FDA looks at the totality of how a product is presented, including a website, sales materials, social media posts, and statements by sales representatives, to determine what the agency believes the product is intended to do. A label alone does not control this determination.
For HCT/Ps, intended use interacts directly with homologous use, one of the criteria in 21 CFR 1271.10 for qualifying under the section 361 framework. Marketing content from a distributor, an affiliate, or a clinic-facing account can shift how FDA reads a product's intended use even when the tissue itself has been minimally manipulated.
FDA has said that it reads distributor, affiliate, website, and social media content as evidence of intended use, and that a "research use only" disclaimer does not protect a product that is actually promoted for clinical application. Clinics should treat a vendor's marketing practices as part of regulatory risk assessment, separate from a vendor's claims about what a product accomplishes, and leave determinations about a given intended use to their own counsel.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
A vendor's marketing choices can change a product's regulatory classification, which is a risk factor a buyer should weigh independent of the tissue itself.