein gave me this, gave me herbs and it helped me with my pain." And then there's a lot of other herbal products on the page. Then they might adapt that and say, "You're really talking about the herbs on the page versus if you had no herbal products on the page and just your practice. It may be viewed quite differently as well. So I think when they're looking at it, you have to think about it not in isolation, that one claim or testimonial, but the whole sum of the parts, because that's how they're going to look at it. It's not what one person, one thing said, but the sum of everything.
I love that comment, the sum of it, the totality of everything. And really, that brings up a really great point, Wilson. Thanks so much for bringing that up. The FDA and FTC, they look at really the 30,000 foot view of a company's online persona. So in this example, the practitioner may have a claim about their services treating pain relief. But also on their social media, they might be highlighting a product. And maybe they're talking about the pain relief properties of this product or on a video. So really when we talk about the sum or the totality, it's important to really step back and think about the complete online persona, if those social media websites in video sites are linked through some type of link, I guess.
Yeah. And I think one of the things that we have to remind the practitioners that are listening to this, we do have a First Amendment right to say a lot of things, right. But there's a difference between, again, which hat you're wearing. You as a public citizen and you as a commercial marketer and commercial speech, and they're regulated quite differently. And I think this is very one of those things, like you almost have to put on and sort of think about it, like, "What hat am I wearing at this moment? And what is this trying to accomplish?" It's such a fascinating area of enforcement and law because sometimes it seems like social media is evolving faster than the rules that apply to it. And it's just very, very enlightening. And you're your Warning Letter Wednesdays and the letters you write out and share, they're really fun, and a fun way to digest information.
Thank you. I certainly have fun writing them. My wife thinks I'm a little crazy because I'm so passionate about enforcement trends. But I think to your point, Wilson, social media or online marketing is evolving quicker than the government can make regulations to control that. And so what do we have? We've got a warning letter precedent. We've got FDA policy statements. So based on these, we can kind of fine tune our guardrails. And I really love your comments about the First Amendment or right to speech. Maybe I could share an example, if that's okay.
Perfect. Of course, I'd love it.
Okay. So let's say that someone that bought Wilson's famous pain relief formula bought it. And they were not compensated in any way. And they wrote on their Facebook posts or social media, "I love this product. It worked great for my pain relief. I'm a better person because of it." Now, they're allowed to say whatever they want, that's uncompensated. Now if the practitioner then said, "Oh, that's so cool. I want to use that in my marketing." Then, if that practitioner reposted that or used that on their website, they're substantiating that claim. And they're inadvertently bridging that gap between potentially protected speech and that commercial connection.
Yeah. And I think it's like you're adopting it by sharing it, right. You're sort of putting your stamp of approval. And the way that the government looks at the first instance where there's no compensation and you don't interact with it, the keyword is "interact with it." You don't know better. You're not responsible for what anyone else says, right. But the second that you start playing with it or interacting with it, then the government says, "Well, now you're sort of adopting it." Like you said, and it could be even sharing. You can comment on it, on their page, and it could still, if the totality and the sum parts indicate that's what you're trying to do, then you might get in trouble as well.
Yeah. Indeed, and that's why it's so important to identify what I call high risk buzzwords, a disease oriented word. So let's say that in this example, someone was talking about, "I use this product for my relief and recovery." Those are not without risk, but they're lower risk. So a higher risk way to say that is, "My inflammation and my pain relief." So if a person then was talking about these in lower risk ways, potentially the practitioner might want to share that and accept that level of risk because it's truthful. It's engaging and it helps share the story of their wonderful product.
Yeah. And I think there's always a spectrum of risk, right? It's how much risk are you really taking on?
Indeed, indeed. Is it worth the risk? Going out of my house in Longmont, Colorado, and going to the gym at sunrise this morning, there's a level of risk in that. Not the same thing at all. I'm being silly of course, but in marketing, nothing is without risk. And thank you so much for that kind introduction. You made me sound really important at the onset of this show, but really I'm just a herbal geek that followed my passion and my creativity throughout dietary supplement manufacturing and hemp product manufacturing.
