FTC & FDA in 2025: New Rules That Could Reshape Your Business

Summary

Special Ops Podcast Episode Summary: FTC & FDA in 2025 – New Rules That Could Reshape Your Business

Release Date: January 14, 2025

Hosts: Emma Rainville & Ryan Potee (Guest)

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Introduction

In this insightful episode of the Special Ops podcast, host Emma Rainville welcomes Ryan Potee, a partner at Gordon Rees and an expert in advertising and e-commerce law. Together, they delve into the anticipated changes in Federal Trade Commission (FTC) and Food and Drug Administration (FDA) regulations for 2025, exploring how these shifts could significantly impact businesses across various industries.

Guest Introduction

Ryan Potee brings a wealth of experience to the table as a partner in Gordon Rees’ Advertising E-Commerce Group, which comprises approximately 1,400 attorneys nationwide. Specializing in areas such as trademark, patents, advertising law, FTC, FDA, PCI compliance, and privacy laws, Ryan serves as an invaluable resource for businesses navigating complex regulatory landscapes.

Ryan Potee [00:50]: "Our firm is about 1400 attorneys... positioned ourselves to be outside general counsel to e-commerce companies."

Overview of 2025 FTC and FDA Changes

Ryan addresses concerns surrounding the new presidential administration, specifically President Trump's return to office. Contrary to popular belief that the FTC may deregulate due to budget cuts or policy shifts, Ryan asserts that the FTC is poised to maintain, if not escalate, its consumer protection efforts.

Ryan Potee [04:31]: "I don't think it's going to change… consumer protection side is really good."

Specific FTC Rule Changes in 2025

Ryan outlines key FTC regulations set to take effect in 2025:

1. Click to Cancel Rule (Negative Option Rule)

   • Description: Mandates that companies offering subscription services must ensure cancellations are clear and straightforward, preventing unauthorized or inadvertent renewals.
   • Quote:

     Ryan Potee [07:56]: "Making sure that your subscriptions are clear, or at least the billing terms are clear."

2. Telemarketing Sales Rule (TSR)

   • Description: Expands from focusing solely on outbound calls to encompassing inbound calls, tightening regulations around telemarketing practices.
   • Quote:

     Ryan Potee [06:38]: "The TSR is going to encompass inbound calls."

3. Business Opportunity Rule

   • Description: Encourages businesses to avoid labeling offerings as "business opportunities," which attracts stringent FTC oversight and requires specific disclosures.
   • Quote:

     Ryan Potee [09:14]: "The FTC has taken the position that... business coaching is actually like I'm going to give you a full blown business opportunity."

4. Truth in Advertising

   • Description: Requires advertisers to ensure all claims are truthful and substantiated, avoiding misleading statements.
   • Quote:

     Ryan Potee [09:06]: "Make sure what you're saying is not convoluted, it's truthful."

Notable Cases and Issues

Ryan discusses recent enforcement actions targeting deceptive business practices, particularly in the business coaching sector. He highlights how the FTC is cracking down on those marketing questionable "business opportunities," often preying on individuals seeking quick success.

Ryan Potee [09:14]: "The more you say I'm going to help you build a business... the FTC has taken the position that that's really no longer a coaching service."

Emma complements this by sharing real-life examples of fraudulent advertising, emphasizing the FTC's role in combating such deceptive practices.

Practical Compliance Strategies

To help businesses remain compliant, Ryan outlines several actionable strategies:

1. Substantiation of Claims

   • Advice: Ensure all product claims are backed by verifiable evidence.
   • Quote:

     Ryan Potee [15:44]: "When you're selling a product, it actually does what you say it's going to do."

2. Monitoring Affiliates and Call Centers

   • Advice: Regularly audit affiliates and conduct mystery shopping to ensure compliance in sales practices.

3. Handling Consumer Complaints

   • Advice: Actively monitor and address consumer feedback on platforms like BBB and Trustpilot to mitigate potential enforcement actions.
   • Quote:

     Ryan Potee [16:52]: "Consumer complaints are seriously the number one driver of enforcement action lawsuits."

4. Implementing Clickwrap Agreements

   • Advice: Utilize enforceable clickwraps during transactions to establish binding contracts, helping to shield against class action lawsuits.
   • Quote:

     Ryan Potee [37:21]: "Terms and conditions are a contract that consumers enter into when they buy your product."

5. Quality Assurance (QA) Processes

   • Advice: Establish thorough QA protocols to ensure that websites and sales processes consistently display accurate terms and conditions, especially during frequent updates or split testing.
   • Quote:

     Ryan Potee [39:30]: "Get a click wrap."

Discussion on FDA Changes

Transitioning to FDA regulations, Ryan discusses the significant implications of telehealth advancements and the burgeoning market for GLP1 drugs like Ozempic. The expansion of telemedicine has facilitated the direct-to-consumer sale of weight loss medications, raising compliance concerns regarding product claims and distribution practices.

Ryan Potee [23:37]: "A bunch of e-commerce brands have built their business around these products being on a short list."

He predicts increased FDA enforcement as certain drugs fall off the “short list,” meaning they are no longer eligible for direct-to-consumer sales without strict regulatory oversight.

Ryan Potee [30:12]: "I think we're going to see enforcement around that."

Conclusion and Final Advice

Wrapping up the episode, Ryan underscores the importance of proactive compliance measures and staying informed about regulatory changes. Emma and Ryan reiterate the crucial role of legal diligence in safeguarding businesses against potential FTC and FDA enforcement actions.

Emma Rainville: "Non-compliance isn't just risky, it's preventable."

Listeners are encouraged to access free compliance resources and playbooks available on the Special Ops website to stay ahead of regulatory changes.

