Supreme Rejuvenation, LLC - 700749 - 05/05/2025

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WARNING LETTER

May 05, 2025

CBER 25-700749

Dear Aracely Cabrera:

The United States Food and Drug Administration (FDA) reviewed your company’s websites at www.supremerejuvenation.com and www.instagram.com/supremeexosomes (last visited May 2025). Your website (www.supremerejuvenation.com) indicates that you sell “100 Billion Exosomes: Human Umbilical Cord Mesenchymal Stem Cell Derived Exosomes,” “15 ml 100 Billion Exosomes: Stem Cell Exosome Gel,” and “30 ml 200 Billion Exosomes: Stem Cell Exosome Gel” 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).

Based on information reviewed by FDA, including your websites, www.supremerejuvenation.com and www.instagram.com/supremeexosomes (last visited May 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,

• Homepage (www.supremerejuvenation.com)
o Under a title, “ABOUT US”
 “Regenerative medicine products are designed to target inflammation and repair damaged tissues. They are intended for use in studies related to hair growth and wound care to addressing Traumatic Brain Injury, joint and ligament repair, Botox alternatives, IV infusions, various other conditions.”
o Under a title, “SCAR REJUVENATION AND WOUND CURATION”
 “The exosome-based technology is designed to support the natural healing process by influencing cellular communication and tissue dynamics.”
 “Research suggests that these exosomes may influence collagen organization and fibroblast activity, which are key factors in skin repair.”
 “MSC-derived exosomes are believed to support tissue health through intercellular communication. These vesicles contain bioactive molecules that may promote cellular responses associated with tissue repair and regeneration.”
o Under a title, “WHAT ARE EXOSOMES”
 “Exosomes act as nature’s messengers, facilitating intercellular communication. When they fuse with target cells, they deliver their payload, thereby kickstarting processes that promote tissue repair, regeneration, and growth.”
o Under a title, “HOW THEY WORK”
 “Stem cell-derived exosomes have shown incredible efficacy in various studies, from peripheral nerve damage and traumatic brain injury to wound healing, bone fusion, and more. They possess anti-inflammatory properties and play vital roles in skin, cartilage, and bone regeneration, making them versatile assets in regenerative medicine.”
o Under a title, “RESEARCH RESULTS”
 “Emerging research suggests that exosomes may play a role in cellular signaling, tissue dynamics, and physiological processes. Studies are investigating their potential influence on skin health, tissue remodeling, and other areas of regenerative science. Additionally, ongoing research continues to examine how exosomes may contribute to broader applications in fields such as cardiology, aesthetics, and neurological research.”
 “In the field of aesthetics, the exosomes have been shown to improve skin texture, reduce wrinkles, and stimulate hair growth. In a study conducted by Dr. Berman, the exosomes were found to stimulate hair growth in patients with androgenetic alopecia.”
 “Furthermore, the exosomes have been shown to have neuro-protective effects and can promote nerve regeneration in conditions such as optic nerve damage and glaucoma. Studies have also shown that the exosomes can improve symptoms in patients with COVID-19 long-haulers and dementia.”
 “In orthopedics, the exosomes have been shown to reduce inflammation and promote cartilage regeneration, making them effective in treating arthritis and other joint-related conditions. The exosomes have also been shown to improve outcomes in spinal cord injuries.”
• Instagram page (www.instagram.com/supremeexosomes)
o With an image titled, “How can Exosome Therapy Benefit Women’s Health,” a caption from your firm states, “Exosome therapy offers exciting possibilities for women’s health! From reducing wrinkles, fine lines, and sagging skin to relieving menopausal symptoms like hot flashes and vaginal dryness, this innovative treatment can rejuvenate and restore balance… Discover how exosome therapy can help you feel your best-call us ... today.”
o “Exosomes have an anti-inflammatory effect which is beneficial for wound and scar healing and treating conditions such as psoriasis, eczema, rosacea and acne.”
o “A diabetic patient that does an Exosome IV injection has been known to decrease their dependency of Insulin injections as soon as two weeks.”
o A video titled, “Exosome therapy for Fibromyalgia” with a caption from your firm states, “Say Goodbye to Fibromyalgia with Exosome Therapy! … Imagine a life where your body can begin to heal and your symptoms finally ease. Enter Exosome Therapy—a cutting-edge, natural treatment that’s changing lives… Why is Exosome Therapy a Game-Changer for Fibromyalgia? ∙Targets Inflammation at its Source…Promotes Cellular Repair…Contact us today…to…find out how this revolutionary treatment can work for you.”

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).

To lawfully market a drug that is a biological product, a valid biologics license must be in effect, 42 U.S.C. 262(a). Such licenses are issued only after showing that the product is safe, pure, and potent. 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. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA statutory and regulatory requirements, 21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR part 312. Although your website, www.supremerejuvenation.com, includes statements that your products are for “research and investigational purposes and are not approved for general medical use,” there is no IND in effect for your product. Nor is there a valid biologics license.

Additional Concerns

We direct your attention to FDA’s Public Safety Notification on Exosome Products, 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 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.

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 to CBERDCMRecommendations@fda.hhs.gov. If you have questions regarding this letter, contact the Division of Case Management, CBER at (240) 402-9156.

Sincerely,
/S/

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