And what's really informed my viewpoint with my consulting company, Supplement Advisory Group, is being in that conference room or that boardroom and having these types of risk oriented decisions for 15, 20 years. Which is, "Here's the reason why we shouldn't say something. Or we shouldn't say that, here's the reason why. And here's a lower risk way to say the same thing that is also truthful, but also gets that marketing message across in a way that's effective, but also compliant." So lowering risk by reducing high risk buzzwords, for example. And that's really the basis of my consulting company, which I obviously like a real lot.
Yeah. I know you love what you do. I think one of the things is high risk words. And that's why following you or reading the warning letters is really important, right? You don't want to say something like, "COVID-19" is really high risk, right? If you said something like, "toenail fungus", maybe not so high risk. But there's a spectrum of enforcement priorities, so even though both may be equal, if viewed by the enforcement agency, both are not kosher or copacetic, but one they're going to enforce. And one, they don't have the resources or time to bother with.
Indeed. Again, yeah. Truthful, not misleading, but yeah, if it's a slower risk and it's accurate, it's unlikely to attract a force of attention. But this is really fascinating, Wilson. A lot of practitioners that are getting these FDA or FDA and FTC warning letters, they're not bad people or companies at all. They're actually wanting to do good things, but they're inadvertently crossing the line from being excited about their products to making high risk claims and statements.
So oftentimes we'll see this with... There was a famous herbalist early in the pandemic that came out with the COVID protocol, lung support, that kind of thing. There were several warning letters that came out, I think, mostly in the herbalist category, where these well intentioned, great practitioners were making this formula because they wanted to get it out to the masses, but they were essentially copying and pasting all the copy about this COVID protocol. And ding, ding, ding, that's making a COVID claim. So that's a really easy way that practitioners can inadvertently adopt high risk things and attract a warning letter.
Another mistake that I see is copying and pasting potential things out of your school notes, or even potentially material in medicine, such as antiviral, anti-inflammatory. These are things that we use to describe herbs and plants as practitioners. But if we're using that to describe the action of an herb in a product that we're selling commercially, then we've crossed that line into the high risk word.
And I would like to say that except for anti oxidant, in my memory, all things with anti in the title are considered a claim, antiviral, anti-inflammatory, all that type of thing. So tips, I do have a video on my YouTube channel you can find through my website, acewaldstein.com. And I made a video called Tips for Understanding If You're Making a Claim, so that's there. Also, anything ending in itis, means inflammation of, that's considered a claim as well.
Yeah. I think those are great tips. And one of the things that people have to remember because of the platforms we're using today, primarily what we're talking about is internet or base platforms such as, it could be social apps. It could be advertising on Google. The reach is a lot further than what we used traditionally.
I won't throw you under the bus Asa. I'll throw myself under the bus. When I was a kid, you could shout at the top of your lungs and not be on someone's radar because the radius or the number of people that can hear that claim or statement is very localized.
But now that with the internet and these platforms, we're talking about making a claim locally, but broadcasting globally. So I think that's the reach issue. So I think one of the things is the FDA, in my opinion, right? And this is really just Wilson's opinion. I think the FDA uses enforcement discretion really well with herbalists, acupuncturists and whatnot, when it relates to scope of their practice.
And I call it the four corners of their office, right. You can have a very informed and open discussion with your patients that, if you were having a broadcast of your intake or treatment sessions, the same thing may be very frowned upon. So I think where you are making these claims is also very important.
Yeah. Great comment. And I love that picture, the four corners of the office or the room. Or maybe it's in a teepee and there's not four corners, it's rounded corners.
It's a metaphorical room. I'm just being silly here.
