Back to All NewsNew Vermont Bill Would Require Disclosure for Stem Cell Therapies
Posted By American Med Spa Association, Thursday, February 13, 2020
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A bill introduced in Vermont would mandate disclosures for certain non-FDA approved treatments. Senate Bill 252 (S 252) is sponsored by Senator Virginia Lyons; you can review the full text of the bill here. S 252 has been referred to the Committee on Health and Welfare for further consideration.
S 252 would create an additional requirement for obtaining informed consent for many treatments and therapies that use stem cells. It would compel physicians, physician assistants (PAs), nurses and naturopathic physicians to disclose the following to the patient prior to any stem cell treatment that is not approved by the U.S. Food and Drug Administration (FDA):
This information must be provided in written form in a language the patient understands, and the patient must sign the consent form prior to treatment.
In addition to this informed consent requirement, S 252 also would require that a written notice in 40-point font stating the treatment’s FDA status and encouraging patients to consult with their primary care physician be given to every patient and posted at the entrance of the office. Additionally, all advertisements must carry a disclaimer regarding the FDA status of the treatment. S 252 would make it an act of unprofessional conduct to not abide by these requirements.
Laws and rules directly addressing stem cell treatments are relatively rare. As these types of treatments become more mature and widespread, it is likely that states will seek to pass laws regulating them.
We will be monitoring S 252 as it works its way through the legislative process. If you would like to contact the bill’s sponsor, she can be reached via her page of the legislature’s website.
S 252 would create an additional requirement for obtaining informed consent for many treatments and therapies that use stem cells. It would compel physicians, physician assistants (PAs), nurses and naturopathic physicians to disclose the following to the patient prior to any stem cell treatment that is not approved by the U.S. Food and Drug Administration (FDA):
This information must be provided in written form in a language the patient understands, and the patient must sign the consent form prior to treatment.
In addition to this informed consent requirement, S 252 also would require that a written notice in 40-point font stating the treatment’s FDA status and encouraging patients to consult with their primary care physician be given to every patient and posted at the entrance of the office. Additionally, all advertisements must carry a disclaimer regarding the FDA status of the treatment. S 252 would make it an act of unprofessional conduct to not abide by these requirements.
Laws and rules directly addressing stem cell treatments are relatively rare. As these types of treatments become more mature and widespread, it is likely that states will seek to pass laws regulating them.
We will be monitoring S 252 as it works its way through the legislative process. If you would like to contact the bill’s sponsor, she can be reached via her page of the legislature’s website.
