FDA WARNING_LETTER - New Life Medical Services, LLC - May 20, 2024

The FDA issued a Warning Letter to New Life Medical Services, LLC, following an inspection conducted from May 14 to May 20, 2024. The agency found that the company is unlawfully selling several human-derived products, including Restor+, Regain, Renyte (from umbilical cord), ReCyte/Cytosomes (from amniotic fluid), and Rexo (an exosome product). These products are classified as unapproved new drugs and unlicensed biological products. The FDA determined that they are intended to diagnose, treat, or prevent diseases and affect body functions, based on company marketing materials. This violates Section 505(a) of the Federal Food, Drug, and Cosmetic Act and Section 351(a)(1) of the Public Health Service Act, which require premarket approval for such products. Furthermore, products like Restor+, Regain, and Renyte, which are human cells, tissues, or cellular or tissue-based products (HCT/Ps), fail to meet specific regulatory criteria under 21 CFR Part 1271. Specifically, they undergo more than "minimal manipulation" and are not intended for "homologous use," meaning their processing alters original characteristics and they are marketed for uses beyond their original function (e.g., healing/supplementing tissue, neuropathy, inflammation reduction, instead of acting as a conduit). Consequently, they are not exempt from drug and biologic regulations. The letter advises New Life Medical Services, LLC, that introducing these unapproved and unlicensed products into interstate commerce is prohibited, signaling the need for immediate corrective action to comply with federal law.