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Key Takeaways:

• FTC Focus: While antitrust enforcement may see restraint under the new administration, consumer protection remains a top priority.
• New Rules: The Click to Cancel and expanded Telemarketing Sales Rules are poised to significantly impact subscription and telemarketing practices.
• Compliance Strategies: Businesses must ensure truthful advertising, proper subscription disclosures, robust monitoring of affiliates, and enforceable contracts to stay compliant.
• FDA Implications: The rise of telehealth and direct-to-consumer pharmaceuticals like GLP1s will attract increased FDA scrutiny, necessitating careful compliance strategies.
• Proactive Measures: Implementing comprehensive QA processes and maintaining clear, substantiated claims are essential to mitigate enforcement risks.

For a more detailed exploration and actionable strategies, listeners are encouraged to download the free playbooks available at specialopspodcast.com.

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Note: This summary is intended to provide an overview of the podcast episode for informational purposes. For specific legal advice, consult with a professional attorney.

Transcript

[Emma Rainville]

Welcome to another episode of Special Ops Podcast where we give actionable insights to direct response and e commerce marketers. I'm Emma Rainville, your host. Please don't forget to like and subscribe for more podcasts like this. Today I'm joined by Ryan Potee of Gordon Reese. We're going to be talking about the FTC and the FDA in 2025. New rules that can reshape your business. Make sure you're ready by watching this episode and subscribing for more insights. Ryan, it's so good to have you back.

[Ryan Potee]

Glad to be here.

[Emma Rainville]

I hope that you come back over and over and over again. Besides being good friends with you, I just absolutely think that you are brilliant and I love getting all the free legal advice. Can you share for our listeners a bit about your background and how you get into law?

[Ryan Potee]

Sure. I am a partner in Gordon Rees Advertising E Commerce Group. Our firm is about 1400 attorneys. We have a group of probably about 40 of us that are really geared towards advertising and commerce. Our clients range from the small to the very large. Service providers, advertising agencies, networks, payment providers, pretty much anyone in the e commerce ecosystem. We've really been successful building out a pretty good team that we position ourselves to be outside general counsel to e commerce companies. So we've done a good job at that for sure.

[Emma Rainville]

Your firm is one of the largest in the nation. You guys have 1400 attorneys across all 50 states, right?

[Ryan Potee]

Correct.

[Emma Rainville]

Including Alaska.

[Ryan Potee]

Even Alaska.

[Emma Rainville]

Okay, so if I get sued in Alaska, you got me. You guys have specialists in specialties. So trademark patents, advertising law, ftc, fda, pci, compliance, privacy pol. Privacy laws, data breach lawyers like you. You guys have everything.

[Ryan Potee]

We're a one stop shop.

[Emma Rainville]

Insurance. I remember calling Damon, one of your partners and saying, hey, I need, I need a divorce lawyer for this client. And he was, you know, her attorney for her corporation. You guys were her. You guys were her attorneys for her corporation. And not only did he find me an alumni person who could take the case, but you guys are very involved in it. I was actually surprised how it all panned out. Your firm is massive and can help just about anybody in direct response. Right.

[Ryan Potee]

And the two chairs of our practice group really brought together a really good team.

[Emma Rainville]

Yeah.

[Ryan Potee]

You know, Damon, who you just mentioned, talks about everybody having their own superpowers. And so like we got our trademark person, we got our copyright person, we got our, you know, M and a guy, you know, whatever it is, we got somebody who can handle. Handle it.

[Emma Rainville]

Yeah, for sure. It's really good working with attorneys who know their stuff rather than paying them a ton of money to research. And you guys are litigators as well, so you actually defend. A lot of people don't understand. So before we get into what we're going to talk about with the FLTC and the FDA there, and I never knew this until I started, I started working for a client who had an attorney who would give her lots of FTC advice. But if something ever happened with the ftc, he couldn't litigate for her, he couldn't represent her. So talk to me about that. Just, just briefly.

[Ryan Potee]

Sure. So, I mean, I. Lawyers try to focus on the advice and counsel side, you know, keeping people out of trouble. And then when things escalate, they bring in the litigators. You know, our advertising, E commerce group, we have, we have some folks who are traditional, you know, you know, transactional types of attorneys. But really, everybody's a litigator. Everybody knows the issues inside and out. They litigate it, you know, so if.

[Emma Rainville]

You give me advice, they're going to.

[Ryan Potee]

Be standing next to you, next to me in court.

[Emma Rainville]

That's kind of important to me for CPA and the lawyers. Thank you for explaining that. I'd love to just dive right in to the changes, upcoming changes. The first thing I want to. I want to go through the changes specifically, but the first thing that I want to address is word on the street, us with the presidential election having come to a final decision and with President Trump, hurts a little to say that sometimes I'm excited in both, not so much. But with President Trump going back into office, a lot of people don't believe because of all of these things about the ftc, you're getting rid of all of these lawyers or cutting budgets. But a lot of people don't believe that it's. We're going to be regulated. And so I'm looking at the changes and actually looks like we're going to be regulated a little more closely. So I'd love to hear overall from you, what are our thoughts? No. Can I not do that?

[Ryan Potee]

Yeah. No, I don't think it's going to change.

[Emma Rainville]

Okay. Okay. You looked at me like, don't ask me that question. So do you think what changes. What changes as far as. As far as. And I want to go through the actual changes, but what changes as far as. Do we think that this new administration. New administration that you do we think that this new administration is going to cause the ofTC and the FDA to back down from advertisers a little bit. Do we think it's going to be the same? Do we think it's going to be heightened? What do you think is going to happen?

