FDA warns stem cell company over unapproved treatments
The US Food and Drug Administration ( FDA) has sent a warning letter to a stem cell company for marketing a number of unapproved treatments for a variety of life-threatening conditions.
The letter, dated Friday May 28, was addressed to David Greene, the CEO of Arizona-based R3 Stem Cell.
The FDA said the products, which are intended to treat conditions such as Lyme disease, diabetes, Parkinson’s disease, stroke and kidney failure, should be subject to regulation. This is because they are classed as “drugs and biological products” under the Federal Food Drug and Cosmetic Act and the Public Health Service Act.
Prior to marketing drugs and biological products, companies must demonstrate that the treatments are safe and effective for their intended use. But, R3 Stem Cell had failed to do so, the FDA said.
Additionally, it said because R3 Stem Sell’s treatments are administered by “high risk routes”, like intravenous therapy, there could potentially be significant safety concerns.
The FDA said that while R3 Stem Cell’s products could have been distributed for clinical use in humans in the developmental stage, even then, an application for an “investigational new drug” should have been filed with the FDA.
Norman Sharpless, acting commissioner of the FDA, said that there is not currently enough evidence to support the use of stem cells for purposes other than creating red and white blood cells.
“We continue to see companies and individuals use questionable marketing campaigns to take advantage of vulnerable patients and their families with unproven claims about their unapproved stem cell products,” Sharpless said.
“We’ve made it clear to the industry and the public that while we are taking a risk-based approach to regulatory actions, the FDA will continue to protect patients from the most egregious actors in this field,” he added.
The FDA added that if R3 Stem Cell fails to comply with FDA requirements, it may be subject to enforcement action, such as seizure, injunction, or prosecution.
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