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WARNING LETTER

August 15, 202

CBER 25-695592

Dear Dr. Whitney: 

The United States Food and Drug Administration (FDA) reviewed your company’s website at https://innatehealthcare.org (last visited August 2025), through which your company markets “umbilical cord mesenchymal stem cells (UC-MSCs),” which you also describe as “UC-MSC therapy” (hereinafter, “your product”) for allogeneic use. This letter is to advise you that your misbranding of your product while held for sale after shipment in interstate commerce violates section 301(k) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 331(k). 

Violations 

Based on information and records reviewed by FDA, https://innatehealthcare.org (last visited August 2025), your product is 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, 

On your website, https://innatehealthcare.org, you provide the following statements:

• “At Innate Healthcare Institute, we combine an effective blend of integrative medicine and regenerative stem cell medicine, treating Autism at its root.”
• “Stem cell therapy has really helped our son with his autism”
• “Stem cell therapy with human umbilical cord tissue derived mesenchymal stem cells (UC-MSCs) corrects the inflammatory process by modulating the immune system from a pro-inflammatory attacking state to an anti-inflammatory healthy state. They also have the ability to regenerate damage done from the autoimmune attack. Stem cells do this by secreting healing activators such as growth factors, cytokines, and exosomes to the surrounding environment.”
• “Stem cell therapy for autism can lead to improvement in cognitive ability, behaviors, and sociability.”
• “Regenerative cell medicine has the potential to help with many conditions such as pain due to osteoarthritis, tendinopathy/tendonitis, degenerative disc disease, herniated discs, neuropathy, fractures, muscle injuries, ligament and tendon injuries, COPD, peripheral neuropathy, sexual dysfunction, autoimmune conditions, heart disease, and many more.”

Therefore, your product is a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(i). 

Your UC-MSCs product is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d) and is 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, Innate Healthcare Institute does not qualify for any exception in 21 CFR 1271.15, and your product fails to meet all criteria in 21 CFR 1271.10(a). 

For example, your UC-MSCs product fails 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 your processing alters the original relevant characteristics of the umbilical cord 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 UC-MSCs product fails 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). Rather, your product is intended for use in the treatment of autism as well as other diseases or conditions, which is not a basic function of the umbilical cord in the donor.

Therefore, this HCT/P is not regulated solely under section 361 of the PHS Act, 42 U.S.C. § 264, and the regulations in 21 CFR part 1271.¹ See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your product is regulated as a drug as defined in section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), and a biological product 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 product is not the subject of an approved BLA.

Furthermore, your product is a misbranded drug under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). A drug is misbranded under section 502(f)(1) if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. 21 CFR 201.5. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, 21 U.S.C. § 353(b)(1)(A), can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your product is intended for use in the treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, your product fails to bear adequate directions for its intended uses and, therefore, is misbranded under section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1). Misbranding your product while it is held for sale after shipment of the drug or one or more of its components in interstate commerce is prohibited under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k).

Additional Concerns

FDA’s review of your website also found that you market exosomes. As a general matter, exosomes 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 are regulated as drugs as defined in section 201(g)(1) of the FD&C Act and biological products under section 351 of the PHS Act and and are subject to premarket review and approval requirements. 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.

Conclusion

This letter is not intended to be an all-inclusive list of deficiencies that may exist in connection with your product. 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.

Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence. Include any documentation necessary to show that the matters have been addressed. If you cannot address these matters within fifteen (15) working days, please explain the reason for your delay and the timeframe for completion. If you do not believe your product is in violation of the FD&C Act, PHS Act, or applicable regulations, include your reasoning and any supporting information for our consideration.

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.

Sincerely,
/S/

Melissa J. Mendoza
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

CC:

Innate Healthcare, LLC
4840 East Indian School Road
Suite 104
Phoenix, AZ 85018

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1 Because your product fails to meet at least one criterion in 21 CFR 1271.10(a), this letter does not evaluate all other criteria in 21 CFR 1271.10(a).