So yeah, I agree with the use of enforcement discretion. And to carry that a little more into compounding or products, the FDA certainly practices enforcement discretion. You can find it in the FDA Small Entity Compliance Guide. You can Google it or ask myself, or Wilson will send you the link. And they practice enforcement discretion if a practitioner is doing one-on-one consultations, and essentially compounding or making those formulas for that patient or that client. Now that enforcement discretion dissipates when a practitioner would make a very large batch of a formula and then sell it to many, many clients or on the worldwide web. So I'm glad you mentioned enforcement discretion from a practitioner intake and consulting side, but also when you're making products for the clients as well too.
And talking about compounding, I want to give everyone all the practitioners out there that are compounding in their clinic. I would highly recommend that you download APHA's Good Compounding Guidelines. And I will put that in the link in the comments as well on the show. So you could go ahead and just access it that way, but it is a great document. I think, Asa, you also worked on it as well, if I remember correctly.
I can't remember. I try to be really helpful with everything I can, especially when it comes to APHA. I can't remember about that one. But yeah, great document, great reference. And APHA has so many wonderful guidance documents. I mean, that's one of the reasons why I think we both volunteer so much of our time to APHA is excellent and lots of great content on APHA.org, the guidance documents, whether it be for compounding, Prop 65 guidance, or even a lot of their free educational webinar material as well, too.
That's absolutely true. Any parting thoughts for practitioners who are also selling products?
Yeah, so I would use caution. And I think I touched on this earlier by using standard terms that might be in your curriculum, in your TCM school or herb school, or MD school. Be careful using those to describe products if you're selling them.
So I think there's really a huge gap. So at naturopathic colleges and all the other practitioner schools applicable here, they don't necessarily teach anything about how to not get in trouble while marketing your products. If you're a practitioner, you make products. So there's a huge educational gap there, which is one of the reasons why I was so excited to come on here and talk to everyone today about this.
So I guess my parting wisdom is if you're going to make a product that's going to be advertised or sold online, it doesn't matter how big or small you are. Be very careful to not inadvertently turn that herbal product or that dietary supplement into a drug. Quick ways to do that are with a hashtag.
So let's say I was making Asa's herbal, why don't I use mood support, that type of thing. So if I was taking Asa's herbal mood support, and then I put it on social media, and then I put #anxiety, I've taken an otherwise relatively low risk social media post and made it high risk just with the hashtag. This includes meta tags, keywords, things on social media, such as infographics, such as "Asa's mood support formula is good for this and this and this." And also use very strong caution when discussing ingredient benefits. This is a very, very, very important enforcement trend in blogs.
So companies that are practitioners that may be talking about ingredient benefits for any products they may be selling, the FDA's line between informational blog to product blog is getting closer and closer and closer. So if a practitioner wants to talk about the benefits of their ingredients in their formulas, I would again use strong caution with using words such as anti-inflammatory or antiviral that are common in our herbalist or practitioner vernacular, but then as we're selling a product, can easily cross the line into claim.
So I could probably talk for hours about this as you could tell, but I think I'll be quiet there.
It's basically, in short, don't turn your herbal product into a drug by using high risk buzzwords or disease oriented words.
Yeah. Thank you Asa for coming on the show and discussing this with me today about practitioner versus product claims. And for practitioners that are selling products that are interested in learning more, I highly suggest that you reach out to Asa. And also, if you want to learn more and I'm going to twist Asa's arm and probably rope another person in it, we can probably put together a webinar just sort of to talk about this and have a more interactive forum for practitioners who are making products. So I think that might be actually a great follow up to this, Asa.
I volunteer. Sounds good. I love it, it sounds good. I can think of another person we could bring into it to potentially even cover some of the manufacturing side. So yeah, I love that idea.
Yeah, me too. So thanks for volunteering and thank you for your time. And it was a pleasure to catch up with you, as usual. Hopefully I will be able to catch a rugby game with you in the future.
So we'll talk about rugby later. And thank you so much, Asa.
Thanks again, Wilson. Thanks to everyone out there. Have a great day. Take care.