Episode 6: FTC + FDA Regulatory Overlap: Supplements, Cosmetics, and Drugs

In Episode 6, the team dives into how the FTC and FDA work together to regulate beauty, wellness, and dietary supplement products, especially when claims cross the line into disease‑treatment territory. While the FTC focuses on truth in advertising, the FDA focuses on product safety, efficacy, and labeling, and together they determine how a product is classified: cosmetic, drug, or dietary supplement.

The hosts explain the decades‑old memorandum of understanding between the agencies, how intended use determines a product’s regulatory category, and why supplements are treated very differently from prescription drugs. They also explore how influencers and celebrities complicate these rules, especially when visually‑implied claims or omissions mislead consumers. Real case studies help illustrate how even a single social media post can trigger regulatory action.

Disclaimer:

The content of this podcast is for informational purposes only. It is not intended to, and does not constitute, legal advice or a solicitation for the formation of an attorney-client relationship. The information in the podcast is not a substitute for obtaining legal advice from an attorney licensed in the appropriate jurisdiction. Podcast listeners should not act upon any information in the podcast without first consulting legal counsel of their own directly.

 This podcast does not constitute the practice of medicine, nursing or other professional health care services, including the giving of medical advice. The use of information on this podcast or materials mentioned in this podcast is at the user’s own risk. 

Transcript

SPEAKER_00 0:01

Welcome to Regulated Beauty, a podcast that brings clarity to the complex legal landscape of beauty and wellness.

SPEAKER_01 0:08

As attorneys in Lee Chatishman's Beauty and Wellness Industry Group, we're here to demystify regulations affecting your favorite brands, friends, and influencers.

SPEAKER_02 0:17

If you've ever wondered about the rules and regulations and why they matter, welcome. You're in the right place. Let's get started. So in the last episode, we were talking about some examples where there's a bit of a crossover between the FTC and the FDA. So as we mentioned, the FTC kind of focuses on marketing and advertising, but as well as consumer protection. But this other three-letter agency is the Federal Food and Drug Administration, the FDA. And they're responsible for ensuring that the products themselves, like drugs, medical devices, and certain wellness products, are basically safe, effective, and properly labeled, right? So for our intents and purposes as it pertains to regulated beauty, there are kind of three main categories that we're going to discuss. Do you want to expand upon what those three categories are?

SPEAKER_00 1:08

Yeah. So in addition to food, which we're setting aside for the moment, the FDA's oversight in this space can really be narrowed down into three categories. The first is cosmetic, a cosmetic product. The next is a drug, and then the last is a dietary supplement. And in terms of identifying how a product becomes one of those three categories, the FDA focuses on the intended use of that product.

SPEAKER_02 1:38

Right. So I think it's important to mention that there's this some there's a concerted effort between the two agencies here, the FTC and the FDA, right? And they have some sort of liaison. Liaison, if you will. Liaison. Liaison, thank you. Um and it's it's it's uh encompassed in a memorandum. Do you want to talk a little bit about that memorandum when it just I know it started decades ago and it's currently still current.

SPEAKER_01 2:03

Yeah. So have we as we've been talking about this whole time, the FTC has always been concerned in the with the truth in advertising, right? Advertising of anything. As we talked about last time, it's health and wellness drugs, it's uh beauty products, it's anything you can imagine. Right? It's not limited to that sphere, but it's really important when it comes down to health products or like supplements that are marketing to consumers in a way that makes them think that their diseases or their ailments, ailments will be treated by the specific supplement or health product that's being put on a market, whether it's a tea or or a powder or um uh a cream or a lotion or you know, any anything like that, right? So I think there was sort of a realization back in the 70s, actually long before our time, um, where the FTC and the FDA got together and really made a concerted effort to join forces to tackle those um sort of nefarious, egregious claims of the efficacy of these supplements or other vitamins or minerals or other products of treating like actual um diseases, although medical cases. So in 1971, or somewhere about that time, the FTC and the FDA actually entered into a memorandum of understanding, which basically outlined that they will forever into the future join forces whenever these types of claims come up. And we've really seen them work together in this space over the last, again, math of 50 or so years, more than 50 years, yeah, to go after companies who are marketing certain health products, um, like Pum Wonderful, like we talked about in a previous episode. Um, so like special juices or other vitamins or other like health pills or like dietary supplements that are claiming to have a certain type of efficacy.

