No, FDA Did Not Change Stem Cell Regulations with One Announcement  

This week, FDA’s Commissioner made a detailed announcement about regulation of adult stem cells which caught everyone’s attention but it lacks specifics and does not indicate a change in the existing rules for the regulation of stem cell clinics. Adult stem cell therapies are available freely in the US from hundreds of providers. There are even well-known lists of these clinics. The stem cell therapies could have cells from bone marrow, cord blood or fat tissue, and are offered to treat practically every ailment. There is no standard manufacturing process or treatment regimen, little quality control, and the product may contain as little as 1-5% stem cells while being labeled and marketed as “mostly” stem cells. Many don’t even care to register with FDA, and those who do claim to be HCT/P and compliant with 21 CFR 1271. Many assert to be beyond FDA’s jurisdiction by labeling their services as surgical and medical treatments. FDA has published numerous guidance documents and a few articles claiming that most of these clinics are not complaint with the existing laws but has done practically nothing. The clinics operate openly, and even advertise their services in major media; doctors do road shows, and thousands of patients pay out of pocket to get these treatments since they are not covered by insurance. Several clinics are even bold enough to register “pay to participate” clinical trials on clinicaltrials.gov with these adult stem cell products. Very few of these clinics have been audited, and very few Warning Letters have been issued to these businesses in the entire history of this regulation. The Warning Letter cited by the Commissioner is the only Warning Letter issued to any stem cell clinic in the last year. And even the subject of that Warning Letter has challenged FDA’s jurisdiction promising a legal battle. The fact that FDA is well aware of the adult stem cell industry and hasn’t done much to regulate it, has created the perception of legitimacy. The announcement touts long standing FDA position about adult stem cells, summarizes some recently passed laws, and promises increased enforcement of the existing laws. But the existing laws have been hard to enforce and the announcement sheds little light on changes in the policy. The Commissioner promised to create “a new working group to pursue unscrupulous clinics through whatever legally enforceable means”. This shows good intent but the statement is vague. Even the two examples used in the announcement to highlight FDA’s stronger enforcement can be argued to be outliers that had it coming anyway. One clinic in California was illegally treating stem cells with vaccinia virus to treat cancers, while the other in Florida had a long history of negative audit findings and recent history of major adverse events listed in a much cited article published a year ago by the last FDA Commissioner. There is certainly a need for FDA action. We are promised a new enforcement policy and clarity on the existing laws. But history breeds skepticism. We will know soon if this is the start of a new chapter in the regulation of stem cell clinics or just another announcement. For now, nothing has changed with this announcement.