What it is
The FDA is the U.S. agency that oversees medical products. It has issued public warnings about unapproved regenerative products. These include some injectable products made from amniotic fluid, amniotic membrane, umbilical cord or Wharton's jelly, and products marketed as exosomes.
The warnings matter most when a product is promoted for joints, pain, hair, skin or general 'regeneration.' In general, injectable amniotic and umbilical cord products are not FDA-approved for those uses. Marketing claims can sound confident even when a product has not been reviewed for them.
Not every amniotic product falls under the warning. Amniotic membrane used as a wound covering and on the surface of the eye is the established use. Many injectable products are also not stem-cell treatments. Most contain no living stem cells after processing, and they should not be described as regrowing cartilage or tissue.
How it’s traditionally been approached
Amniotic membrane has long been used by clinicians as a biological covering for certain wounds and on the eye surface. In those settings it is handled as a covering that is placed on the area, which differs from an injection.
Over time, some clinics began offering injectable products made from amniotic or umbilical cord tissue for orthopedic, pain and cosmetic concerns. This is where regulators have raised the most questions, because the products are often marketed beyond what has been reviewed.
Many people have traditionally approached joint and pain concerns with options that are better established. These include rest, movement-based care, physical therapy, medications, injections with a defined regulatory status, and surgery when a clinician judges it appropriate. Which of these suits a person is a decision for a licensed clinician after an evaluation.
How the right doctor may help
The right provider, such as a doctor in orthopedics and sports medicine or a regenerative medicine clinic, may help you sort out what is established from what is only marketed. A visit generally starts with your history, your symptoms and an exam, and possibly imaging or other tests if the clinician thinks they are needed.
A good provider may explain your options in plain language, including ones that do not involve any amniotic product. They may also tell you plainly when a product is not approved for the use being discussed. No provider can promise a result, and you should be cautious of anyone who does.
Questions worth asking: Is this product FDA-approved for this use, and if not, what is its status? What is its tissue source, and how was it processed? What are the risks? What are the alternatives? What is the total cost, including follow-up visits? Also check with your insurance before treatment, since coverage for unapproved products is often limited.
The whole-person view
Body, mind and stress affect each other. Ongoing pain can raise worry and disrupt sleep. Stress can also make the body feel more tense and sore. When a concern is wearing on you, it is natural to feel drawn to a promising-sounding option, so it helps to slow down and gather good information first.
A whole-person approach can sit alongside medical care. Somatic Experiences offers body-based support for how stress is held in the body, and Therapists.plus offers talk therapy for coping with worry and long-term health concerns. Neither replaces a licensed clinician's evaluation, and many people simply find them useful companions.
Somatic Experiences: nervous system regulation →Somatic Experiences: embodiment and movement →Therapists.plus: mind body connection →
Keep in mind
- Only a licensed clinician can decide what is appropriate for you after an evaluation, and this page is not medical advice.
- Injectable amniotic, umbilical cord, Wharton's jelly and exosome products for joints, pain, hair, skin or 'regeneration' are generally not FDA-approved for those uses, and the FDA has warned the public about unapproved regenerative products.
- Be careful with any claim of guaranteed results, avoiding surgery, or 'stem cell' benefits, and ask for the product's FDA status in writing.
- For an emergency, call 911. If you are in a crisis, call or text the 988 Lifeline.
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Frequently asked questions
What is the FDA amniotic products warning?
The FDA amniotic products warning is a public caution about unapproved regenerative products, including some made from amniotic or umbilical cord tissue. The concern is mainly about injectable products marketed for joints, pain, hair, skin or 'regeneration' without FDA approval for those uses. Ask a licensed provider about any specific product's status.
Are amniotic injections FDA-approved?
Generally, no. Injectable amniotic products promoted for joints, pain or similar uses are not FDA-approved for those purposes. Regulatory status can differ by product, so ask your provider to explain exactly what the product is and how it is regulated.
Is amniotic membrane ever an established treatment?
Yes. Amniotic membrane as a wound covering and on the surface of the eye is the established use. That differs from injectable products marketed for orthopedic, pain or cosmetic purposes.
Are amniotic products stem-cell treatments?
No, they should not be described that way. Most amniotic products contain no living stem cells after processing. Be cautious if a clinic says a product will regrow cartilage or tissue.
What should I ask a provider before considering an amniotic product?
Ask about the product's FDA status, its tissue source, the risks, the alternatives and the total cost. Also ask what evidence supports its use for your situation. Check with your insurance before treatment, since coverage may be limited.
Who can help me understand my options?
A licensed clinician, such as an orthopedic or sports medicine doctor or a regenerative medicine clinic, can evaluate your situation and explain your options. You can look for licensed providers through Providers.plus. A second opinion is always reasonable.
Educational resource. Amniotic Doctors shares general information and connects people with independent doctors. It is not medical advice, diagnosis or treatment. Talk with a licensed professional about your health.