Dietary Supplement Practicum (3 of 21): What the Federal Trade Commission (FTC) Does

By: NIHOD

Regan Bailey: So, our next presenter is Michelle Rusk. She's a senior staff attorney from the Federal Trade Commission, and she's one of the few speakers who's been with us almost every year of this practicum, and she's just such a joy and a delight to have with us again. So, please join me in welcoming her. [applause] Michelle Rusk: I just want to thank the Office of Dietary Supplements for continuing to invite me back [laughs]. It really, I think, is the most important opportunity that the FTC gets, in terms of outreach on dietary supplements. A lot of consumers weren't -- aren't really in a very good position to evaluate which supplements are effective and safe, and which aren't. And too often, they are -- thank you very much, their nutritionists or their healthcare practitioners really can't offer much guidance either, so it's really wonderful to see the number of people who attend this every year.

Obviously, there are a lot of supplements with proven health benefits, or others that show real promise and still need further study. But unfortunately, at the same time, there are a lot of products that really -- are on the market, but not backed by science that don't provide the claimed benefit -- or worse, may even be dangerous. And those are the products that the Federal Trade Commission focuses on, and today, I'm going to talk a little bit about the FTC's role in policing how supplements are marketed, and how we're really working to make sure that the claims in the marketplace are backed by solid science, and not just marketing hype. So, before I get started, since I understand I'm being filmed this year, I'm going to make my fine print disclaimer that my presentation does not represent the views of the FTC, or any individual commissioner. So, today, I'm going to spend a little time explaining the FTC's jurisdiction, how it overlaps with the FDA's authority, which you just heard about from Dr. Swift, and how the two agencies coordinate.

I also want to describe the basics of how we approach a law enforcement case, and claims about efficacy and safety of supplements. And then, I have some recent examples of health fraud in the industry where the FTC's taken action. So, many of you may be less familiar with the Federal Trade Commission than the Food and Drug Administration. Or if you've heard of us, it may be in another context. We operate the Do Not Call registry. We now have 220 million phone numbers on that registry. And I know you still get robocalls, as do I. Maybe you bought a Volkswagen or an Audi, and you're entitled to a rebate because of the false emissions claims.

That's also the FTC. And you may be wondering how that all ties back to dietary supplements. It is part of our mission, which is to protect consumers from deceptive marketing. We are a very small independent law enforcement agency with a very broad mandate. Our mandate is to stop deceptive and unfair practices in commerce, wherever they occur. And that covers all forms of marketing, and that it covers all products and services in the marketplace. So, when I say all forms of marketing, I'm not just talking about traditional advertising like TV, radio, and print. I'm talking about things online, in mobile marketing, websites, Facebook, YouTube, Twitter, banner ads, sponsored links, blog posts, emails, texts.

Dietary Supplement Practicum (3 of 21): What the Federal Trade Commission (FTC) Does

I'm also talking about P.R. By companies. Press releases, media interviews done by executives, appearances on Dr.

Oz, for instance. Event sponsorship. Viral marketing, word of mouth, and also labeling, although in the supplement arena, obviously, we have overlapping authority with the FDA, so we generally defer to them on issues of supplement labeling. And when I say all products and services, I really do mean all. So, this is just a sort of sampling of some of the kinds of actions we brought. The Skechers tone up sneakers -- if you want to have the physique of Kim Kardashian. Robo calls, like Rachel from cardholder services -- I know she calls me often.

Sham cancer charities that aren't really collecting money for charity. Get rich quick schemes. Throttling practices or bill cramming charges by the phone companies. Snapchat photos that don't really disappear instantly, as they promise. Cold and flu remedies. Online brain training. And flushable wipes that aren't really environmentally friendly.

So, I'll just give you a couple of specific examples of recent cases. So, Lumosity, as you may have heard, ads for a couple years ago, or you may still be hearing ads with different claims. It was an online mobile brain training program with endless benefits, the company said. So, it would help your school, your work performance. It would stop dementia, help prevent or delay Alzheimer's disease, traumatic brain injury, PTSD, ADHD, and chemo fog from cancer treatment.

The science did show some improvements on the games that were tested, and closely related lab tests -- tasks, but it didn't really show any real-world benefit. So, you know, this was a case where we challenged both the TV/radio ad campaign, the use of Google ad words that the company purchased, related to dementia and Alzheimer's. And also, testimonials which were actually paid for by contests to win free trips to San Francisco, and iPads, and things like that. And then, one of my favorites.