SPEAKER_02 4:06

So just a quick clarifying question. So it's not like you can be docked under one agency or another. They're working in concert and can be it can something can be flagged by both the FTC and the FDA.

SPEAKER_01 4:19

Sure, because the FDA it depends on the product, right? Sure. If we're in the space of like health products and dietary supplements, then yes, right. Okay. Because uh although the FDA doesn't regulate dietary supplements like it does, um, like prescription drugs, for example, that you get a prescription from your doctor, you go to the pharmacy, they give it to you. Um, the supplements that you see sort of at your local pharmacy, your CVS, your Walgreens, your right aid, um, that are sort of put out there over the counter for consumers to just pull, those are what we consider dietary supplements. And they're not regulated in the same way, again, that prescription drugs are. Yeah. So the FTC also jumps in, and we'll talk about this in a second, but the FTC will jump in also in concert with the FDA when there are issues with dietary supplements, where those types of companies, again, Palm Wonderful was a perfect example of a supplement, uh, of a dietary supplement, like something that comes uh from food or something from a naturally occurring plant or something. We'll talk about dietary ingredients in a second, but something like that that promises consumers to have some kind of significant effect or cure or treatment on a legitimate um ailment.

SPEAKER_00 5:36

And I I think one of the main differentiators here, which I know we're gonna get into, is the fact that dietary supplements don't necessarily require the same pre-approval that a drug would. Exactly. Because when you think about a drug and the intended use of a drug, it is to treat something, it is to heal something or cure something. And when you think about a supplement, it's usually something that is ingested to kind of support your health and not necessarily cure an ailment that you have.

SPEAKER_01 6:06

Exactly. So dietary supplements are actually regulated by the I'm gonna read this for you, this long name, Dietary Supplement, Health and Education Act that was passed in 1994. I'm just gonna call it the Dietary Supplement Act sort of moving forward. Um, and it it amended and added new language to the Federal Food, Drug, and Cosmetic Act, which is where the FDA gets its um enforcement ability from. And basically what it did was add a regulatory framework for the FDA to sort of regulate but primarily monitor um how dietary supplements are put out into the market, make sure that any um new dietary ingredients that aren't available in the market or aren't um like commonly or publicly known do receive certain approvals from the FDA. Um so I just want to make clear that like like what's a dietary ingredient, right? Like what's considered a dietary supplement versus like a drug, right? Like, are these things like biotin, something like that? Sure, like a dietary ingredient, um, something like a botanical, right? Like a plant or or some kind of flower that we're saying in nature.

SPEAKER_02 7:19

Like ashwaganda or something like that. Oshwaganda, yeah, right.

SPEAKER_01 7:22

Echinacea. Sure. Right. Okay. Uh enzymes, live microbials, like all of those probiotic products that we see on the shelves, um, like naturally occurring sort of extracts, and other like sort of non-harmful binders that that bind them. Like those are all considered dietary ingredients that that can be manufactured and marketed and put on the shelves in stores without needing the amount of regulation by the FDA that like prescription drugs require. So dietary supplements are typically in the form of like pills, um, powders, tablets, capsules, gummies. The collagen powders and the exactly those little like like multivitamin once-a-day gummies that we see.

SPEAKER_00 8:08

Um which is really one of the big areas I think that influencers come into play and partner with these dietary supplement brands.

SPEAKER_02 8:20

I'm thinking of a very famous trio sisters that have um a do you know who I'm talking about? The Kardashians? Yeah, yeah, I'm thinking about the brand, like the the influencers that they work with. Like I know they did like some sort of campaign with like Julia Fox, for example, where they're like talking about like a lemming gummy or something like that.

SPEAKER_00 8:39

Oh, oh, the Lemmy Courtney Kardashian's Lemmy.

SPEAKER_02 8:42

Yeah, exactly.

SPEAKER_00 8:42

She has like a bunch of different Yes, dietary supplements.

