I'm not a physician, I'm not a scientist or anything. But I've been in this field for ten years.
Founder of Regen Portal. Host of the Oscar Tellez Podcast. Everyone in this field tells doctors what they can't say. I read the rule out loud, with the source attached, define the term everybody's using loosely, and let you decide.
Somewhere right now a doctor is sitting on a therapy she believes in and saying nothing, because somebody told her one sentence could cost her the license. Somewhere else a grandfather is pricing a flight to another country because somebody told him it's illegal here. Neither of them is wrong to be afraid. Both of them were told what they can't do by people who never showed them the rule.
That's the gap I live in. Ten years of watching the loudest voices win on both sides. The sellers who'll say anything, and the skeptics who'll call it all illegal without reading the document. In the middle are the people I actually care about. The provider who wants to do this and wants to do it right. The patient who has tried everything they were offered and is looking for hope with a process behind it, not hope for sale. The researcher whose life's work keeps getting flattened into a slogan by both camps.
I'm not a physician, I'm not a scientist, I'm not an attorney. I made peace with that a long time ago, because it turns out this field doesn't need one more person with an opinion. It needs a translator. Somebody who will read the rule out loud with the source attached, define the term everybody's using loosely, ask the question the room is avoiding, and then step back and let you decide. I can do that. I've been doing it for ten years, in English and in Spanish, for anyone who'll listen.
So here's what I refuse to accept. That saying nothing is the safe answer. That fear dressed up as caution counts as education. That a whole category can be called illegal, flatly, by someone who never opened 21 CFR 1271. The honest sentence is longer. It depends on the source, how it's processed, what's claimed about it, and which state you're standing in. The lie isn't that risk exists. The lie is that there's nothing to learn.
Where I want this to go is simple to say and hard to do. A field where a provider can explain what they do without one sentence putting the license at risk. Where a patient walks into a clinic with the right questions and walks out knowing whether it's their own tissue or a donor's, and what that means. Where the scientists get the microphone and the sellers get the citation request. Where the credible players are the ones who grow, because the rule was part of the plan, not the thing you route around. If regenerative medicine becomes the credible field it could be, it'll be because enough people decided to define the terms. I want to be the one who kept asking.
MD, DO, NP, PA, PhD. You know there's something beyond managing symptoms and you don't know where to start. You want to do this, and you want to do it right.
The steroid shot, the surgery, the next prescription. You're not looking for the easy way out. You're looking for the right questions, and someone who isn't selling to answer them.
Manufacturer, distributor, clinic. You've watched the reckless ones grow on claims you'd never put in writing, and you know that if one of them blows up, they take the category with them.
Not for the provider stuck in their ways, the patient hunting the easy way out, or the industry person who's only here for the money. I say that with love. There are other websites.
A number without a source is not a number. Every figure here has one.
I came into this field ten years ago with a Bachelor of Science in Exercise Science and Health Promotion from Florida Atlantic University and no medical license. I still don't have one, and I say so in the first two minutes of every conversation. That's not a limitation. That's the whole position.
I worked distribution first. Biologics, devices, birth tissue products, equipment. Then clinical education, building training for the clinicians and practice owners who were buying those products. Then marketing, because the same providers kept asking me the same question. Can I say stem cell on my website, or am I going to lose my license? Right?
In 2022 I founded Regen Portal, the marketing and consulting company that reviews a client's claims against FDA, FTC, Google, Meta, and state rules before anything gets published. I run that review myself. It means I read warning letters for a living, and in my reading, most of them are about a sentence on a website or a brochure, not about something that happened to a patient. That's a marketing problem, and a marketing problem has a fix.
The rest of my week is the podcast. Surgeons, scientists, operators, the people who co-wrote state laws, and the researchers whose work keeps getting flattened into a slogan by the sellers and the skeptics both. I ask what they mean by the word, where it's published, and how many patients. Then I let you read it yourself. At the end of the day, that's the job. Define the terms, attach the source, and get out of the way.
What stem cells are you talking about? From what source, processed how?
The question I ask first, every time. The answer to almost everything depends on it.
Nobody searches for the ingredients. They search for what they want to eat. Your patients search the same way. Define what you do in the words a patient would actually type, and then check what the rule lets you say about it.
That one is Dr. Robert Talac's, not mine, and I use it every week. Prepare the ground before anybody talks about a product. Sleep, movement, food, the basics. There's no claim in that sentence, and it's still the most useful one I have.
I used to say this one. I was wrong. In a regenerative practice, the vacation is the outcome, and the outcome is the claim. That's the claims trap in a marketing hat. Sell the process, the experience, and the confidence. The results stay where they belong, in the published study, with the citation attached.
