What we will not do
We will not describe any product as treating, curing, preventing, or improving a disease, condition, or symptom. We will not name a condition in connection with a product, and we will not use outcome language such as 'results' or 'proven' to describe what a product does in a patient.
We will not market to patients, and we will not advise on clinical use, dosing, indications, or procedures. Those determinations belong to the licensed physician who purchases the product, working with their own clinical judgment and regulatory counsel.
What we will do
We will tell you plainly what a product is, how it was sourced and processed, and what documentation exists for it. We will point you to the FDA and FTC guidance that governs this category so you can read the primary source yourself rather than take our summary on faith.
We will flag, in plain language, where regulatory status is unsettled. FDA states that there are no FDA-approved exosome products. They are generally regulated as biologic drugs under section 351, and decisions about purchasing or clinical use belong to the physician, working with their own regulatory counsel. Wharton's jelly products are offered under the supplier's human cell and tissue product framework; whether a given intended use qualifies for that framework under 21 CFR 1271.10 is a determination for your practice and your counsel, not for us.
Helping you evaluate regulatory posture
We are a distributor, not a regulatory authority and not your legal counsel. When you ask about regulatory posture, we share the documentation we have, point to the public guidance that applies, and tell you directly when a question is outside what we can answer.
These products are not FDA approved or licensed for any disease or condition. Information on this page is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Will you tell me what this product treats?+
No. We do not make or imply disease, condition, or treatment claims for any product, and we don't advise on clinical use. That determination is for your practice and your counsel.
Can you confirm a product qualifies under 21 CFR 1271.10?+
No. We can share the documentation and processing description the supplier provides. Whether a specific intended use meets all applicable criteria in 21 CFR 1271.10 is a determination for your practice and your counsel.