The U.S. Food & Drug Administration (FDA) has been more active in issuing “Consumer Alerts” as of late. On July 22, 2020, the FDA published a new alert pertaining to birth tissue products including exosomes. This is an extremely important article that makes it clear which orthobiologics are and are not legal. Let us explain.
Regenexx Tampa Bay Remains Compliant With FDA Guidelines
Regenexx Tampa Bay has always been compliant with the guidelines set forth by the FDA and will continue to do so. This means using orthobiologics for orthopedic conditions that are exempt from the typical FDA standards for regulating “stem cells” and other tissue products. That is, the tissue is exempt when it is autologous (from the same patient), minimally manipulated, and removed and then placed back in the same patient during the same procedure. While the FDA has indicated that many “stem cell” clinics are in violation of their regulations, the procedures offered by Regenexx Tampa Bay are compliant with those regulations. These include:
- Platelet-rich plasma (PRP) and blood products
- Bone marrow concentrate (BMC, BMAC, stem cells from bone marrow)
- Fat/Adipose grafts (Micro-fragmented fat, MFAT) (NOT stem cells from Fat)
The substances listed above are the most studied within the regenerative medicine industry and have the most safety data behind their use in the field of orthopedics. In particular, Regenexx has published the largest safety research paper in the world on bone marrow stem cells. Regenexx Tampa Bay takes pride in being a leader in the world of Interventional Orthopedics with physicians that are highly trained and versed in the evidence of this arena. Our guiding principle that our procedures are all FDA compliant, safe, and autologous (from the same patient) has been upheld by the FDA time and time again.
FDA Regenerative Medicine Consumer Alert
The FDA’s “Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes” is one of many public warnings and letters that have been issued over the past few years. The reason that this particular article stands out to us is that it is not just another generalized statement. This alert indicates everything that the FDA finds to be an unapproved drug product all in one statement.
In the eyes of the FDA, the information below describes what is NOT legal:
“Anyone considering the use of anything purported to be a regenerative medicine product, including stem cell products, exosome products, or other widely promoted products such as products derived from adipose tissue (this product is also known as stromal vascular fraction), human umbilical cord blood, Wharton’s Jelly, or amniotic fluid should know:
- None of these products have been approved for the treatment or prevention of COVID-19, acute respiratory distress syndrome (ARDS), or any other complication related to COVID-19.
- None of these products have been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain.
- None of these products have been approved to treat any neurological disorder, such as multiple sclerosis, amyotrophic lateral sclerosis (ALS; Lou Gehrig’s disease), Alzheimer’s disease, Parkinson’s disease, epilepsy, or stroke.
- None of these products have been approved for the treatment of any cardiovascular or pulmonary (lung) diseases, such as heart disease, emphysema, or chronic obstructive pulmonary disease (COPD).
- None of these products have been approved to treat autism, macular degeneration, blindness, chronic pain, or fatigue.”
The illegal product list is as follows:
- Adipose stromal vascular fraction
- Umbilical cord blood
- Wharton’s jelly
- Amniotic fluid (one exception is a product called AmnioFix for knee arthritis. This has been approved by the FDA)
The article also states that these products cannot be used to treat any of the following diseases:
- Orthopedic conditions
- Neurologic disorders
- Cardiovascular or pulmonary disorders
- Macular degeneration/blindness
- Chronic pain
Note that three things were not listed on the FDA’s comprehensive list:
- Platelet-rich plasma (PRP) and blood products
- Bone marrow concentrate (BMC, BMAC)
- Fat grafts (Micro-fragmented fat, MFAT)
We would NOT use these autologous products to treat anything other than orthopedic injuries without an IRB approval and a “no-change” randomized controlled clinical trial. We hypothesize that advertising the fact that fraudulent stem cell clinics are using these autologous products to treat neurologic conditions will draw the same negative response from the FDA as above. Straying out of the realm of orthopedic care is likely an FDA violation.
