Calibrate IV Hydration

WARNING LETTE

October 13, 2026

CBER 26-729846

Dear Dr. Neville Campbell:

The United States Food and Drug Administration (FDA) reviewed your company’s website at https://www.calibrateiv.com/ (last visited October 2026), through which your company sells umbilical cord derived and exosome1 products 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 section 351(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 under section 351(a) of the PHS Act is not required to have an approved application under section 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).

Unapproved New Drug and Unlicensed Biological Product Violations

Based on information reviewed by FDA, including your website, https://www.calibrateiv.com/products/stem-cell-and-exosome-combination-packages (last visited October 2026), 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 for Stem Cell IV treatment product, https://www.calibrateiv.com/products/stem-cell-iv-treatment, contains the following statements:

• “Neurology: Supports brain health and may aid in the body’s natural processes related to neurological function.”

• “Immunology: Assists in maintaining a balanced immune response, potentially supporting overall immune health.”

• “Orthopedics & Rehabilitation: Promotes the body’s natural healing processes for joint, muscle, and bone health, which can be especially beneficial for athletes and those recovering from injuries.”

• “Endocrinology: Supports the body’s natural hormonal balance and metabolic health.”

• “Pneumology: May aid in supporting lung health and respiratory function.”

• “Skin Health: Encourages the body’s natural skin regeneration processes, potentially improving skin tone and texture.”

Your website for Exosome IV treatment, https://www.calibrateiv.com/products/exosome-iv-treatment, contains the following statements:

• “Advanced Cellular Communication: Exosomes play a natural role in facilitating communication between cells, supporting the body’s ability to recover and rejuvenate.”

• “Tissue Support & Repair: This therapy may support the body’s natural ability to repair tissues, making it a suitable option for those focusing on recovery, joint health, and maintaining overall vitality.”

• “Inflammation Balance: Exosome IV therapy could be beneficial for those seeking support in managing inflammation associated with various conditions, including joint discomfort and other inflammatory concerns.”

Your website for Stem Cell and Exosome Packages, https://www.calibrateiv.com/products/stem-cell-and-exosome-combination-packages, contains the following statements:

• “Enhanced Cellular Communication: Stem cells and exosomes work together to facilitate better communication between cells, accelerating the body's natural recovery processes.”

• “Tissue Regeneration & Repair: Stem cells support the repair and regeneration of tissues, while exosomes aid in directing and enhancing this process, making this therapy particularly beneficial for joint health, injury recovery, and maintaining vitality.”

• “Inflammation Management: Both therapies work in synergy to help balance inflammation, offering support for those managing chronic inflammation, joint discomfort, or autoimmune concerns.”

• “Immune and Hormonal Support: The combination of stem cells and exosomes may aid in maintaining immune health and balancing hormonal function, promoting overall well-being.”

• “Skin and Anti-Aging: The dual action of stem cells and exosomes encourages skin rejuvenation and repair, contributing to healthier skin tone and texture and addressing signs of aging.”

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 umbilical cord derived 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, Calibrate IV Hydration 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).

Your umbilical cord derived product fails to meet the criterion that the HCT/Ps be “intended for homologous use only.” Homologous use 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 product is intended for use in the treatment of joint pain, arthritis pain, inflammation, damaged tissue, and hip pain, which is not a basic function of 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 1271.2 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 products are not the subject of an approved BLA.

Conclusion

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 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 products are 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 and any questions regarding this letter to CBER’s Office of Compliance and Biologics Quality, Division of Case Management at CBERDCMRecommendations@fda.hhs.gov.

Sincerely,
/S/

Vincent Amatrudo
Director (Acting)
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

________________________________________

1 We 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.

2 Because your products fail 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).