SPEAKER_02 8:46

Yeah. Exactly. Sorry, just was thinking about that as you were talking.

SPEAKER_01 8:50

Well, anyway, so because the FDA doesn't regulate dietary supplements in the same way that it does like prescription drugs that need to go through very extensive approvals and clinical trials and pre-market approvals to be marked in a certain way, because they're um compounded and constituted in a way that can produce like side effects or like contraindications with other drugs, et cetera, right? Like that are just generally like more dangerous to regular consumers than over-the-counter products. Um, their labeling is not regulated necessarily by the FDA. Um, but importantly, what the FDA does require, this is sort of a side note, but an important one. Um any day or any dietary supplement is required to have a label like not approved by the FDA. Right. And it's also required to have um sort of a label or some kind of disclaimer that this is a dietary supplement, hasn't gone through the same approvals by the FDA, not regulated as as other drugs are, right? So thinking about that, thinking about how the FDA doesn't have the same type of oversight, doesn't have the same type of labeling rules and regulations that it does for prescription drugs. It's important to think about like, well, could just dietary supplement manufacturers say whatever they want. Right. If if they're not, if they're not restricted in a specific way, right, by the FDA.

SPEAKER_02 10:17

Yeah.

SPEAKER_01 10:17

Well, obviously the answer is no, right? So we do have the Dietary Health Supplement Act, which does set some boundaries and creates a some kind of framework when it comes to the claims that they're making, especially by influencers, right? Yeah. Especially by celebrities. Oh my gosh, like uh, I'm sure we've all seen weird stuff, sort of controversial stuff on social media, Instagram and TikTok about like all kinds of different teas and powders and the gummies you were just talking about. So that's when the FTC comes back into play, right? So we're talking about the beginning of this episode, how in the even back in the 70s, the FTC and the FDA realized like the importance of the gap. Of their of the gap and the combined efforts that they would need to exert. And they actually, they actually in in the past decade released a very comprehensive um like health products compliance guidance, which again demonstrates their concerted effort and again provides just like just like the advertising and endorsement guidance we talked about in the last episode, this guidance is intended for manufacturers, but also for consumers, you know. It's important um and available, um, that really delineates specific examples of what to do, what not to do, and how the FDA and FTC have worked in concert to tackle these um sort of poorer advertising situations. And still, I think, meet the theme of consumer protection that the FTC cares about so deeply, but also Because again, even in this guidance, they reiterated the same principle that we talked about last time. The FTC and the FDA obviously as well, right? They're not as concerned with the marketer's intent. They're concerned with a consumer's understanding, right? A regular person's understanding that if you're seeing Chloe Kardashian marketing uh, what did you say? Lemm Lemmy Gummy?

SPEAKER_00 12:12

Lemmy Oh, that's yeah, Courtney Kardashian's Lemmy Gummy.

SPEAKER_01 12:15

Yeah, if Courtney Kardashian is marketing a lemming gummy to her 20 million followers on Instagram, and she's saying that this one lemming gummy taken one time a day can increase whatever, yeah.

SPEAKER_00 12:26

Can grow your new belly button in in three days. Yeah. Who's to be clear?

SPEAKER_01 12:31

I don't think she's actually saying that, but if she were not for you, yeah, like it's it's it's about it's about evaluating her typical followers' interpretation of the claims that she's making, right?

SPEAKER_02 12:46

Yeah. Do we have some of the examples we can go through? Yeah, we do. So the first example is a brochure for a weight loss product shows images of doctors in white lab coats looking through microscopes, molecular structures, and a stack of medical journals. These images give an impression of scientific legitimacy and likely convey an implied claim that the product has been clinically proven to be effective for weight loss.

SPEAKER_01 13:06

So there you go, right? Like it's about the written word and it's also about the visual. What they say. If there's a dietary supplement manufacturer that is manufacturing a supplement, dietary supplement for weight loss or like digestive health or whatever, if you have a visual in in addition to the written word or just the visual itself, and it has the implication that it's been clinically approved by somebody and or the FDA, right? This high high up above entity agency, I mean, that creates an implication for the consumer, especially if you slap on the label clinically approved on it. Which that's that's just pure that's just purely deceptive. We know that a lot of them do that. We know that the FTC has really been tackling that issue.

