Stem Cells: FDA Continues Enforcement Effort With Letter to Florida Supplier

Regulatory NewsRegulatory News
| 22 November 2019 | By Michael Mezher 

As part of its ongoing enforcement efforts against companies marketing unapproved stem cell products, the US Food and Drug Administration (FDA) on Wednesday sent an untitled letter to Florida-based manufacturer RichSource Stem Cells over unsubstantiated claims for its Richgen allograft product.
The letter comes months after FDA announced it would step up its enforcement efforts against rogue stem cell clinics and manufacturers for marketing unproven stem cell therapies to patients with little evidence of their safety or efficacy.
The increased efforts come as FDA approaches the end of a 36-month period of enforcement discretion that began in November 2017, during which the agency said it would focus its efforts on products that raise the greatest safety concerns.
RichSource describes Richgen as “a combination of amniotic fluid and membrane, Wharton’s jelly, and placental tissue,” and claims the product can treat various diseases including cancer, diabetes, Lyme’s disease, asthma, arthritis, neuropathy and joint pain, as well as for topical wound healing.
According to FDA, Richgen does not meet the exceptions for human cell, tissue, or cellular or tissue-based products (HCT/Ps) laid out in 21 CFR 1271.15 or the criteria under 21 CFR 1271.10(a), and are not solely regulated under section 361 of the Public Health Service Act and the regulations in 21 CFR Part 1271. As such, FDA says that Richgen is regulated as a drug and a biological product and would require a valid biologics license application (BLA) to be legally marketed.
FDA also notes that the product raises significant safety concerns as it is marketed to treat serious and life-threatening conditions and “because the product is administered by various higher risk routes of administration, including via spinal injections, their use, if contaminated could cause a range of adverse events.”
Leigh Turner, associate professor at the University of Minnesota Center for Bioethics, told Focus he believes the untitled letter, along with other recent actions by FDA, is “part of a pattern of stepping up enforcement against manufacturers and suppliers of birth tissue products.”
Regarding RichSource, Turner said that two issues likely caught FDA’s attention: the way in which the Richgen products are administered and “the breadth of advertising claims being made.”
Turner also said that “FDA seems to be taking [a] fairly understanding approach to these businesses,” by sending warning and untitled letters and advising the companies to come into compliance during the 36-month period of enforcement discretion.
Turner added that he thinks the 36-month period “was too lengthy” and has “provided a period where many more businesses are entering the marketplace.” Corporate records for RichSource show the company was incorporated in 2018, just months after FDA released its regenerative medicines framework and announced the 36-month enforcement discretion window.
In an email to Focus, RichSource President and CEO Sara Oracle said that Richgen is “produced according to all regulations required. I will be inviting the FDA to inspect the ISO 7 certified clean room and ISO 5 production hood tissue processing lab that we purchase the product from. This way confirmation can be made showing that the lab meets and exceeds their regulations. The [American Association of Tissue Banks] AATB just inspected the lab and is in the process of supplying certification.” 


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found