[Ryan Potee]

What I believe the big changes for 2025 with the new incoming administration are going to be is, are going to be focused mainly on the antitrust side. Lina Khan, who is the current chair of the ftc, will be stepping down very soon. She has a very aggressive view of antitrust law and, you know, big tech. You know, she wrote her, her doctorate or dissertation on this. She really wanted to shape antitrust law. I think that is going to change. We have the Elon Musk of the world and some of the, the Republican commissioners talking about how they want to step back from that. But on the consumer protection side, I don't think that we're going to see a three, lot of change. I think 2025 is going to be very similar to what we saw when President Trump was first in office. We, we litigated some very aggressive FTC teams when they were, you know, arguing that they were protecting consumers. And I don't think that's ultimately going to change. What I do think is going to change is I think that they might back down on some of their more aggressive or novel interpretations of their statutory authority. Some of the rules that they have promulgated over the last couple years have been what the Republican commissioners, commissioners would argue exceeded their authority and kind of shoved policy position down the American public's throat. I think we might step away from that. But, you know, their mission is to protect consumers. And they are like the Department of Justice. They are going to be out there enforcing law. And I, and I don't think that's going to change too much on the subscription. On the consumer protection side, it's really good.

[Emma Rainville]

There are a lot of changes in 2025. What, what is changing in 2025? What are the new rules in 2025 that's going to, that we're going to see that are going to change our businesses.

[Ryan Potee]

Got it, Got it. So the new rules in 2025 are going to be the click to cancel rule or the negative, the new negative.

[Emma Rainville]

Option rule, which we have a whole podcast on.

[Ryan Potee]

True. You know, just very high level is going to, I think, bring virtually any, any product or service that is sold under subscription under the FTC's purview and give them civil penalty authority to at least regul, you know, the tsr, the telemarketing sales rule is looking to be expanded. Those, I think, are going to be the really the two biggest ones that are going to impact everyone's business. You know, for at least the tsr, the, the current rule really focuses on inbound calls from consumers that the, the updated rule is going to be encompassing the telemarketing sales rule. You know, until, until relatively recently has been focused on outbound calls, but now it is going to encompass inbound calls. And there's some additional nuances to all of that, but I think really for E commerce businesses, it's going to be the TSR and the Click to Cancel rule.

[Emma Rainville]

Can you walk me through you went over some of the new things? I don't think that some people in our industry even understand what the FTC does or the rules that they need to comply with. In fact, I think they kind of stumble upon it sometimes. So I know that we could talk for hours about what FTC rules all advertisers need to know. But tell me some of the key FTC regulations all advertisers should know.

[Ryan Potee]

The key regulations that all advertisers need to know are the Click to Cancel rule, the Telemarketing Sales Rule, and I'd say the Business Opportunity Rule, and then just more generally, you know, the section five, you know, truth and advertising rules. I mean, you need to, you know, your advertising needs to be truthful, not misleading. And then you got to have evidence to back it up. And so, you know, on the Click to Cancel rule, making sure that your subscriptions are clear, or at least the billing terms are clear, unavoidable, you're getting consent to those terms. And, and then for the tsr, I mean, it's the same thing. When people are coming in, you have specific disclosures that you need to be giving. And if you're accepting payment information over the phone and enrolling folks into subscriptions, you need to be giving additional billing, subscription or billing disclosures. And for the Business Opportunity rule, I would be very, very hesitant to characterize anything as a business opportunity. You know, business coaching. For some reason, at least more recently, the FTC has taken the position that, you know, business coaching is almost like a business in a box, right? And staying away from certain that certain things like that. And then lastly, I think just for truth in advertising, you know, make sure what you're saying is not convoluted, it's truthful. When you say your products work, they actually work how they say they work.

[Emma Rainville]

Can you share with me some cases you've read about that involve some more complex advertising issues?

[Ryan Potee]

We've been involved with quite a few. I think the expansion of the business Opportunity rule has been incredibly concerning. We have what you know, the business opportunity rule is really meant for what you know, it's, it kind of like sounds like I'm offering you a business opportunity. It's an existing business. You, you know, give me some money and I will give you access to this opportunity. Almost like an mlm. MLM is not the best description, but a business in a box is what the term is usually is used. And you know, business coaching for some reason has all of a sudden morphed into what the FTC would argue is a business opportunity, which is definitely not the case. And you know, the more I, you know, because in my mind, business coaching, I'm going to teach you how to be a better, better business owner. I'm going to teach you how to be a better salesman, a better copywriter, whatever it is, the more you say I'm going to help you build a business, I'm going to give you the tools to build that business. The FTC has taken the position that that's really no longer a, you know, a coaching service, but it's actually like I'm going to give you a full blown business opportunity. And when you do that, you have to give certain disclosures and records of, you know, earnings claims and things like that which business coaches don't have because that's not what they do. And unfortunately the FTC is saying, well, you know, we're, we're looking at business coaching. And it's even more problematic when you have the chair of the FTC coming out and saying, well, business coaching doesn't really follow, fall under the existing rule. But then when Frontline staff is out there filing lawsuits, calling business coaches, you know, selling a business opportunity, that's a, that's a, that's a massive problem.

[Emma Rainville]

Can I give you the other side of that?

[Ryan Potee]

Sure.