Yes, it says caffeinated shape wear. So, these undergarments promised to take two inches off your hips and one inch off your thighs in just weeks. They're infused with microencapsulated caffeine -- I don't know what happens once they go through the laundry, but in any event -- [laughter] Michelle Rusk: -- they did not have substantiations, surprise, surprise, for their claims.

And they did end up settling with the commission for $1.5 million against two companies that were marketing similar products. So, that's just a taste of the kinds of cases we bring outside the supplement area. We do, as I said, coordinate closely with the Food and Drug Administration because we do have shared authority here, and we want to strive for consistency in our enforcement efforts. We do have a liaison agreement with the Food and Drug Administration under which FDA has primary authority when the claims are in labeling, and the FTC has primary authority over other forms of advertising. So, very important for us to coordinate. Despite the fact that we have shared authority, we do have a very different legal framework than FDA. So, inevitably, our approach will differ somewhat from the Food and Drug Administration.

As I indicated before, the FTC is primarily a law enforcement agency. And what that means is we don't engage in any kind of pre-market regulatory approval process. So, the FTC law requires that claims in advertising be substantiated before the claims are made. But we don't require companies to submit their substantiation; we don't evaluate it or pre-approve any claims -- even health claims.

Another important distinction is that we don't -- our framework doesn't draw lines between different product categories. So, our approach to evaluating an ad will be the same whether the product is positioned as a food, a drug, a dietary supplement, or a device. And I know there were some questions for FDA on that issue; I'd be happy to address that more. Also, unlike FDA, our regulatory framework doesn't make distinctions between the types of claims.

So, there's no bright line distinction between a structure/function claim or a health claim -- or, for that matter, a disease claim. Really, for all claims, the FTC is going to ask the same question: are they backed by good, solid science? So, because we both have active enforcement programs involving the marketing of supplements, we do interact regularly with FDA. We generally want to make sure that in our enforcement cases, we're not both pursuing the same company.

But we do try to communicate to make sure that our efforts are complementary -- that they're consistent on the science and that we generally are avoiding duplication of effort. So, we do both have limited resources to address the problems in the marketplace for this industry, and we when we want to allocate them in the most efficient way possible. There are some cases where both the agencies will decide to investigate and pursue a joint enforcement action.

And in those cases, we're going to be formally sharing information about the companies, and trying to put the best use of our unique enforcement tools to the matter. So, for instance, the FTC has the power to subpoena documents from a company. That's something that FDA does not have the authority to do. The FDA, however, has authority to inspect facilities and even to seize product and -- although we wish we had that authority, we don't. Our interaction is especially important because, as I said, the FTC is primarily an agency of lawyers and economists, not scientists -- and my apology to any economists in the room. We are relying on FDA's nutrition and health expertise in our cases, and obviously, the Office of Dietary Supplements is a great resource for us, both on sort of giving us a sense of the background science, and helping us identify people with the right expertise for our enforcement actions. For the same reason, because we are a law enforcement agency and we don't have the nutrition expertise, we're generally going to defer to FDA on any issues related to content, purity, or safety of supplements. They have the authority -- they're much better equipped to deal with those issues, and we generally limit our actions on safety to instances where a company has made a specific unfounded claim in their advertising about the safety of a product.

So, just a few minutes on FTC advertising law. It's really fairly simple; there are not a lot of regulations that you need to be familiar with. They are just two sections of the FTC Act. Section 5 prohibits unfair or deceptive acts or practices in commerce. Section 12 prohibits false ads for foods, supplements, drugs, devices, and cosmetics. And really, all that means is that ads have to be truthful and not misleading, and any objective claim you make about your product must be substantiated before the claim is made. So, how do we approach a law enforcement investigation? Generally, when we have suspicions or have received a complaint about particular marketing, we're going to look at the marketing and the ads and ask first, what are the claims conveyed? And second, are those claims substantiated? And I use this slide because I think, occasionally, a company who should really be asking those two questions in the reverse have their marketing team get ahead of their research and development team. So, here, all you need to do -- look, half your work is done.

All you need to do is fill in the top part so we can legally say the bottom part. So, what we're hoping is companies are looking at the science first, seeing what it shows, and then asking what they can fairly say about their product. So, what do I mean when we ask what claims are conveyed? It really is a consumer driven analysis. It's what does the reasonable consumer take away from the ad? So, we're looking not just at what the ads expressly say, but also what implied claims they may communicate.