It is important to note the fact that the above orthobiologics are not on the “illegal list.” This is consistent with the agency’s prior statements that it would give orthopedic treatments a wider scope under “regulatory discretion.”
The FDA’s Approach toward Clinics
Circling back to the FDA’s Consumer Alert, this is a huge leap forward for legitimate regenerative medicine as it clearly outlines what is not legal. This is not necessarily new information. It has been included in various past warning letters and other FDA communications, but not ever in one place directed at consumers. If you’d like to know what is coming next in our industry, the place to find that information is often in the aforementioned warning letters. What can we learn from the FDA’s most recent published warning letter? A significant change in their approach to providers and clinics. The example below showcases this.
This particular letter shows recent trends as well as a few new trends to take note of. This is a letter to a chiropractic clinic in which the FDA and other federal agencies reviewed the claims made on the clinic’s website. However, note this sentence:
“The FDA has observed that you offer an umbilical cord derived stem cell product for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.”
Meaning that the FDA is holding the medical provider, who is in fact the purchaser and user of a product manufactured by another party responsible. Acting as if the clinic was the manufacturer of the violative product. The letter continues: “Your product is also an unlicensed biological product.” The agency refers to “your product” many times throughout the letter even though this clinic is not manufacturing any of its advertised products.
One new trend we have seen is the multi-agency backing. Notice that four federal agencies are listed on this letter — the FDA-CBER, the FTC, the FDA-CDRH, and the FDA-CFSAN.
Both the FDA and the FTC together is worrisome. It is our understanding that responding to an FTC complaint can cost around 6 figures by itself. Further, CDRH is also listed because of the COVID test kits and CFSAN is included because of the IV vitamin treatment protocols and kits.
Stopping the Birth Tissue “Stem Cell” and Exosome Claims
If you are manufacturing, selling, advertising, or using umbilical cord “stem cells”, amniotic or placental derived “stem cells”, or exosomes, these are illegal drug products that do not have the approval to be administered. You need to cease now as you are violating federal law and are criminally liable if you continue to knowingly practice unlawful behavior.
In addition to the concerns about violations in using these unapproved products, the products that claim to have living stem cells in them, actually DO NOT have any. This has been tested by multiple independent academic labs and stem cells have never been found in these off-the-shelf products sold to medical and chiropractic offices despite what the manufacturers are claiming.
The FDA has generally left birth tissue vendors alone that DO NOT claim that their product has living stem cells, specific clinical indications, or more than minimally manipulate the tissue.
This is a thin line to which many birth tissue vendors have successfully walked. The FDA in our example is specifically targeting manufacturers who have taken the incorrect path in order to boost sales. These people claim that their products contain stem cells, often list specific uses for the product like osteoarthritis, and who may or may not more than minimally manipulate the tissue. Sadly, they have now lumped clinics and providers into the same bucket as these manufacturers who are muddying the waters.
Advice for Providers and Patients
If you happen to be a clinic using these products in these ways, you can potentially be targeted and treated as a manufacturer. The FDA can then inspect your clinic site as if you are a drug factory manufacturing millions of medication doses a month, an inspection that any medical clinic will likely fail. Also, the FTC will likely file a complaint blowing the legal costs to defend your practice through the roof.
If you happen to be a patient that is receiving umbilical cord “stem cells” or exosomes, you may find yourself in the unfortunate situation of being in the middle of a gruesome battle. Your appointments may be canceled even though you prepaid for care or you may be present in the clinic when the federal agents show up and shut the practice down.
The bottom line, this new FDA Consumer Alert is a huge leap forward regarding an issue that seems to have gone largely unnoticed. This is a rare look into the FDA’s thought process on orthobiologics that puts all of the critical information in one place. Please take note of the consistent FDA warning letters as well. The agency is now treating clinics as manufacturers and is working with other federal agencies to go after those “bad characters” in our industry.