New Life Medical Services, LLC

The United States Food and Drug Administration (FDA) inspected your facility, located at the above address, between May 14, 2024, and May 20, 2024. During the inspection, FDA documented that your company sells human products derived from umbilical cord (Restor+1, Regain, and Renyte), an amniotic fluid derived product (ReCyte/Cytosomes2), and an exosome product (also referred to as an “extracellular vesicle” product, named Rexo) for allogeneic use (collectively, “your products”).

This letter is to advise you that your products are unapproved new drugs in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. §355(a). Your products are also unlicensed biological products in violation of section351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1). A biological product for which a biologics license application (BLA) has been approved undersection 351(a) of the PHS Act is not required to have an approved application undersection 505 of the FD&C Act, 21 U.S.C. § 355; 42 U.S.C. § 262(j). Otherwise, with certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act. Your introduction or delivery for introduction of your products into interstate commerce, or the causing thereof, is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d).

Based on information and records reviewed by FDA, including your website, www.newliferegen.com, (last visited September 2025) and your Instagram page (newliferegen, last visited September 2025), your products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or are intended to affect the structure or function of the body. For example:

Your website states that “Restor+ facilitates healing by secreting powerful bioactive molecules, creating an optimal environment for tissue repair and regeneration.”

Your Physician Guide states Restor+ “has a strong anti-inflammatory effect reducing the expression of inflammatory cytokines.”

Your training videos demonstrate use of Restor+, occasionally in conjunction with Rexo, in the treatment of several conditions, including neuropathy and bone spurs, as well as treating pain and inflammation.

Your package insert for Regain states it is intended “to supplement the recipient’s tissue and assist in the body’s natural regenerative functions.”

Your Physician Guide states:o “Higher concentration of growth factors in Renyte act as anti-inflammatory and have been shown to prevent cell death.”o Renyte is intended to “supplement or replace damaged or inadequate connective tissue.”

Your product update for Cytosomes to ReCyte indicates that “Recyte is intended to help with inflammation and to enhance the healing process.”

Your website states that “Rexo is an innovative extracellular vesicle product derived from Wharton’s Jelly that offers advanced healing properties.”

One of your Instagram posts states, “Flagship Products … Restor+ and Rexo … Ideal Applications” and lists orthopedic procedures, paraspinal treatments, hair restoration therapies, and neuropathy interventions.

In addition, evidence obtained during the inspection documents your representation that, “[New Life Medical Services] products across the board are utilized for pain management, inflammation of soft tissue, … and non-union fractures. ‘The application for all products are copy, paste.’”

Therefore, your products are drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).

Your Restor+, Regain, and Renyte products are also human cells, tissues, or cellular or tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d) and are subject to regulation under 21 CFR part 1271, issued under the authority of section 361 of the PHS Act, 42 U.S.C. § 264. HCT/Ps that do not meet all the criteria in 21 CFR 1271.10(a) are not regulated solely under section 361 of the PHS Act and the regulations in 21 CFR part 1271. Unless an exception in 21 CFR 1271.15 applies, such products are regulated as drugs, devices, and/or biological products under the FD&C Act and/or the PHS Act and are subject to additional regulation, including applicable premarket review. Based on a review of relevant materials, New Life Medical Services does not qualify for any exception in 21 CFR 1271.15, and Restor+, Regain, and Renyte fail to meet all criteria in 21 CFR 1271.10(a).

For example, your Restor+, Regain, and Renyte products fail to meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue in 21 CFR 1271.3(f)(1), because the processing alters the original relevant characteristics of the umbilical cord tissue related to its utility for reconstruction, repair, or replacement. The processing of the umbilical cord from the form of a conduit into an injectable form, significantly alters the physical state of the HCT/P. The umbilical cord is more than minimally manipulated because such processing alters the original relevant characteristics of the HCT/P relating to its utility to serve as a conduit by effectively altering or eliminating its physical integrity and tubular form.

In addition, your Restor+, Regain, and Renyte products fail to meet the criterion that the HCT/Ps be “intended for homologous use only,” which means that the “labeling, advertising, or other indications of the manufacturer’s objective intent” demonstrate that the HCT/P is intended to perform “the same basic function or functions in the recipient as in the donor” (21 CFR 1271.3(c) and 1271.10(a)(2)). Your product is not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., serving as a conduit for umbilical cord). Rather, your products are intended for use in healing/supplementing tissue, orthopedic procedures, treating neuropathy, and reduction of inflammation which are not basic functions of umbilical cord in the donor.

Therefore, these HCT/Ps are not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.3 See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your Restor+, Regain, and Renyte products are regulated as drugs as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and biological products as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i), as stated above.

Subject to certain exceptions not applicable here, to lawfully introduce or deliver for introduction into interstate commerce a drug that is a biological product, a valid BLA must be in effect under section 351(a)(1) of the PHS Act, 42 U.S.C. § 262(a)(1). Such licenses are issued only after showing that the product is safe, pure, and potent. Your products are not the subject of an approved BLA.

In addition to the violations described above, we have concerns about the following products:

FDA’s review of your website and other records found that you market additional products, an umbilical cord derived product named Restor Charge and an exosome-based product named Rexo Charge4. Based on our review, these products are drugs and/or biological products, which are subject to premarket review and approval requirements. In your response, please provide a customer list for each of these products and indicate whether you believe you sell them in compliance with the FD&C Act. If so, include your explanation why; if not, include your plan for coming into compliance.

We also direct your attention to FDA’s Public Safety Notification on Exosome Products, available at https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products. FDA issued this public safety notification following multiple reports of serious adverse events experienced by patients who were treated with exosome products.

This letter is not intended to be an all-inclusive list of deficiencies that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure full compliance with all applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.

Send your electronic response to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at CBERDCMRecommendations@fda.hhs.gov.