How to Compare a Marketing Claim With the Regulatory Record

Weighing a health claim is not expertise. It is sequence.

You do not have to decide whether a treatment works. That question is not answerable from a web page. What you can do is establish which rung a claim is standing on, using records that are public and free.

Six steps, with a branch at step 3 for the case where nothing turns up, and a section at the end for the steps that do not resolve. Each step has a page behind it with the detail and the sources. This page is the order.

The one thing to get right before you start. The lookup key is the exact product name, not the material. Regulatory records are indexed by product, because a product is what gets approved. The material matters too, but it answers a different question and it answers it later.

Step 1: Write the claim as one sentence

Marketing copy tends not to contain a single claim. It contains several, arranged so they support each other.

Take what you were told or what you read and separate it into single sentences, each making one assertion. “Our evidence-guided approach uses your own cells to address joint pain” is at least three claims: something about evidence, something about the material, something about effect.

Write them as a list. You will check them separately because they are answered by different records.

Step 2: Get the exact name, and then the material behind it

Two names, and you need both. They do different jobs and mixing them up is one way this method fails before it starts.

The exact product or preparation name. The full name as it is written down: trade name, product name, or the name printed on a label or consent document. This is the lookup key. Regulatory records are organised by product, and a product is what gets approved, licensed or cleared. When we looked things up for this site, every successful search ran on a product or device name: MACI, RYONCIL, ALLOCORD, and a device clearance found under the name of a specific platelet separator.

The material behind it. What is physically being administered, and where it comes from. This is not the lookup key, and asking for it instead of the product name is the mistake. What it is for comes in step 3b: if no product turns up under the exact name, the material is what tells you which regulatory route the preparation is travelling on.

Basis: FDA’s licensed product list and device databases are indexed by product; the HCT/P framework and the material vocabulary are on our glossary page, with sources for each term.

Some answers are material descriptions rather than names: “your own cells”, “stem cells”, “an ortho-biologic”. None of those is a lookup key. Ask for the product name in writing. If there is no product name, that answer is itself a finding and it belongs in step 6.

Step 3: Look for that exact product in the current record

Search the relevant current record for the exact name you were given.

Basis: FDA, Approved Cellular and Gene Therapy Products, for cell and tissue products; FDA’s 510(k) and device classification databases where what was cleared is a device. Both are live and both change, which is why the check belongs at the moment you need it rather than at the moment something was written.

Four outcomes, and the third one is the one people get wrong.

Found under that name. Go to step 4 and read what it is licensed for.

Found, but it is a device clearance rather than a product approval. A cleared preparation device is a finding about a machine. Read what the record actually says was cleared; our approvals page works through one such device record in full, including the trap that a code’s classification today is not the classification that governed the decision when it was made.

Not found under the name you searched. Not the same thing as not approved. A trade name, a generic name, a spelling variant or a different listing name all return nothing while an approved product exists. Check the name, then search again.

Genuinely absent from the record. Now the material from step 2 does its work: it tells you which route to check next, and our page on the four criteria is where that continues.

Step 3b: If nothing was found, establish the route

With the material name, work out which framework the preparation sits in rather than guessing that absence means anything.

Not everything offered in this field is an HCT/P, so the route has to be established rather than assumed. Ask directly: which regulatory framework applies, what is the stated basis for that classification, and if an FDA application, authorization, clearance, registration or other identifier applies, what is it?

That last clause matters and it is not hedging. Not every framework produces a number. A product that meets the criteria in 21 CFR 1271.10(a) and is regulated solely under section 361 has no approval number and no clearance number to give you, because no premarket review took place. Asking for one and being told there is none is a correct answer, not an evasion. And where a registration or listing does exist, a registration is not an approval and it is not a finding that the criteria were met; it records that a party told FDA it exists.

Step 4: Match the licensed indication against the proposed use

This step is easy to leave out, because step 3 already feels like an answer.

If a product was found, read what it is licensed for. An approval covers a defined use. Read the licensed indication as it is written in the record; it is the scope, and it is narrower than a disease name. Compare that with what is being proposed to you.

