The Compliant Marketing Kit gives verified accounts claim-safe messaging frameworks, disclosure language patterns, and channel-by-channel guidance so your marketing team can describe a biologics program without drifting into disease, efficacy, or unapproved-therapy claims. This is educational and documentation support, not ghostwritten patient advertising, not a compliance guarantee, and not legal or clinical advice. Your clinic's counsel makes the final call on any claim you publish.
What is in the kit
The kit is a set of reference materials, not finished ads. It includes a messaging framework that separates what a product is (a tissue allograft or an exosome preparation, with its processing and testing description) from what a clinic may imply it does, which is the line FDA enforcement has focused on in recent warning letters.
It also includes disclosure language patterns your team can adapt for website footers, consultation forms, and social bios, plus a short glossary of terms that are safer to use in marketing copy versus terms that regulators treat as red flags.
- Claim-safe messaging framework (what to say, what to avoid)
- Disclosure language patterns for sites, forms, and bios
- Channel-specific do's and don'ts (website, organic social, paid ads)
- A short list of FDA and FTC source materials your counsel can review
Why this matters now
FDA's enforcement discretion period for HCT/Ps ended May 31, 2021, and in 2026 the agency issued warning letters to distributors of private-label Wharton's jelly and exosome products, citing disease claims found on their websites and social accounts (see the R3 Medical Companies, Blue Horizon International, and Dynamic Stem Cell Therapy warning letters). FDA's own consumer alerts on regenerative medicine products, including stem cells and exosomes, make the same point to the public.
Those letters make a consistent argument: FDA treats a company's own marketing as evidence of how a product is intended to be used, regardless of any research-use disclaimer printed elsewhere on the page. A clinic's website and social accounts are read the same way. The FTC's Health Products Compliance Guidance applies the same standard to any health-related claim, direct or implied.
What the kit does not do
It does not write patient-facing ads that reference a disease, condition, or expected result. It does not certify that any specific page, post, or ad your clinic publishes is compliant. Compliance is a judgment call that belongs to your clinic and its own regulatory counsel, informed by your specific claims, channels, and state law.
It also does not offer clinical advice. We do not advise on dosing, injection technique, patient selection, or procedures, and nothing in the kit should be read as a recommendation for a specific clinical use.
Channel notes
Paid advertising carries its own platform-level restrictions on top of FDA and FTC rules. Google's Ads policy on speculative and experimental medical treatments restricts advertising of cell therapies in the United States, which is worth reviewing before a clinic builds a paid campaign around a biologics program.
Website and organic social content face a lower bar to publish but the same regulatory exposure once published, since FDA has pointed to both in recent warning letters. A consistent disclosure, placed where a visitor will actually see it, is one of the simpler risk-reduction steps a clinic can take while its counsel reviews specific page copy.
Who can request the kit
The kit is available to verified clinic accounts. Account verification runs through an NPI number, checked against the NPPES NPI Registry, consistent with the account verification used across our ordering process.
Request access through your account contact or the general contact form. We will confirm your license status before sending materials.
Frequently asked questions
Will you write our ads or website copy for us?+
No. The kit gives your marketing team frameworks, disclosure language patterns, and source references to work from. Your clinic, or its agency, writes and approves the final copy, and your counsel decides what is published.
Does using the kit guarantee our marketing is compliant?+
No. Nothing we provide is a compliance certification. Whether a specific page or ad is compliant depends on its exact wording, channel, and your state's rules, which is a determination for your clinic and its legal counsel, not for us.
Can we call these products stem cell therapy in our marketing?+
We do not support that framing. Published evaluations of commercial Wharton's jelly allografts have found low cell counts and viability with few or no colony-forming mesenchymal stromal cells, so documentation does not support a stem cell therapy claim, and FDA has specifically warned about stem cell and exosome marketing claims in recent letters.
Does this cover state-specific rules like Florida's stem cell statute?+
The kit references that Florida's SB 1768 (Florida Statutes 459.0127, effective 2025-07-01) lets physicians use certain non-FDA-approved stem cell therapies under specific conditions, but a state statute does not override federal FDA rules on the product itself. Clinics in any state should confirm current state law with their own counsel.
What do we need to request the kit?+
A verified clinic account with an NPI number on file. Once verified, your account contact can request the kit materials directly.