SPEAKER_02 13:54

Yeah.

SPEAKER_01 13:55

So that that's that's actually a really great example.

SPEAKER_02 13:57

Okay. So the next one is a magazine ad for a children's nutritional drink features an image of the straw from the drink box encircling a child to create a barrier as another child sneezes in her direction. The image used in the ad likely implies that the product can help protect children from catching colds or other airborne infections. Interesting.

SPEAKER_00 14:15

Sometimes I think the visuals are more powerful than words because everyone kind of knows again something like clinically approved or promotes X, Y, and Z. Like those things are so overused, but there's such a subconscious element that comes in when you use visuals that consumers don't think about. Like that's something that if you see those words, you it resonates something in your head. But if you're just looking at a photo or seeing an ad, you're not thinking about that. And sometimes those are even more problematic than the actual words.

unknown 14:50

True.

SPEAKER_02 14:51

Thinking of that other ad that we were talking about earlier. But, anyways, um, an ad for a vitamin supplement claims that 90% of cardiologists regularly take the product. In addition to the expressed claim about the percentage of cardiologists who use the product, yeah, it likely conveys an implied claim that the product offers some benefit for the heart. Yeah. I feel like when you're mentioning a specific type of doctor and them using it, I mean especially in the dietary supplement space.

SPEAKER_00 15:19

Like if you are associating that with some sort of gummy that you're getting in the grocery store or something like that, I mean, that is again a bold claim that go ties right back into the FTC's guidance of not wanting to deceive customers.

SPEAKER_01 15:37

Yeah. And I think this goes back to your your earlier comment, Michaela, about intended use. Like if you're if you're implying that this is a clinically proven or clinically approved product by a certain number of physicians or approved in a certain clinical study, I mean you're really implying that this dietary supplement that any Joe Schmo can buy at your local pharmacy can cure or like legitimately treat um whatever ailment their the product is marketed for, right? That's a problem.

SPEAKER_00 16:11

And if that is if that is the case, if that is the intended use, then it needs to be treated as a drug and get the pre-approval by the FDA that is required.

SPEAKER_02 16:22

Yeah, absolutely. Okay, this next example is an ad for a topical ointment called ArthroCure claims that a the product maintains joint health and mobility into old age. A before picture shows an elderly woman using a walker, and after picture shows her dancing around with her husband. Even without the product name, which implies the product can cure arthritis, the before and after images, along with the reference to joint health and mobility, likely convey the claim, likely convey a claim that the product can dramatically improve the symptoms of arthritis.

SPEAKER_00 16:54

I think this one's a great example of FTC and FDA working in concert because again, the the FTC, there are so many red flags there from an FTC perspective in terms of what it's claiming to be. Let's talk about substantiation. Yeah, right. And then from an FDA perspective, I the FDA, I don't think, is so much as concerned with the name and the again the marketing of it as it is with what it is intending to do.

SPEAKER_01 17:24

And in that before and after, it's clearly showing it's intending to Yeah, like if there's a qualified health claim, and that that's a term of art, there's a qualified health claim that the manufacturer is trying to make, like Arthur Cure cures arthritis. Like that is something that needs to be submitted and approved by the FDA. You can't just go around making claims like that or or issuing very suggestive visuals into the marketplace that they know consumers will misinterpret. And not just consumers, right? But something like Arthur Cure, clearly the visuals sort of imply that the product itself is marketed towards the older generation, maybe the geriatric population, who are susceptible and maybe more vulnerable than others. Right. Yeah. Right.