Basis: the licensed indication as stated in the FDA listing and the product’s own labeling.

Note the boundary of this step carefully. You are matching the proposed use against the licensed use. You are not deciding whether the treatment is right for your body or your history. That is a clinical judgment, it requires someone who knows your case, and it is deliberately outside what this method does.

Step 5: Open the evidence that was cited

If a study was offered as support, retrieve it and read the fields that determine what it can show: design, population, outcome, duration, size, funding.

If no study was offered, that absence is itself part of the picture.

Basis: FTC, Health Products Compliance Guidance, which sets out what qualifies as competent and reliable scientific evidence and states that anecdotal evidence and animal or laboratory studies are not sufficient to substantiate health claims.

Step 6: Write down what is left

Sort your original list of claims into four columns. The fourth one is the column people leave out, and it is the one that fills up first.

Supported. The record backs it at the level it was stated.

Unsupported. Not that it is false. That the support offered does not reach it.

Conflicting. The record says something different from the claim.

Open. You asked, and the answer is not in yet. A name you requested and have not received, a document you were promised, a record you could not locate with the information you were given. Each entry carries the date you asked and the form the request took, because a written request that went unanswered is a different item from one you only made out loud.

That inventory is the output of this method. It is not a decision and it does not pretend to be one. It is a page you can put in front of a clinician, or read again in a week when the conversation is less fresh.

When a step does not resolve

Every step above assumes an answer arrives. When one does not, the handling of that is part of the method rather than a breakdown of it, and each of the seven cases below has its own correct outcome. Two of them look like conclusions and are not, which is why they are written out rather than left to judgment.

No product name is provided. Step 2 asks for the exact name in writing. If it does not come, step 3 cannot run at all, and searching on the material description is not a substitute for it. What follows is that the check is incomplete and cannot be completed by you alone. What does not follow is that no product name exists, or that anything is being withheld. Put the item in the Open column with the date and the form of the request.

The product is not in the current record. This is step 3’s fourth outcome, and it is the one most easily overread. What follows is precise and narrow: this product did not appear in this record, searched under this name, on this date. That is a fact about a search. What does not follow is that the product is unapproved, unlawful, unsafe or ineffective. A record has a scope, and absence is informative only inside that scope, which is why step 3b asks which framework the preparation sits in rather than treating absence as an answer. Record the record, the name you searched, the date and the result. All four, because in three months you will not remember which name you used.

The preparation turns out not to be in the framework you started checking. This is the failure that looks like an answer, which is what makes it the expensive one. If you begin at the four HCT/P criteria and the preparation is a blood product or a secreted body fluid, every step after that is valid reasoning about the wrong branch, and it will produce a confident conclusion. What follows is that you go back to step 3b and establish the route before going forward again. What does not follow is anything at all about the product, because you have not yet asked a question it could answer. Our glossary names which materials sit outside the HCT/P framework and quotes the regulation that puts them there.

The licensed indication cannot be found. Step 4 depends on there being a licensed use to read, and there are two different reasons it might not be in front of you. If the product was found in the record, the indication is part of that record and the problem is that you have not located it yet, which is an Open item. If the product was never found, step 4 does not apply at all and recording it as a failure of step 4 misdescribes what happened; the unresolved step is step 3. Keeping those two apart matters because they lead to different next actions, one a search and the other a question.

The sources disagree with each other. The listing, the product’s own labeling and what you were told in the room are three separate records and they do not have to agree. When they do not, the disagreement is itself the finding. Do not resolve it by picking whichever seems most authoritative and discarding the other two. Write all three down with their sources, each in the words it uses, and put the item in the Conflicting column. This method is worth doing because it produces a documented discrepancy instead of an impression, and a discrepancy is only documented if both sides of it are written down.

No evidence was cited. Step 5 has an outcome for this and the outcome is not a blank space. If a claim was made and nothing was offered to support it, the claim goes in the Unsupported column and the reason recorded is no evidence was offered. That is a different finding from the evidence offered was weak, and the difference will matter if you ever put the page in front of someone. If a study was named but you could not retrieve it, that is a third case again, and it belongs in Open with the name as you received it.