We're looking at the net impression of the ad -- so, again, not just the literal statements, but the images used, and other elements. The whole mosaic of the ad. Testimonials are frequently used in dietary supplement advertising. We do treat them as efficacy claims, so it's not just a claim that this particular person lost 30 pounds. It's also a claim that the product will -- is effective in creating that substantial weight loss. And then, finally, we look to make sure that claims are not deceptive by virtue of what they fail to disclose to consumers. So, if there is important information that is relevant to the claim being made, it needs to be disclosed prominently -- and mass print footnotes are not an effective form of disclosure.

So, just one example of what I mean by looking at things other than the statements -- looking at the implied messages. Here, this is a unique delivery device. The probiotic in this drink was actually embedded in the straw that comes with the drink. And you can see in this ad, the straw jumps out of the drink box and forms a protective barrier around the girl, just as the boy sneezes at her. So, this is an example of how imagery can be a very powerful communication of a claim. So, I'm going to focus today on the FTC's substantiation standard. And you heard from Sibyl this morning.

She read what we mean by competent and reliable scientific evidence for substantiation. It's no coincidence that the two agencies define that term competent and reliable scientific evidence in the same way. We have coordinated on our guidance about what that term means. And that is the standard that we apply for any health-related claim, and I don't mean health claim. I mean any health-related claim -- structure function claims, disease claims.

Anything about the efficacy or the safety of a dietary supplement. So, what exactly does that term mean? It means rigorous scientific evidence based on accepted norms of the expert in that particular field of research. So, if you're making heart claims, we're going to be talking to cardiologists, for instance, about what type of evidence -- what quality of study they would expect to see to support a claim. There is no fixed formula for the number, the length, the size of studies supporting claims.

Quality is as important as quantity. But I will say that with rare exceptions in this industry for the types of claims we're seeing, we are expecting to see high quality human clinical testing. And the FDA does have substantiation guidance for structure function claims that, as I said, does very closely mirror the FTC's substantiation policy. So, a little more specifically. When we're evaluating the substantiation for a claim, we're looking first at the internal validity of the study.

So, are -- is it a randomized, controlled, double blind study? Does it have appropriate outcomes that are being tested? Has it been peer reviewed and published in a reputable journal? Has it been done independently, or in house? Has it been replicated? None of these are necessarily a, per se, requirement, but certainly, they all go into our analysis to evaluate the weight, the quality of the evidence. And of course, we're looking at whether the findings in that research are both statistically significant and clinically meaningful. So, if you go back to the Lumosity example, that company had done studies showing some very small improvements in scores on lab tests -- tasks, but they weren't significant enough to translate into any real-world benefits, and that was the issue that we had with their claims. And then, this final point. We are seeing examples of companies doing research [coughs], excuse me, failing to find any benefit of their product over placebo. And then, going back and slicing and dicing the data into smaller and smaller subgroups, or looking at single outcomes until they do find some significant result somewhere in the data. And we are looking at that issue. We are aware of the problem of p-hacking.

And so, we are very skeptical of that kind of torturing of the data. Here's an example. Bingo! People who didn't have a stroke are more likely to drink soy latte on Tuesday than green tea daily, or the occasional espresso; therefore, everyone should drink lots of soy lattes. It is a problem that we're seeing, and it is one that we are trying to address when we evaluate substantiation. The second part of our inquiry is to look at the context. So, you know, we evaluate the individual studies, but we also want to know what all of the relevant evidence is -- the entire body of scientific literature. And so, if there are inconsistencies in the results, we're looking to reconcile those.

What is the reason for those inconsistencies? At a minimum, where you have evidence that's inconsistent, you may need to very carefully qualify your claim, and you don't want to make a claim about efficacy if the weight of that evidence generally contradicts the claim. So, here's an example, which I think illustrates some of what I just went over. Pomegranate juice, POM wonderful and their pills and their extracts -- this was a litigated case of the FTC that went all the way to the Supreme Court. The claims were very strong, drug-like claims in some instances.

Thirty percent decrease in arterial plaque, slowed PSA doubling time by nearly 350 percent, 40 percent as effective as Viagra. Right. Amazing, right? So, here is what we found when we looked at the literature that the company was relying on. For heart disease, they did have one small study that suggested a benefit for carotid artery plaque, but they tried to sort of bury the fact that they also had two larger subsequent studies that found no difference on that measure or any other heart-related measure, and it was only when they did some post-talk analysis that they found a benefit in a smaller subgroup of subjects that had high HDL, low LDL.

