Stem Cell Advocates and Critics Push Back on FDA Guidelines
By Alexandra Ossola,
Scientific American
| 09. 21. 2016
Earlier this month the U.S. Food and Drug Administration opened its doors to public commentary on its newest guidelines on the use of therapies derived from human tissues, including stem cells.
The new guidelines, drafted last October, clarify existing regulations by outlining what uses of human tissue can be offered to patients without FDA approval. Many clinics offer patients unregulated, experimental procedures that have not yet undergone the official FDA approval process, which can take years. The major points in the new guidelines specify that: the function of these cells in the recipient’s body must be the same as in the donor; the treatment cells don’t affect the whole body of the recipient; and manufacturers can only manipulate the cells “minimally.” They also state which chemicals manufacturers can use to treat cells and prevent disease transmission.
The FDA notes the revised guidelines are meant to help manufacturers navigate regulations that are already in place. But many interpret them as a crackdown on clinics offering patients experimental procedures. “It is possible that after these public meetings the FDA may step up its...
Related Articles
By Alondra Nelson, Science | 09.11.2025
In the United States, the summer of 2025 will be remembered as artificial intelligence’s (AI’s) cruel summer—a season when the unheeded risks and dangers of AI became undeniably clear. Recent months have made visible the stakes of the unchecked use...
By Emma McDonald Kennedy
| 09.25.2025
In the leadup to the 2024 election, Donald Trump repeatedly promised to make IVF more accessible. He made the commitment central to his campaign, even referring to himself as the “father of IVF.” In his first month in office, Trump issued an executive order promising to expand IVF access. The order set a 90-day deadline for policy recommendations for “lowering costs and reducing barriers to IVF,” although it didn’t make any substantive reproductive healthcare policy changes.
The response to the...
By Johana Bhuiyan, The Guardian | 09.23.2025
In March 2021, a 25-year-old US citizen was traveling through Chicago’s Midway airport when they were stopped by US border patrol agents. Though charged with no crime, the 25-year-old was subjected to a cheek swab to collect their DNA, which...
By Julie Métraux, Mother Jones | 09.23.2025