18 Jul R3 STEM CELL: Responds to FDA Letter to Reaffirm its Commitment to Public Health and Safety
R3 Stem Cell, LLC (R3), a leader in regenerative therapy practices, issued a formal response to a letter it received from the FDA that raised concerns over alleged unapproved stem cell products to treat a variety of diseases and conditions as well as potential safety concerns. R3 assures both its patients and providers that it is reviewing its website and operations, that products recommended by R3 are manufactured in a tissue bank that is subject to FDA regulations and reaffirms its commitment to public health and safety in the developing field of regenerative medicine.
On May 28, 2019, the FDA issued a letter (the “Letter”) to R3 Stem Cell, LLC (“R3”), which noted that based on its review of R3’s website, it appeared that the products discussed on the website would be regulated as drugs by the FDA. Second, the Letter noted possible safety concerns arising from potential contamination. The Letter also noted that it was not intended to be a comprehensive review of R3’s operations.
In response to FDA’s May 28 Letter, R3 is reviewing its website and operations and takes the issues raised in the Letter very seriously. With respect to the potential safety issue from contamination, R3 is aware of no safety issues resulting from contamination.
R3 does not manufacture, package, or distribute any products. The procedures identified on R3’s website and discussed in the Letter involve products manufactured by a tissue bank registered with FDA and subject to FDA regulation. Those products are shipped directly to licensed healthcare practitioners. R3 plays no role in the manufacture, packaging, or distribution of the product, and therefore could play no role whatsoever in any potential contamination.
However, in response to the FDA Letter and to reaffirm its commitment to public health and safety, R3 is undertaking a comprehensive review of its business.
“We respect and appreciate the role of the U.S. FDA in regulating and providing guidance regarding human cells, tissues, and cellular and tissue-based products (HCT/P’s) and share FDA’s goal of promoting public health and safety,” said Dr. David Greene, CEO of R3.
About R3 Stem Cell
R3 Stem Cell is the national leader in regenerative therapies. Its mission is to educate patients and empower providers. R3 partners with top regenerative therapy centers to promote repair and regeneration of damaged tissue leading to health improvement – without the need for surgery. Learn more at www.r3stemcell.com or call (844) GET-STEM