But generally, the weight of the evidence didn't support any heart benefit. On the prostate cancer claim, the study they relied on had no blinding, no control. And our experts said that the slower PSA doubling time was probably due to the fact that all of the subjects had just undergone surgery or radiation, and had nothing to do with the pomegranate juice. And then, on that erectile dysfunction -- and I apologize; it's really hard not to make bad puns here, but the unvalidated measure was just short of statistical significance, and the validated measure was very short of statistical significance, so they really found no evidence of benefit. So, again, the ads were very selectively reporting only favorable results, and ignoring the more reliable evidence. And the third part of our inquiry has to do with okay, do you have good science? It seems to be consistent with the bigger body of relevant literature. But you then have to make sure that it is relevant to your actual product, and to the specific claims that you're making.

So, the products and the claims should match the science. Is it the same amount of the ingredient? Is it the same form of the ingredient? Is the population that was studied the same population that you're marketing the product to? So, a product may be effective in one type of a population, with one specific condition, but not in the general population. Is the degree and the nature of effect matching the science? And we see this problem a lot in the weight loss supplement category, where the company makes very dramatic claims about rapid and substantial weight loss where the evidence shows only very modest weight loss. And then, finally, does the claim accurately reflect the strength of the science? So, if it's only a preliminary emerging area of science, you want to be very careful to make that very clear to consumers.

So, here's just one example of a mismatch between the science and the product. This was a children's gummy vitamin. One of the claims the company made was that 100 milligrams of DHA promotes healthy brain and eye development. And you had to have very good eyesight to be able to notice that actually, one serving provided only 100 micrograms of DHA -- so, 1/1000th of what the company itself was saying the effective dose of DHA. So, as I said, we are a small agency. We do have limited resources to cover all products and services in the marketplace, although health-related products is a priority for our agency.

And these, generally, are enforcement priorities in the supplement market. Anything that presents serious health and safety risks for consumers, including products that are marketed for serious health conditions. And I will say, obesity is one serious health condition, as is the trend that we're seeing in the marketplace to market as the population ages, products for memory or delaying dementia and Alzheimer's. Products targeted for children are going to get our attention. Products that are making egregious outright false claims are a priority. And anything that causes widespread or substantial injury to consumers -- and I don't just mean health injury. I mean economic injury. So, if there's a huge amount of sales or a product's very expensive, that will become a priority as well.

So, let me just wrap up with a few examples. This time, from the dietary supplement marketplace. This first one was a product that we actually brought a case against as part of the joint enforcement sweep with the Department of Justice, FDA, the Department of Defense, and others. This was a product for opiate withdrawal, Elimidrol -- and there, you see an example of the product name, actually conveying a claim about the efficacy. Made very strong claims about helping people overcome opiate addiction and withdrawal symptoms. Used deceptive and overstated testimonials: "Elimidrol saved my life." The product was a blend of multiple herbs and other compounds. Fairly expensive at $75 a bottle. A fairly small operation.

And the owner of the company settled with us for $235,000. This was a product targeted for children called Speak. Claimed to support healthy speech and language in children with autism and verbal apraxia.

It was an omega-3 and -6 vitamin E, vitamin K, I don't -- maybe other ingredients in the product. But they really didn't have any legitimate support for the claim. They also had posted a fake apraxia website that looked like it was an independent source of information for people whose children had apraxia when, in fact, it was just a marketing ploy for the company that linked back to the product. They also paid people to create false testimonials. And this was a case where we were able to get $175,000 back for consumers as part of a much larger settlement against the company. And since I get questions every year that I'm here about Dr. Oz, I wanted to include this example. This was a show that Dr.

Oz had about the miracle pill that burns fat fast. Specifically, green coffee bean extract. Now, I want to be very clear. We did not sue Dr. Oz. We did sue the marketers of green coffee bean extract. In this case, one of the marketers, Lindsey Duncan, had been on the Dr.

Oz show, discussing other botanicals, dietary supplements. The producers invited him on because they had seen a study about green coffee bean extract for weight loss, and he actually knew nothing about it. But he agreed to come on the show. And then, when he was waiting for his episode, he rushed out and purchased a bunch of Google ad words for green coffee bean.

He set up a website. He got some product. He told Walmart he was going to be on the Dr. Oz show. And then, he told the producers that, "Wow, I found this one product that has the least -- it has the purest ingredients, and this is really the product that the show should recommend." He didn't tell the producers that it was his website. So, you know, he portrayed himself as an independent expert, when he was actually the main marketer of the product.