[Emma Rainville]

The amount of people that I've seen spend a lot of money thinking that someone was going to help them because of their lies and their pretending like they're brilliant entrepreneurs and really they like, let's, let's kind of dissect this for a minute. I can show you how to make a, I can show you how to create a nine figure business. I'm driving a Ferrari, by the way. It's rented, it's not mine. Everything that I'm filming is in this multi million dollar mansion also by the way, not mine. I even went in with like four or five of my friends so we could all film there for one day because we could only afford One day I'm always positioning myself to be a successful business owner when in reality I have nothing but a trail of failing businesses and bankruptcies behind me. And then I trick innocent people who just really wanted. They're doing good, but they want to do excellent. And they give me a whole bunch of money. A ridiculous, I really hate this, by the way. A ridiculous amount of money. And I'm making up these lies saying that I'm so much better than what I am and I've done so much more than what I've done. And you hand over every bit of money you have because I guarantee you these are the people they're going after. Maybe not all, but the ones I've seen, I'm actually like, I'm waiting for the rest of them to come down because they ruin people's lives.

[Ryan Potee]

That's exactly the FTC should be going after 100.

[Emma Rainville]

And so I get that there's like all this biz op. There are a lot of people in biz op that are phenomenal human beings and they really help people. There are a lot of them, sadly. I see. I say this all the time. Marketers are on everything for everybody. The second they find someone making money doing something, they jump in and they imitate it. But they don't, in the realm of biz op, they've taken money from people that don't have it and selling these quick get rich quick schemes that aren't real.

[Ryan Potee]

And it just, no, it makes me angry. And it's exactly what the FTC was designed to go.

[Emma Rainville]

The FTC needs to stop going after freaking people who are just trying to make a living and trying to do the right thing and make like one little tiny mistake somewhere and go after these people that are just blatant liars. They're going after dumb things and letting. I'm going to cure your site. I'm going to cure your blindness. Rather you're going to have 2020 sight even though you're clinically blind right now. I'm going to cure your cancer. I'm going to cure your diabetes. You don't have to take. Oh, God. I remember sending Damon this video of a guy doing a demo call for a blood sugar support product. And the telemarketer, the person who's over his team, was talking about how they didn't have to take insulin anymore. They could throw them in the trash as soon as the supplement came. That's who they need to go after. Somehow these people are still in business. They're 15 years later and the nice guys who like, you know, get a, get a little, you know, I can justify the claim because I can find the claim, but I didn't say it in the way that even though the claim, the, the very citation I use said what I said, I can't say it that way. I don't know, I'm on a tangent.

[Ryan Potee]

Well, no, but I mean that, that's what clients ask us all the time. Why me? Or why is this guy getting away with it? It's crazy and it's entirely random. I mean some of it is, you.

[Emma Rainville]

Know, I don't believe that they check. I don't, I don't know how they find the people they find.

[Ryan Potee]

No, I. So I mean, the FTC has a database of consumer complaint. Consumer complaints are the number one drivers of enforcement actions. Like hands down, you know, Sentinel. The FTC has this database called Sentinel where consumers can go file complaints. You know, all the gripe sites, you know, we had a, we had an enforcement action, a pre litigation enforcement action where it was a financial coaching or a financial trading business like stock, stock picks. And you know, all of the companies that were listed on this one website ended up receiving a civil investigative demand from the ftc. So I mean, somebody out there was at least watching. And so, you know, there's not a really good answer for why me or why somebody else is getting away with it. You know, it comes down to, you know, just, I think it's entirely random. And then are you able to sleep at night? You know, one of my colleagues says.

[Emma Rainville]

It, that's a tough question because some people, I feel like, don't have a.

[Ryan Potee]

Soul and some don't. And no matter what is going on, they're still going to do it. And sometimes people just get away with it.

[Emma Rainville]

I remember I was sitting on a beach in Mexico at an event with probably one of the slimiest advertisers I'd ever met. And I had asked him, I had looked at him, I was like, how do you sleep at night? And he was like, if they're stupid enough to believe me, they deserve what they get. Literally what he said. So if I am an advertiser and I want to do the right things, what are the things that I should do to be proactive so that I'm not calling you saying, ryan, why me?

[Ryan Potee]

So it starts with what you're selling. Make sure that you have claim substantiation, that when you are selling a product, it actually does what you say it's going to do. After that, spyware for Monitoring your affiliates, doing compliance audits, calling into your call centers. Like, if you have a call center, you call in, pretend to be a subscriber or a consumer, and say, hey, I like this product. Why did you enroll me into this subscription? Like, force them to, you know, try to downsell you. You know, walk through your entire enrollment path. You know, it sounds kind of simple, but send it to somebody over 65. Like, if they don't understand that they're being enrolled into a subscription, I think you need to go take a, take a look at your enrollment path. And lastly, like, look at your consumer complaints. Like, look at your consumer, your customer service records. If you have a recurring theme, there might be a problem. Go to your BBB profile, your trustpilot, all the consumer review platforms, you know, see what consumers are griping about and fix it and be proactive, respond to the complaints. You know, consumer complaints are seriously the number one driver of enforcement action lawsuits. And, you know, class action attorneys just love to sit on review platforms and look at what people are complaining about. So, you know, respond, make people happy.

[Emma Rainville]

I love that. Thank you. That's really good. He just gave you guys a checklist. That's really good. I would love to. I hear all time like, it's impossible to keep up with all the FTC compliance, blah, blah, blah. For an attorney, there is new stuff, new law, new right law isn't about just one person's perception of the law. It's about what has happened in the past. What's that called?

[Ryan Potee]

Precedent.

[Emma Rainville]

Precedent. Thank you. It's about what cases and what precedent, you know, other judges took. And it's a lot for you as an attorney. What's the most challenging part about keeping up with all of the stuff that's going on with the FLTC and the FDA?

[Ryan Potee]

I think that's actually the easiest part. I mean, they're a government agency. They publish this stuff. There's rulemakings. You know, ever since we've had this kind of transition from the FTC being a traditional law enforcement agency where they didn't issue a legitimate regulation in, you know, I don't know, two decades or something crazy like that, to being a more regulatory agency where they're publishing regulations, I mean, you actually know what the agency is thinking. And so we're not trying to read tea leaves from consent orders to say, well, this is the FTC's position on stuff. They're actually, like, coming out with regulations and there's rulemaking. So I think that's the easiest thing. I think what Concerns, probably advertising attorneys more is like, you guys do a lot of crazy stuff and you guys.

