In the rapidly evolving landscape of regenerative medicine, exosomes have emerged as the latest method promising groundbreaking therapeutic and beautifying potential. These tiny vesicles, derived from cells, are being hailed for their ability to facilitate tissue repair and regeneration, sparking excitement among scientists and clinicians alike. More importantly, such promise has spurred consumers to pursue advertised exosome products and treatments, eager to find another solution to youthfulness and wellness.
What are exosomes and how are they being offered?
Exosomes are lipid spheres released from cells that carry genetic information and protein to other cells, and are involved in numerous biological processes and cell functions. Research suggests that their potential benefits include stimulating desired responses through an exosomes’ stored information. Scientists propose various possible uses, such as for intracellular delivery of drug or genetic treatments, liquid biopsies, and even regenerative medicine practices such as improving cartilage and nerve function. Exosome use for healing and therapy is akin to proposed usages of stem cells, stromal vascular fractions, umbilical cord blood and/or cord blood stem cells, amniotic fluid, Wharton’s jelly, and ortho-biologics.
How are exosomes different from stem cells?
While stem cells and exosomes may be analogous in some ways, stem cells differ in that they are found throughout the body, can be isolated and grown in labs, and also have the ability to replicate and develop into a variety of specialized cell types. Exosomes are generated in particular cells for the purpose of carrying information and cannot be replicated.
Currently medical spas utilizing exosome market the product as a treatment for ‘beauty enhancement’ believing it can improve overall complexion, revitalize hair and hair growth, increase collagen and elastin, reduce acne breakouts, improve the appearance of scars, boost collagen production, address sagging skin, and more. Exosomes are also being offered as a therapy treatment for chronic conditions. Advertised as a method of regenerative medicine, potential benefits could include repairing tissues, preventing chronic inflammation, and even addressing degenerative diseases. If effective, they could ease symptoms of debilitating diseases such as osteoarthritis, fibromyalgia, and even cancers.
What is the legal status for exosomes?
The Food and Drug Administration (“FDA”) has the authority to regulate marketing and approval of regenerative medicine products. The FDA is clear that “exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products.” So what does this mean? First, understanding the classification products can fall into is critical to understanding the regulatory landscape.
On-Label vs. Off-Label Use: Key Differences Explained
When a product has been approved and is being used in accordance with the FDA’s approved use, this is considered “on-label use”. This means the FDA has evaluated the benefits and risks for use, such use is supported by strong scientific data, and there is approved labeling on how to use the product safely and effectively. But many times an approved product is used in a way that is not an approved use. This is referred to as “off-label use” meaning there is no evaluation of benefits and risks for the use, the use is not supported by scientific data, and there is no approved labeling. It is well settled that the FDA does not have any control over a physician’s ability to prescribe “off-label.” Therefore, physicians, generally, may prescribe for off-label use when they have determined that it is medically appropriate for their patient’s medical condition.
The Current FDA Approval Status of Exosome Products
Exosomes are in a more complex situation, unlike ketamine, and more similar to stem cells which are also regulated by the FDA. Currently the only stem cell products that are FDA-approved for use are blood forming stem cells, or hematopoietic progenitor cells, derived from umbilical cord blood. These stem cells can be used in patients with disorders that affect the production of blood, and are not approved for any other use. But according to the FDA, there are currently no FDA-approved exosome products. In other terms, there is no means to market them for human use or to produce them for human use. Exosome products may only be distributed to participating investigators and/or administered to humans if a sponsor has an Investigational New Drug application—an IND—or the products are subject of an approved biologics license application (BLA).
Exosomes as well as stem cells and other biologics have been an active area of concern for the FDA. They have issued multiple consumer alerts and advisories seeking to prevent product mistreatment and potential harm by quelling misleading information or practitioner statements about conditions exosomes are purported to treat. The FDA has also been active in investigating and issuing letters to entities manufacturing or marketing these treatments outside their approved programs.
Can I offer exosome therapy in my medical spa?
Many exosome products are sold to be used as topical creams to avoid the practice of medicine issue. However, some practices will start to incorporate the exosomes into a medical treatment. Since exosomes are not FDA approved and the FDA does not interfere with the practice of medicine, exosomes use for medical purposes is regulated by the medical board. Medical spas must understand the applicable state, especially medical board, rules surrounding the use of non-FDA approved products. This may require initiating an IND, locating a current one to participate in, or seeking approval from an Institutional Review Board (IRB) in addition to other heightened requirements.
Because these are new and developing treatments with a historical scrutiny from the FDA, the risks and legal landscape is in a constant state of change and medical spas should ensure they understand how their jurisdictional rules apply to such a novel, unapproved product.
ByrdAdatto Can Help You Understand Exosomes
At ByrdAdatto, we help guide businesses through the complexities of regenerative medicine. Our legal team can help you navigate regulations surrounding exosome treatments. If you have questions about exosomes or need assistance with other regulatory matters to stay compliant, contact ByrdAdatto.
