PA Green Wellness FDA Warning Letter | Stem Cell Investigation

The U.S. Food and Drug Administration and the Federal Trade Commission issued a joint warning letter dated August 17, 2020, to PA Green Wellness LLC of Pennsylvania. The letter identifies the business as a Predictive Biotech certified facility and copies Predictive Biotech, Inc., of Salt Lake City, Utah. Regulators reviewed the clinic’s website and Facebook page during the early months of the COVID-19 pandemic, and cited consumer concerns.

The Lyon Firm is investigating claims of misleading marketing and potential consumer fraud involving some stem cell clinics and regenerative cell products like Wharton's Jelly.

PA Green Wellness and Predictive Biotech Warning Letter Puts Stem Cell Marketing Under Scrutiny

The warning letter named one product, CoreCyte, which the FDA describes as umbilical cord derived. According to the letter, clinic materials called it a Healthy Lung Injection and described mesenchymal stem cell treatments to support lung health during COVID-19. The FDA stated that CoreCyte has no approved biologics license, no investigational new drug application in effect and no emergency use authorization. The letter does not list any other clinic offerings.

The agency concluded that using CoreCyte to prevent or treat COVID-19 does not match an umbilical cord’s basic function in the donor. On that basis, the FDA regulates the product as an unapproved new drug and a biological product.

The FTC added that disease claims require competent and reliable scientific evidence, and it said no such study was known to exist for COVID-19 use. The letter requested a response within 48 hours. These are regulators’ positions, not court findings, and the letter does not address the clinic’s current practices.

FDA consumer guidance says unapproved regenerative products continue to be marketed broadly for conditions such as autism, chronic pain, arthritis and heart disease, often as safe and effective without adequate study.

The agency also warns that FDA registration or a clinicaltrials.gov listing does not make a product legally marketed, even though patients sometimes hear otherwise. It reports accounts of infections, tumor formation and blindness tied to unapproved products.

If you paid for a stem cell treatment or similar injection and believe claims about its results or safety did not hold up, The Lyon Firm wants to hear from you. Attorney Joseph Lyon has spent 23 years representing consumers in class actions and mass torts across all fifty states, including cases built on deceptive medical advertising.

Gather consent forms, advertisements and messages from the clinic, and contact our class action consumer protection lawyers. Filing deadlines vary by state, so early review matters. Call (513) 381-2333 or request a free, confidential case review.