[Emma Rainville]

No, I don't do crazy stuff.

[Ryan Potee]

No. Clients are always trying to push the.

[Emma Rainville]

Clients are always trying. Not me, not, not me. I'm the naysayer.

[Ryan Potee]

Never, never. No, clients are always trying to do something new and exciting and trying to push the boundary and it's usually trying to fit whatever new shiny object or trend or trend into the existing framework. And so I think that is where, you know, that keeps us on our toes because usually someone call it, we'll get a phone call on a 5 o'clock on a Friday being like, hey, by the way, I'm doing X, Y and Z. This sounds great, isn't it? And then it's huh, why did you.

[Emma Rainville]

Just ruin my weekend though? Truly, I don't love that for you. But I love that you also get those Friday phone calls because me too.

[Ryan Potee]

Always at five.

[Emma Rainville]

It's, it's always at five on Friday. I don't understand it. And it's going to launch on Monday at 8.

[Ryan Potee]

Truly.

[Emma Rainville]

Frick. We can go back and we can look at when Trump was president last time, what the admin with that administration. Administration is a little different this time, but we can look at what that administration did and then we can look at what he's piecemealing together now. I, I just want to, I'm making you do this for a reason. I just want to kind of hear from you what you think is going to happen in 2025 when the new administration gets in and what's going to happen.

[Ryan Potee]

I think we are going to see a kind of, a bit more of a mandate to, to stop pressing the FTC's authority under existing law. I think that they will back away from novel, novel legal theories before Trump was re elected or even Lena Khan when she was testing fine before the one of the House Oversight committees. I mean she was advocating that. She's telling that frontline staff go out there and press the bounds of our law and bounds of our authority. If we lose, then that helps us justify to Congress why you need to give us more power. And I think that, you know, Republicans generally are feeling that the FTC is abusing its authority and I think that we are going to see it return to a much more restrained approach. Now that's not going to mean that the FTC doesn't enforce law and they are going to be going after all of the bad people and all the stuff that was unlawful before Trump got in office is still going to be unlawful. But I think that we're going to see maybe a more rational approach to.

[Emma Rainville]

Enforcement when Trump gets in office. We're going to see a more rational approach. I said no one ever. But I think you're right. But I think it's actually crazy to hear those words. But I do think, I think you're right. I think you're right because it's not been a rational approach. It's been a. It's been absolutely crazy.

[Ryan Potee]

Well, I think we might actually, and this is just Ryan talking, I think we might see the FTC rethink some of the rules that it issued. You know, it, it would require some legal maneuvering, but I think that at least there would be enough support in Congress, as well as with the Republican commissioners to look at some of the rules that are at least in the stages of rulemaking or the rules that have been recently passed to say this was never within our authority to begin with. Let's, let's rethink this.

[Emma Rainville]

This is so interesting. I want to keep kicking on this, if that's okay. I'm genuinely curious. There are rumors of, I don't know if you'd call it rumors or outright people saying. But everything needs to be fact checked. Now. The FTC hired a ton of attorneys and now they're all going to get fired.

[Ryan Potee]

No, no, no, no, that's not true. No, no.

[Emma Rainville]

Talk to me about that.

[Ryan Potee]

No, I mean, you know, government is. They put out, they get positions, they get a budget, they forecast. Nobody. I have a bunch. So living in D.C. most of my friends work in government. It's not like Elon Musk and Ramaswamy, forget the guy's first name. But are going to come in and massively going to start just laying everybody off. They don't have the authority to do that. It's just not going to happen. The FTC is still going to have a very aggressive frontline staff. And by aggressive, I mean not, you know, exceeding their authority, but their mandates to protect consumers. And they have a very important job. And just like you were alluding to before, the bad guys who are out there just, you know, driving Lambos and saying, I'm going to make you millions of dollars. Those are the people that need to be taken down. And that's not going to change at all.

[Emma Rainville]

Okay, let's move to the fda.

[Ryan Potee]

Sure.

[Emma Rainville]

The ftc, I think, scares me more than the fda. I don't know if that's rational. Tell me what changes you think are going to happen with the FDA and what we think is coming in the next four years.

[Ryan Potee]

I think telehealth is going to change quite a bit.

[Emma Rainville]

Talk to me about that.

[Ryan Potee]

So Covid happens. Telehealth explodes. It was awesome, right? You didn't have to sit in the middle of a crowded waiting room because you can sit on zoom and talk to your doctor. But that also let e commerce brands expand into hey, do you want hair restoration products? Do you want fat loss or not fat loss but weight loss drugs, weight loss drugs and all the GLP1s they have been on the FDA shortlist.

[Emma Rainville]

GLP1s mean is that ozempic?

[Ryan Potee]

That's ozempic.

[Emma Rainville]

Semi glutide.

[Ryan Potee]

Semi glutides, Zap bound triazepatide. All the gl. All the. All the.

[Emma Rainville]

The trend that I can go get a quiz in two minutes online, get on face to face with the doctor in wherever and then get a. Without being weighed.