SPEAKER_02 18:14

So there's this really interesting case study that we can talk about with Kim Kardashian and the medic the prescribed the prescription drug cyclegis. Um apologies if I'm mispronouncing that. And it's a morning sickness drug. And this is in the context of 2015. She posted something on Instagram. Uh I'll basically summarize it, but she she talks about how this drug uh has really helped her morning sickness. And that she tried changing things about her lifestyle, nothing really helped. She talked to her doctor, he prescribed her Diclegis. Um, and she felt a lot better. Uh and that basically there was no increased risk to the baby. Um so she talks about you actually said that? She says, he prescribed me dicletis. I felt a lot better, and most importantly, it's been studied and there was no increased risk to the baby. I'm so excited and happy with my results that I'm partnering with Duchessna USA, apologies if I'm mispronouncing that, to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the with the pregnant woman on it and find out more about www.diclegis.com. And that's all that she that she wrote there. Um and so essentially uh the FDA's response was they issued a warning letter to the manufacturer of Diclegis, um, Duchesne. And they they said that the Instagram post was basically false or misleading because it omitted all of the risks, um, all of the risk information regarding pertaining to the medication. Um and so they asked her basically to correct it, and so she had to take down that post and she had to correct it, providing all of the risks associated with the medication. Um so I don't know if anybody wants to talk about what would this general takeaway be. Um, because to me it it seems pretty clear that even if you're posting something on some sort of social media platform, uh you you've got to treat it just as seriously as you would when you see a commercial ad um about a prescription drug on television, you know, where they put all those side effects may include blah, blah, blah, blah, blah, blah, blah situation. It's just, it's gotta be the same thing.

SPEAKER_00 20:25

This kind of reminds me of something you said earlier, Adela, about sometimes omissions are still enough to trigger a red flag because that's still ultimately deceiving to consumers.

SPEAKER_01 20:38

Yeah, I mean, like, I know every time we watch one of those commercials and they list out those horrendous side effects, we roll our eyes and we're like, ugh, why do they need to put these here? They're heavy, they're depressing, right? But ultimately, if we look at it from the agency's perspective, again, they're focusing on consumers' understanding, right? So if you are a person, if you're a person who will probably benefit from this drug, and you see a commercial about it or an Instagram post from a very influential celebrity, and they only showcase the positives and they do not delineate any of the potential side effects or any contraindications with any other drugs that people might be taking, et cetera, or even mention. Like remember to remember to check with your doctor to see if there are any side effects you might encounter or any contraindications with any drugs that you are taking. Maybe there are core more comorbidities that the person is um facing. Like the omission of that information significantly impacts the consumer's understanding of the efficacy of that drug, right? Yeah. Like if we focus on the positive, it might seem all nice and shiny, but ultimately it'll harm the regular consumer. Yeah.

SPEAKER_00 21:51

Yeah, absolutely. So I think the biggest takeaway from this is in terms of dietary supplements. You have to be very careful both in your marketing of it and also in your labeling of it for purposes of the FTC and the FDA. And cosmetics, cosmetic products are a whole different beast in terms of how they're regulated, which we're going to get into next episode. But for the purposes of drugs versus supplements, you have to be clear and you have to focus on consumer understanding and not so much your the manufacturer's intentions. Yeah.

SPEAKER_01 22:31

And again, if you're a dietary supplement manufacturer and you're going to go around making sort of claims that you're clinically approved or what have you, the FTC is going to demand those receipts.

SPEAKER_00 22:44

Yes, it is.

SPEAKER_01 22:45

They're going to demand that you show the evidence, you show the clinical studies that it's a wide enough sample for you to be able to generalize and make those claims. Because otherwise, clearly you are intending to deceive consumers. Right. And don't forget, like in addition to the FTC, the FDA is also ready to come in hot. It's going to come after dietary supplement manufacturers if they mislabel their products or if they adulter them in a way that messes with the approved um dietary ingredients that they allege are in the dietary supplement itself. I mean, the FDA will do, will take similar actions to the FTC. They'll issue warning letters, they'll issue uh consumer um notices, like press releases to the general public. They might even take legal action against dietary supplement manufacturers. So they will not leave unscathed.

SPEAKER_02 23:42

Thanks for joining us on Regulated Beauty, where we bring clarity to the legal side of beauty and wellness. If you found today's discussion insightful, be sure to subscribe and share the podcast.

SPEAKER_01 23:52

Have questions or topics you'd like us to cover, connect with us at leachman.com or follow us on social media.

SPEAKER_00 23:58

Until next time, stay informed and stay well.