FDA Has Taken Several Measures to Ensure Proper Regulation of Stem Cell Clinics

by Leriza Castronuevo | Sep 28, 2019 | Stem Cell News


There has been a massive growth in the number of stem cell clinics around the world in the past few years. Many of these clinics use stem cells to treat conditions that are not currently curable using traditional medicine.

Unfortunately, some clinics are not completely honest when making claims about the conditions that stem cell treatments can cure. In some cases, they will not have scientific evidence that proves stem cells can be effective at treating a specific condition, but will still offer the treatment to patients.

Earlier this year, the U.S. Food & Drug Administration (FDA) announced that they were going to place closer scrutiny on stem cells clinics making false claims. When making this announcement, the FDA said they were primarily concerned about patient safety.

Some stem cell clinics have attempted to sidestep FDA regulations by saying that their treatments were ‘practicing medicine’ instead of providing a medical product. This would place them outside of the FDA’s jurisdiction. Other stem cell clinics have falsely claimed that they were performing research instead of simply offering patient treatments, to escape FDA scrutiny.

The FDA is taking several steps to crack down on these dodgy operators. They are now demanding that companies must show how they manufacture their treatments to guarantee patient safety. There will also need to be testing for potency of stem cell products, which will help to evaluate risks.

In 2017, the FDA sent a warning letter to stem cell clinics to warn them against marketing unapproved products and violating correct manufacturing processes. Even though some stem cell clinics responded by telling the FDA they were not under its jurisdiction, the FDA has decided to investigate and prosecute bad clinics.

The additional scrutiny from the FDA will hopefully make the industry safer and increase consumer trust.

Source: Stem Cell Treatments Pose Risks to Patients: FDA Investigates

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