[Ryan Potee]

Without being weighed and it's shipped to your door and you were happy the next day pretty much. And you know you're off on your fat loss journey. There are a bunch of compliance issues with it because the compounding facilities that are making it are not necessarily always making it according to spec. They're using a salt version of it at least when we're talking about GLP1s which can be dangerous. But more importantly, a bunch of E commerce brands have built their business around these products being on a short list. And when a product is in a short list that means that that compounding facilities can make or not fills not facilities, but pharmacies can make these drugs and sell them to. To companies that make them available to consumers. When that drug falls off of a short list, you can't sell it anymore. And if you do it's unlawful and there's criminal penalties. So there are a bunch of brands that have built their entire business on being able to make something that very well could fall off the short list. And so what's going to happen? And so I think we're going to see enforcement around that. You know and this, this need to start pivoting businesses away from the traditional, you know, not traditional but this newfound.

[Emma Rainville]

Yeah, newfound telemedicine. Because it's not really telemedicine. I genuinely wonder this and hope you don't think I'm dumb. So there are a lot of people who are doing like hair tests or DNA tests to determine what supplements and minerals you should take. And those are really great products. Some of them we know Barton Scott. I freaking love him and I love his product, go to upgradeformulas.com buy his stuff is amazing. But there are many products like his for people who are trying to get rich and not people who are trying to help people. Barton's trying to help people.

[Ryan Potee]

They have these diagnostic tests.

[Emma Rainville]

It's a diagnostic test and then you can pay to get on with the nutritionist or sometimes it's a nurse practitioner, sometimes it's a PA and so are they going to be affected in the same way as the semi glutide people?

[Ryan Potee]

I think it'll be a little different.

[Emma Rainville]

Okay.

[Ryan Potee]

I mean, the semi glutide and the short list, I mean, that's, that's taking something that was previously lawful because it was on a short list. You know, with it not being.

[Emma Rainville]

When do we think it's going to fall off the short list?

[Ryan Potee]

Well, Triazepatide already did. And so there's a bunch of Trizepatide, which is Manjaro and Zepbound fell off back in October.

[Emma Rainville]

Okay.

[Ryan Potee]

And there was a bunch of litigation that forced the FDA to kind of put a hold on enforcement and kind of review that decision. There should be a, another report out later this month about whether or not the FDA is going to keep it on the short list. You can go to Eli Lilly, the manufacturer's website, and actually get it ordered to your door. So I don't think that this drug is in shortage anymore. So I think the FDA is on pretty good ground, on pretty good ground to say, hey, there's not a shortage anymore. And I'm sorry that consumers love being able to get the cheaper version of this, but it's not a shortage. So it's, it's going to fall off. I mean, it's not in shortage anymore. So I think the FDA is going to reaffirm their decision that. I'm sorry, guys, but this is, this.

[Emma Rainville]

Is a huge thing in our industry. I didn't even know this was going to get here today. This is a huge thing. The amount of people that are.

[Ryan Potee]

Oh, I mean, there are entire businesses. That's all that they sell.

[Emma Rainville]

Yeah.

[Ryan Potee]

Now the great thing is they already have, you know, because to do telemedicine the correct way, you have. There are a number of entities that need to be set up. You need provider networks. And typically our clients or the people that we are representing are the advertising arm of the provider network. And you know, to avoid all the anti kickback laws, there's a bunch that you have to do. But if you've already established this provider network, I mean you have qualified healthcare professionals. You just need to figure out what those professionals can cater to. And so perhaps you were a weight loss brand. You know, if there was a, you know, some of the other larger brands have mental health coaching and so if you have psychiatrists on staff and the folks can, who can prescribe and still prescribe drugs that are complementary to your, you know, your brand mission, I, I don't think it's going to be a complete loss, but people are going to have to start thinking about what the mighty will fall.

[Emma Rainville]

So. Interesting. Okay, so that's telemedicine. What else? With the fda.

[Ryan Potee]

So I think the FDA is going to be. I don't think there's going to be a lot of change.

[Emma Rainville]

Okay. I've noticed in recent months, and it may be that I'm just noticing that a lot of what I'm seeing is FDA violations with call centers.

[Ryan Potee]

Really?

[Emma Rainville]

Yeah. So I actually was, I should have sent it to you. I was reading about three different cases, two in Utah and one in Washington. Not Washington, Washington, where it's always freaking Utah for some reason. I don't understand that. But anyway, it was calling the call center, asking about claims, call center commission employees saying whatever they needed to say to get you your bottle. And then it. So FTC violations based upon FTC or fda. I'm sorry? Fda. FDA violations based on. And all I saw was like letters of them, like threatening. I didn't see anything crazy like you're find a bazillion dollars. That's always been my fear. That's so dramatic. But I have noticed, because I watch for these things because I'm craz. I have noticed that. I've not seen the ones with the. I've seen FTC call center stuff before, but it was fda, specifically FDA issues with claims with call centers and commissioned employees. So I'm, I'm curious to hear what you have to say about that. Doesn't sound like you know what I'm talking about.

[Ryan Potee]

No, I mean, I'd be fascinated to see it because if the FDA is really rethinking. So when a drug manufacturer goes out there and gets a drug approved, I mean, there are specific, you know, conditions that it's approved to treat. And so drug manufacturers are not allowed to go out there and advertise unapproved uses. And there's a bunch of case law, especially out of the second Circuit that says, well, there's a first Amendment and you can pretty much want to say, so long as it's truthful, I'd be Curious to see if the FDA is going to be taking a more aggressive approach on off labeled use. You know, there is a bunch of off labeled use in the telemedicine space. I mean, you see men's health brands advertising Sertraline, which is Zoloft, for, you know, premature ejaculation. I would be very curious to see if the FDA is going to be rethinking its enforcement authority over off label use. I mean, a bunch of our clients in the tele space do it. So we'll. I'm all ears. I'd love to hear.

[Emma Rainville]

What do you think is going to happen? You're so wishy washy. What do you think?

