Regulatory Focus™ > News Articles > New California Law Requires Posted Notices of Non-FDA Approved Stem Cell Products

New California Law Requires Posted Notices of Non-FDA Approved Stem Cell Products

Posted 04 October 2017 | By Zachary Brennan 

New California Law Requires Posted Notices of Non-FDA Approved Stem Cell Products

California Gov. Jerry Brown this week signed into law a bill that requires health providers to post notices in their offices when they are administering stem cell treatments that have not been approved by the US Food and Drug Administration (FDA).

The law is part of efforts to crack down on the use and sale of unapproved stem cell treatments, some of which are being hawked as cures for a range of diseases with few or no treatment options, like ALS, autism and spinal cord injuries.

California’s SB 512, which requires any health provider administering non-FDA approved stem cell treatments to post a notice and provide a handout about how the procedure has not been approved by FDA, also would impose maximum fines of $1,000 for each violation of the law.

Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota, told Focus via email: "Perhaps fewer patients will choose to pay for unproven and unlicensed stem cell interventions if they are aware that such products have not been approved by the FDA...However, the new legislation has limitations. For example, it requires health care practitioners to disclose that advertised stem cell interventions are not FDA approved, but the bill provides no guidance concerning how the risks associated with receiving such interventions ought to be discussed with patients.

"Also, the bill emphasizes disclosure and transparency, but it does not address the fundamental question of why health care practitioners are allowed to get away with selling what in some instances are cell-based interventions with genuine risks to patients and little or no prospect of therapeutic benefit," Turner, who's published a paper in Cell on the direct-to-consumer stem cell industry, wrote.  

The California law comes in direct contrast to a Texas law from June that blocks the Texas Medical Board from revoking, failing to renew or suspending a physician’s license based on his or her recommendations regarding access to or the use of a stem cell therapy.

But it's unclear what direction other states are taking. Turner added: "I haven’t noticed comparable legislation or draft bills in other states. California’s Bill 512, acknowledging its limitations, provides a model for how other states might craft legislation intended to protect patients from inaccurate marketing claims about so-called stem cell 'treatments.'"

FDA, meanwhile, said in late August that it is advancing a new framework to better regulate stem cell therapies later this autumn. The plan for the framework was sent out alongside a warning letter for a Florida stem cell clinic, known as US Stem Cell Clinic, and a news release on US Marshals seizing five vials of a vaccine FDA says is reserved for people at high risk for smallpox, such as military personnel.

But so far, FDA has been criticized for failing to crack down on the hundreds of companies nationwide selling unapproved and often unproven stem cell treatments. The agency so far has only issued a limited number of warning letters to companies like Cell Vitals in 2014, Irvine Stem Cell Treatment Center in 2015 and Lavian in 2016.

Updated 10/5/17 with comments from University of Minnesota's Leigh Turner.


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