We did settle with the companies that were involved. Again, the marketers, not Dr. Oz, who was not aware that this was going on, and is since becoming more cautious about what he promotes on his show. We did get $9 million back for consumers. And we recently, I think just yesterday, announced that we had refunded an additional $2 million beyond that.

And then, I mentioned memory-related products. This is one dietary supplement called Procera that would help reverse your mental decline by 15 years. Claimed to have a landmark clinical study. Would keep you out of the nursing home. This case, again, the claims were unsubstantiated. They used a deceptive expert endorsement, and the company settled with us for $1.4 million, and also agreed to end the continuity plan, which means, you know, once you bought the product, you were on auto-renewal/auto-ship program, which the company put an end to.

And we did sue both the founder of the company and the expert endorser, and the company president. Part of the FTC law is that anybody actively engaged in the deception is potentially liable. So, not just the marketer, but others that may be involved. And then, my final example for today is a case that we filed earlier this year. I do need to be careful about what I say about it because it is currently in litigation. The FTC filed our complaint in federal court jointly with the New York Attorney General's office. If any of you watch CNN, you are, unfortunately, still seeing these ads on TV and other major networks as well.

Prevagen, the active ingredient is a jellyfish protein that the company claims will help improve your memory. The one clinical study that was done in house by the company showed no benefit over placebo on any of the nine cognitive tests. And again, this was an instance where having failed to show any benefit over placebo, the company went back and started slicing the data into smaller subgroups until they found a benefit or two. The chart, however, is deceptive. And this chart is in all of their TV ads and on their website in that it only shows the increase in scores in the test group, not the difference between the test group and the placebo. So, if you look at the data, the placebo scores actually went up, pretty much in the same -- to the same degree as the test group scores.

So, really, that should be a flat line, not an increase. And also, the company, if you notice -- I don't know if you can see. It says eight days, 30 days, 90 days. Well, there was also a 60-day measurement, but the scores for everybody dropped dramatically at 60 days, so they conveniently left that out of their chart. But again, this is in litigation; we have not proven our case yet, so stay tuned.

I will say, also, that we did name the two co-founders of the company, who have been intimately involved in both the research and the marketing of the product, including starring in an infomercial about it. So, just to wrap up quickly, obviously, we don't have the ability to stop every deceptive ad in the marketplace, even just the online marketing is more than we can tackle. So, we do try to engage in consumer education. We do link to the Office of Dietary Supplements so that consumers have a reliable source of information to go to about common ingredients. But we also put up teaser sites on the web, using drawing from actual advertising as a way to sort of catch consumers when they're looking for products for certain diseases or conditions. This is one for Viriliteas' erectile dysfunction product. If you click on this site to try to find out more information or to purchase the product, you are told that this actually is a sham. And then, you're offered links to the FTC website, where you can learn more about avoiding being deceived by dietary supplement marketing.

And this is just one of the pieces of our consumer education website. So, with that, I will be happy to take any questions. [applause] Michelle Rusk: And I did put my email and phone number there for a purpose. I'm always happy to answer any questions you have, or to hear about anything that you're seeing in the marketplace, or things that consumers are coming to you with questions about. Yes? Female Speaker: This may be a crazy question because I'm a little bit older than some here. Is there anyone that regulates the physicians on TV? No personal thing against Dr. Phil or Dr. Oz, but many, many times in my career, they've said marginal things because they have the M.D.

Behind their name, it takes months to undo what people hear on TV. Michelle Rusk: So -- Female Speaker: So, is there anybody that regulates them? Or is -- or do they have too much power? Michelle Rusk: So, they are protected under the First Amendment. The FTC's authority only goes to commercial speech. So, the only way that they would potentially come under our jurisdiction is if they were actually -- had a commercial interest in products that they were promoting on their website. And our inquiries into specific instances have suggested they don't have those connections.

Yes? Female Speaker: Is the FTC involved in anything with agricultural or industrial hemp? Michelle Rusk: I'm not aware of any cases that we've brought, and I'm curious about your question. And maybe, if you can explain why you're asking, I might be able to be a little more helpful. Female Speaker: The reason I am asking as a practicing pharmacist is that many of our patients are interested or on it, and we're deciding, as a professional pharmacy, if that's an area we're interested in getting into, but we don't want to break any laws.