[Ryan Potee]

To be honest, on the FDA side, I think it's really going to be just traditional, more of the same.

[Emma Rainville]

Really. So you think all these companies that are shipping these weight loss needles to people's houses are going to be just fine?

[Ryan Potee]

Well, I mean it falls off the short list and then they can't do it anymore.

[Emma Rainville]

But like, but you think that that's happening or you don't think that's.

[Ryan Potee]

Oh no, that's totally happening.

[Emma Rainville]

Okay, okay.

[Ryan Potee]

I mean, well, Tri Zeppeta, Eli Lilly. I can go to Eli Lilly's website.

[Emma Rainville]

Right now and order it direct to your door.

[Ryan Potee]

Yeah.

[Emma Rainville]

When does that end?

[Ryan Potee]

When does that end?

[Emma Rainville]

Yeah, like let's play a game. Like, you know, when's the baby going to be born?

[Ryan Potee]

Oh, well, I think.

[Emma Rainville]

What do we think?

[Ryan Potee]

Well, that's now. I'd say in the next six months.

[Emma Rainville]

So in the next six months, people who are doing that solely as a business, I should get another platform, something else to sell. Because there's a reasonable possibility. I know you're a lawyer, so you got to protect yourself. There's a reasonable possibility that that may not be available to them as a sales tool anymore.

[Ryan Potee]

I put a lot of money on it.

[Emma Rainville]

Okay, that's. Huh.

[Ryan Potee]

I would start.

[Emma Rainville]

I've heard this and heard this and heard this, but I heard this all the way from the beginning when they started doing this. And nothing's been done. And nothing's been done. But here's the thing. I feel like companies like that are going to try and switch to traditional weight loss supplements that we've always done. And these people are so, because they've got the lists, these people are so used to rapid results with no effort whatsoever that it's never going to work for them. It's a house of cards. They need to find something else. Something else completely that that demographic needs.

[Ryan Potee]

My opinion, there Are a ton of medications already out there that in pill form?

[Emma Rainville]

You know, they don't work like that does. Look, I watched Perry Beler lose. He went from big fat ass to cancer patient in a matter of months. He lost so much weight. He lost so much weight, and it was so easy to lose the weight. And now every so often he'll go off and have to go back on because he'll pop on 12 to 20 pounds. Nothing. What was the pill that they took off the market? Hydroxy cut.

[Ryan Potee]

Yeah. Ephedra.

[Emma Rainville]

Ephedrane. Ephedra. They still sell Hydroxycut, but it no longer has ephedrine. It doesn't work nearly as well. Do you hear about hydroxy cut anymore?

[Ryan Potee]

No.

[Emma Rainville]

So this is my thing. Yeah, sure. They've got stuff available to them. It doesn't work the same. And the second I can teach someone in today's world, in today's society, that you can have something in a millisecond, they're gonna go to their doctor and get it. They're not going to buy supplements. I'm just saying.

[Ryan Potee]

Well, the problem is it's a. It's so expensive.

[Emma Rainville]

Yeah. They need. Well for. From their doctors.

[Ryan Potee]

From their doctors.

[Emma Rainville]

I mean, is it more money than from online marketers?

[Ryan Potee]

Oh, absolutely.

[Emma Rainville]

I didn't know that.

[Ryan Potee]

So the, the, the telemedicine brands are selling the compounded version. And so when it still works the same. It still works the same because it has the same active ingredient. And for whatever reason, and not for whatever reason, when a drug is on the short list, the FDA comes out and says, well, there's basically a national emergency. The patients need access to this. So we're going to let compounding facilities make all of this stuff.

[Emma Rainville]

I don't think I understood this till now. So this is a diabetic medication that is not that people desperately needed and marketers ruin everything. So they realized the weight loss component to this, and that's what exploded this in the weight loss world.

[Ryan Potee]

It was Hollywood. The Kardashians started taking this. And all of a sudden, you know, there was this mass craze to get Ozempic, Manjaro, Zepbound, and so now there's.

[Emma Rainville]

An F. So hold on. I just want to. I want to make sure. I want to make sure I understand this. So this is a. This is a diabetic medication. The Kardashians, who are also marketers and ruin everything. They start taking it because they can afford it. They get it from their doctor, and they're using it for weight loss. The rest of the world. And I just want to make sure I'm repeating back what I heard from you because sometimes I tell stories in my head. So they start taking it, everyone starts wanting it. It creates a shortage for diabetics. It hits the short list. Marketers go, oh, hold the on and start mass producing this to every idiot who doesn't give a about their thyroid.

[Ryan Potee]

Pretty much.

[Emma Rainville]

That's brilliant. I, I thought I understood all this. I didn't understand. You think I would have understood all this. I don't work with anybody who sells it. So I, it's just kind of like, you know, okay, okay, okay. So they're all going down. I, I, I think I, in my opinion, in my opinion after, even more so now they need to find something that, that demographic because they have the list built, they have the customer base. They need to find something completely different than weight loss that they can sell to these people. What else would they want other than weight loss? Because they're not going to be able to make them happy with weight loss.

[Ryan Potee]

Yeah, I mean, well, if, if not.

[Emma Rainville]

After, not after the patients can.

[Ryan Potee]

I mean, there's some other stuff out there like contrave and some other, the other active ingredient. Contrave, not well.

[Emma Rainville]

And what the fuck, Kardashians. You made it so diabetics can have their medicine.

[Ryan Potee]

The another Kardashian problem.

[Emma Rainville]

Wipe them off the freaking planet. Jesus. Okay.

