The FDA have sent urgent warnings to several companies.
The FDA have issued warnings to several companies that had been selling medical products derived from umbilical cord blood.
Umbilical cord blood is a great source of stem cells. These are unspecialized cells that have the ability to transform into virtually any type of cell.
For this reason, stem cell therapy is becoming increasingly sought after for the treatment of all sorts of conditions and physical injuries. This is despite the fact that research into this form of therapy is still in its early stages in many ways.
This is also why the FDA have issued detailed and strict regulations regarding which products derived from umbilical cord blood can receive approval to be sold to medical professionals and their patients, as well as under what conditions.
Recently, however, the FDA identified several companies that were selling umbilical cord-derived products without their approval.
What is more, many of these companies appeared not to have abided by the FDA guidelines when harvesting umbilical cord blood and preparing their products. This can put people using these products at very serious risk.
The FDA have therefore issued warnings to each of these companies, asking them to immediately address the issues and to reply to the warnings, detailing the steps they intend to take in order to remedy these issues.
Should the companies fail to respond appropriately, they may face seizures, injunctions, or even prosecution.
Products may have been contaminated
Following the May inspection of the Liveyon Labs and Liveyon LLC facilities in Yorba Linda, CA, FDA officials found that the companies were unlawfully harvesting, processing, and selling umbilical cord blood-derived products intended for use in individuals who were unrelated to the blood donors.
This type of usage means that the products must meet regulations issued both for drugs and for biological products, which requires that the companies file for special licensing in order to market them.
However, the products — called PURE and PURE PRO — obtained no such licenses. It also appears that the companies had not applied for appropriate licensing in the first place.
According to FDA officials, PURE and PURE PRO also failed to comply with current good tissue practice and good manufacturing practice regulations. This means that the companies had not appropriately screened the donors to make sure that they met all the required health markers before harvesting their umbilical cord blood.
The handling of the collected blood was also inappropriate, say the FDA. This means that the resulting products may have been contaminated with viruses or other potentially dangerous microorganisms.
The FDA have also sent untitled letters to two other companies — RichSource Stem Cells and Chara Biologics — because they found that these companies were selling unapproved stem cell products.
They also sent another 20 letters to manufacturers and healthcare providers that may also be offering people stem cell products that have not received FDA approval.
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, explains: "The FDA's mission includes protecting public health by helping to ensure the safety and efficacy of medical products that [people] rely on. The agency is aware that there are establishments who prey upon vulnerable populations by commercially marketing stem cell products with false and misleading claims about their effectiveness for treating serious diseases."
"As evidenced by the number of actions that the agency has taken this month alone, there are still many companies that have failed to come into compliance with the Federal Food, Drug, and Cosmetic Act and FDA's regulations during the period in which the agency intends to exercise enforcement discretion [...] when the use of the product does not raise reported safety concerns or potential significant safety concerns."
Dr. Peter Marks
"The agency continues to urge these manufacturers to engage with the agency about their regulatory requirements in the coming months," he adds.
Further reports of unsafe cellular products
The FDA have also issued a safety alert about exosome products. These are products involving tiny extracellular vesicles called exosomes.
According to some researchers, exosome therapy is the next step following on from stem cell therapy. However, as with any medical product involving cellular material, exosome products could cause serious adverse effects if people do not handle them properly.
However, some companies have also been offering faulty exosome products.
The FDA note that the Centers for Disease Control and Prevention (CDC) have brought to their attention the fact that a number of people in Nebraska have received treatments with unapproved products allegedly containing exosomes. Many experienced serious adverse effects as a result.
At present, the FDA are investigating these reports. They also urge people who wish to access stem cell or exosome products to only do so via FDA-sanctioned channels and programs.