Beaute Bounty – FDA Warning Letter, Sep 1, 2026

On September 25, 2026, the FDA issued a warning letter to the Malaysian company Beaute Bounty following a review of its website earlier that month. The agency identified several products, including Evgenis Totipotent Embryonic Stem Cells and human placenta extracts, being marketed as treatments for serious medical conditions such as cardiovascular disease, diabetes, and neurodegenerative disorders. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, these products are classified as drugs and biological products. The FDA found that Beaute Bounty is distributing unapproved new drugs and unlicensed biological products. Specifically, the company failed to prove that these products are intended for "homologous use," meaning they are being used for purposes other than their natural biological functions. The FDA expressed concern that these products have not undergone the necessary premarket review to ensure their safety, purity, and potency. Beaute Bounty is required to take immediate action to correct these violations and prevent their recurrence. The company must submit a written response within 15 working days outlining its plan for compliance and providing supporting documentation. Failure to address these concerns may result in regulatory enforcement, including product seizures or legal injunctions.