Unproven stem cell treatments: Is the US Supreme Court sending a message?

Recently, the US Supreme Court declined to hear an appeal from stem cell clinics, which challenged the Food and Drug Administration (FDA)'s authority to regulate unproven stem cell treatments.

In California Stem Cell Treatment v United States, the Supreme Court refused to review the decision of the Court of Appeals for the Ninth Circuit, and denied the Goldwater Institute's motion to file a related brief for consideration. This decision means that the previous ruling will stand, affirming the FDA's regulatory oversight of stem-cell-based treatments (see BioNews 1260). This has important implications for stem cell clinics and their patients.

The FDA has become concerned about for-profit entities that advertise stem cell therapies as treatments for various diseases and medical conditions, without robust scientific evidence supporting the safety and efficacy of these medical procedures. In 2017, the agency developed governance for regulating regenerative medicine products and cellular therapies. Moreover, it expressed the intention to expand enforcement of rules relating to cellular therapies. The FDA has brought lawsuits to prevent unscrupulous stem cell businesses from administering stem cell products derived...