Biologics · Letter issue date: Sep 25, 2026

Beaute Bounty

5 extracted findings

FDA source excerpt, selected passage

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”

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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”

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).

Your products are not the subject of an approved BLA.

Sections and clauses cited

As cited in this historical letter, not a statement of current regulatory requirements.

21 CFR 1271.10(a)21 CFR 127121 CFR 1271.15 21 CFR 1271.3(d)21 CFR 1271.3(c)21 CFR 1271.1 21 CFR 1271.20

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