I get corrected on the air and I say thank you, because we need more of that. Here's what I've said out loud and had to walk back. It stays on the record.
The marketing and consulting company for regenerative medicine practices. Compliant growth, claim review before anything publishes, and the introductions people need.
Founder. regenportal.comHands-on clinical training for licensed providers. Home of the free e-course I teach, FDA Legal Foundations of Regenerative Medicine.
Free course. regenmedacademy.comConnects patients who want to bank their own adipose tissue with providers who collect it. The patient's own tissue, not a donor's, which is the first fork in every conversation I have.
Regen Portal company. savemyfat.comLong-form conversations with the people who did the work. Cut for the question and the definition, never the promise. Skeptics get the same microphone as believers.
Host. youtube.com/@oatellezThe in-person working session for clinic owners who run their own growth. January 2027. Produced by Regen Portal in partnership with Regen Med Academy.
January 2027. regengrowthlive.comThat word is doing a lot of work. Which product, from what source, processed how, and what are you claiming about it? Define it first. Then pull up what the rule actually says and read it yourself.
It isn't. PRP is platelets, growth factors, and cytokines from the patient's own blood. Stem cells is a category, not a product, and the source and the processing decide everything. That's the whole reason we have to define the terms.
Go read the warning letters. In my reading, most of them are about a claim on a website or a brochure, not about something that happened to a patient. That's a marketing problem, and a marketing problem has a fix.
Then nobody learns what you do. The question isn't whether you say it. It's what the rule says you can say about it, on which platform. I'll walk you through how I read it, with the source. You and your counsel decide.
I won't answer that one, on purpose. What I'll give you is the questions. First, is it the patient's own tissue or a donor's? For a donor product, ask the manufacturer about source, processing, donor screening, the certificate of analysis, and what is actually being counted in the vial. For PRP or bone marrow drawn in the room, there is no certificate of analysis to ask for. Ask what the device is cleared for and what the preparation contains.
Disclosure: I work with multiple manufacturers and I'm not tied to any one of them. I don't promote specific products in educational content. When a post touches a category I sell, I say so in the post.
I read it against the rule it would trip, show you the rule, and tell you how I'd write it. Your counsel gets the final word. That's how it should be.
Source, screening, processing, and how the products actually differ from each other. Your own tissue or a donor's. What each one is, what it is not, and which questions apply to it.
An attorney who works in this space. A clinic that does it right. A scientist or a specialist who will pick up the phone. Ten years in, I know who to call. Ask.
Not from a discount, and not from a claim they'll have to take down later. The rule is part of the plan, not an obstacle to route around, and not a reason to say nothing.
Do your own research. Ask the questions. And if you're stuck on a sentence, send it to me and I'll take a look. Oscar@regenportal.com
FDA, FTC, Google, and Meta. Warning letters read against the rule they cite, so the lesson is the point and no practice is the target.
State laws, FDA pathways, 351 versus 361, the court cases, and the 351 classification debate presented as the question it is, never as permission to ignore the current rule.
The patient's own tissue or a donor's. What each product is, what it is not, and the questions that apply to it. Compared only through what published research measured.
Corrections and debate, with the citation. The critics get the same sources as the advocates. A post that carries only one side is a pitch.
The podcast and everything cut from it. The person who did the work, asked what they mean by the word and where it's published.
Every statistic, statute, case, and study has a source, or it does not appear. A number without a source is not a number. I change my mind in public when the source says I should, and the correction stays in.
Every episode opens the same way: the day, the date, and "I have the pleasure." Then I bring the surgeon, the scientist, or the operator who did the work, and I ask what they mean by the word, where it's published, and how many patients.
My listening word is "interesting." My agreement word is "100%." When a guest tells me an outcome, my word is a question. Is that published? Where can people read it? The skeptics get the same microphone as the believers, and when I'm wrong, the correction stays in the episode.
The Exosome Vendor Checklist came out of one of those lives. It's Dr. Carla Mazzeo's, and I helped build it. A shared checklist walked through on screen, with the company names redacted, is still the strongest format I have.
The views expressed by guests are their own. Statements about outcomes reflect the guest's experience and published work, not a claim by Oscar Tellez or Regen Portal.
A working session, not a conference. Clinic owners build the marketing engine for their own practice, in the room, on their own laptop. No sponsors, no booths, no pitches. The city and the venue get published when the contracts are signed.
regengrowthlive.comOne place for the position, the podcast, and the questions. Education, never a pitch.
The in-person working session for clinic owners, produced by Regen Portal with Regen Med Academy.
Marketing, compliance review, and consulting for regenerative medicine practices. Every client claim reviewed before publish.
Florida Atlantic University, 2011 to 2015. The degree, and the reason I keep saying I'm not a physician.