And if I were to tell somebody in my pharmacy -- you now, just a regular retail pharmacy that this might be something they would want to look into, or if I sold a product like that, you know? Michelle Rusk: Yeah. So, we would get involved if there was a product being marketed directly to consumers. And I think the first question we would ask is whether -- are there laws related to controlled substances that apply here. Should we be deferring to another agency on this? The second question, if those laws don't prohibit the marketing of the product, what are the claims being made? And what is the science behind the benefits? So, I'm not aware of any commercially marketed hemp product that's making benefit claims that we have looked at so far. I don't know whether the Office of Dietary Supplements has any material -- they're shaking their head no, they don't have anything on hemp. I do know that you're going to be hearing, later in the week, from Patricia Duester at Department of Defense, and I know they have a website that they recently relaunched and improved, called Operation Supplement Safety. Female Speaker: Okay.

Michelle Rusk: And that may provide -- Female Speaker: Yeah. Michelle Rusk: -- information about hemp. I would encourage you to look at what position they take on that. Female Speaker: Okay.

Thank you. Michelle Rusk: Yes? Oh, and I'll come to you next. Yes, go ahead. Female Speaker: So, are websites regulated as well, or is it just if they're marketing, say, like ads on newspapers or you know, TV ads? Michelle Rusk: Websites are definitely something that we look at as part of the marketing of the product.

All of our cases now -- I don't think that there's any company that markets any product right now that doesn't also have a website. And we'll be looking at the statements made on that website. Any statement that the company makes that's intended to induce consumers to purchase the product is marketing. So, not just traditional advertising. And I will say that in the case of the website, it may also come under FDA's jurisdiction over labeling, especially if you can purchase the product on the website. Yes? Female Speaker: I think I may know the answer to this, from what you said, but what about organizations that provide products for free? For example, a needle exchange program, or a clinic that serves low-income women, and doesn't charge them for anything that they give them? So, it may be using products that, say, reduce craving for opioids, or help with symptoms of chemotherapy, but they're not charging for those products.

Michelle Rusk: Well, I think two issues with that. One is, you know, is that commerce if they're selling a product? If they're not marketing it, I think that would be an analysis we'd have to think about very carefully. But the other is that those kinds of things that may be more appropriate for others in the medical community to be regulating, and not the Federal Trade Commission. Female Speaker: Thanks. Michelle Rusk: Yes? Male Speaker: I was just wondering why the lawsuit against Prevagen was filed jointly with the New York attorney general. Michelle Rusk: So, we often coordinate with the state A.G.s in our cases, and in this case, they happened to have a parallel investigation that was kind of at the same stage as ours. So, it's not that uncommon for us to file jointly with the state. Yes, in the back? Female Speaker: I just have a question about how you monitor mail.

I work with individuals who are primarily older adults in rural areas. I had a gentleman who took maybe four prescribed medications, and was taking 12 supplements -- oral dietary supplements. And one of which he received marketing advertisement through the mail -- a huge booklet, which gave all these claims and how great it was, and this false research. How in particular do you look at mail? Michelle Rusk: So, that's a good question. I mean, that is definitely marketing under the FTC's definition. It is harder for us to monitor than traditional TV advertising or websites.

A lot of times, the company will come to our attention through other forms of marketing. But if we open an investigation, they're required to turn over all of their materials, and that would include any direct mail. The other way that we would learn about that is from consumers. Female Speaker: Okay. Michelle Rusk: Or from healthcare practitioners -- Female Speaker: Okay. Michelle Rusk: -- who learn about it and bring it to our attention. You can file a complaint on the FTC website.

It is something that we -- we have Consumer Sentinel. We share that with other enforcement agencies. And you know, in that example, it also may be an issue for mail fraud, if it's sent through the mail, and the U.S. Postal Service may also be involved.

Female Speaker: Okay. Thank you. Michelle Rusk: Yes? Female Speaker: Thank you for including POM as a example of a company that was being really deceptive with their advertising. My question, though, is -- has to do with the claims that they were making. They sound, or two of them, potentially, could be the decrease in arterial plaque or the PSA doubling -- maybe those are structure/function claims because they're not being really specific about the disease. But if POM -- is pomegranate juice considered a food or a dietary supplement? And if it's a food, are food manufacturers able to make claims that are this specific? Michelle Rusk: So, that's a very good question, and the nice thing about the Federal Trade Commission's authority is that DSHEA did not amend the FTC Act.

So, there's no distinction under the FTC Act for structure/function claims versus disease claims versus health claims, or for whether it's a food, a drug, a dietary supplement. It's what's the substantiation. So, they -- that company may have run afoul of FDA law as well, in terms of making unapproved drug claims. But that really isn't an inquiry that is factored into our analysis. Okay. Thank you.

[applause].

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