Unknown is a state, not a failure. Supported, unsupported and conflicting are all conclusions. Any step above can end without one, and an inventory with nowhere to put that outcome will push it into one of the other three, where it will be read as a conclusion you never reached. The column it lands in is unsupported, which quietly converts I have not established this into this is not supported. Those are not the same statement and only one of them is true. Keeping the fourth column honest is what stops the method from producing a firmer answer than the evidence gave you, and an open question is more useful than a premature conclusion because it tells you what to ask next.

A worked example

The following claim is invented for this page. It is not taken from any real business, and any resemblance to wording you have seen elsewhere is a function of how this kind of copy is generally written.

Invented example. This is not a quotation from any record.
“Our evidence-guided protocol uses material taken from you, so it sits outside FDA requirements, and published research supports it.”

Step 1. Four claims: the approach is evidence-guided; the material is autologous; being autologous places it outside FDA requirements; published research supports this use.

Step 2. Two names, and this claim supplies neither. “Material taken from you” is not a product name, so there is no lookup key yet; and it is not a material name either, because it does not say which cells, from which tissue, processed how. Both requests go in writing. Until the product name arrives, step 3 cannot run at all.

Step 3. With the exact product name, search the current record for it. Suppose the answer comes back as a trade name: search that name, and read which of the four outcomes you got. If nothing is found under it, check the name before concluding anything, then search again.

Step 3b. If it is genuinely absent, the material name now does its work: which framework is this preparation in, what is the stated basis for that, and is there an identifier that goes with it? Ask directly rather than inferring from absence, and remember that some frameworks produce no number at all.

Step 4. If a product was found, compare its licensed indication with joint pain as proposed here.

Step 5. Ask for the published research and work through the nine fields.

Step 6. The third claim can already be sorted without waiting for the others. Being autologous is a condition inside a four part test and also relates to a separate exception, and neither of those is a general exemption. The claim as phrased overstates what being autologous establishes. That belongs in the conflicting column, with a note pointing to the criteria.

Notice what the exercise produced. Not a judgment about anyone’s honesty. One specific sentence that does not hold as phrased, which goes in the Conflicting column, and three questions still unanswered, which go in the Open one and stay there with the date attached. Nothing in that inventory is invented and nothing in it is a verdict.

What this method does not do

It does not tell you whether a treatment works. It does not tell you whether something is right for you. It does not establish that anyone has acted improperly.

It tells you what the public record says, where it differs from what you were told, and which questions remain open. For a decision of this size, that is a reasonable thing to have in hand. How long it takes depends on how quickly the answers come back, and some of them will not come back quickly.

Where to go from here

Each step has a page behind it. Work through them in order rather than by interest: the material comes before the approval, and the approval comes before the evidence.

Before you leave this page: write your list of separated claims now, before the conversation fades. Step 1 is the one that gets harder with time, and every other step depends on it.

What this does not mean

This page describes a method for comparing statements with public records. It does not evaluate any treatment, product, practice or individual case. The example above is invented. Completing this exercise does not replace a conversation with a qualified clinician who knows your history, and it is not intended to.

Official sources behind the steps on this page. This page quotes no official record. The one quotation above is invented copy, labelled as such where it appears. Each step rests on one of the records below, and the pages that examine them quote from them in full. The method on this page is only worth something if you run it, and running it starts on one of these five.

FDA · Approved Cellular and Gene Therapy Products · accessed 18 September 2026
FDA · Minimal Manipulation and Homologous Use (guidance, July 2020) · accessed 18 September 2026
FDA · Same Surgical Procedure Exception under 21 CFR 1271.15(b) (PDF) · accessed 18 September 2026
FTC · Health Products Compliance Guidance · accessed 18 September 2026
FDA · 510(k) Premarket Notification database and Product Classification database · accessed 18 September 2026 · step 3 sends you to these whenever what was cleared is a device rather than a product; they are live records and they are what the second of the four outcomes is about

Written and fact-checked against the sources above on 18 September 2026. No independent expert review has taken place yet, and this page says so rather than implying one. This page is reviewed every six months and updated whenever a step’s underlying page changes.