This is one of many businesses across the nation that offer treatments for a wide array of illnesses using products that are said to contain stem cells which have healing and regenerative properties. Stem cells used by some of these clinics are extracts derived from fat; others use the patients’ own bone marrow, and some use cord blood or amniotic membranes.
This injunction only applies to the one company in Florida, but it sets a precedent and sends a clear warning to others that are performing similar procedures. This injunction states that U.S Stem Cell’s fat extracts are legally a drug which makes them subject to US FDA regulation, as such the company can no longer produce or market the extracts unless they meet standards for good manufacturing practice.
The company claimed it could treat neurological, degenerative, orthopedic, and autoimmune diseases including ALS, Parkinson’s, arthritis, back problems, heart and lung disease, and other ailments. It’s clinic was removing fat from the patient, then processing it to extract stem cells to inject back into the patients.
The company’s chief scientific officer tried to argue that the extracts contained the patient’s own cells and were therefore not a drug and were exempt from FDA regulation. Regardless a judge granted the FDA request for the initial injunction on June 3, 2019. The company said at the initial ruling it will stop using stem cells derived from fat, but it would continue to offer treatment using bone marrow and birth tissues as the judge had limited the injunction to procedures involving fat extracts.
In the ruling Judge Ungaro outline the steps the company would have to take to resume using the fat extracts which includes the company having to hire and independent expert to inspect their facilities and manufacturing practices, and certify to the FDA that the company is complying with the agency’s rules. Additionally the FDA will also have to inspect the company’s facilities, if passed inspection an auditor would then need to be hired to inspect the facility at minimum once every six months for two years and then once a year after that, all of which is to be done at the company’s expense.
The FDA can order manufacturing to stop and recall products if the company fails to comply with the FDA, and the FDA can fine the company $15,000 for each violation plus $15,000 a day for as long as the violation continues. According to the FDA this injunction sends a strong message to other companies who also manufacture unapproved stem cell products.
According to an FDA statement, “We know that there are clinics across the country that manufacture or market violative stem cell products to patients, claiming that they don’t fall under the regulatory provisions for drugs and biological products. The F.D.A. has consistently stated that this is not true, and the result of this case proves that.”
According to experts this ruling suggests the FDA is likely to win an injunction that has been requested against another stem cell business in California with dozens of affiliates across the nation.
