What the FDA has to say
1. The regenerative medicine industry was given a 3.5-year grace period. (Will I be scientifically accountable, or will I go rogue?)
The deadline came and went a year ago. They made their choices.
Innovative Regenerative Medicine Therapies – Patient Safety Comes First
In 2017, the FDA issued guidance on the regulatory framework for regenerative medicine therapies.
This policy gave manufacturers three-and-a-half-years to determine the appropriate regulatory pathway for their products, and if an application is needed, ample time to prepare and submit the appropriate application to the FDA.
[The FDA is] once again reminding manufacturers, clinics, and health care practitioners and providers that the compliance and enforcement discretion policy for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies, ended on May 31, 2021.
2. The risks are real.
Important Patient and Consumer Information About Regenerative Medicine Therapies
FDA has received reports of blindness, tumor formation, infections, and more, detailed below, due to the use of these unapproved products….
Potential Risks of Treatment with Unapproved Regenerative Medicine Products
It is of utmost concern that unapproved regenerative medicine products that have no proven clinical benefit and that may cause serious harm are marketed to patients.
Because these products are not FDA-approved, it’s very likely that adverse events are underreported by health care providers who treat patients with these products, and by patients who may have been harmed.
3. Myths and deception abound.
(Do you really want to trust a company that goes to great lengths to lie to you?)
Important Patient and Consumer Information About Regenerative Medicine Therapies
The US Food and Drug Administration (FDA) regulates regenerative medicine products….These products require FDA licensure/approval to be marketed to consumers. Before approval, these products require FDA oversight in a clinical trial….
FDA is aware that patients and consumers are… told that a product is registered with FDA, as a way to suggest that the products being offered are in compliance with FDA laws and regulations. This is often false. The… fact that a firm has registered with FDA and listed its product does not mean the product is legally marketed.
Please know that if you are being charged for these products or offered these products outside of a clinical trial, you are likely being deceived and offered a product illegally.
If you are being offered any of these products outside of a clinical trial for which FDA has oversight, please contact FDA at ocod@fda.hhs.gov
Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes
4. The FDA is not inhuman. You can actually talk to them and ask them questions. (We did! You can too!)
If you are considering receiving one of these products, please contact FDA at ocod@fda.hhs.gov. [Rebecca says that CBER offered their email, CBERProductJurisdiction@fda.hhs.gov as the best alternative for eye care providers, and also this phone number: 240-402-7912.]
If you are being offered any of these products outside of a clinical trial for which FDA has oversight, please contact FDA at ocod@fda.hhs.gov. Additionally, contact FDA if you are considering treatment with any of these products and have questions, or if you have been treated with these products and wish to report any adverse effects or file a complaint. We take these reports seriously and want to hear from you.