Beaute Bounty

WARNING LETTER

September 25, 2026

CBER 26-729163

Dear Beaute Bounty,

The United States Food and Drug Administration (FDA) reviewed your company’s website at https://beautebountymy.com/collections/stem-cell-placenta (last visited September 2026), through which your company sells embryonic stem cell and placenta derived products such as Evgenis Totipotent Embryonic Stem Cells, Laennec, and Melsmon Placenta Japan 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. The 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://beautebountymy.com/collections/stem-cell-placenta (last visited September 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 Evgenis Totipotent Embryonic Stem Cell product contains the following statements:
o “Reduce pain, even chronic joint pain, with less need for medications”
o “Spinal cord injuries, brain trauma and spinal stenosis”
o “Cardiovascular diseases, including hypertension, coronary heart disease, stroke and congestive hear[t]”
o “Diabetes and other pancreatic dysfunction”
o “Neurodegenerative disease such as Parkinson’s, multiple sclerosis and Alzheimer’s”

Your website for Laennec, described as “Human Placenta hydrolysis,” contains the following statements under the heading “Clinical Proven Effects:”
o “Prevent the hardening of liver”
o “Improve the effects of anemia”
o “Relieves diabetic condition”
o “Relieves cold feet and piles, kidney ailment, hypertension, gum disease, constipation.”

Your website for Melsmon Placenta Japan, described as “Human placenta hydrolysate,” contains the following statements under the heading “Major functions of Melsmon:”
o “Strengthen the function of internal organs and promotes cells rejuvenation”
o “Stimulates hematopoietic function”
o “Accelerates skin rejuvenation after injuries”
o “Intensive revascularization”
o “Regeneration of epidermis cells”

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 embryonic stem cell and placenta derived 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, Beaute Bounty does not qualify for any exception in 21 CFR 1271.15, and your products fail to meet all criteria in 21 CFR 1271.10(a).

Your embryonic stem cell and placenta derived products fail 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 products are not intended solely to perform the same basic function or functions of the HCT/P in the recipient as in the donor (e.g., to differentiate into the specialized cell types for purposes of fetal development for human embryonic stem cells and to serve as a selective barrier that provides transport function for the placenta). Rather, your products are intended for use in the treatment of neurodegenerative diseases, cardiovascular disease, diabetes, anemia, and revascularization, which are not basic functions of embryonic stem cells or the placenta 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 1271.1 See 21 CFR 1271.20. In addition to being regulated under section 361 of the PHS Act and 21 CFR part 1271, your 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.

Conclusion

This letter is not intended to be an all-inclusive list of deficiencies that may exist in connection with your products or website. Please examine your website to ensure no additional products are in violation. 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 applicable requirements in the FD&C Act, PHS Act, and all applicable regulations.

This letter notifies you of our concerns and provides you with an opportunity to address them. Failure to adequately address these matters may result in regulatory 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 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).