For product manufacturers and distributors
FDA reads your marketing as intent. Check it before it ships.
RegenCompliance.AI checks the marketing of makers and distributors of tissue, exosome, topical and supplement products against its own product rules: product pages, sell sheets, clinic kits, labels and posts.
Free for 12 months. No card to apply. A person reads every application and replies within two business days.
25 beta spots.
If you are approved, the reply includes your activation link. Activating starts your 12 free months, no card needed to start.
Where product marketing goes wrong
Four places a claim turns into a status problem. Each one is checked.
Tissue, cord and amniotic products
FDA looks at what your labeling, advertising and other signs of intent say the product is for. A claim that a cord, amniotic or Wharton's jelly product treats a disease or condition is the claim FDA cites when it finds an unapproved drug and an unlicensed biologic. Registering with FDA or listing a trial does not mean a product is legally marketed.
21 CFR 1271.10FDA patient and consumer informationExosome products
FDA says there are currently no FDA-approved exosome products. Exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products, so treatment and efficacy wording is a problem before it is a style choice.
FDA public safety notification on exosome productsTopicals
FDA treats a topical as a drug when its claims reach structure or function, such as removing wrinkles or raising collagen. "Cosmeceutical" has no meaning under the law. Cosmetic wording stays on how skin looks.
FDA on wrinkle treatments and anti-aging productsFDA on cosmetic, drug or bothSupplements
A dietary supplement may carry structure or function statements only. A statement may not claim to affect a specific disease or class of diseases, and it needs the FDA disclaimer, prominently displayed in bold.
21 USC 34321 CFR 101.93What it checks
Built around what you make. Checked by product category.
The scanner uses the product category in your profile to decide which rules matter most. These are the checks for each category.
Tissue, cord and amniotic products
The scanner looks for disease and condition claims, mechanism claims about what cells or tissue do in the body, and wording that implies FDA approval. For a tissue claimed under section 361, it also looks for uses that are not homologous use, such as orthopedic or injection uses for membrane. It flags registration used as proof of legality or approval.
Exosome products
The scanner flags treatment, efficacy and repair claims and wording that implies FDA approval. It expects plain status wording: "There are currently no FDA-approved exosome products." Science education that has no product benefit and no buy button attached is treated differently from a product claim.
Amniotic fluid products
FDA treats amniotic fluid as a secreted bodily fluid, not as a cell or tissue product under 21 CFR Part 1271. The scanner flags pain and inflammation claims, tissue claims, and "361" claims for these products.
Topicals
The scanner flags structure and function claims, drug-like claims behind the word "cosmeceutical," and therapeutic or injectable-replacement claims for growth factor, conditioned media or exosome topicals. It checks that appearance wording stays on appearance.
Dietary supplements
The scanner flags disease claims, including disease claims that a product name, formulation, picture or citation implies. It checks that structure or function statements carry the FDA disclaimer, and it flags products that are not ingested but are sold as supplements.
Across every category
The scanner checks reviews and endorsements: fake, bought or hidden reviews, and paid endorsements without a clear disclosure.
Your product profile
Tell us what you make. Set it up now.
At setup you can add your product name, your product category, the regulatory status you believe applies, and the claims on your current label or materials. All of it is optional and self-reported. We do not verify it.
Your profile gives the scanner context. Your stated status is not treated as proof, and the claims you paste are background only. They never make a flagged claim acceptable.
How it works
Three steps. Set up, scan, fix.
When the problem is the product's regulatory status and not the wording, the scan flags it instead of offering a rewrite.
Apply and set up
Apply for the beta, choose the product manufacturer side, and add your product profile.
Scan what you publish
Paste text, enter a URL or upload a file: product pages, sell sheets, clinic kits, labels, ads and posts. Up to 200 scans a day for each scan type (text, URL and file).
Review the flags and suggested rewrites
Each flag shows a severity and a plain-English reason, with a suggested rewrite where wording can fix it. Treat every rewrite as a draft for your own legal review.
Beta, open to product manufacturers
Free for 12 months. No card needed to start.
25 beta spots. Product manufacturers and distributors can apply now. Beta members help shape the platform before public launch. That is why the rate stays locked while you stay subscribed.
- Scan product pages, sell sheets, clinic kits, labels, ads and posts against rules built for product makers.
- Up to 200 scans a day for each scan type (text, URL and file).
- Each flag shows a severity and a plain-English reason, with a suggested rewrite where wording can fix it. Re-scan to check the new wording.
- 3 seats: you plus two teammates, such as regulatory, marketing or a sales lead.
- Money-back guarantee: 30 days from your first payment, if you keep going after the 12 free months. Cancel anytime.
- For product manufacturers, the beta is free for 12 months. No card needed to start. The 12 months start the day you activate your seat. After that, add a card any time before your end date to keep going at $100 a month, locked in for life as long as you stay subscribed. No card on file? Access ends on that date and nothing is charged.
Free for 12 months. No card to apply. A person reads every application and replies within two business days.
- No patient records needed. Never paste PHI.
- Encrypted and US-hosted.
FAQ
Product manufacturer questions. Short answers.
Companies that make or sell tissue, cord, amniotic, exosome, topical and supplement products to clinics or to consumers, and the distributors that carry them. Other regenerative product makers can apply too; tell us what you make in the application.
Yes, once you are approved for the beta. Set up your account and product profile, then scan text, a URL or a file.
Clinic accounts are checked against clinic treatment-marketing rules. Device accounts are checked against device-promotion rules and the Indications for Use you paste in. Product manufacturer accounts are checked against their own rules, built around what a product is said to be for, the status words you use, topical and supplement claim lines, and reviews and endorsements. Each account is one side, chosen at signup. A business on more than one side runs a separate account for each.
No. They are drafts. A flag is not a legal finding, and a clean scan does not mean copy is lawful. Your own legal review makes the final call on anything that ships.
No to both. We are not legal counsel. We help you write clearer, more compliant copy before it goes to your own legal review. The scanner checks wording. It does not decide what your product is, and the status you enter in your profile is yours; we do not verify it.
Partly, as notes. Results for product manufacturer accounts include state law notes for Florida, Georgia, Tennessee, Utah, Vermont, Washington, California, Texas and Maryland, where they apply to the copy or the product category. The notes are advisory. They never change your score, and meeting a state rule does not make copy compliant with federal law.
Copy you scan is encrypted and US-hosted. The scanner reads marketing text only, so never paste patient information. For how scan data is used, read our Privacy page.
Your marketing shows what your product is for. Check it before it ships.
Apply, choose the product manufacturer side, and add your product profile at setup.
Not ready for the beta? The waitlist keeps you posted.
We are not legal counsel. We help you write clearer, more compliant copy before it goes to your own legal review. Not affiliated with the FDA or FTC. Not legal advice. Not medical advice. Please consult with your attorney and a licensed provider.