January 21, 2021

The Niche

Trusted stem cell blog & resources

4,000+ comments on FDA stem cell guidances, mostly clones of “My cells are my cells”

Keep your hands off of my cells!

At least, that is what many are telling the FDA regarding stem cells.

The FDA issued four draft guidances related to stem cells in the past year or so, held two public stem cell meetings, and now must decide what it is going to do with an out of control direct-to-consumer stem cell clinic industry. In part it will need to sort through all public comments from the meeting and those submitted online.


There are 4,251 comments on the online docket on the FDA stem cell guidances and commenting is now closed. As of a few weeks ago I think there were just something like 15 comments.

Commenters have been busy.

Is there anything to be learned from these comments?

For one thing, a quick look at the comments finds that many are essentially identical. In fact more than 700 use the exact same phrase “My cells are MY cells” and it looks like hundreds more comments have the exact same or similar language is used in more extensive forms. “My cells are my property”. “My cells are mine”. And so forth.

It would seem the point is that these particular commenters believe that cells taken from their bodies should not be regulated as drugs under any circumstances.

Everyone is of course entitled to their own opinion, but cells can be drugs if they are changed or used in ways that are not homologous because these factors make them have higher risk to patients. To ask for cells to never be regulated as drugs is asking for chaos and many harms to patients, but people may not realize that.

It’s also notable that more than 260 comments appear to mention “big pharma”, likely invoking a common myth that big pharma controls the FDA and they are together working to block stem cell therapy development.

You can read Leigh Turner’s comment here and my comment here. I couldn’t find comments from others within academia on a brief search.

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