[Ryan Potee]

No, but I mean, I think there's some other drugs that the, that at least the existing brands could pivot to short term. They don't work as well. They still work on kind of like the same mechanism in the brain, but it doesn't, it doesn't treat the, the blood sugar component of it, so it's not going to be as effective. But mental health coaching, I think this may be a great way. I mean, a lot of the existing brands already kind of, you know, these drugs work. GLP1s work best when paired with mental health professionals. A lot of the brands that at least we've worked with already have that attached to their brand. So building that out, I mean, every, I think everybody needs therapy, honestly. So like 100, building that out and.

[Emma Rainville]

Being 100 and people who don't think they need therapy or people who need therapy the most.

[Ryan Potee]

Exactly. And so even if it's re, even if that brand, I don't want to say dies, but moves into something else or rebrands, you still have the back end on that.

[Emma Rainville]

Right.

[Ryan Potee]

Of that business. So, you know, the marketing arm is still in place. You stop the Provider, network, you know, the whole fee. It's not even fee sharing, but the compensation structure already exists. So you don't need to reinvent the wheel, it's just reinventing branding.

[Emma Rainville]

What? Should I have asked you that? I did not.

[Ryan Potee]

What's the easiest thing to keep me out of trouble?

[Emma Rainville]

Holy crap. What's the easiest thing to keep me out of trouble, Ryan?

[Ryan Potee]

Website terms and conditions? No, at least from a class action perspective, I mean, if you're selling something online, make sure you have a click wrap that's enforceable and make sure you have binding arbitration at least. I mean, that's not going to keep the FTC from knocking down your door, but at least from, you know, crippling class action liability, that's going to be the, the absolute most important thing that if you don't hear anything that anyone ever says, having an enforceable click wrap can save your company.

[Emma Rainville]

Can you explain to people who don't know what that is, what that is?

[Ryan Potee]

A click rack is an agreement. It is a contract that consumers enter into when they buy an agreement. What?

[Emma Rainville]

No, I'm. I'm just getting to the point that terms and conditions is a contract. Yeah, so many people don't know that. I'm just trying to make sure that you point that out.

[Ryan Potee]

No, terms and conditions are a contract that consumers into. Enter into when they buy your product. Unfortunately. I mean, I've had a client, we've given them absolute perfect terms, but never had a. Never put them at the checkout page. And so when they get hit with a class action, you, you and I.

[Emma Rainville]

Have dealt with this for a long time. They'll pay you a ton of money and, and don't put it on every page.

[Ryan Potee]

And to be honest, it's not because they didn't want to. It's because.

[Emma Rainville]

Stupid. Well, no, stupid.

[Ryan Potee]

It's a disconnect between the, the creative team, whoever controls the website.

[Emma Rainville]

Well, what happens is you do updates, right? You do updates for marketing purposes. And if you're really, really good at. In this industry, you're constantly doing split tests and you're constantly changing things and you're constantly trying to beat what you've already done. You're launching new products, whatever, and there needs to be a product launch, sales page update, checkout page update, SOP that every single marketer ever has, and a QA process that says, do I see the copyright on the bottom of the page? Do I see the terms and conditions on the bottom of the page? Is it clickable? Can I scroll all the way down? Is anything wrong with it? Believe it or not, that actually happens. Is the privacy policy there? Is it clickable? Can I scroll all the way down? Can I see everything? These aren't difficult things.

[Ryan Potee]

No. I mean, I've been in litigate, or at least what turns it is about to turn into litigation, where the plaintiffs are sending me pictures of our website, and it's actually better than our current website because whatever day that they were visiting it, you know, we're doing some sort of split testing, and then when I go back two days later, it is different again. And so there's no when you split test.

[Emma Rainville]

Here's the thing. When you split test, you're sending a percentage of the traffic to one page and a percentage of a traffic to another page. That could be up to four times, depending on the amount of traffic. Right. So you could click on it today and see a different page and then click on it again two seconds later and see a different page. So you got to look at all of the pages that are live on the site and always have a QA process that does not involve the person building the page. If they missed it once, they will likely miss it twice, even with the checklist, even with an sop. But, yeah, that's. That's makes total sense to me. Yeah.

[Ryan Potee]

Get a click wrap.

[Emma Rainville]

Get a clip. Right. Which is a contract. Ryan, thank you. Just love having you on. I just. Absolutely. This has just been so great. Thank you so much. We've done several compliance guides and checklists in my members area for people. And again, you have the whole compliance guide that we're going to link for people. You've spent a lot of time creating free resources for our community. And I think that it's. Of course, there's a little bit of lead generation in that. Right. Because you create goodwill for people. They're going to come to you when they need help. But really, I haven't really met someone. You, Damon, your whole team really, really just care about people and really just care about. You're not necessarily in it for the money, although I'm sure the money is nice. I don't feel like any of you are in it for the money.

[Ryan Potee]

No, we. I think we built a really good team. I mean, we like fixing problems.

[Emma Rainville]

It's. It's a. It's. It's a passion of problem solvers. Yeah, absolutely. Absolutely. And. And you guys really care about the people you represent. No, I mean that in a. In a deep way. You care about. I've. You and I have been friends for a while you've called me, you haven't been able to tell me what you were upset about because you can't share any of the details. But you've been really upset about things that have happened with clients and you just need someone to talk to because you take that with you and that's really special in an attorney. So, Ryan, thank you so much for being here. As always, it's a pleasure. I love mixing ops and legal. Ops is a lot of legal and legal has a lot of operations that needs to get done in order for it to be implemented properly. If if you want to come back ever, ever, ever, I will have you over and over and over again. To non compliance isn't just risky, it's preventable. Sign up for our members area@special opspodcast.com to get exclusive strategies and checklists designed to keep your business ahead of the game. Don't forget to like and subscribe so you can get notified whenever we drop a new podcast. Thank you for listening and see you next time.